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Nivolumab BMS is a brand name for Nivolumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks. Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Posology Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Medicinal product no longer authorised 3 Table 1:
Recommended treatment modifications for Nivolumab BMS Immune-related adverse reaction Severity Treatment modification Immune-related pneumonitis Grade 2 pneumonitis Withhold Nivolumab BMS until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete Grade 3 or 4 pneumonitis Permanently discontinue Nivolumab BMS Immune-related colitis Grade 2 or 3 diarrhoea or colitis Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids, if needed, is complete Grade 4 diarrhoea or colitis Permanently discontinue Nivolumab BMS Immune-related hepatitis Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin Withhold Nivolumab BMS until laboratory values return to baseline and management with corticosteroids, if needed, is complete Grade 3 or 4 elevation in AST, ALT, or total bilirubin Permanently discontinue Nivolumab BMS Immune-related nephritis and renal dysfunction Grade 2 or 3 creatinine elevation Withhold Nivolumab BMS until creatinine returns to baseline and management with corticosteroids is complete Grade 4 creatinine elevation Permanently discontinue Nivolumab BMS Immune-related endocrinopathies Symptomatic endocrinopathies (including hypothyroidism, hyperthyroidism, hypophysitis, adrenal insufficiency and diabetes) Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
0 (NCI-CTCAE v4). a Recommendation for the use of hormone replacement therapy is provided in section
Nivolumab is most commonly associated with immune-related adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Summary of the safety profile In the pooled dataset of two studies in squamous NSCLC (CA209017 and CA209063), the most frequent adverse reactions (≥ 10% of patients) were fatigue (33%), decreased appetite (15%), and nausea (12%). The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Tabulated summary of adverse reactionsMedicinal product no longer authorised 9 Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063) Infections and infestations Uncommon bronchitis, upper respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon histocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Immune system disorders Uncommon anaphylactic reaction, hypersensitivity, infusion related reaction Endocrine disorders Common hypothyroidism Uncommon adrenal insufficiency, thyroiditis Metabolism and nutrition disorders Very common decreased appetite Nervous system disorders Common peripheral neuropathy, headache, dizziness Uncommon myasthenic syndrome, polyneuropathy Cardiac disorders Uncommon tachycardia Vascular disorders Uncommon vasculitis Respiratory, thoracic and mediastinal disorders Common pneumonitis, dyspnoea, cough Uncommon lung infiltration Gastrointestinal disorders Very common nausea Common diarrhoea, stomatitis, vomiting, abdominal pain, constipation, dry mouth Uncommon colitis, duodenal ulcer Skin and subcutaneous tissue disorders Common rash, pruritus Uncommon urticaria Musculoskeletal and connective tissue disorders Common musculoskeletal pain,a arthralgia Uncommon polymyalgia rheumatica Renal and urinary disorders Uncommon tubulointerstitial nephritis, renal failure General disorders and administration site conditions Very common fatigue Common pyrexia, oedema Investigations Very common increased AST,bincreased ALT,b increased alkaline phosphatase,b increased creatinine,b decreased lymphocytes,b decreased platelet count,b decreased haemoglobin,b hypercalcaemia,b hypocalcaemia,b hyperkalaemia,b hypokalaemia,b hypomagnesaemia,b hyponatraemiab Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab Uncommon Increased lipase, increased amylase a Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, spinal pain.
4. 4) or for inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day. Medicinal product no longer authorised 4 Special populations Paediatric population The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
No data are available. 2). Data from patients 75 years of age or older are too limited to draw conclusions on this population. 2). Data from patients with severe renal impairment are too limited to draw conclusions on this population. 2).
Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations. 5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Method of administration Nivolumab BMS is for intravenous use only. It is to be administered as an intravenous infusion over a period of 60 minutes. 2 μm. Nivolumab BMS must not be administered as an intravenous push or bolus injection.
9%) solution for injection or glucose 50 mg/mL (5%) solution for injection. 6. 1. 4 Special warnings and precautions for use Nivolumab is associated with immune-related adverse reactions. Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy.
For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes. Based on the severity of the adverse reaction, nivolumab should be withheld and corticosteroids administered.
If immunosuppression with corticosteroids is used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement. Rapid tapering may lead to worsening of the adverse reaction. Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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b Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements. 1). 4. 2% (13/248). 6% (4/248) of patients, respectively. No Grade 4 or 5 cases reported in these studies. 1%) with NSCLC receiving nivolumab 3 mg/kg.
1). 1). Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis. 4). 3% (23/248). 6% (4/248) of patients, respectively. No Grade 4 or 5 cases were reported in these studies.
0). 1). One patient required permanent discontinuation of nivolumab due to Grade 3 diarrhoea. 0). 2% (3/248). 4% (1/248) of patients. No Grade 3-5 cases were reported in these studies. 1). None of these patients received high-dose corticosteroids.
One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases. 3+); + denotes a censored observation. In […]
Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy. Medicinal product no longer authorised 5 Nivolumab must be permanently discontinued for any severe immune related adverse reaction that recurs and for any life threatening immune related adverse reaction.
8). , focal ground glass opacities, patchy filtrates), dyspnoea, and hypoxia. Infectious and disease-related aetiologies should be ruled out. Immune-related pneumonitis For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
For Grade 2 (symptomatic) pneumonitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents. Upon improvement, nivolumab may be resumed after corticosteroid taper. If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
8). Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool. Infectious and disease-related aetiologies should be ruled out. Immune-related colitis For Grade 4 diarrhoea or colitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
For Grade 3 diarrhoea or colitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. Upon improvement, nivolumab may be resumed after corticosteroid taper. If worsening or no improvement occurs despite initiation of corticosteroids, nivolumab must be permanently discontinued.
For Grade 2 diarrhoea or colitis, nivolumab should be withheld. 5 to 1 mg/kg/day methylprednisolone equivalents. Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed. If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose […]