Nivolumab Brand Name– Opdivo
What is Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking monoclonal antibody; it binds with ligands PD-L1 and PD-L2 resulting in immune response inhibition.
Nivolumab is indicated for the treatment of certain types of melanoma, lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, and microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Immune-mediated adverse reactions including colitis, pneumonitis, hepatitis, hypophysitis, nephritis, hypothyroidism/hyperthyroidism, and encephalitis have been reported with nivolumab therapy in clinical trials; treatment with high-dose corticosteroids may be necessary in patients who develop immune-mediated toxicity.
Indications
- colorectal cancer
- esophageal cancer
- head and neck cancer
- hepatocellular cancer
- Hodgkin lymphoma
- malignant melanoma
- non-small cell lung cancer (NSCLC)
- renal cell cancer
- small cell lung cancer (SCLC)
- urothelial carcinoma
For the treatment of malignant melanoma
NOTE: The FDA has designated nivolumab as an orphan drug for the treatment of stage IIB to IV melanoma.
for the treatment of unresectable or metastatic melanoma, as single-agent therapy
Side Effects
- abdominal pain
- abdominal pain
- acneiform rash
- adrenocortical insufficiency
- adrenocortical insufficiency
- alopecia
- alopecia
- anemia
- anemia
- anorexia
- anorexia
- antibody formation
- aplastic anemia
- arthralgia
- arthralgia
- arthropathy
- ascites
- ascites
- asthenia
- asthenia
- atopic dermatitis
- atrial fibrillation
- back pain
- back pain
- blurred vision
- bone pain
- bullous rash
- chills
- colitis
- colitis
- constipation
- constipation
- cough
- cough
- cranial nerve palsies
- dehydration
- diabetes mellitus
- diabetic ketoacidosis
- diarrhea
- diarrhea
- dizziness
- dizziness
- dysesthesia
- dysesthesia
- dyspepsia
- dyspnea
- dyspnea
- edema
- edema
- elevated hepatic enzymes
- elevated hepatic enzymes
- encephalopathy
- enterocolitis
- eosinophilia
- erythema
- erythema multiforme
- exfoliative dermatitis
- fatigue
- fatigue
- fever
- fever
- folliculitis
- gastritis
- GI bleeding
- GI perforation
- graft-versus-host disease (GVHD)
- Guillain-Barre syndrome
- headache
- headache
- hemoptysis
- hepatic failure
- hepatitis
- hepatotoxicity
- hyperamylasemia
- hyperamylasemia
- hyperbilirubinemia
- hyperbilirubinemia
- hypercalcemia
- hypercalcemia
- hypercholesterolemia
- hypercholesterolemia
- hyperesthesia
- hyperesthesia
- hyperglycemia
- hyperglycemia
- hyperkalemia
- hyperkalemia
- hypertension
- hypertension
- hyperthyroidism
- hypertriglyceridemia
- hypertriglyceridemia
- hypocalcemia
- hypocalcemia
- hypoesthesia
- hypoesthesia
- hypoglycemia
- hypoglycemia
- hypokalemia
- hypokalemia
- hypomagnesemia
- hypomagnesemia
- hyponatremia
- hyponatremia
- hypophysitis
- hypophysitis
- hypopituitarism
- hypotension
- hypothyroidism
- hypothyroidism
- infection
- infection
- influenza
- infusion-related reactions
- infusion-related reactions
- insomnia
- interstitial lung disease
- interstitial nephritis
- iritis
- leukopenia
- leukopenia
- lymphopenia
- lymphopenia
- maculopapular rash
- malaise
- malaise
- migraine
- muscle cramps
- musculoskeletal pain
- musculoskeletal pain
- myalgia
- myasthenia
- myocarditis
- myopathy
- nasal congestion
- nausea
- nausea
- neuritis
- neutropenia
- neutropenia
- palmar-plantar erythrodysesthesia (hand and foot syndrome)
- pancreatitis
- paresthesias
- paresthesias
- pericarditis
- peripheral edema
- peripheral edema
- peripheral neuropathy
- peripheral neuropathy
- pharyngitis
- pharyngitis
- pleural effusion
- pneumonitis
- pneumonitis
- pruritus
- pruritus
- psoriasis
- pulmonary edema
- pulmonary embolism
- rash
- rash
- renal failure (unspecified)
- rhabdomyolysis
- rhinitis
- rhinitis
- sinusitis
- sinusitis
- sinusoidal obstruction syndrome (SOS)
- skin hypopigmentation
- Stevens-Johnson syndrome
- stomatitis
- synovitis
- thrombocytopenia
- thrombocytopenia
- toxic epidermal necrolysis
- tracheoesophageal fistula
- urticaria
- uveitis
- vasculitis
- veno-occlusive disease (VOD)
- ventricular tachycardia
- vertigo
- vesicular rash
- Vogt-Koyanagi-Harada syndrome
- vomiting
- vomiting
- weight loss
- xerostomia
Monitoring Parameters
- blood glucose
- chest x-ray
- LFTs
- pregnancy testing
- serum creatinine
- thyroid function tests (TFTs)
Contraindications
- adrenal insufficiency
- allogeneic stem cell transplant
- autoimmune disease
- breast-feeding
- colitis
- contraception requirements
- Crohn’s disease
- diabetes mellitus
- diabetic ketoacidosis
- diarrhea
- encephalopathy
- hepatic disease
- hepatitis
- hyperglycemia
- hyperthyroidism
- hypophysitis
- hypopituitarism
- hypothyroidism
- immunosuppression
- inflammatory bowel disease
- infusion-related reactions
- jaundice
- mental status changes
- multiple myeloma
- organ transplant
- pneumonitis
- pregnancy
- pregnancy testing
- pulmonary disease
- renal disease
- renal impairment
- reproductive risk
- serious rash
- systemic lupus erythematosus (SLE)
- thyroid disease
- treatment outside of a clinical trial
- type 1 diabetes mellitus
- ulcerative colitis
- viral infection
Interactions
- Palifermin
- Penicillamine
- Tuberculin Purified Protein Derivative, PPD
Palifermin: (Moderate) Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents.
Penicillamine: (Major) Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity.
Tuberculin Purified Protein Derivative, PPD: (Moderate) Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Consider deferring the skin test until completion of the immunosuppressive therapy
