Nivolumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic melanoma; Locally advanced or metastatic non-small cell lung carcinoma; Advanced renal cell carcinoma; Locally advanced or metastatic squamous cell carcinoma of the head and neck; Relapsed or refractory classical Hodgkin; Locally advanced or metastatic urothelial carcinoma 3 mg/kg every 2 weeks. Metastatic melanoma Combined with ipilimumab: 1 mg/kg every 3 weeks for 4 doses, followed by ipilimumab. Thereafter, 3 mg/kg every 2 weeks. Metastatic colorectal cancer; Hepatocellular carcinoma 240 mg every 2 weeks.
Dosage Details
Intravenous
Advanced renal cell carcinoma, Locally advanced non-small cell lung carcinoma, Locally advanced squamous cell carcinoma of the head and neck, Locally advanced urothelial carcinoma, Metastatic melanoma, Metastatic non-small cell lung carcinoma, Metastatic squamous cell carcinoma of the head and neck, Metastatic urothelial carcinoma, Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma
Adult: 3 mg/kg, given via infusion over 60 minutes, every 2 weeks. Continued until disease progression or unacceptable toxicity.

Intravenous
Metastatic colorectal cancer
Adult: 240 mg, given via infusion over 60 minutes, every 2 weeks. Continued until disease progression or unacceptable toxicity.
Child: ≥12 years Same as adult dose.

Intravenous
Hepatocellular carcinoma
Adult: 240 mg, given via infusion over 60 minutes, every 2 weeks. Continued until disease progression or unacceptable toxicity.

Intravenous
Metastatic melanoma
Adult: In combination with ipilimumab: 1 mg/kg, given via infusion over 60 minutes, every 3 weeks for 4 doses, followed by ipilimumab. Thereafter, 3 mg/kg over 60 minutes, every 2 weeks, as monotherapy. Continued until disease progression or unacceptable toxicity.
Reconstitution
Dilute vials labelled as containing 10 mg/mL with NaCl 0.9% solution or glucose 5% solution to provide a solution containing approx 1-10 mg/mL. Do not shake.
Special Precautions
Patient with history or concurrent active brain metastases or active auto-immune disease, ocular/uveal melanoma, symptomatic interstitial lung disease, poor prognosis or aggressive disease, and medical conditions requiring systemic immunosuppression. Patient with carcinoma of the nasopharynx or salivary gland when used for the treatment of head and neck cancer. Patient who received hematopoietic stem cell transplant. Moderate to severe hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Adrenal insufficiency, type 1 diabetes mellitus, diabetic ketoacidosis; elevation of ALT, AST, alkaline phosphatase, bilirubin; hypophysitis, immune-mediated nephritis, and other immune-related adverse reactions (e.g. auto-immune neuropathy, demyelination, uveitis). Rarely, severe infusion-related reactions.
Blood and lymphatic system disorders: Lymphocytopenia, anaemia, leucopenia, thrombocytopenia.
Gastrointestinal disorders: Nausea, constipation, vomiting, abdominal pain, intestinal perforation, stomatitis.
General disorders and administration site conditions: Fatigue, malaise, weakness, febrile reaction.
Investigations: Increased serum amylase, lipase, triglycerides, cholesterol.
Metabolism and nutrition disorders: Peripheral oedema, decreased appetite, hyponatraemia, hyperkalaemia, hypocalcaemia, hypomagnesaemia.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, back pain, arthralgia, myopathy.
Nervous system disorders: Headache, peripheral neuropathy, neuritis, peripheral nerve palsy.
Renal and urinary disorders: UTI.
Respiratory thoracic and mediastinal disorders: Upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Rash, pruritus, vitiligo, erythema.
Vascular disorders: Hypertension.
Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis, neutropaenia, dyspnoea, renal failure; immune-mediated encephalitis, diarrhea/colitis, hepatitis, hypophysitis, thyroid dysfunction, pneumonia, pneumonitis or interstitial lung disease, pulmonary embolism. Rarely, myotoxicity (e.g. myositis, myocarditis, rhabdomyolysis).
Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor LFT, serum creatinine, thyroid function at baseline and periodically thereafter; blood glucose. Monitor for signs and symptoms of electrolyte disturbance, dehydration, immune-mediated colitis, hypophysitis, pneumonitis, hepatitis, thyroid disorder, rash, encephalitis, adrenal insufficiency and other immune-related adverse reactions; cardiac and pulmonary adverse reactions, myotoxicity, and infusion reactions during and at least 5 months after discontinuation of therapy.
Drug Interactions
Potentially Fatal: Decreased therapeutic effect with immunosuppressants.
Action
Description: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody which binds to negative immunoregulatory protein programmed death-1 (PD-1) receptor. This results in the activation of immune response to tumour cells.
Pharmacokinetics:
Distribution: Crosses the placenta.
Metabolism: Catabolised into small peptides and amino acids.
Excretion: Terminal elimination half-life: Approx 25 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze. Reconstituted solution: Stable for 8 hours when stored between 20-25°C and 24 hours between 2-8°C.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01XC17 - nivolumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by MIMS based on Nivolumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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