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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)?
Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist that you are using this medication.
Do not have...
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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