TORISEL- temsirolimus kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TEMSIROLIMUS (UNII: 624KN6GM2T) (TEMSIROLIMUS - UNII:624KN6GM2T)

Available from:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

TEMSIROLIMUS

Composition:

TEMSIROLIMUS 25 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2)] . Risk Summary Based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Although there are no data on the use of TORISEL in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproductive studies, oral daily administration of temsirolimus to pregnant rats and rabbits during organogenesis caused adverse embryo-fetal effects at approximately 0.04 and 0.12 times the AUC in patients at the recommended dose, respectively (see Data) . Advise pregnant women of the potential hazard to a fetus. The estimated background risk of major birth defects and m

Product summary:

NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL. Each kit is supplied in a single carton containing one single-use vial of 25 mg/mL of temsirolimus and one DILUENT vial which includes a deliverable volume of 1.8 mL, and must be stored at 2º–8º C (36º–46º F). Protect from light. TORISEL is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .

Authorization status:

New Drug Application

Summary of Product characteristics

TORISEL- TEMSIROLIMUS
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TORISEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TORISEL.
TORISEL KIT (TEMSIROLIMUS) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
TORISEL
is a kinase inhibitor indicated for the treatment of advanced renal
cell carcinoma. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3)
CONTRAINDICATIONS
TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTIONS (INCIDENCE ≥30%) ARE RASH,
ASTHENIA, MUCOSITIS,
NAUSEA, EDEMA, AND ANOREXIA. THE MOST COMMON LABORATORY ABNORMALITIES
(INCIDENCE
≥30%) ARE ANEMIA, HYPERGLYCEMIA, HYPERLIPIDEMIA,
HYPERTRIGLYCERIDEMIA, ELEVATED ALKALINE
PHOSPHATASE, ELEVATED SERUM CREATININE, LYMPHOPENIA, HYPOPHOSPHATEMIA,
THROMBOCYTOPENIA, ELEVATED AST, AND LEUKOPENIA. (6)TO REPORT SUSPECTED
ADVERSE
REACTIONS, CONTACT WYETH PHARMACEUTICALS INC. AT 1-800-934-5556 OR FDA
AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH
®
®
The recommended dose of TORISEL is 25 mg administered as an
intravenous infusion over a 30–60
minute period once a week. Treat until disease progression or
unacceptable toxicity. (2.1)
Antihistamine pre-treatment is recommended. (2.2)
Dose reduction is required in patients with mild hepatic impairment.
(2.4)
TORISEL (temsirolimus) injection vial contents must first be diluted
with the enclosed diluent before
diluting the resultant solution with 250 mL of 0.9% Sodium Chloride
Injection. (2.5)
Hypersensitivity/Infusion Reactions (including some life-threatening
and rare fatal reactions) can occur
early in the first infusion of TORISEL. Patients should be monitored
throughout the infusion. (5.1)
To treat hypersensitivity