CAMPTOSAR Indication and Important Safety Information
Please scroll to see the Indication below.
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a physician who is experienced in the use of cancer
chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment
facilities are readily available. CAMPTOSAR can induce both early and late forms of diarrhea that appear to be mediated by
different mechanisms. Both forms of diarrhea may be severe. Early diarrhea (occurring during or shortly after infusion of
CAMPTOSAR) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis,
flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea and other cholinergic symptoms
may be prevented or ameliorated by atropine (see PRECAUTIONS, General). Late diarrhea (generally occurring more than 24
hours after administration of CAMPTOSAR) can be life threatening since it may be prolonged and may lead to dehydration,
electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide. 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 (see WARNINGS). Administration of CAMPTOSAR should be interrupted and
subsequent doses reduced if severe diarrhea occurs (see DOSAGE AND ADMINISTRATION).
Severe myelosuppression may occur (see WARNINGS).
Important Safety Information
With CAMPTOSAR, both early and late forms of diarrhea can occur and may be life threatening.
Late diarrhea should be managed promptly with loperamide and supportive care including
antibiotics as needed.
CAMPTOSAR can induce severe myelosuppression. Depending on the severity of neutropenia,
dose delay, dose reduction, or use of a colony-stimulating factor should be considered.
Particular caution should be exercised in monitoring the effects of CAMPTOSAR in
the elderly (>65), in patients who have previously received pelvic/abdominal
irradiation, in patients with performance status of 2 or higher, and in patients
known to be homozygous for the UGT1A1*28 allele.
Rare cases of ileus, complicated colitis, or renal impairment have been observed.
It is recommended that patients receive premedication with antiemetic agents. Prophylactic
or therapeutic administration of atropine should be considered in patients experiencing
cholinergic symptoms.
Provided intolerable toxicity does not develop, treatment with additional courses
may be continued indefinitely as long as patients continue to experience clinical
benefits.
Thromboembolic events have been observed but the specific cause has not been determined.
CAMPTOSAR should not be used in patients with severe bone marrow failure. Vaccination
with a live vaccine should be avoided in patients receiving irinotecan due to the
potential for serious or fatal infections. In addition, patients with hereditary
fructose intolerance should not be given CAMPTOSAR, as this product contains sorbitol.
Indication
CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. CAMPTOSAR is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.