DESFERAL- deferoxamine mesylate injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DEFEROXAMINE MESYLATE (UNII: V9TKO7EO6K) (DEFEROXAMINE - UNII:J06Y7MXW4D)

Tilgjengelig fra:

Novartis Pharmaceuticals Corporation

INN (International Name):

DEFEROXAMINE MESYLATE

Sammensetning:

DEFEROXAMINE MESYLATE 500 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

DESFERAL is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. DESFERAL is indicated for the treatment of transfusional iron overload in patients with chronic anemia. Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). Desferal is contraindicated in patients with: - A history of a hypersensitivity reaction to deferoxamine or any of its inactive ingredients [see Description (11)] . Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . - Severe renal disease or anuria since the drug and the iron chelate are excreted primarily by the kidney [see Warnings and Precautions (5.3)] . Risk Summary There are no available data on Desferal use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriages or adverse maternal or fetal outcomes. In animal reproduction studies subcutaneous administration of deferoxamine to pregnan

Produkt oppsummering:

How Supplied Desferal is supplied in single-dose vials containing 500 mg of deferoxamine mesylate (corresponding to 426.82 mg of deferoxamine as free base) as a sterile, white to almost white lyophilized powder. Desferal is supplied in cartons of 4 vials (NDC 0078-0467-91). Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

Autorisasjon status:

New Drug Application

Preparatomtale

DESFERAL- DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESFERAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESFERAL.
DESFERAL (DEFEROXAMINE MESYLATE) FOR INJECTION, FOR INTRAMUSCULAR,
INTRAVENOUS, OR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1968
INDICATIONS AND USAGE
DESFERAL is an iron-chelating agent indicated:
As an adjunct to standard measures for the treatment of acute iron
intoxication. (1.1)
For the treatment of transfusional iron overload in patients with
chronic anemia. (1.2)
Limitations of Use (1.3)
Desferal is not indicated for the treatment of primary hemochromatosis
(since phlebotomy is the method
of choice for removing excess iron in this disorder).
DOSAGE AND ADMINISTRATION
Acute Iron Intoxication: (2.1)
Intramuscular Administration: Use for patients not in shock. Initial
dose is 1,000 mg. Depending upon
the clinical response, subsequent doses of 500 mg may be administered
every 4 hours to 12 hours.
Maximum dose is 6,000 mg in 24 hours.
Intravenous Administration: Only for patients in a state of
cardiovascular collapse. Initial dose is 1,000
mg at a rate not to exceed 15 mg/kg/hr. Depending upon the clinical
response, subsequent doses of
500 mg may be administered every 4 hours to 12 hours at a rate of up
to 125 mg/hr. Maximum dose is
6,000 mg in 24 hours.
Chronic Iron Overload: (2.2)
Subcutaneous Infusion: Average daily dose is between 20 and 60 mg/kg.
In patients with serum ferritin
level below 2,000 ng/mL require about 25 mg/kg/day. Patients with
serum ferritin level between 2,000
and 3,000 ng/mL require about 35 mg/kg/day. Patients with higher serum
ferritin may require up to 55
mg/kg/day.
Intravenous Administration: 20 mg/kg/day to 40 mg/kg/day for pediatric
patients and 40 mg/kg/day to
50 mg/kg/day over 8 hours to 12 hours in adults for 5 days to 7 days
per week. In pediatric patients and
adults, maximum