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OPDIVO
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
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Drug Name:

OPDIVO Rx

Generic Name and Formulations:
Nivolumab 10mg/mL; per vial; soln for IV infusion after dilution; preservative-free; contains mannitol.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for OPDIVO:

Advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy. 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:

Give as IV infusion over 30mins. 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 or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

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. Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.

Adult:

Give as IV infusion over 30mins. Continue until disease progression or unacceptable toxicity. CRC: Single-agent: 240mg 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 (as single agent). HCC: 240mg every 2 weeks or 480mg every 4 weeks. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

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:

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

Children:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

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:

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

Children:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

Indications for OPDIVO:

As a single agent for patients with BRAF V600 wild-type or BRAF V600 mutation (+) unresectable or metastatic melanoma. In combination with ipilimumab for unresectable or metastatic melanoma. Adjuvant treatment for melanoma in patients with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Adult:

Give as an IV infusion over 30mins. 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:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

Indications for OPDIVO:

Metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.

Adult:

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

Children:

Not established.

Warnings/Precautions:

See full labeling. Monitor for any immune-mediated adverse reactions; permanently discontinue or withhold, and give corticosteroids (at 1–2mg/kg/day prednisone equivalents) based on severity of event. Permanently discontinue for any life-threatening (Grade 4) adverse reaction, Grade 3 or 4 pneumonitis, Grade 3 or 4 or recurrent colitis (with ipilimumab), Grade 4 or recurrent colitis (as single agent), AST/ALT >5xULN (non-HCC) or AST/ALT >10xULN (HCC) or total bilirubin >3xULN, SCr >6xULN, Grade 4 hypophysitis, Grade 3 or 4 adrenal insufficiency, Grade 4 hyperglycemia, Grade 4 rash (or confirmed SJS or TEN), immune-mediated encephalitis, recurring Grade 3 adverse reactions, Grade 3 myocarditis, requirement for ≥10mg/day prednisone (or equivalent) for >12 weeks, or persistent Grade 2 or 3 adverse reactions lasting ≥12 weeks. Grade 2 pneumonitis, Grade 2 or 3 (as single agent) colitis, elevations in AST/ALT or bilirubin from baseline (see full labeling), SCr >1.5–6xULN, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycemia, Grade 3 rash (or suspected SJS or TEN), new onset moderate-to-severe neurologic symptoms, other Grade 3 adverse reactions (1st occurrence); withhold dose, give corticosteroids, and resume when return to Grade 0 or 1. Interrupt or decrease infusion rate if mild or moderate infusion reactions occur; discontinue if severe or life-threatening. Monitor for abnormal liver tests, elevated serum creatinine, hyperglycemia, and thyroid function prior to and during treatment; give replacement therapy for hypothyroidism. Monitor for allogeneic HSCT-related complications (eg, hyperacute, acute or chronic GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease) and treat promptly. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥5 months after final dose. Pregnancy (esp. during 2nd & 3rd trimesters), nursing mothers: not recommended.

Pharmacological Class:

Human programmed death receptor-1 (PD-1)-blocking antibody.

Adverse Reactions:

Fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper RTI, pyrexia, headache, abdominal pain; also with ipilimumab: vomiting; immune-mediated reactions (may be fatal).

Generic Availability:

NO

How Supplied:

Single-use vial (4mL, 10mL, 24mL)—1

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