YERVOY
IMPORTANT SAFETY INFORMATION5
Clinical use:
Efficacy and safety not established in pediatric patients.
Contraindications:
In patients with active, life-threatening autoimmune disease, or with organ transplantation graft where further immune activation is potentially imminently life threatening.
Most serious warnings and precautions:
Severe/fatal immune-mediated adverse reactions (imARs): YERVOY as monotherapy or in combination with OPDIVO (nivolumab) can cause severe/fatal imARs, including enterocolitis, intestinal perforation, hepatitis, dermatitis (incl. toxic epidermal necrolysis), Stevens-Johnson syndrome, neuropathy, endocrinopathy, pneumonitis, interstitial lung disease, myocarditis, encephalitis, myasthenia gravis, autoimmune hemolytic anemia and other organ system toxicities. Most occurred during the induction period; onset months after the last dose has been reported. Early diagnosis and appropriate management are essential to minimize life-threatening complications. Monitor patients for signs and symptoms suggestive of imARs. Permanently discontinue treatment for any severe imAR reaction that recurs and for any life-threatening imAR.
Consult the OPDIVO (nivolumab) Product Monograph prior to initiation of YERVOY in combination with OPDIVO.
Administration: Administer YERVOY under the supervision of physicians experienced in the treatment of cancer.
Other relevant warnings and precautions:
• imARs have occurred at higher frequencies when YERVOY was administered in combination with OPDIVO vs. YERVOY alone
• Patients who have had a severe or life-threatening skin adverse reaction on a prior cancer immune stimulatory therapy
• Severe cases of these imARs have been observed, including fatal cases. Monitor for signs/symptoms of:
- Gastrointestinal adverse reactions
- Hepatic adverse reactions
- Pulmonary adverse reactions
- Skin adverse reactions
- Encephalitis
- Neuropathies
- Endocrinopathies, including diabetes mellitus (including fulminant type 1 diabetes), and diabetic ketoacidosis
• Other imARs including ocular events
• Haemophagocytic lymphohistiocytosis (HLH)
• Vogt-Koyanagi-Harada syndrome
• Serous retinal detachment
• Graft-versus-host disease (GVHD)
• Solid organ transplant rejection in the post-marketing setting
• Infusion reaction
• Patients on immunosuppressive therapy for life-threatening disease or condition
• Autoimmune hemolytic anemia
• Myotoxicity (myositis, myocarditis, and rhabdomyolysis)
• Patients on controlled sodium diet
• Concurrent administration with vemurafenib
• Caution when driving or operating machinery
• Patient counselling information: imARs and fatigue
• Not studied in patients with hepatic impairment
• Not studied in patients with renal impairment
• Pregnancy and nursing women
• Effective contraception in women of reproductive potential
• Close monitoring required: liver function tests, thyroid function test, electrolytes, any signs of imARs
For more information:
Please consult the YERVOY Product Monograph for important information relating to adverse reactions, drug interactions, and dosing (particularly do not shake), which may not have been discussed in this piece.
The Product Monograph is also available by calling us at: 1-866-463-6267.
References:
1. OPDUALAG Product Monograph. Bristol-Myers Squibb Canada Co. September 13, 2023.
2. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Melanoma: Cutaneous. Version 1.2024. February 12, 2024. Available here.
3. Long GV, Hodi FS, Lipson EJ, et al. Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. N Engl J Med Evid 2023;2(4).
4. Tawbi HT et al. Abstract 9524 ASCO 2024.
5. OPDIVO Product Monograph. Bristol-Myers Squibb Canada Co. May 17, 2024.
6. YERVOY Product Monograph. Bristol-Myers Squibb Canada Co. December 7, 2023.