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Denileukin Diftitox - ONTAK®
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|Stability / Miscellaneous|
Mechanism Of Action
1. INDICATIONS AND USAGE
2.1 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. 2.2 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. 3. DOSAGE FORMS AND STRENGTHS
5. WARNINGS AND PRECAUTIONS
5.1 Infusion Reactions
For patients completing at least 4 courses of Ontak treatment in Study 1 [see PACKAGE INSERT FOR Clinical Studies (14.1)], the incidence of infusion reactions was lower in the 3rd and 4th cycles as compared to the 1st and 2nd cycles of Ontak.
Resuscitative equipment should be available during Ontak administration. Immediately stop and permanently discontinue Ontak for serious infusion reactions.
5.2 Capillary Leak Syndrome
The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of Ontak.
Regularly assess patients for weight gain, new onset or worsening edema, hypotension (including orthostatic changes) and monitor serum albumin levels prior to the initiation of each course of therapy and more often as clinically indicated. Withhold Ontak for serum albumin levels of less than 3.0 g/dL [see Warnings and Precautions (5.5)].
5.3 Visual Loss
5.4 CD25 Tumor Expression and Evaluation
5.5 Laboratory Monitoring/Hypoalbuminemia
HOW SUPPLIED/STORAGE AND HANDLING
Store frozen at or below -10°C (14°F).
|1) [PACKAGE INSERT DATA] : ONTAK (denileukin diftitox) injection, solution. Eisai Medical Research Inc. Woodcliff Lake, NJ 07677. Revised: 03/2010.|