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Epiruba is indicated for:
Pharmacology
Epirubicin Hydrochloride is an anthracycline with cytotoxic properties. It works by slipping between the base pairs of the DNA strand, which physically blocks DNA and RNA synthesis and triggers DNA cleavage through the enzyme topoisomerase II. It also inhibits an enzyme called DNA helicase and generates cytotoxic free radicals.
Distribution: After being given intravenously, Epirubicin spreads rapidly and widely into body tissues. About 77% of the drug binds to plasma proteins, mainly albumin, and this binding does not change with drug concentration.
Metabolism: Epirubicin is broken down quickly and extensively by the liver, and is also metabolized by other organs and cells, including red blood cells.
Excretion: Epirubicin and its major breakdown products are cleared mainly through bile and, to a lesser extent, through urine. Its terminal elimination half-life is 30 to 40 hours.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Where possible, to lower the risk of cardiotoxicity in patients who start Epirubicin after stopping other cardiotoxic agents, especially those with long half-lives such as Trastuzumab, Epirubicin-based therapy should be delayed until those agents have cleared from the circulation. Epirubicin Injection should be given by intravenous infusion. Epirubicin is given in repeated cycles of 3 to 4 weeks. The total dose of Epirubicin may be given on day 1 of each cycle, or divided equally and given on days 1 and 8 of each cycle. The recommended dose of Epirubicin is 100 to 120 mg/m². The following regimens are recommended. CEF-120: Cyclophosphamide 75 mg/m² orally on days 1 to 14, Epirubicin 60 mg/m² intravenously on days 1 and 8, and 5-Fluorouracil 500 mg/m² intravenously on days 1 and 8, repeated every 28 days for 6 cycles. FEC-100: 5-Fluorouracil 500 mg/m², Epirubicin 100 mg/m² and Cyclophosphamide 500 mg/m², with all drugs given intravenously on day 1 and repeated every 21 days for 6 cycles. Patients receiving the 120 mg/m² regimen of Epirubicin should be given prophylactic antibiotic therapy. Or, as directed by the registered physician.
Side Effects
The most commonly reported side effects are myelosuppression, cardiotoxicity, hair loss, very high fever, lethargy, absence of menstrual periods, nausea, vomiting, diarrhoea, fever, rash, loss of appetite, and a harmless reddish colour of the urine for 1 to 2 days.
Cautions & Contraindications
Warnings & Precautions
Storing the solution for injection in a refrigerator can cause it to form a gel. This gelled product returns to a slightly viscous or free-flowing solution after 2 to 4 hours at controlled room temperature (15°C to 25°C). Before giving any injectable medicine, check it by eye for particles and discolouration whenever the solution and container allow. Follow the correct procedures for handling and disposing of anticancer drugs when handling and preparing Epirubicin Sandoz. Epirubicin Sandoz Injection should be given only under the supervision of qualified doctors with experience in cytotoxic therapy. Before starting treatment with Epirubicin Sandoz, patients should have recovered from the acute toxicities of any previous cytotoxic treatment, such as stomatitis, neutropenia, thrombocytopenia and generalised infections. The first course of Epirubicin Sandoz should also be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, AST and creatinine, and cardiac function as measured by left ventricular ejection fraction (LVEF). Patients should be watched closely during treatment for clinical complications caused by myelosuppression. Supportive care may be needed to treat severe neutropenia and serious infections. Monitoring for possible cardiotoxicity is also important, particularly as the cumulative dose of Epirubicin Sandoz increases.
Contraindications
Epirubicin must not be given to anyone with a known hypersensitivity to Epirubicin, to other anthracyclines or anthracenediones, or to any other ingredient of this product.
Pregnancy & Breastfeeding
Pregnancy Category D. Well-controlled studies in pregnant women are lacking, so this medicine should only be used during pregnancy if the potential benefit to the mother is judged to outweigh the possible risk to the unborn child. Whether it passes into human breast milk is not known. Because nursing infants could be exposed to serious adverse effects from Epirubicin, the mother and her doctor should decide together whether to stop breastfeeding or to stop the medicine, weighing how important the treatment is for her.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Epirubicin Hydrochloride doses within a treatment cycle are adjusted for hematologic and non-hematologic toxicities. The triggers are nadir platelet counts <50,000/mm³, absolute neutrophil counts (ANC) <250/mm³, neutropenic fever, or Grades 3/4 nonhematologic toxicity. In the following cycles, the Day 1 dose should be reduced to 75% of the Day 1 dose given in the current cycle. Day 1 chemotherapy should also be delayed in later courses until platelet counts are ≥100,000/mm³, ANC is ≥ 1500/mm³, and nonhematologic toxicities have recovered to ≤ Grade 1.
Bone Marrow Dysfunction
A lower starting dose (75 to 90 mg/m²) should be considered for heavily pretreated patients, for patients with pre-existing bone marrow depression, or when neoplastic bone marrow infiltration is present. Some patients receive Epirubicin Hydrochloride as a divided dose (day 1 and day 8). For them, the day 8 dose should be 75% of the day 1 dose if platelet counts are 75,000 to 100,000/mm³ and ANC is 1000 to 1499/mm³. The day 8 dose should be omitted if day 8 platelet counts are <75,000/mm³, ANC is <1000/mm³, or Grades 3/4 nonhematologic toxicity has occurred.
Hepatic Impairment
No recommendations are available for patients with hepatic impairment, because patients with hepatic abnormalities were not included in the adjuvant trials. For patients with elevated serum AST or serum total bilirubin, these dose reductions are recommended. With bilirubin 1.2 to 3 mg/dL or AST 2 to 4 times the upper limit of normal, give ½ of the recommended starting dose. With bilirubin >3 mg/dL or AST >4 times the upper limit of normal, give 1/4 of the recommended starting dose.
Renal Impairment
The available data are limited, so no specific dose recommendation can be made for patients with renal impairment. Lower doses should still be considered in patients with severe renal impairment (serum creatinine > 5 mg/dL).
Pediatric Use
The safety and effectiveness of Epirubicin Hydrochloride have not been established in pediatric patients. They may be at greater risk of anthracycline-induced acute manifestations of cardiotoxicity and of chronic CHF. The pharmacokinetics of Epirubicin Hydrochloride in pediatric patients have not been evaluated.
Geriatric Use
Trials in elderly female patients did not use a lower starting dose of Epirubicin Hydrochloride. Even so, particular care should be taken in monitoring toxicity when it is given to female patients ≥70 years of age.
Overdose
If someone receives an overdose of epirubicin hydrochloride, the treatment is supportive. That can include antibiotics, blood and platelet transfusions, colony-stimulating factors, and intensive care where needed. This continues until the toxic effects have recovered.
Delayed CHF has been seen months after anthracycline treatment. So patients should be watched carefully over time for signs of CHF and given suitable supportive therapy if it appears.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Epirubicin Hydrochloride in a refrigerator, at 2-8°C. Don't let it freeze. Keep it away from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Epiruba 2 mg/ml
What is Epiruba 2 mg/ml IV Infusion?
Epiruba 2 mg/ml IV Infusion is a medicine that contains Epirubicin Hydrochloride. It is made by Drug International Unani Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Epiruba used for?
Epiruba is used for: Cancer.
What are the side effects of Epiruba?
The most commonly reported side effects are myelosuppression, cardiotoxicity, hair loss, very high fever, lethargy, absence of menstrual periods, nausea, vomiting, diarrhoea, fever, rash, loss of appetite, and a harmless reddish colour of the urine for 1 to 2 days.
Can I take Epiruba during pregnancy or while breastfeeding?
Pregnancy Category D. Well-controlled studies in pregnant women are lacking, so this medicine should only be used during pregnancy if the potential benefit to the mother is judged to outweigh the possible risk to the unborn child. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Epiruba?
If someone receives an overdose of epirubicin hydrochloride, the treatment is supportive. That can include antibiotics, blood and platelet transfusions, colony-stimulating factors, and intensive care where needed. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Epiruba?
Keep Epirubicin Hydrochloride in a refrigerator, at 2-8°C. Don't let it freeze.
Can I take other medicines with Epiruba?
Some medicines can interact with Epirubicin Hydrochloride, for example: Paclitaxel, Cimetidine, Docetaxel. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Epiruba?
Epiruba is a prescription (Rx) medicine. Take it as your doctor advises.