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How Supplied


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].


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.

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.


Dosage Forms And Strengths

Solution in a single-use vial containing 150 mcg/mL (300 mcg in 2 mL).

Storage And Handling

Ontak 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: Jubilant HollisterStier. Contract: Manufacturing & Services Division: 3525 N. Regal Street, Spokane, WA 99207. Distributed by: Eisai Inc., Woodcliff Lake, NJ 07677. Revised: Aug 2011

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/11/2016

How Supplied

Ontak - User Reviews

Ontak User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ontak sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


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