Ontak
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Ontak® is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor [see Warnings and Precautions (5.4)].
History
There is currently no drug history available for this drug.
Other Information
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 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.
Sources
Ontak Manufacturers
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Eisai Inc.
![Ontak (Denileukin Diftitox) Injection, Solution [Eisai Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ontak | Eisai Inc.
2.1 Dosing Schedule and Administration Premedicate with an antihistamine and acetaminophen prior to each Ontak infusion. Administer at 9 or 18 mcg/kg/day by intravenous infusion over 30-60 minutes for 5 consecutive days every 21 days for 8 cycles. Do not administer as a bolus injection. Withhold administration of Ontak if serum albumin levels are less than 3.0 g/dL. Discontinue for adverse infusion reactions. 2.2 Preparation and Administration Thaw vials in the refrigerator at 2 to 8°C (36 to 46°F) for not more than 24 hours or at room temperature for 1 to 2 hours. Bring Ontak to room temperature, before preparing the dose. Mix the solution in the vial by gentle swirling; do not shake. Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, colorless and without visible particulate matter. After thawing, a haze may be visible which should clear when the solution is at room temperature. Do not refreeze Ontak after thawing. Prepare and hold diluted Ontak in plastic syringes or soft plastic IV bags. Do not use glass containers. Maintain concentration of Ontak at 15 mcg/mL or higher. during all steps in the preparation of the solution for IV infusion. Withdraw the calculated dose from the vial(s) and inject it into an empty IV infusion bag. Do not add more than 9 mL of sterile saline without preservative to the IV bag for each 1 mL of Ontak. Do not mix Ontak with other drugs. Do not administer Ontak through an in-line filter. Administer prepared solutions of Ontak within 6 hours, using a syringe pump or IV infusion bag. Discard unused portions of Ontak immediately.
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