lixisenatide

may increase the hypoglycemic effect

sotagliflozin

may increase the hypoglycemic effect

ethinyl estradiol

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

ethynodiol diacetate

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

etonogestrel

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

glipizide

may have an increased hypoglycemic effect when combined with sulfonylureas

gliquidone

may have an increased hypoglycemic effect when combined with sulfonylureas

insulin beef

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

nateglinide

may have an increased hypoglycemic effect when combined with meglitinides

repaglinide

may have an increased hypoglycemic effect when combined with meglitinides

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

dulaglutide

may have an increased hypoglycemic effect when combined with insulin

insulin aspart

may have an increased hypoglycemic effect when combined with insulin

glyburide

may have an increased hypoglycemic effect when combined with sulfonylureas

glymidine

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

insulin human

may have an increased hypoglycemic effect when combined with insulin

insulin lispro

may have an increased hypoglycemic effect when combined with insulin

insulin pork

may have an increased hypoglycemic effect when combined with insulin

alogliptin

may increase the hypoglycemic effect

sitagliptin

may increase the hypoglycemic effect

may increase the hypoglycemic effect of Sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

acetaminophen

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

warfarin

may have an increased anticoagulant effect when combined with vitamin k antagonists

halometasone

When halometasone is used together with lixisenatide, this leads to elevated risk or seriousness of hyperglycemia

diazoxide

When lixisenatide is used together with diazoxide, this leads to reduction in therapeutic effectiveness of lixisenatide

methylprednisolone hemisuccinate

When methylprednisolone hemisuccinate is aided with lixisenatide, this leads to elevated hyperglycemia risk

oxandrolone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

nandrolone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

fluoxymesterone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

nandrolone decanoate

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

danazol

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

tranylcypromine

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

isocarboxazid

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

phenelzine

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

rasagiline

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

safinamide

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

indomethacin

may decrease the therapeutic effect when combined with glucagon and its analogs

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

warfarin

may have an increased anticoagulant effect when combined with vitamin k antagonists

dienogest/estradiol valerate

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

glipizide

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

mestranol

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

dienogest

hormonal contraceptives decrease the efficacy of lixisenatide

Dosage Forms & Strengths

Subcutaneous injectable

20 mcg/0.2 mL

Type II Diabetes Mellitus

Indicated for Diabetes Mellitus Type 2
Initial dose: 10 mcg subcutaneously every day for 14 days
Maintenance dose: Enhance the dose to 20 mcg every day from Day-15 It is used to improve glycemic control as with addition to diet and regular exercise

Safety and efficacy not established

Refer to adult dose

Frequency not defined

Low blood sugar

Dizziness

Nausea

Vomiting

Diarrhea

Headache

Black Box Warning:

None

Contraindication/Caution:

Contraindication

lixisenatide has certain contraindications, which are specific situations or conditions in which medication use is not recommended.

Hypersensitivity: lixisenatide is contraindicated in individuals with known hypersensitivity or allergy to lixisenatide or its components. Allergic reactions can range from mild skin reactions to severe anaphylaxis, a life-threatening allergic response.
Personal/Family History of Medullary Thyroid Carcinoma (MTC): lixisenatide is contraindicated in individuals with a personal/family history of medullary thyroid carcinoma or in those with a known genetic condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). lixisenatide can stimulate the growth of existing MTC or increase the risk of developing MTC.
Multiple Endocrine Neoplasia syndrome type 2: lixisenatide is contraindicated in individuals with MEN 2, a genetic condition characterized by developing tumors in the endocrine glands. This condition includes medullary thyroid carcinoma (MTC), which lixisenatide may worsen.

Caution

While lixisenatide is generally safe and well-tolerated, there are some cautions and precautions to be aware of when using this medication.

Pancreatitis: GLP-1 receptor agonists, including lixisenatide, have been associated with an increased risk of pancreatitis (pancreas inflammation). Symptoms of pancreatitis may include persistent severe abdominal pain that can radiate to the back, with or without vomiting. If pancreatitis is suspected, lixisenatide should be discontinued, and appropriate medical treatment should be sought.
Hypoglycemia: lixisenatide, combined with other antidiabetic medications like sulfonylureas, may increase the risk of hypoglycemia (low blood sugar). Monitoring of blood glucose levels is essential, especially when initiating or adjusting the dose of lixisenatide or concomitant antidiabetic medications.
Renal Impairment: lixisenatide should be used cautiously in patients with renal impairment. Dose adjustments may be necessary for individuals with moderate-severe renal impairment or end-stage renal disease. Close monitoring of renal function and glycemic control is recommended in these patients.
Gastrointestinal Effects: lixisenatide may cause gastrointestinal adverse effects, like nausea, vomiting, diarrhea, and abdominal pain. These effects are usually mild and transient, but medical advice should be sought if they persist or become severe.
Thyroid C-cell Tumors: lixisenatide has been associated with an enhanced risk of thyroid C-cell tumors in animal studies. Routine monitoring of serum calcitonin or thyroid ultrasound is not recommended unless there is a history of MTC or MEN 2.
Injection-Site Reactions: Localized injection-site reactions, including redness, swelling, and itching, may occur with lixisenatide. Proper injection technique and rotation of injection sites can help minimize these reactions.
Hypersensitivity Reactions: Rare hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with lixisenatide.

Pregnancy consideration:

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Lactation:  

Excreted into human milk: Not known.

Pregnancy category:

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   
Category N: There is no data available for the drug under this category

Pharmacology:

lixisenatide is a GLP-1 receptor agonist that exerts its pharmacological effects by mimicking the action of endogenous glucagon-like peptide-1 (GLP-1). lixisenatide activates GLP-1 receptors upon subcutaneous injection, leading to multiple physiological actions. It enhances glucose-dependent insulin secretion from pancreatic beta cells, reducing blood glucose levels.

lixisenatide also suppresses glucagon release from pancreatic alpha cells, further contributing to glycemic control. Additionally, it slows gastric emptying, resulting in reduced postprandial glucose excursions. lixisenatide may also promote satiety and reduce appetite, potentially leading to weight loss. These mechanisms collectively help improve glycemic control in individuals with type 2 diabetes mellitus.

Pharmacodynamics:

Mechanism of action: lixisenatide exerts its pharmacological effects through its mechanism of action as a glucagon-like peptide-1 receptor agonist.

GLP-1 Receptor Activation: lixisenatide selectively binds and activates the GLP-1 receptors, predominantly found in various tissues, including the pancreas, gastrointestinal tract, and central nervous system.
Glucose-Dependent Insulin Secretion: lixisenatide enhances glucose-dependent insulin secretion upon activation of GLP-1 receptors on pancreatic beta cells. It stimulates insulin release from beta cells in response to elevated blood glucose levels. This action helps to lower blood sugar levels and maintain glycemic control.
Suppression of Glucagon Secretion: lixisenatide also suppresses glucagon secretion, a hormone pancreatic alpha cells produce. Glucagon typically promotes the release of stored glucose from the liver, increasing blood sugar levels. By inhibiting glucagon secretion, lixisenatide helps to prevent excessive glucose production and further supports glucose control.
Delayed Gastric Emptying: lixisenatide slows down the rate at which food leaves the stomach (gastric emptying). This delayed gastric emptying can help regulate the rise in blood sugar levels after meals, reducing postprandial hyperglycemia. It allows for better matching of insulin release with the absorption of nutrients from the GIT (gastrointestinal tract).
Satiety and Weight Management: lixisenatide may promote satiety, making individuals more satisfied and reducing appetite. This effect can lead to reduced food intake and potential weight loss in some individuals.

Pharmacokinetics:

Absorption

lixisenatide is administered via subcutaneous injection, allowing direct absorption into the bloodstream. After injection, lixisenatide is rapidly absorbed, reaching peak plasma concentrations within 1-3 hours. The absolute bioavailability of lixisenatide following subcutaneous administration is approximately 40%.

Distribution

In terms of distribution, lixisenatide has a relatively small volume of distribution, indicating limited extravascular distribution. It binds extensively to plasma proteins, primarily albumin. The protein binding is concentration-independent, with approximately 98% of lixisenatide bound to plasma proteins.

Metabolism

Metabolism of lixisenatide primarily occurs via enzymatic degradation. The main metabolic pathway involves proteolytic cleavage by dipeptidyl peptidase-4 (DPP-4), resulting in the formation of metabolites with minimal biological activity. These metabolites are further degraded to smaller peptides and amino acids.

Elimination and Excretion

lixisenatide is eliminated mainly through renal excretion. After administration, approximately 15-20% of the dose is excreted unchanged in the urine. The elimination half-life of lixisenatide is relatively short, ranging from 2-4 hours, indicating rapid clearance from the body.

Administration:

Subcutaneous administration

lixisenatide is typically administered as a subcutaneous injection.

Injection Sites:

lixisenatide is usually injected into the thigh, upper arm, or abdomen. The injection site should be rotated within the same region to diminish the risk of lipodystrophy (changes in the fatty tissue) or injection site reactions. Avoid injecting into areas with bruises, scars, or hardened skin.

Preparing the Injection:

Wash your hands thoroughly with soap and water.
Gather the necessary supplies, including a lixisenatide pen injector or syringe, alcohol swabs, and a sharps container.
Check the drug label to ensure it is correct and has not expired.
If using a pen injector, attach a new pen needle securely. If you are using a syringe, attach an appropriate needle.

Administration Steps:

Clean the injection site area with the alcohol swab and allow it to dry.
If using a pen injector, remove the cap and hold the pen at a 90-degree angle to the skin. If you are using a syringe, hold it like a pencil.
Pinch a fold of skin at cleaned injection site.
Insert the needle into the skin at the chosen angle (usually 45 to 90 degrees) and inject the medication slowly and steadily.
Once the injection is complete, remove the needle from the skin.
If using a pen injector, hold the pen against the skin for a few seconds before removing it to ensure the total dose is delivered.
Do not rub the injection site after the administration.
Disposal of Sharps: Place used needles and syringes in a sharps container immediately after use. Do not recap the needle.

Patient information leaflet

Generic Name: lixisenatide

Pronounced: [ LIX-i-SEN-a-tide ]

Why do we use lixisenatide?

lixisenatide is primarily used for the treatment of type 2 diabetes mellitus. It is prescribed to help control blood sugar levels in individuals with this condition.

Type 2 Diabetes Mellitus: lixisenatide is indicated as additive to diet and exercise to improve glycemic control in the adults with type 2 diabetes. It is used when blood sugar levels are not adequately controlled with the diet and exercise alone or when other oral antidiabetic medications have not provided sufficient glycemic control.
Monotherapy: lixisenatide can be used as a monotherapy in individuals with type 2 diabetes when diet and exercise alone are insufficient to control blood sugar levels and when metformin cannot be tolerated due to contraindications or intolerance.
Combination Therapy: lixisenatide is commonly prescribed with other antidiabetic medications for better glycemic control. It can be combined with oral antidiabetic drugs such as metformin, sulfonylureas, thiazolidinediones, and dipeptidyl peptidase-4 (DPP-4) inhibitors. It can also be used in combination with basal insulin.
Cardiovascular Risk Reduction: lixisenatide has demonstrated cardiovascular benefits in clinical trials. It has been shown to diminish the risk of major cardiovascular events, like the heart attack and stroke, in individuals with type 2 diabetes who are at high risk. Therefore, it may be prescribed to individuals with diabetes and cardiovascular disease or those at increased risk of cardiovascular complications.

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lixisenatide

Brand Name :

Adlyxin (DSC)

Synonyms :

lixisenatide

Class :

Glucagon-like Peptide-1 Agonist, Antidiabetics

Dosage Forms & Strengths

Subcutaneous injectable

20 mcg/0.2 mL

Type II Diabetes Mellitus

Safety and efficacy not established

Refer to adult dose

DRUG INTERACTION

lixisenatide

&

Pembrolizumab / Berahyaluronidase
Bumetanide Intranasal
Gemcitabine intravesical
Rilzabrutinib
Zopapogene
Aceclidine
aluminium hydroxide
benzralizumab (Rx)
Rituximab
Trimetrexate Glucuronate
Mirdametinib
Suzetrigine
Potassium acid phosphate
Acellular Tissue Engineered Vessel
crinecerfont (pending approval from FDA)
Revumenib
pembrolizumab (Rx)
azathioprine (Rx)
Gemcitabine (Rx)
Seladelpar
Atezolizumab / Hyaluronidase-tqjs
Axatilimab-csfr
Afamitresgene Autoleucel
Lazertinib
Ocrelizumab / Hyaluronidase ocsq
Lebrikizumab
naloxone intranasal
clomiphene
patisiran
imetelstat
phenylephrine ophthalmic
myoinositol
vasicinone
soda lime
fisetin
Reynoutria Japonica
Coco Monoethanolamide
Betadex
lithopone
cyperus rotundus
papaya juice
1-naphthaleneacetic acid
Nordazepam
Glechoma hederacea
Alternanthera sessilis
nicofetamide
napthol asol
cocamidopropyl betaine
musa x paradisiaca
dicyclomine/mefenamic acid
Sorghum
Manganese citrate
tovorafenib
mefenamic acid/paracetamol
eschscholzia californica
canna indica root
tranexamic acid/mefenamic acid
dexverapamil
sitogluside
secalciferol
cefatrizine
Sedum Acre
Flurogestone
Fluocortin
Bifendate
piprozolin
aminacrine undecylate
ethylenediamine mandelate
pelubiprofen
hesperetin
butethamine
epitiostanol
androstenediol
Nitroxoline
Iocarmic acid
Capobenic acid
dordaviprone (investigational drug)
Vitexin
Friluglanstat (investigational drug)
scorias spongiosa
Luseogliflozin
indoxacarb
prademagene zamikeracel
fidanacogene elaparvovec-dzkt
albifylline
idanpramine
araneus diadematus
Sulfamazone
Lycosa tarantula
malotilate
Ethacizine
Namilumab
Latrunculin B
stachyose
platinic oxide
iopronic acid
calcium chloride / potassium chloride/lactic acid/ sodium chloride/sodium hydroxide/sodium lactate solution
citric acid/ sodium bicarbonate/ sodium carbonate anhydrous
vadadustat
permethrin medical grade cis/trans isomers 25/75
lutetium, isotope of mass 177
human normal immunoglobulin
sacrosidase
apadamtase alfa, recombinant
acetyl hexapeptide-8 amide
pemivibart (Investigational)
govorestat
Zanidatamab
sotatеrcеpt
MV 140 vaccine
leuprorelin implant
cinchocaine hydrochloride/fluocortolone hexanoate/fluocortolone pivalate
Beautyberry
risedronate/calcium/vitamin D3
rhubarb extract/senna leaf/sulphur purified/wood charcoal
boric acid/kaolin/methyl salicylate/peppermint oil/thymol
docosahexaenoic acid/eicospentaenoic acid
aluminium hydroxide/magnesium hydroxide/simethicone
gentamicin/hydrocortisone
succinylcholine
sinefungin
letibotulinumtoxinA
coal tar/coconut oil/salicylic acid
camphor/camphor oil white/capsicum oleoresin /menthol/methyl salicylate
thioglycolic acid
acetic acid auricular
roluperidone
hydrocortisone/crotamiton topical
nystatin/chlorhexidine
aluminium chloride hexahydrate
ketoprofen topical
Chlormethine
podophyllotoxin
urea/lactic acid
autologous chondrocytes implant
afelimomab
gepotidacin
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fentanyl transdermal
erythromycin/zinc acetate
dibotermin alfa powder
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choline salicylate/magnesium salicylate
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betamethasone/dexchlorpheniramine maleate
benzalkonium chloride solution/cetrimide
barzolvolimab
ascorbic acid / calcium laevulinate / nicotinamide / calcium pantothenate / calcium chloride / riboflavine / pyridoxine hydrochloride / thiamine hydrochloride
argipressin
arachis oil refined/chlorobutanol hemihydrate
arachis oil/eucalyptol/nutmeg oil/terpineol
ammonium chloride/diphenhydramine hydrochloride/levomenthol
amino acid mixture d / calcium chloride dihydrate / glucose monohydrate / glycine / magnesium chloride hexahydrate / olive oil / potassium chloride / sodium acetate trihydrate / sodium glycerophosphate pentahydrate / soya-bean oil
biotin/colecalciferol/copper (ii)sulfate dried/ cyanocobalamine/ dl-alpha tocopherol acetate/dibasic calcium phosphate anhydrous/folic acid/iron (ii)sulfate dried/ lecithin/ magnesium sulfate dried/ nicotinamide/ pyridoxine hydrochloride/ riboflavin
ampicillin sodium / cloxacillin sodium
undecylenic acid, undecylenate salts, zincundecate
omeprazole/sodium bicarbonate
efgartigimod alfa/hyaluronidase
xylometazoline/ipratropium
cefepime and enmetazobactam
isotonic sodium chloride
bee venom allergen injection
fentanyl intranasal
alglucosidase alfa
triprolidine/pseudoephedrine
pegademase bovine
castor oil and peru balsam
camphor/eucalyptus oil/menthol
oxyquinoline/sodium lauryl sulfate
somatorelin
menotrophin injection
menadiol
hylan g-f 20
cefepime and taniborbactum
water avens
camphor/menthol
acoramidis
elafibranor
arrowroot
miconazole nitrate/hydrocortisone
vildagliptin/metformin
dobesilic acid
aroxybutynin and atomoxetine
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linvoseltamab
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Andiroba
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wormseed
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ursodeoxycholic acid
rhubarb extract/salicylic acid
butamirate citrate
fumitory
taheebo
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vervain
coleus
coltsfoot
crampbark
plantain
potassium nitrate and silver nitrate
gelsemium
gentian
glucomannan
walnut
meadowsweet
midomafetamine
pennyroyal
periwinkle
betony
bitter orange
bladderwrack
bloodroot
emu oil
garcinia
yellow dock
burdock
dehydroepiandrosterone
aucubin
jasmone
resacetophenone
ecamsule ditriethanolamine
feclobuzone
fenoprop triethanolamine
verdyl acetate
caffeic acid
cyclamen aldehyde
dicetyldimonium chloride
wogonin
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laurylpyridinium chloride
stepronin
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sakuranin
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sandalore
sabinene
oxypaeoniflora
ethylhexyl pelargonate
acrylonitrile
allyl alcohol
dipalmitoylethyl hydroxyethylmonium methosulfate
butidrine
clothiapine
propanediol dicaprylate
buchu
undecanol
enilconazole
xymenynic acid
angelica
nizubaglustat
resomelagon
ulecaciclib
apple cider vinegar
bacopa
barley grass
dandelion
deer velvet
dolomite
bugleweed
bupleurum
glyceryltrinitrate
pociredir
asnuciclib
actalycabtagene autoleucel
butantan–dengue vaccine
travoprost/timolol
furosemide/potassium chloride
amylamine
jaborandi
patritumab deruxtecan
jackfruit
sterculia
ascorbigen
ashitaba
androstenetrione
andrachne
cosibelimab
racecadotril
neomycin/chlorhexidine
octocog alfa
cetrimide
ispaghula husk
polyhexanide
octenidine
polygeline
heparinoid
jewelweed
boldo
anizatrectinib
alpinia
henbane
cynanchum vincetoxicum root and sulfur
boditrectinib
izumerogant
zavondemstat
abuta
fadogia agrestis
fly agaric mushroom
meptazinol
methoxyflurane
tramadol/dexketoprofen
betaine/polyhexanide
filgotinib
inosine acedoben dimepranol
alverine citrate
hyoscine butylbromide
senna+ ispaghula
cabbage palm
cajeput oil
calanus oil
calamint
canada balsam
carnosine
alverine citrate/simeticone
dihydroartemisinin/piperaquine
mebeverine/ispaghula
calcipotriol
tacalcitol
triethyl citrate/ethyl linoleate
sodium dilauramidoglutamide lysine
fazamorexant
avibactam tomilopil and ceftibuten
drostanolone
tigilanol tiglate
isorhynchophylline
rhynchophylline
crisugabalin
epigallocatechin gallate
clomocycline
corynoxeine
isocorynoxeine
Culmerciclib
Neladenoson
ambrein
hexylcaine
phensuximide
resencatinib (investigational)
rolusafine
pumecitinib
arhalofenic acid
berdazimer sodium
benzquinamide
clidinium
sulfametopyrazine
fulzerasib (Investigational Drug)
rovadicitinib (Investigational Drug)
Upleganan (Investigational Drug)
menthyl ethylamido oxalate
quaternium-90 montmorillonite
unecritinib (investigational drug)
etohexadiol
guaiol
proximadiol
verdinexor
sofnobrutinib
talbutal
ethoxzolamide
propiomazine
enprofylline
phenmetrazine
merigolix
pralurbactam
neracorvir
vonifimod
apaziquone hydroquinone
darizmetinib
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xininurad
ritivixibat
amiselimod phosphate (investigational drug)
emzeltrectinib (investigational drug)
ficonalkib
cinalukast
ulobetasol
candoxatril
nitrofural
acetyldigitoxin
bentiromide
dextrothyroxine
chlorotrianisene
remikiren
pipobroman
vidarabine
immune globulin intravenous, human-stwk
spermine
serine
N-acetyl glucosamine
valine
adenine
asparagine
citrulline
adinazolam
interferon alfacon-1
interferon alfa-n1
felypressin
birch triterpenes
pyridoxal phosphate
technetium Tc-99m arcitumomab
beta-alanine
dihomo-gamma-linolenic acid
urea/hydrocortisone
R21/Matrix-M vaccine
povidone-iodine (ophthalmic)
pheniramine
hydrocortisone rectal
chloroxylenol/pramoxine/zinc acetate
chloroxylenol/pramoxine
dextrose/sucrose/vitamin C/zinc sulphate
furazolidone/metronidazole/dicyclomine
ergocalciferol (vitamin D2)
benoxaprofen (discontinued)
teicoplanin
carbomer
chromic chloride / iron (ii) chloride tetrahydrate / potassium iodide / manganese chloride / sodium fluoride / sodium selenite pentahydrate / sodium molybdate dihydrate / zinc chloride/ cupric chloride
bufylline
lidocaine/prilocaine
opium tincture, squill oxymel
dibrompropamidine
metronidazole/tetracycline/bismuth subsalicylate
agnus- castus
velaglucerase alfa
alendronic acid / colecalciferol
bimatoprost / timolol
efbemalenograstim alfa
dried ferrous sulfate/folic acid
dried ferrous sulfate / sodium ascorbate
nirogacestat
soya-bean oil, medium-chain triglycerides
demeclocycline hydrochloride and triamcinolone acetonide
fusidic acid / hydrocortisone acetate
macrogol
storax, benzoin
nomegestrol acetate/estradiol
flumetasone pivalate/ clioquinol
berdazimer topical (Pending FDA Approval)
buflomedil
butobarbital
andexanet alfa
methoxypolyethylene glycol-epoetin beta
viscum abietis
pramoxine vaginal
bupivacaine implant
cromolyn sodium, inhaled
pneumococcal vaccine 20-valent
bimatoprost ophthalmic implant
tick-borne encephalitis vaccine
chloroprocaine ophthalmic
travoprost intraocular implant (Pending FDA approval)
typhoid polysaccharide vaccine
sodium phosphate
human papillomavirus vaccine, nonavalent
peanut immunotherapy epicutaneous (FDA approval pending)
cromolyn sodium, intranasal
red blood cells(Blood component)
oral mucoadhesive
clindamycin vaginal
whole blood (Blood Component)
fibrinogen/thrombin
levothyroxine/liothyronine
ipratropium intranasal
metronidazole vaginal
cyamemazine
brinase
reviparin
ulinastatin
saruplase
acepromazine
emylcamate
methionine
amino acids and electrolytes in dextrose with calcium
slippery elm
camostat
hemoglobin crosfumaril
moperone
chlormidazole
brilaroxazine
palopegteriparatide
diazepam buccal
benegrastim (pending for FDA approval)
COVID-19 vaccine, adjuvanted-Novavax
vestronidase alfa-vjbk
tebipenem (Pending FDA Approval)
tislelizumab (Pending FDA Approval)
zolbetuximab (Pending FDA Approval)
zoliflodacin (pending FDA approval)
zibotentan and dapagliflozin
fluorine F18 DCFPyL
debamestrocel
givinostat
amubarvimab and romlusevimab(Pending FDA Approval)
sabizabulin(Pending FDA approval)
fexapotide(Phase 3 Clinical trial)
diatrizoic acid
drotaverine
diethyl phthalate
enclomiphene
epalrestat
ethamsylate
flupirtine
imidurea
sodium glycolate
feracrylum
ethacridine
furazolidone/metronidazole
ozagrel hydrochloride
leptazol
l-glutamic acid /vitamin B complex
etizolam
etizolam/propranolol
ethoheptazine citrate
etophylline and theophylline
etophylline
finger millet
drotaverine/mefenamic acid
dichloroxylenol
pneumococcal 7-valent vaccine
diclofenac and metaxalone
dipivefrin ophthalmic
enbucrilate
potassium citrate and citric acid
potassium gluconate
aclarubicin
alfuzosin/dutasteride
adrenochrome monosemicarbazone
selenium sulfide topical
sertaconazole
amorolfine cream
amsacrine
amylmetacresol
sulfonated phenolics in aqueous solution
technetium Tc-99m sulfur colloid
raltitrexed
romiplostim
acediasulfone
azulene
acebrophylline
clonazepam/escitalopram oxalate
allylestrenol
andrographolide
artemotil
technetium Tc-99m sestamibi
rubidium Rb-82
somapacitan
sodium sulfate, magnesium sulfate and potassium sulfate
almitrine
gramicidin
nikethamide
technetium Tc-99m sodium pertechnetate
betiatide
prilocaine/epinephrine
amlexanox
acetaminophen/salicylamide/phenyltoloxamine
neomycin topical
zilucoplan
antazoline and xylometazoline
toripalimab
iron isomaltoside
meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine
meningococcal A C Y and W-135 diphtheria conjugate vaccine
tetradecyl Sulfuric Acid
benzoyl peroxide, clindamycin phosphate, adapalene
ethylephedrine
actarit
pyrantel tartrate
tenofovir disoproxil fumarate or tenofovir DF
melitracen
amitriptylinoxide(Phase 4 Clinical Trials)
threonine
ditiocarb zinc
epicriptine
levallorphan
kinetin
laurocapram
pentagastrin
parthenolide
nicoboxil
protionamide
prulifloxacin
proscillaridin
tizanidine and rofecoxib
tolnaftate, gentamicin, chinoform and betamethasone valerate
pine bark extract
pipenzolate methylbromide
bephenium hydroxynaphthoate
niclosamide
pyrvinium
pipenzolate methylbromide/phenobarbitone
piracetam/ginkgo biloba/vinpocetine
benzyl benzoate/disulfiram
benzyl benzoate
loperamide/simethicone
piroctone olamine
sodium fusidate
piroxicam topical/capsaicin/menthol/methyl salicylate
sodium metabisulfite
sodium lauryl sulfate
taspoglutide
glyclopyramide
tolnaftate, gentamicin, iodochlorohydroxyquinoline, chlorocresol, betamethasone valerate
serratiopeptidase
sodium antimony gluconate
triamterene / benzthiazide
tribenoside / lidocaine
triclocarban
triprolidine/dextromethorphan
vitamins/minerals/omega-3 Fatty acids
soyabean oil
sucralfate/oxethazaine
sucralfate/tinidazole/povidone iodine
sodium cromoglycate
aloe vera/liquid paraffin/white soft paraffin
aloe vera/jojoba oil/vitamin E
allantoin/triclosan/vitamin e/zinc oxide
alpha-Lipoic acid/minerals/multivitamins
alprazolam/paracetamol
alprazolam/melatonin
azithromycin/ambroxol
atorvastatin/clopidogrel/aspirin
aceclofenac, paracetamol and serratiopeptidase
alfacalcidol, vitamin B-complex, minerals and antioxidants
alpha- lipoic acid, vitamin b complex and vitamin c
alpha-galactosidase and simethicone
alpha-galactosidase, amylase, proteases, lipase and lactase
amikacin and cefepime
aminophylline, ephedrine and phenobarbitone
artesunate, sulphadoxine and pyrimethamine
finasteride/tamsulosin
flavoxate/ofloxacin
fenofibrate/metformin
lignocaine, hydrocortisone topical and allantoin
linoleic acid and sodium lactate
troxerutin
meclizine/nicotinic acid
mecobalamin/ginkgo Biloba
spirulina
loperamide and furazolidone
ketoconazole/cetrimide
ketoconazole/zinc pyrithione
lercanidipine/atenolol
levocetirizine/montelukast/ambroxol
levarterenol
levocetirizine/phenylpropanolamine
indapamide/amlodipine
itopride/methyl polysiloxane
mebendazole/levamisole
eberconazole/mometasone
gliclazide/metformin/pioglitazone
fluconazole/tinidazole
haemocoagulase
halometasone
hesperidin
imipramine/chlordiazepoxide
idebenone / l-arginine / zinc sulphate/selenium/proanthocyanidin
mecobalamin and piracetam
mesterolone
mosapride and pantoprazole
atorvastatin, co enzyme q10, vitamin e, zinc, and selenium
azithromycin and benzalkonium chloride
beta carotene, vitamin c, vitamin e, minerals, lutein, eicosapentaenoic acid, docosahexenoic acid and vit b12
alpha-galactosidase
aloe vera gel/vitamin e/lactic acid
aloe vera gel/jojoba/vitamin e/glycerine
famotidine and domperidone
faropenem medoxomil
nedosiran
fluconazole/ornidazole/azithromycin
ebastine/montelukast
eberconazole
dienogest/estradiol valerate
ambroxol/salbutamol
benzoic acid/salicylic acid/ichthammol/ triamcinolone acetonide
desloratadine/ambroxol
dexibuprofen/paracetamol
atorvastatin/ramipril
diastase
diastase and simethicone
diazepam and propranolol
dexrabeprazole / domperidone
dexrabeprazole
dexketoprofen /paracetamol
beta carotene/vitamin C/minerals
aloe vera gel/urea
aloe vera gel/glycerine
alpha-lipoic acid/benfotiamine/chromium/folic acid/mecobalamin / vit b6
alprazolam/propranolol
alprazolam /sertraline
ibuprofen/dextropropoxyphene
ambroxol/cetirizine/phenylephrine/ guaiphenesin/menthol
dextropropoxyphene/dexchlorpheniramine maleate/bromhexine
promegestone
batroxobin
bencyclane
benfluorex
acetylpheneturide
abarelix
abetimus
naftidrofuryl
nalorphine
oxiracetam
letosteine
lafutidine
leuprorelin
levodropropizine
glutaral
losartan/ramipril
gallopamil
lanatoside c
lauromacrogol
gestodene
aceclofenac/methyl salicylate/menthol/linseed oil/capsaicin
aceclofenac/paracetamol/tizanidine
alginic acid/magaldrate/simethicone
aceclofenac/paracetamol
aceclofenac/rabeprazole
alginic acid
pantoprazole and domperidone
urokinase
rimiterol
olanzapine/fluoxetine
normethadone/hydroxyephedrine
myrtol
moxonidine
propylhexedrine
sodium hypochlorite solution
sodium chloride/sodium citrate
Hepatitis B Vaccine (Recombinant [Adjuvanted])
Hepatitis B Vaccine (Recombinant)
aceclofenac and serratiopeptidase
levosulpiride
niaprazine
tromantadine
trimetazidine
vinburnine
mizoribine
molgramostim
mosapride
eugenol
tolperisone
etamsylate
etynodiol
mizolastine
metenolone
reproterol
rebamipide
mephenoxalone
metandienone
furosemide/spironolactone
hydroxycarbamide
tenonitrozole
fenoverine
fenquizone
tiapride
tibolone
furazolidone
furosemide & amiloride
fosfestrol
fluclorolone
flubendazole
tertatolol
tetracosactide
tetryzoline
tolciclate
trapidil
troxipide
temoporfin
telbivudine
teprenone
hexamidine
mebhydrolin
mepartricin
fencamfamin
medazepam
theodrenaline
thiamazole
thiocolchicoside
psilocybin
veralipride
pyritinol
opipramol
oprelvekin
betamethasone + gentamicin
betamethasone + neomycin
betamethasone + salicylic acid
oxedrine
bopindolol
orgotein (investigational)
oxaceprol
ormeloxifene
bevantolol
bifemelane
clebopride
demoxytocin
cicletanine
cefsulodin
chlortalidon
sisomicin
somatrem
carbazochrome
caroverine
cathine
ipriflavone
isepamicin
silymarin
simethicone
sermorelin
diloxanide
dimethindene
diosmin/hesperidin
calamine
canrenone
captodiame
imidapril
cefetamet
cefodizime
cefoperazone + sulbactam
ivermectin + albendazole
serrapeptase
bromisoval
beraprost
pridinol
proglumide
bamipine
barnidipine
bamifylline
benzbromarone
betamethasone/fusidic acid
para-chlorophenol
pantethine
nomifensine
pemoline
parnaparin
pentolinium
nialamide
novobiocin
nicergoline
octocrylene
octisalate
oftasceine
oxolamine
oxyphencyclimine
penfluridol
pentoxyverine
phenoxymethylpenicillin
picloxydine
pilsicainide hydrochloride
piperazine
pirarubicin
policresulen
prifinium bromide
prethcamide
pristinamycin
pirenzepine
piribedil
pimethixene
pargyline
phosphatidyl choline
phthalylsulfathiazole
phytomenadione
pranlukast
pinazepam
oxyphenonium
noxytiolin
periciazine
pethidine
phenindamine
histidine
isoleucine
proline
lauric acid
lymecycline
hypromellose
abiraterone acetate and niraparib
ichthammol
levamisole
naftazone
nefopam
oxprenolol
oxybuprocaine
elranatamab-bcmm
lapyrium
isoaminile
iotrolan
mazindol
masoprocol
lypressin
meradimate
molsidomine
monobenzone
mequinol/gluconolactone/ lactobionic acid/ arbutin
medifoxamine
mebutamate
metergoline
methantheline
methdilazine
metocurine
micronomicin
metaraminol
mephenesin
menadione
medrysone
metixene
levobetaxolol
guaiacol glycerol ether
eucalyptol
sodium tetradecyl sulfate
sugammadex
carbetocin
certoparin
chlorcyclizine/pseudoephedrine
cephapirin
indecainide
iobitridol
iomeprol
chlorphenesin
msud analog
msud maxamum
iceland moss
glutethimide
hexachlorophene
haloprogin
deferoxamine
ethchlorvynol
dexpanthenol topical
etilefrine
deslanoside
carbocromen
diazolidinylurea
dibenzepin
etofamide
guanoxan
halazepam
guanadrel sulfate
dapiprazole
soapwort
debrisoquine
l-tryptophan
chlormerodrin
chlorquinaldol
cetrimonium
carbocisteine
chlorcyclizine/codeine
technetium Tc-99m tetrofosmin
technetium Tc-99m disofenin
technetium Tc-99m gluceptate
technetium Tc-99m labeled red blood cells
amylmetacresol/dextromethorphan hydrobromide
anileridine phosphate
pyrethrins
pyrantel pamoate
quinagolide
spiramycin
standard hyperkalemic cardioplegia solution
technetium tc-99m mertiatide
technetium tc-99m medronate
bemotrizinol / bisoctrizole
benfotiamine
bemotrizinol + titanium dioxide + zinc oxide
technetium Tc-99m oxidronate
technetium Tc-99m pentetate
technetium Tc-99m pyrophosphate
benziodarone
octinoxate/bisoctrizole
bicisate dihydrochloride
technetium Tc-99m bicisate
norelgestromin/ethinyl estradiol
norgestimate/ethinyl estradiol
ximelagatran (investigational)
xamoterol
trioxsalen
poly-urea urethane
rilmenidine
pemirolast
oxitriptan
beclomethasone, intranasal
thimerosal
camphor gel
camphor
mumps virus vaccine, live
rubella virus vaccine, live
aluminum chloride (dental)
alum irrigation
framycetin, phenylephrine, and gramicidin
ombitasvir, paritaprevir, ritonavir, and dasabuvir
olipudase alfa
etonogestrel/ethinyl estradiol
mycophenolate
fluoroestradiol F 18
donor organ cardioplegia solution
fluciclovine F 18
fusidic acid (ophthalmic)
fusidic acid and hydrocortisone
framycetin, dexamethasone, and gramicidin
fludeoxyglucose F-18
fluorouracil/salicylic acid
indium In-111 oxyquinoline
indium In-111 pentetreotide
indium In-111 capromab pendetide
lusutrombopag
mitomycin (ophthalmic)
mifepristone and misoprostol
minoxidil (systemic)
methyl aminolevulinate (topical)
methyl folate, methylcobalamin, and acetylcysteine
ciclesonide/formoterol/tiotropium
nedocromil (Oral Inhalation)
batefenterol (Investigational)
neostigmine and glycopyrrolate
nepafenac ophthalmic
netupitant/palonosetron
meperidine and promethazine
mepivacaine and levonordefrin
maltodextrin
medical cannabis
medium chain triglycerides
mometasone/glycopyrrolate (glycopyrronium)/ indacaterol
moxifloxacin ophthalmic
neomycin/fluocinolone
nadroparin
iodine I-125 iothalamate
amikacin liposome (oral inhalation)
bupivacaine liposome
natamycin
lopinavir and ritonavir
lysine
macitentan and tadalafil
mitomycin pyelocalyceal
moclobemide
mometasone and indacaterol
efinaconazole
blue-green algae
indocyanine green
follitropin beta
lumasiran
glycerin/lidocaine
edrophonium/atropine
indigo carmine
lutropin alfa
instant glucose/intravenous dextrose
iobenguane I-123
ixekizumab
isosulfan blue dye
levofloxacin ophthalmic
levonorgestrel oral/ferrous bisglycinate/ ethinylestradiol
ethinyl estradiol/levonorgestrel transdermal
hydroquinone
hydroxypropyl methylcellulose
icodextrin
lipid emulsion (soybean, medium-chain triglyceride, olive, and fish oils; [SMOF])
iodinated I 125 albumin
iodinated I 131 albumin
lipid emulsion (plant oil-based)
levonorgestrel intrauterine
levonorgestrel/ethinyl estradiol
lactic acid and sodium-PCA
lactated Ringer solution
ketotifen (systemic)
lanolin
leuprolide and norethindrone
levodopa and benserazide
gonadorelin acetate
hemodialysis solutions
nirsevimab
gentian violet
gallium ga-68 dotatate
fusidic acid and betamethasone
gallium citrate Ga-67
gadopentetate dimeglumine
gadofosveset
follitropin delta
follitropin alfa and lutropin alfa
follitropin alfa
rocatinlimab
grass pollens allergen extract
flotufolastat F18
fluorescein ophthalmic
barium
balanced salt solution
air polymer type A intrauterine device
clodronate
bentoquatam
clobetasone
alfacalcidol
citric acid/glucono-delta-lactone/magnesium carbonate
benzoin
desirudin
immune globulin IV (IGIV)
dequalinium
pseudoephedrine/desloratadine
clofedanol
cyproterone and ethinyl estradiol
dextranomer and hyaluronic acid or derivatives
diatrizoate meglumine and diatrizoate sodium
glucosamine sulfate, chondroitin sulfate and Msm
squill
gotu kola
blessed thistle
bitter melon
apraclonidine
chlophedianol/dexbrompheniramine/pseudoephedrine
wild jujube
chitosan
cilazapril/hydrochlorothiazide
dexbrompheniramine and phenylephrine
diethylene triamine penta-acetic acid
dexchlorpheniramine and pseudoephedrine
lily of the valley
diflucortolone
corydalis
lemon balm
MSM
calcium polystyrene sulfonate
caprylidene
peppermint oil
efavirenz/lamivudine/tenofovir DF
emtricitabine/tenofovir DF /efavirenz
dutasteride/tamsulosin
milk thistle
centaury
horseweed
lycopus
agrimony
alfalfa
kava
cetrorelix
cetylpyridinium
chlophedianol and dexbrompheniramine
betahistine
choline C-11
boric acid vaginal suppository
aluminum acetate
aluminum chloride hexahydrate
14-C urea breath test
absorbable collagen
valoctocogene roxaparvovec-rvox
amlodipine and celecoxib
aspirin and omeprazole
azilsartan and chlorthalidone
landiolol (Pending FDA approval)
isosorbide dinitrate/hydralazine
losartan/hydrochorothiazide
udenafil
dextromethorphan/quinidine
onasemnogene abeparvovec
orphenadrine/aspirin/caffeine
Trace elements
sodium phenylbutyrate/ taurursodiol
fish oil triglycerides
infant formula
glutamine
chloroquine phosphate
afatinib
quinidine gluconate
methylergonovine
prothrombin complex concentrate, human
BCG intravesical live
capivasertib
cedazuridine
carbonyl iron
iron dextran complex
lovotibeglogene autotemcel (FDA Approval Pending)
sodium benzoate/sodium phenylacetate
mineral oil otic
zolmitriptan transdermal
midazolam intranasal
fosinopril/hydrochlorothiazide
caplacizumab
arginine
sodium phenylbutyrate
meloxicam/rizatriptan
manganese
acetaminophen/pamabrom/pyridoxine
varicella zoster immune globulin, human
amitriptyline/perphenazine
narsoplimab (Pending FDA Approval)
amlodipine/perindopril
imiglucerase
canagliflozin/metformin
tafamidis meglumine
somatrogon-ghla
glimepiride/rosiglitazone
becaplermin
lithium
loxapine inhaled
nicotine transdermal
tixagevimab and cilgavimab (Investigational)
muromonab CD3
ansuvimab
coal tar bath products
fibrin sealant
arimoclomol (FDA Approval Pending)
varenicline intranasal
aducanumab
oxycodone/naloxone
ritlecitinib
sodium polystyrene sulfonate
calcipotriene/betamethasone
calcium hydroxylapatite
cantharidin topical
doxepin cream
clocortolone
formaldehyde topical
sodium sulfide topical
collagenase
selegiline transdermal
foscarbidopa/foslevodopa (FDA approval pending)
saxagliptin/metformin
linagliptin/metformin
linzagolix (FDA approval pending)
efgartigimod/hyaluronidase SC
Elamipretide
rozanolixizumab
diazoxide
glimepiride/pioglitazone
cipaglucosidase alfa
dihydroergotamine intranasal
delandistrogene moxeparvovec
beremagene geperpavec
hyaluronic acid and derivatives
hyaluronic acid, non-animal stabilized
eplontersen (FDA Approval Pending)
nitric oxide gas
sodium phenylbutyrate and taurursodiol
treprostinil SC
viltolarsen
albuterol/ipratropium
budesonide inhaled
budesonide rectal
palovarotene
sodium sulfate/potassium chloride/magnesium sulfate/polyethylene glycol
amino acids mixture
aminobenzoate potassium
elivaldogene autotemcel
naproxen and sumatriptan
sumatriptan intranasal
alglucerase
metformin/rosiglitazone
ertugliflozin/metformin
elosulfase alfa
calcium carbonate/magnesium hydroxide
starch suppository
abicipar pegol (FDA Approval Pending)
riboflavin 5′-phosphate ophthalmic
povidone ophthalmic
glycerin oropharyngeal
dimethicone topical
menthol topical, dimethicone topical
pramoxine topical, menthol topical and dimethicone topical
phosphorated carbohydrate
brilliant blue G ophthalmic
brolucizumab intravitreal
purified water, ophthalmic
hydroxyethyl cellulose ophthalmic
ranibizumab intravitreal implant
sodium chloride hypertonic, ophthalmic 
cetirizine ophthalmic
phentolamine ophthalmic
ganciclovir ophthalmic
triamcinolone intravitreal
ocriplasmin intravitreal
atoltivimab/maftivimab/odesivimab
pegcetacoplan intravitreal
triamcinolone acetonide extended-release injectable suspension
tobramycin/loteprednol ophthalmic
2-octyl cyanoacrylate
vitamins A & D topical
diphenhydramine/allantoin topical
pyrethrins/piperonyl butoxide
lodoxamide ophthalmic
obeticholic acid
fluocinolone intravitreal implant
sincalide
linaclotide
nedocromil ophthalmic
cysteamine ophthalmic
avacincaptad pegol intravitreal
azelastine ophthalmic
bacitracin ophthalmic
propylene glycol ophthalmic
rimexolone ophthalmic
metoclopramide intranasal
mirikizumab
netarsudil ophthalmic
cenegermin
dexamethasone ophthalmic insert
prednisolone ophthalmic
phenylephrine and cocoa butter rectal
phenylephrine and witch hazel topical
phenylephrine, pramoxine, glycerin and petrolatum rectal
bisacodyl rectal
aluminum hydroxide/magnesium carbonate
aluminum hydroxide/magnesium hydroxide
hyoscyamine spray
methenamine/methylene blue/ hyoscyamine/ sodium phosphate monobasic/ phenyl salicylate
phenylephrine
chlorophyll
castor oil
cholic acid
phenol oropharyngeal
articaine/epinephrine
antithymocyte globulin equine
aluminum hydroxide/magnesium trisilicate
methenamine/hyoscyamine
hydrocortisone topical/pramoxine topical
sodium fluoride topical
mesna
C1 esterase inhibitor recombinant
menthol and pectin
menthol oropharyngeal
pectin oropharyngeal
gepirone
Goldenseal
polyethylene glycol and electrolytes
polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid
brompheniramine/pseudoephedrine/dextromethorphan
brompheniramine phenylephrine
acetaminophen/doxylamine/phenylephrine
doxylamine/acetaminophen/pseudoephedrine/dextromethorphan
acetaminophen/doxylamine/dextromethorphan
acetaminophen/doxylamine/dextromethorphan/phenylephrine
eslicarbazepine
fluticasone and salmeterol
codeine, acetaminophen, butalbital and caffeine
codeine, chlorpheniramine and phenylephrine
iodine
povidone iodine
butalbital/aspirin/caffeine/codeine
polyethylene glycol 400/propylene glycol ophthalmic 
pegvaliase
amivantamab
iopamidol
codeine and pseudoephedrine
emtricitabine, rilpivirine, tenofovir DF
penicillin G aqueous
miconazole topical
miconazole vaginal
ciprofloxacin inhaled (Pending FDA approval)
ceftazidime/avibactam
ceftolozane/tazobactam
aztreonam inhalation
amphotericin B cholesteryl sulfate
miconazole oral
elvitegravir/cobicistat/emtricitabine/tenofovir DF
isavuconazonium sulfate
dapivirine intravaginal (FDA Approval Pending)
lamivudine/raltegravir
codeine/triprolidine/pseudoephedrine
cadexomer iodine
brompheniramine/pseudoephedrine
codeine/acetaminophen
codeine/guaifenesin
beclomethasone inhaled
epoetin beta/methoxy polyethylene glycol
voreloxin(Orphan Drug)
rociletinib
pitcher plant
phosphatidylserine
telotristat ethyl
copper CU 64 dotatate
urea topical
exenatide subdermal implant
asenapine transdermal
ethiodized oil
urea oral
miglustat
acalisib(Investigational)
acetophenazine
guggul
aceneuramic acid
mestranol/norethindrone
reishi
lactitol
vonoprazan fumarate
motherwort
silver nitrate
salicylic acid/sulfur shampoo
salicylic acid topical
ketorolac ophthalmic
ketoconazole topical
Japanese encephalitis virus vaccine
dibucaine topical ointment
ketorolac intranasal
ketorolac/phenylephrine ophthalmic
rotavirus oral vaccine, live
guarana
hops
krill oil
salicylic acid/coal tar shampoo
sufentanil SL
pancrelipase
passion flower
pepdite one plus
nivolumab and relatlimab
relatlimab (Pending FDA Approval)
benzalkonium chloride/benzocaine
ketotifen, drug-eluting contact lens
calcitriol topical
oxymetazoline topical
alclometasone topical
capsaicin topical
diclofenac/misoprostol
diclofenac ophthalmic
diclofenac topical
pramoxine/calamine topical
veverimer
tolazoline
olopatadine ophthalmic
lutetium lu 177-dota-tate
lutetium lu 177 vipivotide tetraxetan
strontium 89 chloride
interferon alfa n3
lutetium Lu 177- Diethylenetriamine Pentaacetic acid-omburtamab (FDA Approval Pending)
samarium sm 153 lexidronam
cytomegalovirus immune globulin (CMV IG)
antithymocyte globulin rabbit
inolimomab (Pending FDA Approval)
olopatadine intranasal
olopatadine intranasal/mometasone, intranasal
benzocaine/butamben/tetracaine topical
antipyrine/benzocaine/phenylephrine
dyclonine/menthol
surufatinib
fruquintinib
dostarlimab
hepatitis B immune globulin (HBIG)
remestemcel-L
benzocaine/menthol oropharyngeal
interferon beta 1b
tetracaine/oxymetazoline intranasal
benzocaine oropharyngeal
benzalkonium chloride/menthol/petrolatum topical
inamrinone
alpha 1 proteinase inhibitor
potassium bicarbonate/potassium citrate
potassium phosphate/sodium acid phosphate
asparaginase Erwinia chrysanthemi recombinant
motixafortide
pegloticase
etesevimab
Rho(D) immune globulin
tetanus immune globulin (TIG)
reltecimod (pending FDA approval)
avasopasem
trimethoprim/polymyxin B ophthalmic
naphazoline ophthalmic
sulfacetamide topical
sirolimus intravitreal (pending FDA approval)
sirolimus protein bound
sirolimus topical
glycopyrronium tosylate topical
sofpironium
olmesartan, amlodipine and hydrochlorothiazide
dovitinib (Pending FDA Approval)
epinephrine inhaled
quizartinib (Pending FDA Approval)
ranibizumab intravitreal injection
sodium hyaluronate
bacitracin and lidocaine topical
brimonidine topical
benzoyl peroxide and tretinoin topical
talquetamab
betrixaban
acetaminophen/caffeine/pyrilamine
fentanyl transmucosal
bacitracin topical
buprenorphine,long-acting injection
buprenorphine buccal
nalmefene intranasal
sulbactam/durlobactam
metronidazole topical 
daratumumab/hyaluronidase
glofitamab
rituximab-hyaluronidase
drospirenone/ethinyl estradiol/levomefolate
loncastuximab tesirine
ingenol mebutate topical
momelotinib
trastuzumab/deruxtecan
trastuzumab/hyaluronidase
trastuzumab duocarmazine
lifileucel
umbralisib
eflornithine/sulindac
cytarabine/daunorubicin liposomal
doxorubicin liposomal
epcoritamab
lanadelumab  
esomeprazole/naproxen 
terbinafine topical
ravulizumab
clotrimazole topical
choline magnesium trisalicylate
tacrolimus ointment
mechlorethamine topical
donislecel
pozelimab (Pending FDA Approval)
human rabies immune globulin (HRIG)
melphalan flufenamide
sintilimab (Pending FDA Approval)
oportuzumab monatox (Pending FDA Approval)
sotorasib
irinotecan liposomal
sulfur topical
silver sulfadiazine
capsaicin transdermal
sutimlimab
tretinoin topical
acetaminophen rectal
menthol topical
naftifine
oatmeal, colloidal topical
oxiconazole
methylsalicylate/menthol topical
C1 inhibitor human
lifitegrast ophthalmic
prednisolone/sulfacetamide ophthalmic
mannitol inhalation
ofloxacin otic
petrolatum & mineral oil topical
clascoterone topical
gefapixant (Pending FDA Approval)
colesevelam
technetium Tc 99m succimer
nebivolol/valsartan
ciprofloxacin/fluocinolone acetonide, otic
finafloxacin otic
magnesium hydroxide/mineral oil
phenylephrine/mineral oil/petrolatum rectal
carbamide peroxide oral
atropine ophthalmic
sodium sulfacetamide/sulfur
sulfacetamide ophthalmic
lucinactant
benzonatate
besifloxacin ophthalmic
benzhydrocodone/acetaminophen
beractant
trimagnesium citrate anhydrous
vitamin b2
carbamide peroxide otic
mineral oil topical
ethyl alcohol intranasal
boric acid/alcohol otic
absorbable gelatin compressed sponge, USP
absorbable gelatin sponge, USP
vincristine liposomal
technetium Tc 99m albumin aggregated injection
metaproterenol
budesonide inhaled/formoterol/glycopyrrolate inhaled
epinephrine racemic
umeclidinium bromide/vilanterol inhaled
indacaterol, inhaled/glycopyrrolate inhaled
betaine  
laronidase 
estrogens esterified/methyltestosterone            
cerliponase alfa
ertugliflozin/sitagliptin
hawthorn
shepherd’s purse
thiamine
naphazoline/glycerin ophthalmic
oxymetazoline ophthalmic
dorzolamide
dexamethasone intraocular
dexamethasone/ciprofloxacin
dexamethasone ophthalmic
metipranolol ophthalmic
timolol ophthalmic
boron
fezolinetant
pegunigalsidase alfa-iwxj
biotin
pantothenic acid
silicon
sodium acid phosphate
hypochlorous acid topical
methenamine/sodium acid phosphate
aviptadil 
bremelanotide
glucagon intranasal
metformin and repaglinide
bai ji
pau d’arco
juzentaihoto
mistletoe
quercetin
rosemary
sheng di huang
chasteberry
maitake
grapefruit
lentinan
juniper
nettle
parsley
rose hips
tongkat ali
horny goat weed
damiana
yohimbe
insulin NPH
aprocitentan
noni Juice
sodium iodide I-131
green tea
sea cucumber
wheat germ extract
fenofibrate micronized 
rogisen
danshen
lutein
witch hazel
dextroamphetamine transdermal
amphetamine/dextroamphetamine
hoodia
kolanut
boswellia
opuntia ficus indica
lavender
nadh
tea tree oil
metformin/sitagliptin 
dapagliflozin/ metformin/saxagliptin  
antihemophilic factor recombinant
inclisiran
bempedoic acid/ezetimibe
volanesorsen
omega 3 carboxylic acids
pericyazine
levomepromazine (methotrimeprazine)
betaxolol ophthalmic
respiratory syncytial virus vaccine, adjuvanted
phenylephrine hydrochloride and tropicamide ophthalmic
alirocumab
neomycin/polymyxin B/gramicidin ophthalmic
factor IX
gentamicin topical
ansofaxine (Pending FDA Approval)
zuranolone
factor IX, recombinant
factor IX complex
factor XIII A-subunit, recombinant
factor X, human
mesalamine rectal
etrasimod
anti-inhibitor coagulant complex
factor IX, recombinant/albumin fusion protein
fibrinogen, human
aminocaproic acid
metyrosine
nonoxynol-9 vaginal
progesterone intravaginal gel
ipecac syrup
botulinum antitoxin, heptavalent
pentetate calcium trisodium
crotalidae polyvalent immune FAB (ovine)
dehydrated alcohol injection
gold sodium thiomalate (Discontinued)
lactic acid/citric acid/potassium bitartrate vaginal
von Willebrand factor, recombinant
luspatercept
digoxin immune FAB (Antidote)
crotalidae immune FAB (equine)
magnesium (Antidote)
pyridoxine (Antidote)
edetate calcium disodium
albumin IV
nitroglycerin sublingual
obiltoxaximab
anthrax immune globulin
nitroglycerin topical
dextrose
nesiritide
estradiol vaginal
bazedoxifene/conjugated estrogens
botulism immune globulin iv
amoxicillin/omeprazole/rifabutin
synthetic human angiotensin II
nitroglycerin IV
nitroglycerin translingual
nitroprusside sodium
tetrahydrozoline/zinc sulfate/hypromellose ophthalmic
sodium citrate/citric acid
pemetrexate
Methicillin
plasminogen 
acai
american ginseng
cordyceps
tramadol/acetaminophen
belladonna alkaloids/phenobarbital
erythromycin topical/benzoyl peroxide
glucosamine sulfate
panax ginseng (suppl/herb)
tolnaftate
sulopenem etzadroxil/probenecid
sulfur hexafluoride
sotrovimab
arbaclofen
rifampin/isoniazid
clindamycin /tretinoin topical
benzoyl peroxide/clindamycin topical
apremilast
antivenins, centuroides (scorpion)
bamlanivimab and etesevimab
vilobelimab
gadobenate
pentosan polysulfate sodium
methylsalicylate/menthol/camphor topical
antivenin, black widow spider
benzoyl peroxide and hydrocortisone
clindamycin topical
isometheptene, dichloralphenazone and acetaminophen
acetaminophen and phenyltoloxamine
erythromycin topical
erythromycin ophthalmic
alpha hydroxy acids, topical
buprenorphine transdermal
butalbital/acetaminophen/caffeine
buprenorphine/samidorphan
buprenorphine subdermal implant
celecoxib/tramadol
drospirenone/ethinyl estradiol
resorcinol/sulfur
eflornithine
rifampin/isoniazid/pyrazinamide
tofersen
devil’s claw
ticarcillin/clavulanate
atropine/pralidoxime
aprepitant
suramin
phenelzine
artichoke
american dogwood
attapulgite
atlantic cedar
axalimogene filolisbac
sodium thiosulfate & sodium nitrite
ataluren
omidubicel-onlv
capsicum
ginger
cryoprecipitate
bictegravir/emtricitabine/tenofovir DF
emtricitabine/tenofovir DF
fo-ti
siberian ginseng
granulocytes
zinc substituted heme C
zinc trihydroxide
ashwagandha 
cat’s claw
glandular products
SAMe
shark cartilage
altovis
feverfew
horse chestnut
magnesium aspartate
octacosanol
pleurisy root
star anise
butterbur
elderberry
licorice (Suppl/herb)
aconite
pentetate zinc trisodium
menthol topical/zinc oxide topical
corn-starch/kaolin/zinc oxide topical
5-hydroxytryptophan (5-htp)
butcher’s broom
articulin
bearberry
goldenrod
progesterone, natural
black cohosh
wild yam
cranberry
dong quai
phytoestrogens
norethindrone
false Unicorn Root
raspberry Leaf
asafoetida
turmeric
dehydroepiandrosterone (DHEA)
hyaluronan
aliskiren/amlodipine
octreotide (Antidote)
tranexamic acid injection
duocal
neocate infant formula
pediatric Eo28
aloe
red clover
propolis
androstenedione
heartsease
comfrey
bilberry
chamomile
eyebright
calendula
sage
yucca
polypody
odevixibat
vinpocetine
olanzapine/samidorphan
creatine
yerba mate
spesolimab
azficel-T
tiludronate
estetrol and drospirenone
pseudoephedrine/fexofenadine
lincomycin
neomycin oral
fluocinolone acetonide, otic
tretinoin/ hydroquinone/ fluocinolone
halobetasol topical
hydrocortisone/iodoquinol
penicillin G procaine /penicillin G benzathine
hydrocortisone probutate topical
colistin/neomycin/hydrocortisone/thonzonium otic
ebola zaire vaccine
hepatitis a/b vaccine
vibegron
lindane
nystatin topical
respiratory syncytial virus (RSV) vaccine
chikungunya vaccine, live
tenecteplase
reteplase
anthrax vaccine adsorbed, adjuvanted
meningococcal ABCWY pentavalent vaccine
eculizumab
cholestyramine
tinzaparin
taurolidine/citrate/heparin
protein C concentrate
antithrombin alfa
antithrombin III
multivitamins, vision
ibuprofen/chlorpheniramine/pseudoephedrine
acetaminophen/ibuprofen
ibuprofen/pseudoephedrine
paclitaxel protein-bound
acetic acid vaginal
acetic acid otic
hydrocodone/ ibuprofen
methyl salicylate / isopropanol/ citronellyl acetate/ citric acid
ibuprofen and phenylephrine
acetylcysteine (Antidote)
iron/folic acid/vitamin/mineral
iobenguane I-131
dolutegravir/rilpivirine
chlorhexidine topical
chlorhexidine oral
thyroid desiccated
proparacaine ophthalmic
podophyllum resin
phendimetrazine
phenoxybenzamine
polidocanol
phentermine and topiramate
piflufolastat F18
piperacillin/tazobactam
prednisolone and gentamicin ophthalmic
promethazine and codeine
poractant alfa
protamine sulfate
aflibercept intravitreal
prednicarbate
promethazine/dextromethorphan
codeine, phenylephrine, and promethazine
potassium phosphate
glatiramer acetate
gentamicin (Ophthalmic)
leniolisib
rezafungin
fluorometholone
dalfampridine
hydrocortisone topical 
empagliflozin and linagliptin
triamcinolone topical
minocycline topical
minocycline dental
ketotifen ophthalmic
darunavir and cobicistat
lidocaine topical
neomycin/polymyxin B/bacitracin/lidocaine (OTC)
lidocaine/ hydrocortisone
lidocaine anesthetic
lidocaine ophthalmic
lidocaine/tetracaine
desonide
dabigatran
fexofenadine
fluoride
decitabine and cedazuridine
dasiglucagon
hydroxypropyl cellulose ophthalmic
epoetin alfa
ibritumomab tiuxetan
trimethobenzamide
dexamethasone/ tobramycin
tafasitamab
valacyclovir
mebendazole
levoleucovorin
flaxseed
germanium
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lycopene
pygeum
horseradish
ziv-aflibercept
micafungin
trofinetide
taliglucerase alfa
tildrakizumab
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thyrotropin alfa
birch
thrombin, topical
tivozanib
tafluprost
methohexital
urea and hydrocortisone
unoprostone ophthalmic
trihexyphenidyl
ezetimibe
evolocumab
trifluridine and tipiracil
methenamine
misoprostol
miltefosine
rimantadine
maralixibat
coenzyme Q10
chlorella
garlic
forskolin
zavegepant
menotropins
margetuximab
meprobamate
melarsoprol
evening primrose oil
lemongrass
molindone
fenugreek
phytosterols
red yeast rice
uridine triacetate
tropicamide
incobotulinumtoxinA
Grape Seed Extract
carbachol ophthalmic
cosyntropin
cyclopentolate and phenylephrine
carteolol ophthalmic
pentazocine/naloxone
pentazocine/acetaminophen
casimersen
carisoprodol, aspirin, and codeine
carisoprodol
carboprost tromethamine
flurandrenolide

lixisenatide +

regular insulin

may increase the hypoglycemic effect

pioglitazone

may increase the hypoglycemic effect

dapagliflozin

may increase the hypoglycemic effect

may increase the hypoglycemic effect

sotagliflozin

may increase the hypoglycemic effect

ethinyl estradiol

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

ethynodiol diacetate

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

etonogestrel

lixisenatide: they may decrease the therapeutic effect of hormonal contraceptives

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

glipizide

may have an increased hypoglycemic effect when combined with sulfonylureas

gliquidone

may have an increased hypoglycemic effect when combined with sulfonylureas

insulin beef

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

may have an increased hypoglycemic effect when combined with insulin

nateglinide

may have an increased hypoglycemic effect when combined with meglitinides

repaglinide

may have an increased hypoglycemic effect when combined with meglitinides

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

dulaglutide

may have an increased hypoglycemic effect when combined with insulin

insulin aspart

may have an increased hypoglycemic effect when combined with insulin

glyburide

may have an increased hypoglycemic effect when combined with sulfonylureas

glymidine

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

insulin human

may have an increased hypoglycemic effect when combined with insulin

insulin lispro

may have an increased hypoglycemic effect when combined with insulin

insulin pork

may have an increased hypoglycemic effect when combined with insulin

alogliptin

may increase the hypoglycemic effect

sitagliptin

may increase the hypoglycemic effect

may increase the hypoglycemic effect of Sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

may have an increased hypoglycemic effect when combined with sulfonylureas

acetaminophen

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

warfarin

may have an increased anticoagulant effect when combined with vitamin k antagonists

halometasone

When halometasone is used together with lixisenatide, this leads to elevated risk or seriousness of hyperglycemia

diazoxide

When lixisenatide is used together with diazoxide, this leads to reduction in therapeutic effectiveness of lixisenatide

methylprednisolone hemisuccinate

When methylprednisolone hemisuccinate is aided with lixisenatide, this leads to elevated hyperglycemia risk

oxandrolone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

nandrolone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

fluoxymesterone

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

nandrolone decanoate

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

danazol

may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects

tranylcypromine

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

isocarboxazid

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

phenelzine

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

rasagiline

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

safinamide

may enhance the hypoglycemic effect of agents with blood glucose lowering effects

indomethacin

may decrease the therapeutic effect when combined with glucagon and its analogs

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

may have an increased anticoagulant effect when combined with vitamin k antagonists

warfarin

may have an increased anticoagulant effect when combined with vitamin k antagonists

dienogest/estradiol valerate

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

glipizide

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

mestranol

It may diminish the effect when combined with lixisenatide by inhibiting gastrointestinal absorption

It may enhance the effect when combined with lixisenatide by pharmacodynamic synergism

dienogest

hormonal contraceptives decrease the efficacy of lixisenatide

Actions and Spectrum:

Action:

GLP-1 Receptor Agonist: lixisenatide activates GLP-1 receptors, which are primarily located in the pancreas, leading to several physiological effects.
Glucose-Dependent Insulin Secretion: lixisenatide enhances glucose-dependent insulin secretion from pancreatic beta cells. It stimulates the release of insulin when blood sugar levels are elevated, thereby helping to control blood glucose levels.
Suppression of Glucagon Secretion: lixisenatide reduces glucagon secretion, a hormone that increases blood sugar levels, from pancreatic alpha cells. This action further contributes to glucose control.
Slows Gastric Emptying: lixisenatide slows down the rate at which food leaves the stomach, resulting in reduced postprandial (after-meal) glucose excursions. It helps to regulate the rise in blood sugar levels after meals.
Appetite Control: lixisenatide may promote satiety and diminish appetite, which can leads to weight loss in some individuals.

Spectrum:

Type 2 Diabetes Mellitus: lixisenatide is primarily indicated for managing type 2 diabetes mellitus. It is an adjunct to diet and exercise to improve glycemic control in adults with this condition.
Monotherapy: lixisenatide can be used as a monotherapy in individuals whose blood sugar levels are inadequately controlled with diet.
Combination Therapy: lixisenatide is often prescribed with other antidiabetic medications, such as metformin, sulfonylureas, thiazolidinediones, or basal insulin, to achieve better glycemic control.
Cardiovascular Benefits: lixisenatide has shown cardiovascular benefits in clinical trials, including a reduction in major cardiovascular events, like heart attacks and strokes, in patients with type 2 diabetes who are at high cardiovascular risk.

Frequency not defined

Low blood sugar

Dizziness

Nausea

Vomiting

Diarrhea

Headache

Black Box Warning:

None

Contraindication/Caution:

Contraindication

lixisenatide has certain contraindications, which are specific situations or conditions in which medication use is not recommended.

Hypersensitivity: lixisenatide is contraindicated in individuals with known hypersensitivity or allergy to lixisenatide or its components. Allergic reactions can range from mild skin reactions to severe anaphylaxis, a life-threatening allergic response.
Personal/Family History of Medullary Thyroid Carcinoma (MTC): lixisenatide is contraindicated in individuals with a personal/family history of medullary thyroid carcinoma or in those with a known genetic condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). lixisenatide can stimulate the growth of existing MTC or increase the risk of developing MTC.
Multiple Endocrine Neoplasia syndrome type 2: lixisenatide is contraindicated in individuals with MEN 2, a genetic condition characterized by developing tumors in the endocrine glands. This condition includes medullary thyroid carcinoma (MTC), which lixisenatide may worsen.

Caution

While lixisenatide is generally safe and well-tolerated, there are some cautions and precautions to be aware of when using this medication.

Pancreatitis: GLP-1 receptor agonists, including lixisenatide, have been associated with an increased risk of pancreatitis (pancreas inflammation). Symptoms of pancreatitis may include persistent severe abdominal pain that can radiate to the back, with or without vomiting. If pancreatitis is suspected, lixisenatide should be discontinued, and appropriate medical treatment should be sought.
Hypoglycemia: lixisenatide, combined with other antidiabetic medications like sulfonylureas, may increase the risk of hypoglycemia (low blood sugar). Monitoring of blood glucose levels is essential, especially when initiating or adjusting the dose of lixisenatide or concomitant antidiabetic medications.
Renal Impairment: lixisenatide should be used cautiously in patients with renal impairment. Dose adjustments may be necessary for individuals with moderate-severe renal impairment or end-stage renal disease. Close monitoring of renal function and glycemic control is recommended in these patients.
Gastrointestinal Effects: lixisenatide may cause gastrointestinal adverse effects, like nausea, vomiting, diarrhea, and abdominal pain. These effects are usually mild and transient, but medical advice should be sought if they persist or become severe.
Thyroid C-cell Tumors: lixisenatide has been associated with an enhanced risk of thyroid C-cell tumors in animal studies. Routine monitoring of serum calcitonin or thyroid ultrasound is not recommended unless there is a history of MTC or MEN 2.
Injection-Site Reactions: Localized injection-site reactions, including redness, swelling, and itching, may occur with lixisenatide. Proper injection technique and rotation of injection sites can help minimize these reactions.
Hypersensitivity Reactions: Rare hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with lixisenatide.

Pregnancy consideration:

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Lactation:  

Excreted into human milk: Not known.

Pregnancy category:

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   
Category N: There is no data available for the drug under this category

Pharmacology:

Pharmacodynamics:

Mechanism of action: lixisenatide exerts its pharmacological effects through its mechanism of action as a glucagon-like peptide-1 receptor agonist.

GLP-1 Receptor Activation: lixisenatide selectively binds and activates the GLP-1 receptors, predominantly found in various tissues, including the pancreas, gastrointestinal tract, and central nervous system.
Glucose-Dependent Insulin Secretion: lixisenatide enhances glucose-dependent insulin secretion upon activation of GLP-1 receptors on pancreatic beta cells. It stimulates insulin release from beta cells in response to elevated blood glucose levels. This action helps to lower blood sugar levels and maintain glycemic control.
Suppression of Glucagon Secretion: lixisenatide also suppresses glucagon secretion, a hormone pancreatic alpha cells produce. Glucagon typically promotes the release of stored glucose from the liver, increasing blood sugar levels. By inhibiting glucagon secretion, lixisenatide helps to prevent excessive glucose production and further supports glucose control.
Delayed Gastric Emptying: lixisenatide slows down the rate at which food leaves the stomach (gastric emptying). This delayed gastric emptying can help regulate the rise in blood sugar levels after meals, reducing postprandial hyperglycemia. It allows for better matching of insulin release with the absorption of nutrients from the GIT (gastrointestinal tract).
Satiety and Weight Management: lixisenatide may promote satiety, making individuals more satisfied and reducing appetite. This effect can lead to reduced food intake and potential weight loss in some individuals.

Pharmacokinetics:

Absorption

Distribution

Metabolism

Elimination and Excretion

Administration:

Subcutaneous administration

lixisenatide is typically administered as a subcutaneous injection.

Injection Sites:

lixisenatide is usually injected into the thigh, upper arm, or abdomen. The injection site should be rotated within the same region to diminish the risk of lipodystrophy (changes in the fatty tissue) or injection site reactions. Avoid injecting into areas with bruises, scars, or hardened skin.

Preparing the Injection:

Wash your hands thoroughly with soap and water.
Gather the necessary supplies, including a lixisenatide pen injector or syringe, alcohol swabs, and a sharps container.
Check the drug label to ensure it is correct and has not expired.
If using a pen injector, attach a new pen needle securely. If you are using a syringe, attach an appropriate needle.

Administration Steps:

Clean the injection site area with the alcohol swab and allow it to dry.
If using a pen injector, remove the cap and hold the pen at a 90-degree angle to the skin. If you are using a syringe, hold it like a pencil.
Pinch a fold of skin at cleaned injection site.
Insert the needle into the skin at the chosen angle (usually 45 to 90 degrees) and inject the medication slowly and steadily.
Once the injection is complete, remove the needle from the skin.
If using a pen injector, hold the pen against the skin for a few seconds before removing it to ensure the total dose is delivered.
Do not rub the injection site after the administration.
Disposal of Sharps: Place used needles and syringes in a sharps container immediately after use. Do not recap the needle.

Patient information leaflet

Generic Name: lixisenatide

Pronounced: [ LIX-i-SEN-a-tide ]

Why do we use lixisenatide?

lixisenatide is primarily used for the treatment of type 2 diabetes mellitus. It is prescribed to help control blood sugar levels in individuals with this condition.

Type 2 Diabetes Mellitus: lixisenatide is indicated as additive to diet and exercise to improve glycemic control in the adults with type 2 diabetes. It is used when blood sugar levels are not adequately controlled with the diet and exercise alone or when other oral antidiabetic medications have not provided sufficient glycemic control.
Monotherapy: lixisenatide can be used as a monotherapy in individuals with type 2 diabetes when diet and exercise alone are insufficient to control blood sugar levels and when metformin cannot be tolerated due to contraindications or intolerance.
Combination Therapy: lixisenatide is commonly prescribed with other antidiabetic medications for better glycemic control. It can be combined with oral antidiabetic drugs such as metformin, sulfonylureas, thiazolidinediones, and dipeptidyl peptidase-4 (DPP-4) inhibitors. It can also be used in combination with basal insulin.
Cardiovascular Risk Reduction: lixisenatide has demonstrated cardiovascular benefits in clinical trials. It has been shown to diminish the risk of major cardiovascular events, like the heart attack and stroke, in individuals with type 2 diabetes who are at high risk. Therefore, it may be prescribed to individuals with diabetes and cardiovascular disease or those at increased risk of cardiovascular complications.

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