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Ontak® (denileukin diftitox) 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].
DOSAGE AND ADMINISTRATION
Dosing Schedule and Administration
- Premedicate with an antihistamine and acetaminophen prior to each Ontak (denileukin diftitox) 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 (denileukin diftitox) if serum albumin levels are less than 3.0 g/dL.
- Discontinue for adverse infusion reactions.
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 (denileukin diftitox) 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 (denileukin diftitox) after thawing.
- Prepare and hold diluted Ontak (denileukin diftitox) in plastic syringes or soft plastic IV bags. Do not use glass containers.
- Maintain concentration of Ontak (denileukin diftitox) 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 (denileukin diftitox) .
- Do not mix Ontak (denileukin diftitox) with other drugs.
- Do not administer Ontak (denileukin diftitox) through an in-line filter.
- Administer prepared solutions of Ontak (denileukin diftitox) within 6 hours, using a syringe pump or IV infusion bag.
- Discard unused portions of Ontak (denileukin diftitox) immediately.
Dosage Forms And Strengths
Single-use vial containing 150 mcg/mL (300 mcg in 2 mL).
Storage And Handling
Ontak (denileukin diftitox) is supplied as 150 mcg/ml, sterile, frozen solution (300 mcg in 2 mL) in a sterile single-use vial.NDC 62856-603-01, 6 vials in a package.
Store frozen at or below -10° C (14° F).
Manufactured by: Eisai Medical Research Inc. Ridgefield Park, NJ 07660. Manufactured at: Hollister-Stier Labs LLC Spokane, WA 99207. Distributed by: Eisai Inc., Woodcliff Lake, NJ 07677. FDA revision date: 10/16/2008
Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Ontak Information
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