May 3, 2016
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Ontak

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Ontak




Indications
Dosage
How Supplied

INDICATIONS

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].

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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

Indications
Dosage
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

 

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.


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