May 24, 2016
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Yervoy

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Yervoy




Indications
Dosage
How Supplied

INDICATIONS

Unresectable Or Metastatic Melanoma

YERVOY is indicated for the treatment of unresectable or metastatic melanoma [see Clinical Studies].

Adjuvant Treatment Of Melanoma

YERVOY is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Recommended Dosing For Unresectable Or Metastatic Melanoma

The recommended dose of YERVOY is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a maximum of 4 doses. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose [see Clinical Studies].

Recommended Dosing For Adjuvant Treatment Of Melanoma

The recommended dose of YERVOY is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years [see Clinical Studies]. In the event of toxicity, doses are omitted, not delayed.

Recommended Dose Modifications

Table 1: Recommended Treatment Modifications for Immune-Mediated Adverse Reactions of YERVOY

Target/Organ System Adverse Reaction (CTCAE v3) Treatment Modification
Endocrine Symptomatic endocrinopathy Withhold YERVOY Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0 to 1) and who are receiving less than 7.5 mg prednisone or equivalent per day.
 
  • Symptomatic reactions lasting 6 weeks or longer
  • Inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
Permanently discontinue YERVOY
Ophthalmologic

Grade 2 through 4 reactions

  • not improving to Grade 1 within 2 weeks while receiving topical therapy or
  • requiring systemic treatment
Permanently discontinue YERVOY
All Other Grade 2 Withhold YERVOY Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0 to 1) and who are receiving less than 7.5 mg prednisone or equivalent per day.
  • Grade 2 reactions lasting 6 weeks or longer
  • Inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Grade 3 or 4
Permanently discontinue YERVOY

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-to-white, 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

Injection: 50 mg/10 mL (5 mg/mL)
Injection: 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. Revised: Oct 2015

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

Last reviewed on RxList: 11/5/2015

Indications
Dosage
How Supplied

Yervoy - User Reviews

Yervoy User Reviews

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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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