Persistent Grade 2 or 3 adverse reactions despite treatment modification Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCICTCAE v4). a Recommendation for the use of hormone replacement therapy is provided inPRECAUTIONS. SPECIAL POPULATIONS Paediatric patients The safety and efficacy of OPDIVO in children below 18 years of age have not been established. No data are available. OPDIVO should not be used in children below 18 years of age. Elderly patients No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years). No dose adjustment is required for elderly patients (≥ 65 years) (see section PHARMACOKINETICS). Patients with renal impairment The safety and efficacy of OPDIVO have not been studied in patients with severe renal impairment. Based on the population pharmacokinetic (PK) results, no dose adjustment is required in patients with mild or moderate renal impairment (see section PHARMACOKINETICS). Data from patients with severe renal impairment are too limited to drawn conclusions from this population.. Patients with hepatic impairment The safety and efficacy of OPDIVO have not been studied in patients with moderate or severe hepatic impairment. Based on the population PK results, no dose adjustment is required in patients with mild hepatic impairment (see section PHARMACOKINETICS). Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations. OPDIVO must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment. PREPARATION AND ADMINISTRATION INSTRUCTIONS Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis. Calculating the dose The prescribed dose for the patient is given in mg/kg. Based on this prescribed dose, calculate the total dose to be given. More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.
Persistent Grade 2 or 3 adverse reactions despite treatment modification Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCICTCAE v4). a Recommendation for the use of hormone replacement therapy is provided inPRECAUTIONS. SPECIAL POPULATIONS Paediatric patients The safety and efficacy of OPDIVO in children below 18 years of age have not been established. No data are available. OPDIVO should not be used in children below 18 years of age. Elderly patients No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years). No dose adjustment is required for elderly patients (≥ 65 years) (see section PHARMACOKINETICS). Patients with renal impairment The safety and efficacy of OPDIVO have not been studied in patients with severe renal impairment. Based on the population pharmacokinetic (PK) results, no dose adjustment is required in patients with mild or moderate renal impairment (see section PHARMACOKINETICS). Data from patients with severe renal impairment are too limited to drawn conclusions from this population.. Patients with hepatic impairment The safety and efficacy of OPDIVO have not been studied in patients with moderate or severe hepatic impairment. Based on the population PK results, no dose adjustment is required in patients with mild hepatic impairment (see section PHARMACOKINETICS). Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations. OPDIVO must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment. PREPARATION AND ADMINISTRATION INSTRUCTIONS Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis. Calculating the dose The prescribed dose for the patient is given in mg/kg. Based on this prescribed dose, calculate the total dose to be given. More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.
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