DAUNORUBICIN HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DAUNORUBICIN HYDROCHLORIDE (UNII: UD984I04LZ) (DAUNORUBICIN - UNII:ZS7284E0ZP)

Available from:

Hisun Pharmaceuticals USA, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults. Daunorubicin hydrochloride injection is contraindicated in patients who have shown a hypersensitivity to it.

Product summary:

DAUNOrubicin Hydrochloride Injection, 5 mg/mL, is available as a deep red sterile liquid in butyl-rubber-stoppered vials as follows: NDC 42658-021-01 20 mg, 4 mL per vial, single-dose vials; individually-boxed. NDC 42658-021-02 20 mg, 4 mL per vial, single-dose vials; individually-boxed and then carton of 10. NDC 42658-019-01 50 mg, 10 mL per vial, single-dose vial; individually-boxed. To report SUSPECTED ADVERSE REACTION, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-855-554-4786.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DAUNORUBICIN HYDROCHLORIDE- DAUNORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
HISUN PHARMACEUTICALS USA, INC.
----------
DAUNORUBICIN HYDROCHLORIDE INJECTION
RX ONLY
WARNING
1. Daunorubicin Hydrochloride Injection must be given into a rapidly
flowing
intravenous infusion. It must never be given by the intramuscular or
subcutaneous route. Severe local tissue necrosis will occur if there
is
extravasation during administration.
2. Myocardial toxicity manifested in its most severe form by
potentially fatal
congestive heart failure may occur either during therapy or months to
years
after termination of therapy. The incidence of myocardial toxicity
increases after
a total cumulative dose exceeding 400 to 550 mg/m
in adults, 300 mg/m
in
children more than 2 years of age, or 10 mg/kg in children less than 2
years of
age.
3. Severe myelosuppression occurs when used in therapeutic doses; this
may lead
to infection or hemorrhage.
4. It is recommended that daunorubicin hydrochloride be administered
only by
physicians who are 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.
DESCRIPTION
Daunorubicin hydrochloride is the hydrochloride salt of an
anthracycline cytotoxic
antibiotic produced by a strain of _Streptomyces coeruleorubidus_. It
is provided as a deep
red sterile liquid in vials for intravenous administration only. Each
mL contains 5 mg
daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9
mg sodium
chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH),
and water for
injection, q.s. It has the following structural formula which may be
described with the
chemical name of
(1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy