OPDIVO Infusion
Nivolumab
10mg/ml
Bristol Myers Squibb Company
| Pack size | 4ml Vial |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 4488.00 AED |
Available as:
Indications
OPDIVO Infusion is used for:
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, Metastatic colorectal cancer, Hepatocellular carcinoma, Metastatic melanoma.
Adult Dose
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.
Metastatic colorectal cancer
Adult: 240 mg, given via infusion over 60 minutes, every 2 weeks or 480 mg for every 4 weeks.
Continued until disease progression or unacceptable toxicity.
Child: >12 years Same as adult dose.
Hepatocellular carcinoma
Adult: 240 mg, given via infusion over 60 minutes, every 2 weeks or 480 mg for every 4 weeks.
Continued until disease progression or unacceptable toxicity.
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.
Child Dose
Intravenous
Metastatic colorectal cancer
Child: >12 years
240 mg, given via infusion over 60 minutes, every 2 weeks or 480 mg for every 4 weeks.
Continued until disease progression or unacceptable toxicity.
Renal Dose
Administration
IV Preparation
Admixture
Withdraw required volume for calculated dose and transfer to an IV container
Dilute with either 0.9% NaCl or D5W to a final concentration ranging from 1-10 mg/mL
Total volume of infusion must not exceed 160 mL
Mix diluted solution by gentle inversion; do NOT shake
Discard partially used vials or empty vials
IV Administration
Infuse IV over 30-60 min in an IV line containing a sterile, nonpyrogenic, low protein-binding inline filter (pore size of 0.2-1.2 microns)
For adult and pediatric patients (<40 kg): Total volume of infusion must not exceed 4 mL/kg of body weigh
Do not co-administer other drugs through the same IV line
When administered in combination with ipilimumab, infuse nivolumab first followed by ipilimumab on the same day; use separate infusion bags and filters for each infusion
Flush the IV line at end of infusion
Contra Indications
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.
Lactation
Unknown if distributed in human breast milk; advise women to discontinue breastfeeding during treatment
Pregnancy-Lactation
Interactions
Potentially Fatal: Decreased therapeutic effect with immunosuppressants.
Adverse Effects
Side effects of Nivolumab :
>10% (All grades)
Melanoma
Increased AST (28%)
Hyponatremia (25%)
Increased alkaline phosphatase (22%)
Rash (21%)
Pruritus (19%)
Cough (17%)
Increased ALT (16%)
Hyperkalemia (15%)
URTI (11%)
NSCLC
Fatigue (50%)
Lymphopenia (47%)
Dyspnea, hyponatremia (38%)
Musculoskeletal pain (36%)
Cough (32%)
Nausea (29%)
Increases creatinine (22%)
Hypercalcemia, hypokalemia, hypomagnesemia (20%)
Vomiting, asthenia (19%)
Hypocalcemia, hyperkalemia, diarrhea (18%)
Edema, pyrexia (17%)
Abdominal pain, rash, increased AST (16%)
Increased alkaline phosphatase, thrombocytopenia (14%)
Chest pain, arthralgia, decreased appetite and weight (13%)
Increased ALT (12%)
1-10% (all grades)
Melanoma
Peripheral edema (10%)
NSCLC
Pneumonia (10%)
Pain (10%)
1-10% (grades 3-4)
Melanoma
Hyponatremia (5%)
Increased AST (2.4%)
Increased alkaline phosphatase (2.4%)
Hyperkalemia (2%)
Increased ALT (1.6%)
NSCLC
Dyspnea (9%)
Fatigue (7%)
Musculoskeletal pain (6%)
Pneumonia (5%)
Decreased appetite (2.6%)
Pain (2.6%)
Nausea (1.7%)
Abdominal pain (1.7%)
Asthenia (1.7%)
Edema (1.7%)
Cough (1.7%)
Mechanism of Action
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.
Note
OPDIVO 10mg/ml Infusion manufactured by Bristol Myers Squibb Company. Its generic name is Nivolumab. OPDIVO is availble in United Arab Emirates.
Farmaco UAE drug index information on OPDIVO Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.