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Yervoy

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Yervoy

Yervoy

INDICATIONS

YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of YERVOY is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of 4 doses.

Recommended Dose Modifications

  • Withhold scheduled dose of YERVOY for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy. For patients with complete or partial resolution of adverse reactions (Grade 0–1), and who are receiving less than 7.5 mg prednisone or equivalent per day, resume YERVOY at a dose of 3 mg/kg every 3 weeks until administration of all 4 planned doses or 16 weeks from first dose, whichever occurs earlier.
  • Permanently discontinue YERVOY for any of the following:

Preparation And Administration

  • Do not shake product.
  • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. Discard vial if solution is cloudy, there is pronounced discoloration (solution may have pale-yellow color), or there is foreign particulate matter other than translucent-towhite, amorphous particles.
Preparation Of Solution
  • Allow the vials to stand at room temperature for approximately 5 minutes prior to preparation of infusion.
  • Withdraw the required volume of YERVOY and transfer into an intravenous bag.
  • Dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 2 mg/mL. Mix diluted solution by gentle inversion.
  • Store the diluted solution for no more than 24 hours under refrigeration (2°C to 8°C, 36°F to 46°F) or at room temperature (20°C to 25°C, 68°F to 77°F).
  • Discard partially used vials or empty vials of YERVOY.

Administration Instructions

  • Do not mix YERVOY with, or administer as an infusion with, other medicinal products.
  • Flush the intravenous line with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after each dose.
  • Administer diluted solution over 90 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein-binding in-line filter.

HOW SUPPLIED

Dosage Forms And Strengths

50 mg/10 mL (5 mg/mL)
200 mg/40 mL (5 mg/mL)

Storage And Handling

YERVOY is available as follows:

Carton Contents NDC
One 50 mg vial (5 mg/mL), single-use vial NDC 0003-2327-11
One 200 mg vial (5 mg/mL), single-use vial NDC 0003-2328-22

Store YERVOY under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect vials from light.

Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev December 2013

Last reviewed on RxList: 12/17/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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