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Special Alert

IMPORTANT ERROR PREVENTION ADVISORY


September 16, 1996 special issue

ISMP has been made aware of several unrelated accidental overdoses of Camptosar(r) Injection (irinotecan hydrochloride injection, CPT-11) that have taken place since the product's launch on July 29th, 1996. The product, an antineoplastic agent marketed by the Pharmacia & Upjohn Company, is indicated in patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following fluorouracil based therapy.

Although the container labels meet FDA requirements, some individuals preparing doses have confused the drug's 20 mg per mL concentration, assuming this indicated the entire vial contents. In fact, the vials contain a total volume of 5 mL or 100 mg. However, the "5 mL" notation is in smaller print in the upper right corner of the label, away from the concentration information, and has been overlooked. In three of the cases, a patient received a five-fold overdose. A death in one of the patient s may be related to the overdose.

Pharmacia & Upjohn Company is aware of the above cases and has interacted with FDA officials in order to make appropriate labeling changes. If your hospital or ambulatory cancer center uses Camptosar(r), please be sure to send a copy of this alert t o all individuals who prepare doses of this medication. Since it may take several months for any newly designed product labels to reach active inventory, as an added layer of safety, we recommend that auxiliary labels be affixed to each vial to clarify that the vial contains 100 mg. Prepared doses of antineoplastics should always be checked independently by at least two health professionals. Wherever possible, one of these should be a pharmacist. The need for more than two vials of this product to prepare a single dose should raise suspicion that an incorrect interpretation has been made.

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