Zavedos (idarubicin hydrochloride) lyophilisate for infusions 5 mg. vial №1


For the treatment of acute myeloid leukemia in adults, for the induction of remission in previously untreated patients, or in patients with relapsed or refractory disease. As a second-line drug for the treatment of relapses of acute lymphoblastic leukemia in adults and children.



Composition and form of release
The drug is produced in capsules. Each capsule contains 10 mg of idarubicin hydrochloride. The drug is sold in 1 capsule in a bottle, 1 bottle in a cardboard box.
The active ingredient is idarubicin hydrochloride.
Pharmacological properties
Idarubicin is an anthracycline glycoside with antimitotic and cytotoxic effects and is a DNA intercalating analogue of daunorubicin, which inhibits the synthesis of nucleic acids by incorporation into the DNA strand and activation of topoisomerase II in.
The absence of a methoxy group at position 4 of the anthracycline structure gives this compound high lipophilicity, which leads to an increase in the rate of its uptake by cells compared to doxorubicin and daunorubicin. Idarubicin has a higher activity than daunorubicin and is an effective agent against leukemia and lymphoma in mice, both intravenously and orally.
Idarubicin has antimitotic and cytotoxic effects and is used in combination chemotherapy with other cytotoxic agents. Idarubicin in oral form is used in the treatment of such forms of cancer as:

  • acute non-lymphoblastic leukemia;
  • common breast cancer.

Intolerance to idarubicin, anthracyclines or anthracenediones, severe hepatic and renal impairment, arrhythmia, persistent myelosuppression, uncontrolled infections, severe cardiomyopathy. The drug is not used in the treatment of patients who have recently suffered a myocardial infarction.
The drug is not used in cases where the patient was treated with maximum cumulative doses of idarubicin or other anthracyclines or anthracenediones. In the treatment of pregnant women, the tool is used only after careful weighing of the harm, benefits and potential risks.
Use during pregnancy and breastfeeding
Studies have shown that idarubicin has embryotoxic potential, but controlled clinical trials in pregnant women have not been performed, so the use of the drug in the treatment of such patients is possible only in extreme cases.
Breast-feeding should be discontinued when idarubicin hydrochloride is used for therapeutic purposes.
Method of application and dose
Most often, the dose of the drug is calculated in milligrams per square meter of body surface. Oral idarubicin can be used in combination with other anticancer drugs.
When idarubicin is used in monotherapy of acute non-lymphoblastic leukemia, the recommended adult dose is 30 mg per square meter of the patient’s body per day for 3 days. When using the tool in combination therapy with other antileukemic drugs – from 15 to 30 mg per square meter of body per day for 3 days.
When idarubicin is used in the monotherapy of advanced breast cancer, the recommended dose is 45 mg per square meter of body area. The drug can be used in one day or divided into the next three days at 15 mg per square meter of skin. Treatment is repeated every three or four weeks. The drug in a dosage of 35 mg per square meter of skin can be used once in conjunction with other chemotherapeutic agents, in which case the dose of other cytostatics must be taken into account.
The integrity of the capsule should be checked before swallowing. The drug is swallowed whole without damaging the capsule shell. Eating a small amount of food does not reduce the therapeutic potential of the tool.
Taking high doses of idarubicin can cause acute myocardial toxicity within 24 hours, as well as severe myelosuppression within 10 or 14 days after taking the drug.
Acute heart failure can occur for several months after taking high doses of anthracyclines.
After an overdose, patients should be under medical supervision for six months. At development of symptoms of cardiotoxicity to the patient appoint traditional treatment.
Side effects
Sepsis, septicemia, secondary leukemia, anemia, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, anorexia, dehydration, intracerebral hemorrhage, tumor lysis syndrome, bradycardia, sinus tachycardia, periocardiomyopathy, cardiomyopathy, tachycardia erosions or gastric ulcers, alopecia, acral erythema, headache, chills.
Conditions and terms of storage
Zavedos should be stored in places protected from children at room temperature. Shelf life – 3 years.