Serious and fatal infusion reactions. Administer Ontak in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue Ontak for serious infusion reactions [see Warnings and Precautions (5.1)].
Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during Ontak treatment [see Warnings and Precautions (5.2)].
Loss of visual acuity and color vision [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
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)].

2 DOSAGE AND ADMINISTRATION
2.1 Dosing Schedule and Administration
Premedicate with an antihistamine and acetaminophen prior to each Ontak infusion.
Administer at 9 or 18mcg/kg/day by intravenous infusion over 30-60minutes for 5consecutive days every 21days for 8cycles.
Do not administer as a bolus injection.
Withhold administration of Ontak if serum albumin levels are less than 3.0g/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 24hours or at room temperature for 1 to 2hours.
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 15mcg/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 9mL of sterile saline without preservative to the IV bag for each 1mL of Ontak.
Do not mix Ontak with other drugs.
Do not administer Ontak through an in-line filter.
Administer prepared solutions of Ontak within 6hours, using a syringe pump or IV infusion bag.
Discard unused portions of Ontak immediately.
3 DOSAGE FORMS AND STRENGTHS
Solution in a single-use vial containing 150mcg/mL (300mcg in 2mL).

4 CONTRAINDICATIONS
None.