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Solution for Intravenous use
SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY. The following adverse reactions have been reported:
Serious and fatal infusion reactions. Administer Ontak (denileukin diftitox) in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue Ontak (denileukin diftitox) for serious infusion reactions [see WARNINGS AND PRECAUTIONS].
Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during Ontak treatment [see WARNINGS AND PRECAUTIONS ].
Loss of visual acuity and color vision [see WARNINGS AND PRECAUTIONS].
Ontak (denileukin diftitox), is a recombinant DNA-derived cytotoxic protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met1-Thr387)-His and the sequences for human interleukin-2 (IL-2; Ala1-Thr133). It is produced in an E. coli expression system and has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product. Ontak (denileukin diftitox) 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 range of 6.9 to 7.2.
What are the possible side effects of denileukin diftitox (Ontak)?
You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- blurred vision, changes in color vision;
- swelling in your...
What are the precautions when taking denileukin diftitox (Ontak)?
Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.
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