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

Description

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

Composition

active substance: idarubicin hydrochloride;

1 vial contains 5 mg of idarubicin hydrochloride;

Excipient: lactose anhydrous.

Dosage form

porous red-orange lyophilisate in the form of a piece or mass.

Pharmacotherapeutic group

Cytotoxic antibiotics and related drugs. Anthracyclines and related compounds. Idarubicin. ATX code L01D B06.

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.

Indications

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.

Contraindications

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.

Method of application and dose

Exclusively for intravenous use. The drug is not intended for intrathecal administration. The dose is calculated by body surface area.

Acute myeloid leukemia:

• Adults
  12 mg / m2 body surface area / day intravenously daily for 3 days in combination with cytarabine or 8 mg / m2 body surface area / day intravenously daily for 5 days in combination or separately.
• Children
  10–12 mg / m2 body surface area / day intravenously for 3 days in combination with cytarabine.

Acute lymphoblastic leukemia:

• Adults
  12 mg / m2 of body surface intravenously daily for 3 days as monotherapy.
• Children
  10 mg / m2 of body surface intravenously daily for 3 days as monotherapy.

Note. These recommendations are generalized. To determine the exact dosage, it is necessary to take into account the data of individual treatment protocols.

At the same time, all these dosing regimens should take into account the patient’s hematological status and the dosage of other cytotoxic drugs when used in combination with other drugs.

Patients who have developed severe mucositis should delay the start of the second cycle of treatment until complete disappearance of toxic effects. It is also recommended to reduce the dose by 25%.

To obtain a 1 mg / ml solution for intravenous injection, the product must be diluted in 5 ml of water for injections. The reconstituted solution is clear, red-orange, virtually free of visible to the naked eye mechanical particles.

Intravenous administration. The reconstituted solution of Zavedos® should be administered intravenously only. The drug should be administered slowly, over 5-10 minutes, into the intravenous infusion system, through which the patient’s body freely enters 0.9% sodium chloride solution. The drug is not recommended to be administered by conventional injection due to the risk of the drug entering the vessel, which may occur even with adequate blood flow to the syringe when aspirating with a needle.

Overdose

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.