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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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