"The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
Unresectable Or Metastatic Melanoma
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.|
||Permanently discontinue YERVOY|
Grade 2 through 4 reactions
|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.|
||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.
- 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.
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:
|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 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/5/2015
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