OPDUALAG
IMPORTANT SAFETY INFORMATION1
Clinical use:
Safety and efficacy in pediatrics <12 years of age has not been established.
Contraindications:
Hypersensitivity to nivolumab or relatlimab or to any ingredient in the formulation.
Most serious warnings and precautions:
Severe/fatal immune-mediated adverse reactions (imARs): OPDUALAG can cause severe and fatal imARs, including pneumonitis, acute edema of the lung and hemophagocytic lymphohistiocytosis (HLH). Severe and fatal imARs have been observed with nivolumab, which is a component of OPDUALAG. Healthcare professionals should consult the OPDIVO (nivolumab) Product Monograph prior to initiation of OPDUALAG. imARs may involve any organ system. Onset may occur during treatment or months after the last dose. Early diagnosis and appropriate management are essential to minimize potential life-threatening complications. Monitor patients for signs and symptoms of imARs. Permanently discontinue for any severe imAR that recurs and for any life-threatening imAR.
Administration: Administer OPDUALAG under the supervision of physicians experienced in the treatment of cancer.
Other relevant warnings and precautions:
· Severe cases of these imARs have been observed, including fatal cases. Monitor patients for signs and symptoms of:
– Pneumonitis or interstitial lung disease
– Diarrhea and additional symptoms of colitis
– Hepatitis
– Nephritis and renal dysfunction
– Endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and diabetes mellitus
– Rash
– Myocarditis
– Other imARs, including uveitis, pancreatitis, Guillain-Barre syndrome, myositis/rhabdomyolysis, encephalitis, hemolytic anemia, and Vogt Koyanagi-Harada syndrome (VKH)
· Solid organ transplant rejection
· Hemophagocytic lymphohistiocytosis (HLH) has been observed with nivolumab as monotherapy, in combination with relatlimab, and in combination with other agents
· Graft-versus-host disease can be severe and can lead to death in patients who have had prior allogeneic HSCT
· Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been observed with nivolumab monotherapy and could potentially occur with OPDUALAG
· Infusion-related reactions
· Monitor prior to and periodically during treatment: liver function tests, thyroid function tests, blood glucose, electrolytes
· Caution when driving or operating machinery
· Has not been studied in patients with severe hepatic or severe renal impairment
· Not recommended during pregnancy. Use effective contraception during treatment with OPDUALAG and for at least 5 months following the last dose of OPDUALAG
· Do not breast-feed during treatment with OPDUALAG and for at least 5 months after your last dose of OPDUALAG
For more information:
Please consult the OPDUALAG 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.