MedWatch - Camptosar (irinotecan hydrochloride) Dear Doc letter

The FDA Safety Information and Adverse Event Reporting Program

2002 Safety Alert - Camptosar (irinotecan hydrochloride injection)

This is the retyped text of a letter from Pharmacia. Contact the company for a copy of any referenced enclosures.

May 10, 2002

Dear Healthcare Professional:

Pharmacia is pleased to share recent changes in the prescribing information for CAMPTOSAR indicated as a component of therapy for first-line treatment of metastatic colorectal cancer in combination with 5-fluorouracil (5-FU) and leucovorin (LV) and for treatment of metastatic colorectal cancer that has recurred or progressed following initial 5-FU based treatment.

The labeling changes for CAMPTOSAR arose following the recommendations made at a December 6, 2001 meeting of the Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC). This committee was convened to review all available safety data for the combination regimen of CAMPTOSAR plus bolus 5-FU/LV. Consistent with ODAC's unanimous conclusions, FDA has agreed with the following:

Both the bolus and the infusional regimens of CAMPTOSAR plus 5-FU/LV remain approved regimens for the first-line treatment of patients with metastatic colorectal cancer.
The starting dose and schedule for both regimens remain unchanged:

Regimen	Drugs	Starting Doses	Cycle Schedule
Bolus	Irinotecan LV 5-FU	125 mg/m2 IV over 90 minutes 20 mg/m2 IV bolus 500 mg/m2 IV bolus	Weekly for 4 weeks in 6-week cycles
Infusional	Irinotecan LV 5-FU	180 mg/m2 IV over 90 minutes 200 mg/m2 IV over 2 hours 400 mg/m2 IV bolus, then 600 mg/m2 IV over 22 hours	Day 1 Day 1, 2 Biweekly x3 in 6-week cycles Day 1, 2

The prescribing information has been revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines, and to augment the information about management of treatment--related toxicities. The principal changes are as follows:

"... Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated, or antibiotic therapy if they develop ileus, fever, or severe neutropenia..." Please refer to the boxed warning in the enclosed package insert.
In patients receiving either irinotecan/5-FU/LV or 5-FU/LV in the clinical trials, higher rates of hospitalization, neutropenic fever, thromboembolism, first-cycle treatment discontinuation, and early deaths were observed in patients with a baseline performance status of 2 than in patients with a baseline performance status of 0 or 1." Please refer to the section, Warnings - General, in the enclosed package insert.
"...After the first treatment, subsequent weekly chemotherapy treatments should be delayed in patients with active diarrhea until return of pretreatment bowel function for at least 24 hours without need for antidiarrhea medication. If grade 2, 3, or 4 late diarrhea occurs, subsequent doses of CAMPTOSAR should be decreased within the current cycle..." Please refer to the section Warnings - Diarrhea and associated text in PRECAUTIONS - Information for Patients in the enclosed package insert.

Pharmacia is committed to the safety and well being of all patients receiving CAMPTOSAR. If you have any questions, please contact your local Pharmacia representative or the Pharmacia Medical and Drug Information 24-hour hotline at 1-800-323-4204 or via the Pharmacia Oncology Web site (www.pharmaciaoncology.com).

Sincerely,

Langdon Miller, MD
Vice President, Clinical Research Oncology, US

Please see enclosed full prescribing information for CAMPTOSAR

PharmaciaCorporation
P.O. Box 800
Peapack, New Jersey 07977
tel 908.901.8000
fax 908.901.7700
www.pharmacia.com

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