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Yervoy Dosage

Medically reviewed by Drugs.com. Last updated on Nov 13, 2020.

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

Patient Selection

Select patients with metastatic NSCLC for treatment with YERVOY in combination with nivolumab based on PD-L1 expression [see Clinical Studies (14.6)].

Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosages of YERVOY as a single agent are presented in Table 1.

Table 1: Recommended Dosages for YERVOY as a Single Agent

Indication

Recommended YERVOY Dosage

Duration of Therapy

Unresectable or metastatic melanoma

3 mg/kg every 3 weeks

(90-minute intravenous infusion)

Maximum of 4 doses

Adjuvant treatment of melanoma

10 mg/kg every 3 weeks

followed by 10 mg/kg every 12 weeks

(90-minute intravenous infusion)

Every 3 weeks up to a maximum of 4 doses

Every 12 weeks for up to 3 years

The recommended dosages of YERVOY in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with YERVOY for recommended dosage information, as appropriate.

Table 2: Recommended Dosages of YERVOY in Combination with Other Therapeutic Agents

Indication

Recommended YERVOY Dosage

Duration of Therapy

Advanced renal cell carcinoma

1 mg/kg every 3 weeks

with nivolumab 3 mg/kg

(30-minute intravenous infusion on the same day)

In combination with nivolumab
for 4 doses.

After completing 4 doses of combination therapy, administer nivolumab as single agent until intolerable toxicity or disease progression.

Microsatellite instability-high (MSI‑H) or mismatch repair deficient (dMMR) metastatic colorectal cancer

1 mg/kg every 3 weeks

with nivolumab 3 mg/kg

(30-minute intravenous infusion on the same day)

After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity

Hepatocellular carcinoma

3 mg/kg every 3 weeks

with nivolumab 1 mg/kg

(30-minute intravenous infusion on the same day)

In combination with nivolumab
for 4 doses.

After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity

Metastatic non-small cell lung cancer expressing PD‑L1

1 mg/kg every 6 weeks

with nivolumab 3 mg/kg every 2 weeks

(30-minute intravenous infusion)

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Metastatic or recurrent non-small cell lung cancer

1 mg/kg every 6 weeks

with nivolumab 360 mg every 3 weeks

(30-minute intravenous infusion)

and histology-based platinum‑doublet chemotherapy every 3 weeks

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

2 cycles of histology-based platinum-doublet chemotherapy

Malignant pleural mesothelioma

1 mg/kg every 6 weeks

with nivolumab 360 mg every 3 weeks

(30-minute intravenous infusion)

In combination with nivolumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Recommended Dosage Modifications for Adverse Reactions

No dose reduction for YERVOY is recommended. In general, withhold YERVOY for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue YERVOY for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, persistent moderate (Grade 2) or severe (Grade 3) reactions lasting 12 weeks or longer after last YERVOY dose (excluding endocrinopathy), or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids. Dosage modifications for YERVOY or YERVOY in combination with nivolumab for adverse reactions that require management different from these general guidelines are summarized in Table 3.

When YERVOY is administered in combination with nivolumab, withhold or permanently discontinue both YERVOY and nivolumab for toxicity.

Table 3: Recommended Dosage Modifications for Adverse Reactions
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit of normal
* Based on Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03.
a Resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
b If AST/ALT are less than or equal to ULN at baseline, withhold or permanently discontinue YERVOY based on recommendations for hepatitis with no liver involvement.
c This guidance is only applicable to HCC patients who are being treated with YERVOY in combination with nivolumab.
d Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.

Adverse Reaction

Severity*

Dosage Modifications

Immune-Mediated Adverse Reactions [See Warnings and Precautions (5.1)]

Colitis

Grade 2

Withholda

Grade 3 or 4

Permanently discontinue

Hepatitis with no tumor involvement of the liver

or

Hepatitis with tumor involvement of the liver/non-HCC

AST or ALT increases to more than 3 times and up to 5 times the ULN

or

Total bilirubin increases to more than 1.5 times and up to 3 times the ULN

Withholda

AST or ALT more than 5 times the ULN

or

Total bilirubin more than 3 times the ULN

Permanently discontinue

Hepatitis with tumor involvement of the liverb/HCCc

Baseline AST/ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN

or

Baseline AST/ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN.

Withholda

AST/ALT increases to more than 10 times ULN

or

Total bilirubin increases to more than 3 times ULN.

Permanently discontinue

Exfoliative Dermatologic Conditions

Suspected SJS, TEN, or DRESS

Withhold

Confirmed SJS, TEN, or DRESS

Permanently discontinue

Endocrinopathiesd

Grades 3 or 4

Withhold until clinically stable or permanently discontinue depending on severity

Pneumonitis

Grade 2

Withholda

Grade 3 or 4

Permanently discontinue

Nephritis with Renal Dysfunction

Grade 2 or 3 increased blood creatinine

Withholda

Grade 4 increased blood creatinine

Permanently discontinue

Neurological Toxicities

Grade 2

Withholda

Grade 3 or 4

Permanently discontinue

Myocarditis

Grade 2, 3 or 4

Permanently discontinue

Ophthalmologic

Grade 2, 3, or 4 that does not improve to Grade 1 within 2 weeks while receiving topical therapy or that requires systemic treatment

Permanently discontinue

Other Adverse Reactions

Infusion-Related Reactions [see Warnings and Precautions (5.2)]

Grade 1 or 2

Interrupt or slow the rate of infusion

Grade 3 or 4

Permanently discontinue

Preparation and Administration

Do not shake product.
Visually inspect 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 vial(s) 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 a final concentration ranging from 1 mg/mL to 2 mg/mL. Mix diluted solution by gentle inversion.
After preparation, store the diluted solution either refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature of 20°C to 25°C (68°F to 77°F) for no more than 24 hours from the time of preparation to the time of infusion.
Discard partially used or empty vials of YERVOY.

Administration

Do not co-administer other drugs through the same intravenous line.
Flush the intravenous line with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after each dose.
Administer diluted solution 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. When administered with nivolumab and platinum-doublet chemotherapy, infuse nivolumab first followed by YERVOY and then platinum-doublet chemotherapy on the same day. Use separate infusion bags and filters for each infusion.

Further information

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