"Nov. 4, 2014 -- Twenty-year-old Milton Wright III's life seemed to finally be on track. After a lifetime of interruptions to his education, his football career, and his plans to join the Marines, he found his way. He had launched a modeling caree"...
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
Ontak - User Reviews
Ontak User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.