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YERVOY
Safety Information2

Clinical use:

Efficacy and safety not established in pediatric
patients.

Contraindication:

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 counseling 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 at
https://www.bms.com/assets/bms/ca/documents
/productmonograph/YERVOY_EN_PM.pdf for important information relating to adverse reactions, management of imARs, drug interactions, and dosing information, which have not been discussed in this piece.

The Product Monograph is also available by calling
us at: 1-866-463-6267.

References

  1. OPDIVO Product Monograph. Bristol-Myers Squibb Canada Co.
  2. YERVOY Product Monograph. Bristol-Myers Squibb Canada Co.
  3. Health Canada. Notice of Compliance information. New indication. July
    2, 2021. Accessed on January 21, 2022.
    https://health-products.canada.ca/noc-ac/info.do?lang=en&no=26237
  4. Health Canada. Notice of Compliance information. New indication.
    October 28, 2021. Accessed on January 21, 2022.
    https://health-products.canada.ca/noc-ac/info.do?lang=en&no=26948