IDAMYCIN PFS Solution for injection (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

0013-2576 0013-2586 0013-2596

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BOXED WARNING SECTION

<b>IDAMYCIN PFS Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is ...

1. Description

IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride ...

2. Clinical Pharmacology

Mechanism of Action Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence ...

3. Indications and Usage

IDAMYCIN PFS Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications ...

5. Warnings

Idarubicin is intended for administration under the supervision of a physician who is experienced in leukemia chemotherapy. Idarubicin is a potent bone marrow suppressant. Idarubicin should not be given ...

6.1. General

Therapy with idarubicin requires close observation of the patient and careful laboratory monitoring. Hyperuricemia secondary to rapid lysis of leukemic cells may be induced. Appropriate measures must be ...

6.3. Laboratory Tests

Frequent complete blood counts and monitoring of hepatic and renal function tests are recommended.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Formal long-term carcinogenicity studies have not been conducted with idarubicin. Idarubicin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental ...

6.7. Pregnancy

(See WARNINGS.)

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from idarubicin, ...

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

6.11. Geriatric Use

Patients over 60 years of age who were undergoing induction therapy experienced congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more ...

7. Adverse Reactions

Approximately 550 patients with AML have received idarubicin in combination with cytarabine in controlled clinical trials worldwide. In addition, over 550 patients with acute leukemia have been treated ...

9. Overdosage

There is no known antidote to idarubicin. Two cases of fatal overdosage in patients receiving therapy for AML have been reported. The doses were 135 mg/m² over 3 days and 45 mg/m² of idarubicin and 90 ...

10. Dosage and Administration

(See WARNINGS) For induction therapy in adult patients with AML the following dose schedule is recommended: IDAMYCIN PFS Injection 12 mg/m² daily for 3 days by slow (10 to 15 min) intravenous injection ...

11. How Supplied

IDAMYCIN PFS Injection (idarubicin hydrochloride injection). Single Dose Cytosafe Vials: Sterile single-dose only, contains no preservative. Discard unused portion. NDC 0013-2576-91 5 mg/5 mL vial (1 mg/mL), ...

12. Storage and Handling

Store under refrigeration 2º to 8ºC (36º to 46ºF), and protect from light. Retain in carton until time of use.

13. Clinical Studies

Four prospective randomized studies, three U.S. and one Italian, have been conducted to compare the efficacy and safety of idarubicin (IDR) to that of daunorubicin (DNR), each in combination with cytarabine ...

14. References

ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999: 32–41. Recommendations for the Safe Handling of Parenteral ...