Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for OPDIVO:

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 in patients with intermediate or poor risk, previously untreated advanced RCC. Locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Adult Dosage:

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 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. Dose modifications: see full labeling.

Children Dosage:

<18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx

Colorectal and other GI cancers:

Indications for OPDIVO:

As a single agent or in combination with ipilimumab for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) in patients ≥12yrs who has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. As a single agent or in combination with ipilimumab for the treatment of hepatocellular carcinoma (HCC) in patients previously treated with sorafenib. Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine and platinum-based chemotherapy. In combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC).

Adult Dosage:

Give as IV infusion over 30mins. For CRC, HCC, ESCC: Continue until disease progression or unacceptable toxicity. CRC: ≥12yrs: Single-agent (≥40kg): 240mg every 2 weeks or 480mg every 4 weeks; (<40kg): 3mg/kg every 2 weeks. 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 (≥40kg) or 3mg/kg every 2 weeks (<40kg) as single agent. HCC: ≥18yrs: Single-agent: 240mg every 2 weeks or 480mg every 4 weeks. 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 as single agent. ESCC: ≥18yrs: 240mg every 2 weeks or 480mg every 4 weeks. GC, GEJC, EAC: ≥18yrs: 240mg every 2 weeks or 360mg every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy until disease progression, unacceptable toxicity, or up to 2 years. Dose modifications: see full labeling.

Children Dosage:

CRC: <12yrs: not established. HCC, ESCC, GC, GEJC, EAC: <18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx

Head and neck cancer:

Indications for OPDIVO:

Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Adult Dosage:

Give as IV infusion over 30mins. ≥18yrs: 240mg every 2 weeks or 480mg every 4 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children Dosage:

<18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx

Leukemias, lymphomas, and other hematologic cancers:

Indications for OPDIVO:

Classical Hodgkin lymphoma (cHL) that relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after 3 or more lines of systemic therapy that includes autologous HSCT.

Adult Dosage:

Give as IV infusion over 30mins. ≥18yrs: 240mg every 2 weeks or 480mg every 4 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children Dosage:

<18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx

Melanoma and other skin cancers:

Indications for OPDIVO:

As a single agent or in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. Adjuvant treatment for melanoma in patients with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Adult Dosage:

Give as an IV infusion over 30mins. ≥18yrs: Single agent: 240mg every 2 weeks or 480mg every 4 weeks until disease progression or unacceptable toxicity. 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 (as single agent) until disease progression or unacceptable toxicity. 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 Dosage:

<18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx

Respiratory and thoracic cancers:

Indications for OPDIVO:

In combination with ipilimumab for first-line treatment of metastatic non-small cell lung cancer (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.

Adult Dosage:

Give as IV infusion over 30mins. ≥18yrs: NSCLC with PD-L1: 3mg/kg every 2 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. 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. Combination therapy: administer Opdivo first followed by ipilimumab, and/or platinum doublet chemotherapy on the same day. Dose modifications: see full labeling.

Children Dosage:

<18yrs: not established.

OPDIVO Warnings/Precautions:

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Higher risk of hepatotoxicity (with cabozantinib); monitor liver enzymes more frequently. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

OPDIVO Classification:

Programmed death-ligand 1 (PD-L1) blocking antibody.

OPDIVO Interactions:

Increased mortality when nivolumab is added to thalidomide analogue plus dexamethasone regimen in multiple myeloma: not recommended. Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain, vomiting; infusion-related reactions; also with ipilimumab: hypothyroidism, decreased weight, dizziness; also with cabozantinib: hepatotoxicity, palmar-plantar erythrodysaesthesia syndrome, stomatitis, hypertension, hypothyroidism, dysgeusia; also with fluoropyrimidine- and platinum-containing chemotherapy: peripheral neuropathy.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (4mL, 10mL, 24mL)—1

Pricing for OPDIVO

24ml of 240mg/24ml vial (Qty: 1)
Appx. price $6822
GoodRx