CAMPTOSAR® (irinotecan hydrochloride injection)Description

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Prescribing Information

CAMPTOSAR^® (irinotecan hydrochloride injection)
Description


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CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11.

CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. It is available in two single-dose sizes: 2 mL-fill vials contain 40 mg irinotecan hydrochloride and 5 mL-fill vials contain 100 mg irinotecan hydrochloride. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol NF powder, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.

Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7] -indolizino[1,2-b]quinolin-9-yl- [1,4'bipiperidine] -1'-carboxylate, monohydrochloride, trihydrate. Its structural formula is as follows:

Irinotecan hydrochloride is a pale yellow to yellow crystalline powder, with the empirical formula C₃₃H₃₈N₄O₆•HCl•3H₂O and a molecular weight of 677.19. It is slightly soluble in water and organic solvents.

PRINTER-FRIENDLY

CAMPTOSAR Safety Information

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.

Please see full prescribing information.

CAMPTOSAR^® (irinotecan hydrochloride injection)

Full Prescribing Information