A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
Free CME credits
Both our subscription plans include Free CME/CPD AMA PRA Category 1 credits.
Brand Name :
Opzelura
Synonyms :
ruxolitnib topical
Class :
Janus Kinase inhibitors, Dermatologics
Brand Name :
Opzelura
Synonyms :
ruxolitnib topical
Class :
Janus Kinase inhibitors, Dermatologics
Dosage Forms & Strengths
Topical cream
1.5%(15mg/g)
Apply a thin coating of cream to affected regions of up to 20% body surface area twice a day; do not exceed >60 g/week or one 100-gram tube/2 weeks
After the signs and symptoms of atopic dermatitis (such as itching, rash, and redness) have subsided, discontinue the use
Apply a thin application to affected regions of up to 10% body surface area twice a day; do not exceed >60 g/week or one 100-gram tube/2 weeks
A satisfactory patient response may necessitate therapy for more than 24 weeks
The patient should be re-evaluated if no significant repigmentation is noticed after 24 weeks
Dosage Forms & Strengths
Topical cream
1.5%(15mg/g)
<12 years: Safety and efficacy not established
≥12 years: Apply a thin coating of cream to affected regions of up to 20% of body surface area twice a day; do not exceed >60 g/week or one 100-gram tube/2 weeks
After the signs and symptoms of atopic dermatitis (such as itching, rash, and redness) have subsided, discontinue use
Re-examine the patient if signs and symptoms do not improve after eight weeks
Indicated for topical treatment of nonsegmental vitiligo:
<12 years: Safety and efficacy not established
≥12 years: Apply a thin coating, up to 10% of the body's surface area, twice daily; do not use more than 60 g per week or one 100-gram tube every two weeks
Therapy may go longer than 24 weeks, depending on the patient's reaction
At 24 weeks, reassess the patient if there has been no appreciable repigmentation
Refer adult dosing
may decrease the diagnostic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of immunosuppressive agents
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
measles, mumps, rubella, and varicella vaccine, live (Rx)
may decrease the therapeutic effect of immunosuppressants
measles mumps and rubella vaccine, live
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
smallpox (vaccinia) vaccine, live
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may have an increased neutropenic effect when combined with deferiprone
may have an increased myelosuppressive effect when combined with ropeginterferon alfa-2b
may increase the Myelosuppressive effect of each other when combined
deferiprone: they may increase the neutropenic effect of myelosuppressive agents
Ropeginterferon Alfa-2b: they may increase the myelosuppressive effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the toxic effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may enhance the serum concentration
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may increase the toxic effect of immunosuppressive agents
may increase the immunosuppressive effect of immunosuppressive agents
may have an increased myelosuppressive effect when combined with fexinidazole
cladribine: they may increase the myelosuppressive effect of myelosuppressive agents
fexinidazole: they may increase the myelosuppressive effect of myelosuppressive agents
abiraterone acetate and niraparib
may increase the neutropenic effect of myelosuppressive agents
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
may increase the level by affecting hepatic enzyme CYP3A4 metabolism
BCG vaccine: it may decrease the therapeutic effect of myelosuppressive agents
dipyridamole: it may decrease the therapeutic effect of myelosuppressive agents
olopatadine: it may decrease the therapeutic effect of myelosuppressive agents
paraldehyde: it may decrease the therapeutic effect of myelosuppressive agents
may increase the hypersensitivity reactions of immunosuppressants
may enhance the serum concentration of CYP3A4 inhibitors
may increase the immunosuppressive effect of immunosuppressive agents
may have an increased myelosuppressive effect when combined with myelosuppressive agents
may have an increased myelosuppressive effect when combined with olaparib
may have an increased adverse effect when combined with clozapine
may have an increased adverse effect when comb
may decrease the therapeutic effect when combined with BCG vaccine
may have an increased myelosuppressive effect when combined with myelosuppressive agents
may increase the toxic effect of myelosuppressive agents
may have an increased myelosuppressive effect when combined with myelosuppressive agents
may have an increased myelosuppressive effect when combined with myelosuppressive agents
5-Aminosalicylic Acid Derivatives: they may increase the myelosuppressive effect of myelosuppressive agents
5-Aminosalicylic Acid Derivatives: they may increase the myelosuppressive effect of myelosuppressive agents
chloramphenicol: they may increase the toxic effect of myelosuppressive agents
promazine: they may increase the myelosuppressive effect of myelosuppressive agents
olaparib: they may increase the myelosuppressive effect of myelosuppressive agents
It may enhance the risk of adverse effects when combined with Hormone Antagonists
when both drugs are combined, there may be a decrease in the therapeutic effect
ozanimod: it may decrease the therapeutic effect of myelosuppressive agents
tofacitinib: it may decrease the therapeutic effect of myelosuppressive agents
The immunosuppressive effect of immunosuppressants (cytotoxic chemotherapy) may be increased by denosumab
Actions and Spectrum:
Frequency defined
1-10%
Diarrhea (1%)
Ear infection (1%)
Folliculitis (1%)
Tonsillitis (3%)
Bronchitis (1%)
Rhinorrhea (1%)
Eosinophil count increased(1%)
Urticaria (1%)
Nasopharyngitis (1%)
<1%
Staphylococcal infection
Herpes zoster
Otitis externa
Acneiform dermatitis
Allergic conjunctivitis
Pyrexia
Seasonal allergy
Neutropenia
Black box warning:
ruxolitinib has a black box warning for the increased risk of serious infections, including tuberculosis, bacterial, fungal, and viral infections. It is essential for patients to be monitored for signs of infection during treatment with ruxolitinib and to be treated promptly if an infection occurs
ruxolitinib may also increase the risk of developing certain cancers, including non-melanoma skin and lymphoma
Contraindications/caution:
Contraindications:
None
Caution:
Pregnancy consideration: Insufficient data available
Lactation: Excretion of the drug in human breast milk is unknown
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:
Pharmacokinetics
Absorption
ruxolitinib is rapidly absorbed after oral administration, and its maximum plasma concentration is reached within 1-2 hours
Distribution
ruxolitinib is highly protein-bound, primarily to albumin and α-1 acid glycoprotein, with a binding capacity of approximately 98%.
Metabolism
ruxolitinib is extensively metabolized in the liver by the cytochrome P450 enzyme system, primarily by CYP3A4, to form multiple metabolites
Elimination and excretion
The half-life of ruxolitinib is approximately 3-4 hours. The drug is primarily eliminated in the feces (74%), and urine (22%) as metabolites, with less than 1% excreted unchanged. The total clearance of ruxolitinib is approximately 20 L/hour
Administration:
Topical administration:
Only for topical usage
Not to be used intravenously, orally, or topically
Storage:
Storage at 20-25 °C (68-77 °F); excursions are allowed to 15 °C (59 °F) to 86 °C
Patient information leaflet
Generic Name: ruxolitinib topical
Pronounced: [ RUX-oh-LI-ti-nib-TOP-i-kal ]
Why do we use ruxolitinib topical?
ruxolitinib is a Janus kinase (JAK) inhibitor that is used in topical form for the treatment of atopic dermatitis and eczema. Atopic dermatitis and eczema are chronic inflammatory skin conditions that can cause intense itching, redness, and scaling of the skin.
Both our subscription plans include Free CME/CPD AMA PRA Category 1 credits.
On course completion, you will receive a full-sized presentation quality digital certificate.
A dynamic medical simulation platform designed to train healthcare professionals and students to effectively run code situations through an immersive hands-on experience in a live, interactive 3D environment.
When you have your licenses, certificates and CMEs in one place, it's easier to track your career growth. You can easily share these with hospitals as well, using your medtigo app.
