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Yervoy Dosage

Generic name: IPILIMUMAB 5mg in 1mL
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

2.1   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 (14.1)].

2.2   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 (14.2)]. In the event of toxicity, doses are omitted, not delayed.

2.3   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

2.4   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.
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