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OPDIVO is a brand name for Nivolumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics); therefore, Health Canada has not authorized an indication for pediatric use (see 8 ADVERSE REACTIONS; 8.2.1 Clinical Trial Adverse Reactions - Pediatrics and 10.3 Pharmacokinetics, Special Populations and Conditions, Pediatrics). 7.1.4. Geriatrics No overall differences in safety or efficacy were…
Verbatim from this product's HC label. Tap a section to expand.
for management guidelines for these adverse reactions]. Opdivo or Opdivo in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
Healthcare professionals should consult the ipilimumab Product Monograph prior to initiation of Opdivo in combination with ipilimumab. 4. 1.
Dosing Considerations Patient Selection Metastatic NSCLC:
Select patients with metastatic NSCLC for treatment with Opdivo in combination with ipilimumab based on PD-L1 expression. A test authorized by Health Canada which is equivalent to that used in clinical trials should be required (see 7 WARNINGS AND PRECAUTIONS and 14 CLINICAL TRIALS).
MSI-H/dMMR mCRC:Patients should be selected for treatment based on MSI-H or dMMR tumour status as determined by an experienced laboratory using validated testing methods (see 14 CLINICAL TRIALS). 2.
Recommended Dose and Dosage Adjustment Recommended Dose Opdivo as monotherapy:
The recommended dose of Opdivo as monotherapy is presented in Table 1: Table 1: Recommended Dosages for Opdivo as a Single Agent Indication Recommended Opdivo Dosage Duration of Therapy Unresectable or metastatic melanoma 3 mg/kg every 2 weeks or Opdivo (nivolumab) Page 12 of 272 Indication Recommended Opdivo Dosage Duration of Therapy Metastatic non-small cell lung cancer 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Advanced or metastatic renal cell carcinoma Squamous cell carcinoma of the head and neck Classical Hodgkin lymphoma Adjuvant Treatment of Resected Esophageal or Gastroesophageal Junction 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) After completing 16 weeks of therapy, administer as 480 mg every 4 weeks until disease progression or unacceptable toxicity for a total treatment duration of 1 year.
Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Adjuvant treatment of melanoma (Stage III/IV) 3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for up to 1 year.
]. Early diagnosis and appropriate management are essential to minimize potential life-threatening complications. Patients should be monitored for signs and symptoms suggestive of immune-mediated adverse reactions [see 7 WARNINGS AND PRECAUTIONS and 4 DOSAGE AND ADMINISTRATION for management guidelines for these adverse reactions].
Opdivo or Opdivo in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction. Healthcare professionals should consult the ipilimumab Product Monograph prior to initiation of Opdivo in combination with ipilimumab.
4. 1.
Dosing Considerations Patient Selection Metastatic NSCLC:
Select patients with metastatic NSCLC for treatment with Opdivo in combination with ipilimumab based on PD-L1 expression. A test authorized by Health Canada which is equivalent to that used in clinical trials should be required (see 7 WARNINGS AND PRECAUTIONS and 14 CLINICAL TRIALS).
MSI-H/dMMR mCRC:Patients should be selected for treatment based on MSI-H or dMMR tumour status as determined by an experienced laboratory using validated testing methods (see 14 CLINICAL TRIALS). 2.
Recommended Dose and Dosage Adjustment Recommended Dose Opdivo as monotherapy:
The recommended dose of Opdivo as monotherapy is presented in Table 1: Table 1: Recommended Dosages for Opdivo as a Single Agent Indication Recommended Opdivo Dosage Duration of Therapy Unresectable or metastatic melanoma 3 mg/kg every 2 weeks or Opdivo (nivolumab) Page 12 of 272 Indication Recommended Opdivo Dosage Duration of Therapy Metastatic non-small cell lung cancer 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
, Immune-mediated adverse reactions]. Immune-mediated adverse reactions may involve any organ system. While most of these reactions occurred during treatment, onset months after the last dose has been reported [see 7 WARNINGS AND PRECAUTIONS and
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adjuvant treatment of melanoma (Stage IIB/IIC) 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (unacceptable toxicity) for up to 1 year.
Opdivo (nivolumab) Page 13 of 272 Indication Recommended Opdivo Dosage Duration of Therapy Adjuvant treatment of urothelial carcinoma (UC) 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for up to 1 year.
If patients need to be switched from the 3 mg/kg or 240 mg every 2 weeks schedule to the 480 every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 3 mg/kg or 240 mg dose. 3 Pharmacokinetics).
Opdivo in combination with ipilimumab:
The recommended dosages of Opdivo in combination with ipilimumab is presented in Table 2.
Table 2:
Recommended doses of Opdivo in combination with ipilimumab Indication Recommended Opdivo Dosage Duration of Therapy Unresectable or metastatic melanoma Combination Phase 1 mg/kg every 3 weeks (30-minute intravenous infusion) with ipilimumab 3 mg/kg intravenously over 30 minutes on the same day Single Agent Phase 3 mg/kg every 2 weeksa or 240 mg every 2 weeksa or 480 mg every 4 weeksb (30-minute intravenous infusion) In combination with ipilimumab every 3 weeks for the first 4 doses or until unacceptable toxicity, whichever occurs earlier.
After completing combination therapy, administer Opdivo as single agent. Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer Combination phase 240 mg every 3 weeks (30-minute intravenous infusion) with ipilimumab 1 mg/kg intravenously (30-minute intravenous infusion) Single Agent Phase 240 mg every 2 weeksa or 480 mg every 4 weeksa (30-minute intravenous infusion) In combination with ipilimumab for a maximum of 4 doses After completing a maximum of 4 doses of combination therapy, administer Opdivo as single agent until disease progression or unacceptable toxicity, or up to 2 years Metastatic renal cell carcinoma Combination phase 3 mg/kg every 3 weeks (30-minute intravenous infusion) In combination with ipilimumab every 3 weeks for the first 4 doses Opdivo (nivolumab) Page 14 of 272 with ipilimumab 1 mg/kg intravenously over 30 minutes on the same day Single Agent Phase 3 mg/kg every 2 weeksa or 240 mg every 2 weeksa or 480 mg every 4 weeksb (30-minute intravenous infusion) After completing combination therapy, administer as Opdivo as single agent.
Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Previously treated metastatic MSI-H/dMMR colorectal cancer Previously untreated metastatic NSCLC 3 mg/kg every 2 weeks or 360 mg every 3 weeks (30-minute intravenous infusion) with ipilimumab 1 mg/kg every 6 weeks (30-minute intravenous infusion) Select patients based on the presence of positive PD-L1 expression as determined by an experienced laboratory using a validated test.
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Advanced or metastatic renal cell carcinoma Squamous cell carcinoma of the head and neck Classical Hodgkin lymphoma Adjuvant Treatment of Resected Esophageal or Gastroesophageal Junction 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) After completing 16 weeks of therapy, administer as 480 mg every 4 weeks until disease progression or unacceptable toxicity for a total treatment duration of 1 year.
Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Adjuvant treatment of melanoma (Stage III/IV) 3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for up to 1 year.
Adjuvant treatment of melanoma (Stage IIB/IIC) 240 mg every 2 weeks or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (unacceptable toxicity) for up to 1 year.
Opdivo (nivolumab) Page 13 of 272 Indication Recommended Opdivo Dosage Duration of Therapy Adjuvant treatment of urothelial carcinoma (UC) 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30-minute intravenous infusion) Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for up to 1 year.
If patients need to be switched from the 3 mg/kg or 240 mg every 2 weeks schedule to the 480 every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 3 mg/kg or 240 mg dose. 3 Pharmacokinetics).
Opdivo in combination with ipilimumab:
The recommended dosages of Opdivo in combination with ipilimumab is presented in Table 2.
Table 2:
Recommended doses of Opdivo in combination with ipilimumab Indication Recommended Opdivo Dosage Duration of Therapy Unresectable or metastatic melanoma Combination Phase 1 mg/kg every 3 weeks (30-minute intravenous infusion) with ipilimumab 3 mg/kg intravenously over 30 minutes on the same day Single Agent Phase 3 mg/kg every 2 weeksa or 240 mg every 2 weeksa or 480 mg every 4 weeksb (30-minute intravenous infusion) In combination with ipilimumab every 3 weeks for the first 4 doses or until unacceptable toxicity, whichever occurs earlier.
After completing combination therapy, administer Opdivo as single agent. Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer Combination phase 240 mg every 3 weeks (30-minute intravenous infusion) with ipilimumab 1 mg/kg intravenously (30-minute intravenous infusion) Single Agent Phase 240 mg every 2 weeksa or 480 mg every 4 weeksa (30-minute intravenous infusion) In combination with ipilimumab for a maximum of 4 doses After completing a maximum of 4 doses of combination therapy, administer Opdivo as single agent until disease progression or unacceptable toxicity, or up to 2 years Metastatic renal cell carcinoma Combination phase 3 mg/kg every 3 weeks (30-minute intravenous infusion) In combination with ipilimumab every 3 weeks for the first 4 doses Opdivo (nivolumab) Page 14 of 272 with ipilimumab 1 mg/kg intravenously over 30 minutes on the same day Single Agent Phase 3 mg/kg every 2 weeksa or 240 mg every 2 weeksa or 480 mg every 4 weeksb (30-minute intravenous infusion) After completing combination therapy, administer as Opdivo as single agent.
Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. Previously treated metastatic MSI-H/dMMR colorectal cancer Previously untreated metastatic NSCLC 3 […]