Hazard Alert! Captosar® Injection
From the September 16, 1996 issue of
MSA Acute Care Edition newsletter
ISMP has been made aware of several unrelated accidental overdoses
of Captosar® 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
2o mg per mL concentration, assuming this indicated the entire
vial contents. In fact, the vials contain at total volume
of 5 mL or 100mg. However, the “5 mL” notation
is in smaller print in the upper right corner of the labe,
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 patients may be related to the overdose.
Pharmacia and 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 center uses
Camptosar®, please be sure to send a copy of this alert
to 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 100mg. 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 doses should raise suspicion
that an incorrect interpretation has been made.
The product’s current label is depicted below:
Additional information about the incidents will
be make available in the next issue of ISMP Medication Safety Alert!
