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Opdivo Dosage

Generic name: NIVOLUMAB 10mg in 1mL
Dosage form: injection

Medically reviewed by Drugs.com. Last updated on Nov 10, 2020.

Patient Selection

Select patients with metastatic NSCLC for treatment with OPDIVO in combination with ipilimumab based on PD-L1 expression [see Clinical Studies (14.3)].

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 OPDIVO as a single agent are presented in Table 1.

Table 1: Recommended Dosages for OPDIVO as a Single Agent

Indication

Recommended OPDIVO Dosage

Duration of Therapy

Unresectable or metastatic melanoma

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

Until disease progression or unacceptable toxicity

Metastatic non-small cell lung cancer

Advanced renal cell carcinoma

Classical Hodgkin lymphoma

Squamous cell carcinoma of the head and neck

Urothelial carcinoma

Hepatocellular carcinoma

Esophageal squamous cell carcinoma

Adjuvant treatment of melanoma

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

Until disease recurrence or unacceptable toxicity for up to 1 year

Small cell lung cancer

240 mg every 2 weeks

(30-minute intravenous infusion)

Until disease progression or unacceptable toxicity

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

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

Until disease progression or unacceptable toxicity

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks

(30-minute intravenous infusion)

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

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

Indication

Recommended OPDIVO Dosage

Duration of Therapy

Unresectable or metastatic melanoma

1 mg/kg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 3 mg/kg intravenously

over 90 minutes on the same day

In combination with ipilimumab for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

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

Metastatic non-small cell lung cancer expressing PD-L1

3 mg/kg every 2 weeks

(30-minute intravenous infusion)

with ipilimumab 1 mg/kg every 6 weeks

(30-minute intravenous infusion)

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

Metastatic or recurrent non-small cell lung cancer

360 mg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 1 mg/kg every 6 weeks

(30-minute intravenous infusion)

and histology-based platinum

doublet chemotherapy every 3 weeks

In combination with ipilimumab 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

360 mg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 1 mg/kg every 6 weeks

(30-minute intravenous infusion)

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

Advanced renal cell carcinoma

3 mg/kg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 1 mg/kg intravenously

over 30 minutes on the same day

In combination with ipilimumab
for 4 doses

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

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

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

3 mg/kg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 1 mg/kg intravenously

over 30 minutes on the same day

In combination with ipilimumab
for 4 doses

Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more:

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

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

Pediatric patients age 12 years and older and weighing less than 40 kg:

3 mg/kg every 2 weeks

(30-minute intravenous infusion)

Hepatocellular carcinoma

1 mg/kg every 3 weeks

(30-minute intravenous infusion)

with ipilimumab 3 mg/kg intravenously

over 30 minutes on the same day

In combination with ipilimumab
for 4 doses

240 mg every 2 weeks

(30-minute intravenous infusion)

or

480 mg every 4 weeks

(30-minute intravenous infusion)

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

Dose Modifications

No dose reduction for OPDIVO is recommended. In general, withhold OPDIVO for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue OPDIVO for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, 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 OPDIVO or OPDIVO in combination with ipilimumab for adverse reactions that require management different from these general guidelines are summarized in Table 3, unless otherwise noted.

When OPDIVO is administered in combination with ipilimumab, withhold or permanently discontinue both ipilimumab and OPDIVO for an adverse reaction meeting these dose modification guidelines.

Table 3: Recommended Dosage Modifications for Adverse Reactions
a Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
b Resume in patients with complete or partial resolution (Grade 0 to 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.
c If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue OPDIVO based on recommendations for hepatitis with no liver involvement.
d Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.
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 normal

Adverse Reaction

Severitya

Dosage Modification

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

Pneumonitis

Grade 2

Withholdb

Grades 3 or 4

Permanently discontinue

Colitis

For colitis in patients treated with combination therapy with ipilimumab, see Table 4.

Grade 2 or 3

Withholdb

Grade 4

Permanently discontinue

Hepatitis with no tumor involvement of the liver

For liver enzyme elevations in patients treated with combination therapy with ipilimumab, see Table 4.

AST/ALT increases to more than 3 and up to 8 times ULN

or

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

Withholdb

AST or ALT increases to more than 8 times ULN

or

Total bilirubin increases to more than 3 times ULN.

Permanently discontinue

Hepatitis with tumor involvement of the liverc

For liver enzyme elevations in patients treated with combination therapy with ipilimumab, see Table 4.

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.

Withholdb

AST/ALT increases to more than 10 times ULN

or

Total bilirubin increases to more than 3 times ULN.

Permanently discontinue

Endocrinopathiesd

Grade 3 or 4

Withhold until clinically stable or permanently discontinue depending on severity

Nephritis with Renal Dysfunction

Grade 2 or 3 increased blood creatinine

Withholdb

Grade 4 increased blood creatinine

Permanently discontinue

Exfoliative Dermatologic Conditions

Suspected SJS, TEN, or DRESS

Withhold

Confirmed SJS, TEN, or DRESS

Permanently discontinue

Myocarditis

Grades 2, 3, or 4

Permanently discontinue

Neurological Toxicities

Grade 2

Withholdb

Grade 3 or 4

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

Table 4: Recommended Dosage Modifications for Adverse Reactions in Patients Treated with Combination Therapy
a Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
b Resume in patients with complete or partial resolution (Grade 0 to 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.
c If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue OPDIVO in combination with ipilimumab based on recommendations for hepatitis with no liver involvement.

Treatment

Adverse Reaction

Severitya

Dosage Modification

OPDIVO in combination with ipilimumab

Colitis

Grade 2

Withholdb

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/ALT increases to more than 3 and up to 5 times ULN

or

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

Withholdb

AST or ALT more than 5 times ULN or

Total bilirubin more than 3 times ULN.

Permanently discontinue

Hepatitis with tumor involvement of the liverc/HCC

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.

Withholdb

AST/ALT increases to more than 10 times ULN

or

Total bilirubin increases to more than 3 times ULN.

Permanently discontinue

Preparation and Administration

Visually inspect for particulate matter and discoloration. OPDIVO is a clear to opalescent, colorless to pale-yellow solution. Discard if cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles. Do not shake.

Preparation

Withdraw the required volume of OPDIVO and transfer into an intravenous container.
Dilute OPDIVO with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare an infusion with a final concentration ranging from 1 mg/mL to 10 mg/mL. The total volume of infusion must not exceed 160 mL.
• For adult and pediatric patients with body weight ≥40 kg, do not exceed a total volume of infusion of 160 mL.
• For adult and pediatric patients with body weight <40 kg, do not exceed a total volume of infusion of 4 mL/kg of body weight.
Mix diluted solution by gentle inversion. Do not shake.
Discard partially used vials or empty vials of OPDIVO.
The product does not contain a preservative.

After preparation, store the diluted solution either:
• at room temperature for no more than 8 hours from the time of preparation to end of the infusion. Discard diluted solution if not used within 8 hours from the time of preparation; or
• under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to end of infusion. Discard diluted solution if not used within 24 hours from the time of preparation.
Do not freeze.

Administration

Administer the infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micrometer to 1.2 micrometer).
Administer OPDIVO in combination with other therapeutic agents as follows:
o
With ipilimumab: administer OPDIVO first followed by ipilimumab on the same day.
o
With platinum-doublet chemotherapy: administer OPDIVO first followed by platinum-doublet chemotherapy on the same day
o
With ipilimumab and platinum-doublet chemotherapy: administer OPDIVO first followed by ipilimumab and then platinum-doublet chemotherapy on the same day.
Use separate infusion bags and filters for each infusion.
Flush the intravenous line at end of infusion.
Do not co-administer other drugs through the same intravenous line.

Further information

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

Frequently Asked Questions