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Yervoy Dosage

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

Medically reviewed on July 10, 2018.

Recommended Dosing for Unresectable or Metastatic Melanoma

The recommended dose of YERVOY is 3 mg/kg administered intravenously (IV) 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)].

Recommended Dosing for Adjuvant Treatment of Melanoma

The recommended dose of YERVOY is 10 mg/kg administered IV 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.

Recommended Dosing for RCC

The recommended dose of YERVOY in combination with nivolumab is nivolumab 3 mg/kg administered as an intravenous infusion over 30 minutes, followed by YERVOY 1 mg/kg administered as an intravenous infusion over 30 minutes on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.3)]. After completing 4 doses of the combination, administer nivolumab as a single agent, either:

240 mg every 2 weeks, or
480 mg every 4 weeks

as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. Review the Prescribing Information for nivolumab prior to initiation.

Recommended Dosing for Colorectal Cancer

The recommended dose of YERVOY is:

YERVOY 1 mg/kg administered as an intravenous infusion over 30 minutes, immediately following nivolumab administered on the same day, every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression [see Clinical Studies (14.4)]. Review the Prescribing Information for nivolumab prior to initiation.

Recommended Dose Modifications

Recommendations for YERVOY modifications are provided in Table 1. When YERVOY is administered in combination with nivolumab, if YERVOY is withheld, nivolumab should also be withheld. Review the Prescribing Information for nivolumab for recommended dose modifications.

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Table 1: Recommended Treatment Modifications for Immune-Mediated Adverse Reactions of YERVOY
Target/Organ System Adverse Reaction (CTCAE v4) 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.

When administered in combination with nivolumab, infuse nivolumab first followed by YERVOY on the same day. Use separate infusion bags and filters for each infusion.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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