HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OPDIVO safely and effectively. See full prescribing information for OPDIVO.
OPDIVO (nivolumab) injection, for intravenous use
Initial U.S. Approval: 2014
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2015
Dosage and Administration (2) 11/2015
Warnings and Precautions (5) 11/2015
INDICATIONS AND USAGE
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment:
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as a single agent, of patients with BRAF V600 wild-type unresectable or metastatic melanoma. (1.1)
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as a single agent, of patients with unresectable or metastatic, BRAF V600 mutation-positive melanoma and disease progression following ipilimumab and a BRAF inhibitor. (1.1) This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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in combination with ipilimumab, of patients with BRAF V600 wild-type unresectable or metastatic melanoma (1.1). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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of patients with metastatic non-small cell lung cancer in patients with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. (1.2)
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of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. (1.3)
DOSAGE AND ADMINISTRATION
Administer as an intravenous infusion over 60 minutes.
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Unresectable or metastatic melanoma
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OPDIVO 3 mg/kg every 2 weeks. (2.1)
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OPDIVO in combination with ipilimumab: OPDIVO 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then OPDIVO 3 mg/kg every 2 weeks. (2.1)
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Metastatic non-small cell lung cancer
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OPDIVO 3 mg/kg every 2 weeks. (2.2)
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Advanced renal cell carcinoma
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OPDIVO 3 mg/kg every 2 weeks. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 40 mg/4 mL and 100 mg/10 mL solution in a single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. (5.1)
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Immune-mediated colitis:
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OPDIVO as a single agent: Withhold for moderate or severe and permanently discontinue for life-threatening colitis. (5.2)
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OPDIVO in combination with ipilimumab: Withhold for moderate and permanently discontinue for severe or life-threatening colitis. (5.2)
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Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. (5.3)
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Immune-mediated endocrinopathies: Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis. Withhold for moderate and permanently discontinue for severe or life-threatening adrenal insufficiency. Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. Monitor for hyperglycemia. Withhold for severe and permanently discontinue for life-threatening hyperglycemia. (5.4)
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Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation. (5.5)
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Immune-mediated rash: Withhold for severe and permanently discontinue for life-threatening rash. (5.6)
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Immune-mediated encephalitis: Monitor for changes in neurologic function. Withhold for new-onset moderate to severe neurological signs or symptoms and permanently discontinue for immune-mediated encephalitis. (5.7)
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Embryofetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.10, 8.1, 8.3)
Most common adverse reactions (≥20%) in patients with melanoma were:
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OPDIVO as a single agent: fatigue, musculoskeletal pain, rash, and pruritus. (6.1)
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OPDIVO in combination with ipilimumab: rash, pruritus, headache, vomiting, and colitis. (6.1)
Most common adverse reactions (≥20%) in patients with metastatic non-small cell lung cancer were fatigue, musculoskeletal pain, decreased appetite, cough, and constipation. (6.1)
Most common adverse reactions (≥20%) in patients with advanced renal cell carcinoma were: asthenic conditions, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain, and arthralgia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Discontinue breastfeeding. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Unresectable or Metastatic Melanoma
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OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma [see Clinical Studies (14.1) ].
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OPDIVO as a single agent is indicated for the treatment of patients with unresectable or metastatic, BRAF V600 mutation-positive melanoma and disease progression following ipilimumab and a BRAF inhibitor [see Clinical Studies (14.1)].
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This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma [see Clinical Studies (14.1)].
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This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
1.2 Metastatic Non-Small Cell Lung Cancer
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO [see Clinical Studies (14.2)].
1.3 Renal Cell Carcinoma
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy [see Clinical Studies (14.3)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Melanoma
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The recommended dose of OPDIVO administered as a single agent is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
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The recommended dose of OPDIVO is 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.1)]. The recommended subsequent dose of OPDIVO, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Review the Full Prescribing Information for ipilimumab prior to initiation.
2.2 Recommended Dosage for NSCLC
The recommended dose of OPDIVO is 3 m |
