IFOSFAMIDE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IFOSFAMIDE (UNII: UM20QQM95Y) (IFOSFAMIDE - UNII:UM20QQM95Y)

Available from:

Baxter Healthcare Corporation

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. Ifosfamide for Injection is contraindicated in patients with: Ifosfamide for Injection can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide‑containing chemotherapy regimens during pregnancy. Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo . In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m2 dose of ifosfamide was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams rec

Product summary:

Ifosfamide for injection is available in single‑dose vials as follows: Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from temperatures above 30°C (86°F). Exercise caution when handling Ifosfamide for Injection. The handling and preparation of ifosfamide should always be in accordance with current guidelines on safe handling of cytotoxic agents. Several guidelines on this subject have been published.1-4 Skin reactions associated with accidental exposure to Ifosfamide for Injection may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing Ifosfamide for Injection. If Ifosfamide for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.

Authorization status:

New Drug Application

Summary of Product characteristics

IFOSFAMIDE- IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IFOSFAMIDE FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IFOSFAMIDE FOR
INJECTION.
IFOSFAMIDE FOR INJECTION, INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1988
WARNING: MYELOSUPPRESSION, NEUROTOXICITY, AND UROTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Ifosfamide for Injection is an alkylating drug indicated for use in
combination with certain other approved antineoplastic
agents for third-line chemotherapy of germ cell testicular cancer. It
should be used in combination with mesna for
prophylaxis of hemorrhagic cystitis. (1)
DOSAGE AND ADMINISTRATION
Dosage and duration of treatment and/or treatment intervals depend on
the scheme of combination therapy, the patient’s
general state of health and organ function, and the results of
laboratory monitoring. (2)
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
Myelosuppression can be severe and lead to fatal infections (5.1)
CNS toxicities can be severe and result in encephalopathy and death
(5.2)
Nephrotoxicity can be severe and result in renal failure. Hemorrhagic
cystitis can be severe. (5.3)
Ifosfamide for Injection should be administered as a slow intravenous
infusion lasting a minimum of 30 minutes at a
dose of 1.2 grams per m2 per day for 5 consecutive days. (2)
Treatment is repeated every 3 weeks or after recovery from hematologic
toxicity. (2)
To prevent bladder toxicity, Ifosfamide for Injection should be given
with extensive hydration consisting of at least 2
liters of oral or intravenous fluid per day. (2, 5.3)
Mesna should be used to reduce the incidence of hemorrhagic cystitis.
(2)
Single dose vials: 1 gram, 3 grams (3)
Known hypersensitivity to administration of ifosfamide. (4)
Urinary outflow