Ontak

Drug Description

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ONTAK® (denileukin diftitox)

Rx Only

WARNING: Only physicians experienced in the use of antineoplastic therapy and management of patients with cancer should use ONTAK (denileukin diftitox). Patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation and where the patient can be closely monitored for an appropriate period based on his or her health status.

DRUG DESCRIPTION

ONTAK (denileukin diftitox), a recombinant DNA-derived cytotoxic protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met ₁-Thr ₃₈₇)-His followed by the sequences for interleukin-2 (IL-2; Ala ₁-Thr ₁₃₃), is produced in an E. coli expression system. ONTAK has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product. The product is purified using reverse phase chromatography followed by a multistep diafiltration process.

ONTAK is supplied in single use vials as a sterile, frozen solution intended for intravenous (IV) administration. Each 2 mL vial of ONTAK contains 300 mcg of recombinant denileukin diftitox in a sterile solution of citric acid (20 mM), EDTA (0.05 mM) and polysorbate 20 (<1%) in Water for Injection, USP. The solution has a pH of 6.9 to 7.2.

Brand Name: Ontak
Generic Name: Denileukin Diftitox

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