IDARUBICIN HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

IDARUBICIN HYDROCHLORIDE

Composition:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Idarubicin Hydrochloride injection, USP 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:

Idarubicin Hydrochloride Injection, USP Single Dose Glass Vials: Sterile single use only, contains no preservative. NDC 0143-9306-01 5 mg/5 mL vial (1 mg/mL), individually boxed. NDC 0143-9307-01 10 mg/10 mL vial (1 mg/mL), individually boxed. NDC 0143-9308-01 20 mg/20 mL vial (1 mg/mL), individually boxed. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
IDARUBICIN HYDROCHLORIDE INJECTION
RX ONLY
FOR INTRAVENOUS USE ONLY
WARNINGS
WARNINGS
1. Idarubicin Hydrochloride 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.
2. As is the case with other anthracyclines the use of idarubicin
Hydrochloride 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.
3. As is usual with antileukemic agents, severe myelosuppression
occurs when idarubicin
hydrochloride is used at effective therapeutic doses.
4. It is recommended that idarubicin hydrochloride 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.
5. Dosage should be reduced in patients with impaired hepatic or renal
function. (See DOSAGE
AND ADMINISTRATION.)
DESCRIPTION
Idarubicin Hydrochloride Injection, USP contains idarubicin
hydrochloride and is a sterile, semi-
synthetic, preservative-free solution (PFS) antineoplastic
anthracycline for intravenous use. Chemically,
idarubicin hydrochloride is
(1_S_,3_S_)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-
naphthacenyl 3-amino-2,3,6-trideoxy-α-L-_lyxo_-hexopyranoside,
hydrochloride. The structural formula
is as follows:
STRUCTURAL FORMULA
C
H NO •HCl
C
H NO •HCl
M.W. 533.95
Idarubicin Hydrochloride Injection, USP is a sterile, red-orange,
isotonic parenteral preservative-free
solution, a