IDAMYCIN PFS- idarubicin hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

IDARUBICIN HYDROCHLORIDE

Composition:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 M1 through M7.

Product summary:

IDAMYCIN PFS Injection (idarubicin hydrochloride injection) is a clear, orange-red, aqueous, preservative-free solution, free from visible particles containing 1 mg/mL idarubicin hydrochloride. Single Dose Cytosafe™ Vials: Sterile single-dose only, contains no preservative. Discard unused portion. Unit of Sale Concentration NDC 0013-2576-91 Carton of 1 Single-dose Vial 5 mg/5 mL (1 mg/mL) NDC 0013-2586-91 Carton of 1 Single-dose Vial 10 mg/10 mL (1 mg/mL) NDC 0013-2596-91 Carton of 1 Single-dose Vial 20 mg/20 mL (1 mg/mL) Store under refrigeration 2º to 8ºC (36º to 46ºF), and protect from light. Retain in carton until time of use. Single Dose Glass Vials: Sterile single-dose only, contains no preservative. Discard unused portion. Unit of Sale Concentration NDC 0013-2576-05 Carton of 1 Single-dose Vial 5 mg/5 mL (1 mg/mL) NDC 0013-2586-10 Carton of 1 Single-dose Vial 10 mg/10 mL (1 mg/mL) NDC 0013-2596-20 Carton of 1 Single-dose Vial 20 mg/20 mL (1 mg/mL) Store under refrigeration 2º to 8ºC (36º to 46ºF), and protect from light. Retain in carton until time of use.

Authorization status:

New Drug Application

Summary of Product characteristics

IDAMYCIN PFS- IDARUBICIN HYDROCHLORIDE SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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IDAMYCIN PFS
IDARUBICIN HYDROCHLORIDE INJECTION
RX ONLY
FOR INTRAVENOUS USE ONLY
WARNINGS
1.
2.
3.
4.
5.
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 is 5, 12-Naphthacenedione,
9-acetyl-7-[(3-amino-
2,3,6-trideoxy-α-L-_lyxo_-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-
trihydroxyhydrochloride, (7S-_cis_). The structural formula is as
follows:
®
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
EXTRAVASATION DURING ADMINISTRATION.
AS IS THE CASE WITH OTHER ANTHRACYCLINES THE USE OF IDAMYCIN PFS
CAN CAUSE MYOCARDIAL TOXICITY LEADING TO CONGESTIVE HEART FAILURE.
CARDIAC TOXICITY IS MORE COMMON IN PATIENTS WHO HAVE RECEIVED PRIOR
ANTHRACYCLINES OR WHO HAVE PRE-EXISTING CARDIAC DISEASE.
AS IS USUAL WITH ANTILEUKEMIC AGENTS, SEVERE MYELOSUPPRESSION
OCCURS WHEN IDAMYCIN PFS IS USED AT EFFECTIVE THERAPEUTIC DOSES.
IT IS RECOMMENDED THAT IDAMYCIN PFS BE ADMINISTERED ONLY UNDER
THE SUPERVISION OF A PHYSICIAN WHO IS EXPERIENCED IN LEUKEMIA
CHEMOTHERAPY AND IN FACILITIES WITH LABORATORY AND SUPPORTIVE
RESOURCES ADEQUATE TO MONITOR DRUG TOLERANCE AND PROTECT AND
MAINTAIN A PATIENT COMPROMISED BY DRUG TOXICITY. THE PHYSICIAN AND
INSTITUTION MUST BE CAPABLE OF RESPONDING RAPIDLY AND COMPLETELY TO
SEVERE HEMORRHAGIC CONDITIONS AND/OR OVERWHELMING INFECTION.
DOSAGE SHOULD BE REDUCED IN PATIENTS WITH IMPAIRED HEPATIC OR RENAL
FUNCTION. (SEE DOSAGE AND ADMINISTRATION.)
C
H
NO ∙HCL M.W. 533.96
IDAMYCIN PFS is a sterile, red-orange, isotonic parenteral
preservative-free solution,
available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-dose
only vials.
Each mL contains Idarubicin HCL, USP 1 mg (equivalent t