Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
As a single agent for treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. In combination with cabozantinib for first-line treatment of advanced RCC. In combination with ipilimumab for first-line treatment in patients with intermediate or poor risk advanced RCC. Adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. In combination with cisplatin/gemcitabine for the first-line treatment of patients with unresectable or metastatic UC. Locally advanced or metastatic UC in patients who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Opdivo Dosage and Administration
Adult
Give as IV infusion over 30mins. ≥18yrs (as single-agent or in combination with cabozantinib): 240mg every 2 weeks or 480mg every 4 weeks, until disease progression or unacceptable toxicity. In combination with cisplatin/gemcitabine (given on same day): 360mg every 3 weeks for up to 6 cycles, then followed by 240mg every 2 weeks or 480mg every 4 weeks as single agent, until disease progression, unacceptable toxicity, or up to 2 years from first dose. In combination with ipilimumab: 3mg/kg (followed by ipilimumab on the same day) every 3 weeks for 4 doses, then followed by 240mg every 2 weeks or 480mg every 4 weeks as single agent, until disease progression, unacceptable toxicity, or up to 2yrs. Adjuvant: 240mg every 2 weeks or 480mg every 4 weeks, until disease recurrence or unacceptable toxicity for up to 1 year. Dose modifications: see full labeling.
Children
<12yrs: not established.
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
Opdivo Dosage and Administration
Adult
Children
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
Opdivo Dosage and Administration
Adult
Children
<12yrs: not established.
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
Opdivo Dosage and Administration
Adult
Children
<12yrs: not established.
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
As a single agent or in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. Adjuvant treatment for completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
Opdivo Dosage and Administration
Adult
Give as an IV infusion over 30mins. ≥12yrs: (≥40kg): 240mg every 2 weeks or 480mg every 4 weeks; (<40kg): 3mg/kg every 2 weeks or 6mg/kg every 4 weeks. As a single agent (for unresectable or metastatic melanoma): continue until disease progression or unacceptable toxicity; (for adjuvant treatment): continue until disease recurrence or unacceptable toxicity for up to 1 year. In combination with ipilimumab: 1mg/kg (followed by ipilimumab on the same day) every 3 weeks for 4 doses, then followed by 240mg every 2 weeks or 480mg every 4 weeks (if ≥40kg) or 3mg/kg every 2 weeks or 6mg/kg every 4 weeks (if <40kg) as a single agent until disease progression or unacceptable toxicity. Dose modifications: see full labeling.
Children
<12yrs: not established.
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
Opdivo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Opdivo Indications
Indications
In combination with platinum-doublet chemotherapy, as neoadjuvant treatment of resectable (tumors ≥4cm or node positive) non-small cell lung cancer (NSCLC). In combination with ipilimumab for first-line treatment of metastatic NSCLC in patients whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations, as determined by an FDA-approved test. In combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for first-line treatment of metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. Metastatic NSCLC with progression on or after platinum-based chemotherapy. In combination with ipilimumab for first-line treatment of unresectable malignant pleural mesothelioma.
Opdivo Dosage and Administration
Adult
Give as IV infusion over 30mins. ≥18yrs: Neoadjuvant of resectable NSCLC: 360mg every 3 weeks with platinum-doublet chemotherapy (on the same day) every 3 weeks for 3 cycles. Metastatic NSCLC with PD-L1: 360mg every 3 weeks (with ipilimumab 1mg/kg every 6 weeks), continue with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. Metastatic or recurrent NSCLC: 360mg every 3 weeks (with ipilimumab 1mg/kg every 6 weeks) and histology-based platinum-doublet chemotherapy every 3 weeks (for 2 cycles only), continue with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. Metastatic NSCLC (single-agent): 240mg every 2 weeks or 480mg every 4 weeks, until disease progression or unacceptable toxicity. Mesothelioma: 360mg every 3 weeks (with ipilimumab 1mg/kg every 6 weeks), continue with ipilimumab until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. In combination therapies with other agents: administer Opdivo first followed by ipilimumab, and/or platinum-doublet chemotherapy on the same day. Dose modifications: see full labeling.
Children
<12yrs: not established.
Opdivo Contraindications
Not Applicable
Opdivo Boxed Warnings
Not Applicable
Opdivo Warnings/Precautions
Warnings/Precautions
Opdivo Pharmacokinetics
Absorption
Steady-state concentrations of nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and systemic accumulation was 3.7-fold.
Distribution
Mean volume of distribution at steady state (Vss) and coefficient of variation (CV%): 6.8 L (27.3%).
Elimination
Nivolumab clearance (CL) decreases over time, with a mean maximal reduction from baseline values (CV%) of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered clinically relevant. Half-life (geometric mean): 25 days.
Opdivo Interactions
Interactions
Opdivo Adverse Reactions
Adverse Reactions
Opdivo Clinical Trials
See Literature
Opdivo Note
Not Applicable
Opdivo Patient Counseling
See Literature
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