- Bladder, kidney, and other urologic cancers
- Colorectal and other GI cancers
- Head and neck cancer
- Leukemias, lymphomas, and other hematologic cancers
- Melanoma and other skin cancers
- Respiratory and thoracic cancers
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. Adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. 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.
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. 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 receptor-1 (PD-1) 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
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. In combination with ipilimumab for the treatment of hepatocellular carcinoma (HCC) in patients previously treated with sorafenib. Adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer (GEJC) with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy. Unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy, or in combination with ipilimumab. Unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. In combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer (GC), GEJC, and esophageal adenocarcinoma (EAC).
Adult Dosage:
Give as IV infusion over 30mins. For CRC, HCC: 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; combination therapy (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 (if ≥40kg) or 3mg/kg every 2 weeks (if <40kg) as single agent. HCC (with ipilimumab): ≥18yrs: 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. Resected esophageal or GEJC: ≥18yrs: 240mg every 2 weeks or 480mg every 4 weeks, until disease progression or unacceptable toxicity for up to 1 year. ESCC: ≥18yrs: Single agent: 240mg every 2 weeks or 480mg every 4 weeks, until disease progression or unacceptable toxicity. First-line combination therapy (with fluoropyrimidine- and platinum-containing chemotherapy): 240mg every 2 weeks or 480mg every 4 weeks (followed by fluoropyrimidine- and platinum-containing chemotherapy on the same day); (with ipilimumab): 3mg/kg every 2 weeks or 360mg every 3 weeks (followed by ipilimumab on the same day). Both combinations: continue until disease progression, unacceptable toxicity, or up to 2 years. GC, GEJC, EAC (with fluoropyrimidine- and platinum-containing chemotherapy on the same day): ≥18yrs: 240mg every 2 weeks or 360mg every 3 weeks 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 receptor-1 (PD-1) 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
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 receptor-1 (PD-1) 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
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 receptor-1 (PD-1) 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
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 receptor-1 (PD-1) 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
Respiratory and thoracic cancers:
Indications for: OPDIVO
In combination with platinum-doublet chemotherapy for resectable (tumors ≥4cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting. 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.
Adult Dosage:
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. 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. 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 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 receptor-1 (PD-1) 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
