Nivolumab (Opdivo) is an immune checkpoint inhibitors that targets PD-1, a protein on immune system cells (called T cells) that normally help keep these cells from attacking other cells in the body. By blocking PD-1, this drug boosts the immune response against melanoma cells. This can often shrink tumors and help people live longer. These drugs are given as an intravenous (IV) infusion every 2 weeks.
Negotiations have concluded for the provinces as of February, 2017. Awaiting provincial listings on the formularies. Has received NOC (Notice of Compliance with Health Canada) as of September 25, 2015, so is available for out of pocket purchase with a treating physician’s prescription or potentially through private insurance. Please check with your private insurance company regarding the terms of your plan’s coverage.
OPDIVO™ (NIVOLUMAB) for Metastatic Melanoma
Information from www.pcodr.ca
This information is current as of March 6, 2017
Note: Funding criteria as listed on the decision date. Please refer to the provincial drug programs for the most recent funding criteria and program eligibility.
Nivolumab for the treatment of patients with unresectable or metastatic BRAF wild-type melanoma who are previously untreated, with good performance status and who have stable brain metastases (if present). Treatment should continue until unacceptable toxicity or disease progression. Not to be used for the treatment of patients with BRAF V600 mutations positive unresectable or metastatic melanoma. Not to be used for the treatment of patients who have previously received treatment with ipilimumab or pembrolizumab.
Unresectable stage 3 or stage 4 metastatic melanoma in patients: Ipilimumab naïve, wild type BRAF V600 mutation status. Patients are eligible to receive pembrolizumab or ipilimumab or nivolumab but not sequential use of these agents. Good performance status; Adequate hepatic and renal function; Access to a treatment centre with expertise to manage immunemediated adverse reactions of nivolumab. BC Cancer Agency Compassionate Access Program (CAP) approval must be obtained
For the treatment of patients with: – Primary unresectable or metastatic melanoma AND – Confirmed BRAF wild-type AND – A good performance status.
As first line single agent therapy for the treatment of unresectable or metastatic BRAF wild-type melanoma in patients who are previously untreated, with good performance status and, who have stable brain metastases (if present). Treatment should be discontinued upon disease progression or unacceptable toxicity.
Patients with unresectable or metastatlc BRAF wild-type melanoma who are previously untreated, with good performance status and who have stable brain metastates (if present). Treatment should continue until unacceptable toxicity or disease progression.
As a single agent treatment option for patients with advanced melanoma (unresectable or metastatic BRAF wild type) who are previously untreated. Patients should have a good performance status and if present stable brain metastases. Treatment duration should continue until unacceptable toxicity or disease progression.
Treatment for patients with unresectable or metastatic BRAF wild-type melanoma who are previously untreated, with good performance status and who have stable brain metastases (if present).
Prince Edward Island
As a treatment for patients with BRAF wild-type unresectable or metastatic melanoma who are previously untreated, with good performance status and who have stable brain metastases (if present).
Common side effects can include fatigue, cough, nausea, itching, skin rash, decreased appetite, constipation, joint pain, and diarrhea.
Always talk to your doctor, pharmacist or nurse about your side effects so they can help you manage them.
PROPER USE OF THIS MEDICATION
Nivolumab is an intravenous (IV) infusion
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
– Fax toll-free to 1-866-678-6789, or
– Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
Dr. Marcus Butler
Expanding Horizons in Melanoma Treatment
Dr. Marcus Butler cares for patients with melanoma and gynecologic malignancies and is the Clinical Head of the Immune Monitoring Team at Princess Margaret Cancer Centre.
His work focuses on the development of immunotherapy trials, which include studies, alone and in combination, of immune checkpoint blocking antibodies, immunomodulators, and adoptive cell transfer.