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Camptosar

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Indication

CAMPTOSAR Injection (irinotecan hydrochloride injection) is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following fluorouracil therapy.

Contraindications

CAMPTOSAR is contraindicated in patients with a known hypersensitivity to the drug.

Preparation of Solution

CAMPTOSAR should be diluted in 5% Dextrose Injection, USP (preferred), or 0.9% Sodium Chloride Injection, USP, to a final concentration range of 0.12 to 1.1 mg/mL. In most clinical trials, CAMPTOSAR was administered in 500 mL of 5% Dextrose Injection, USP.

Dosage and Administration

The recommended starting dose of CAMPTOSAR Injection is 125 mg/m² administered as a 90-minute IV infusion. The recommended treatment regimen (one treatment course) is 125 mg/m² administered once weekly for 4 weeks followed by a 2-week rest period. Thereafter, additional treatment courses may be repeated every 6 weeks (4 weeks on therapy followed by 2 weeks off therapy). CAMPTOSAR may be continued indefinitely in patients who attain a response or in patients whose disease remains stable, provided intolerable toxicity does not develop.

Preparation and Administration Precautions

Exercise caution in the handling and preparation of infusion solutions containing CAMPTOSAR. The use of gloves is recommended. If a solution containing CAMPTOSAR contacts the skin, wash the skin immediately and thoroughly with soap and water. If CAMPTOSAR contacts the mucous membranes, flush thoroughly with water.

Adverse Reactions

Gastrointestinal: Diarrhea, nausea, and vomiting were common adverse events and could be severe. These events occurred early (during or within 24 hours of administration) or late (more than 24 hours after administration). The median time to onset of late diarrhea was 11 days following administration.

Hematology: Typical adverse hematologic events of CAMPTOSAR included neutropenia, leukopenia (including lymphocytopenia), and anemia. Severe myelosuppression may occur. Serious thrombocytopenia was uncommon. Only 5.6% of patients received growth colony stimulating factor (G-CSF) for the treatment of neutropenia.

Information for Patients

Patients and patient care givers should be informed of the expected toxic effects of CAMPTOSAR, particularly of its gastrointestinal manifestations, such as nausea, vomiting, and diarrhea. Each patient should be instructed to have antidiarrheal medication (loperamide) readily available and should begin treatment for late diarrhea at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent that usual.

How Supplied

CAMPTOSAR Injection is available as 100-mg, single-dose vials in the following package size:

5-mL amber glass vial (NDC 0009-7529-01)

Storage

Store at controlled room temperature 15°C to 30°C (59°F to 86°F). It is recommended that the vial (and backing/plastic blister) should remain in the carton until the time of use.

Stability

The solution is physically and chemically stable for up to 24 hours at room temperature and in ambient fluorescent lighting. Solutions diluted in 5% Dextrose Injection, USP, are physically and chemically stable for 48 hours when stored at refrigerated temperatures.

Please see the package insert for full prescribing information.


©1996 Pharmacia & Upjohn Company      USX 5843.00 August 1996

Pharmacia & Upjohn Yakult

©1996 Pharmacia & Upjohn Company

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