- May 7, 2022
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Brand Name :
Ellence
Synonyms :
epirubicin
Class :
Antineoplastics, Anthracycline
Dosage Forms & Strengths
Solution (injectable)
Single use vials containing 2mg/ml (50 mg/25 ml and 200 mg/100 ml)
Dosage Forms & Strengths
Safety and efficacy not determined.
Refer to adult dosing
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
measles, mumps, rubella, and varicella vaccine, live (Rx)
may diminish the therapeutic effect
measles mumps and rubella vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
smallpox (vaccinia) vaccine, live
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
may diminish the therapeutic effect
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
it may increase the levels of serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates
when both drugs are combined, there may be an increased risk or severity of adverse effects
when both drugs are combined, there may be an increased risk or severity of adverse effects
may increase the risk of cardiotoxicity
may increase the risk or severity of toxic effects when combined
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may increase the levels of serum concentrations
may decrease the levels of serum concentrations
may decrease the levels of serum concentrations
may decrease the levels of serum concentrations
may decrease the levels of serum concentrations
may decrease the levels of serum concentrations
may reduce the therapeutic effect of typhoid Vaccine
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may decrease the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may decrease the serum concentration
may decrease the serum concentration
Actions and Spectrum:
epirubicin prevents cancer cells from growing and replicating by interfering with their ability to synthesise DNA. It is a member of the anthracycline family of chemotherapy medications, which are well-known for their potency in the treatment of cancer.
Bladder cancer, and stomach cancer, breast cancer, ovarian cancer, lung cancer is just a few of the many malignancies that epirubicin is effective against. To boost its efficacy, it is frequently used in conjunction with other chemotherapy medications. The kind and stage of the disease, as well as other personal considerations, will influence the chemotherapy regimen selection.
Frequency Defined
>10%
Alopecia (96%)
Anemia (72%)
Mucositis (59%)
Hot flashes (39%)
Diarrhea (25%)
Conjunctivitis (15%)
Nausea and vomiting (92%)
Leukopenia or neutropenia (80%)
Amenorrhea (72%)
Thrombocytopenia (49%)
Lethargy (46%)
<1%
Acute lymphoid leukemia
Esophagitis
Acute myelogenous leukemia
Hyperpigmentation
Myelodysplastic syndrome
Atrioventricular block
1-10%
Skin changes (5%)
Anorexia (3%)
Rash (9%)
Fever (5%)
Frequency Not Defined
Risk of secondary AML
Myocardial toxicity (including CHF)
Severe myelosuppression
Post marketing Reports
Infections and infestations: Pneumonia, sepsis
Metabolism and nutrition disorders: Hyperuricemia, dehydration
Immune system disorders: Anaphylaxis
Gastrointestinal disorders: Ulcerations, pain or burning sensation, bleeding, Erosions, hyperpigmentation of the oral mucosa
Vascular disorders: Hemorrhage, embolism arterial, shock, thrombophlebitis, phlebitis
Respiratory, mediastinal and thoracic disorders: Pulmonary embolism
Renal and urinary disorders: Red coloration of urine for 1 to 2 days after administration
General disorders and administration site conditions: Fever, chills
Poisoning, injury and procedural complications: Chemical cystitis
Subcutaneous and skin tissue disorders: flushes, nail and skin hyperpigmentation, Erythema, photosensitivity, hypersensitivity to irradiated skin, urticaria
Black Box Warning
epirubicin comes with a black box warning that lists a few potentially fatal adverse effects, including cardiotoxicity and secondary cancers.
While giving epirubicin, medical professionals should keep an eye out for symptoms of cardiotoxicity, such as shortness of breath, ankle puffiness, and an erratic or fast heartbeat.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
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 available 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
epirubicin is an anthracycline antibacterial that inhibits DNA and RNA synthesis by binding to DNA to produce its anticancer effects. Moreover, it produces free radicals that damage DNA and result in cell death.
epirubicin is injected intravenously and spread throughout the body, with the liver and spleen having the highest quantities. A little portion of the medicine is excreted by the kidneys, while the majority of the drug’s metabolism and elimination occur in the liver through biliary excretion.
Pharmacodynamics:
By combining between the base pairs of DNA, altering its natural structure and obstructing replication and transcription, epirubicin prevents the creation of DNA and RNA. The medication also produces free radicals, which contribute to its cytotoxic effects by damaging DNA through oxidation.
Pharmacokinetics:
Absorption
epirubicin is absorbed quickly and thoroughly into the circulation since it is delivered intravenously. Thus, it has a 100% bioavailability.
Distribution
epirubicin is widely dispersed throughout the body and is strongly protein-bound, mostly to albumin. The drug’s volume of distribution is rather large, and it penetrates tissues including tumors effectively. The spleen, liver and kidney have the greatest levels of epirubicin.
Metabolism
epirubicin is extensively metabolized in the liver, mostly by the enzyme alcohol dehydrogenase, to produce epirubicinol, which is a less potent metabolite than the original molecule. Via the cytochrome P450 enzyme system, epirubicin also undergoes oxidative metabolism, creating several secondary metabolites.
Elimination and excretion
epirubicin and its metabolites are mostly removed in the feces and excreted in the bile. The medication is eliminated unaltered in modest amounts in the urine. epirubicin has an elimination half-life of around 28 hours, however individuals with kidney or liver impairment may experience a longer half-life.
Administration:
Injections or intravenous infusions are used to give epirubicin.
epirubicin should be provided with caution as it can have hazardous effects on healthy body cells, especially those with high rates of proliferating, such blood cells and digestive tract lining cells.
Since the liver and kidneys oversee metabolizing and removing the medication from the body, the dose of epirubicin could require being changed in individuals with these conditions.
Patient information leaflet
Generic Name: epirubicin
Why do we use epirubicin?
A kind of chemotherapy medicine called epirubicin is used to treat different cancers. It is primarily used to treat breast cancer, where it is frequently combined with other chemotherapy medications or used in a treatment plan that also includes surgery, radiation therapy, or hormone therapy.
Other solid tumours, such as ovarian cancer, lung cancer, and stomach cancer, are also treated with epirubicin. Moreover, it has demonstrated some efficacy when used to treat hematological malignancies such lymphomas.