Important safety information

Clinical use:

BREYANZI is not indicated for pediatric populations (<18 years of age).

Contraindications:

• In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most serious warnings and precautions:

• Cytokine Release Syndrome (CRS): including fatal or life-threatening reactions, can occur following treatment with BREYANZI. Delay the infusion of BREYANZI if the patient has unresolved serious events (including pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies, active uncontrolled infection or inflammatory disorder, or active graft-versus-host disease (GVHD). Monitor for CRS after treatment with BREYANZI. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.

• Neurologic toxicities: including immune effector cell-associated neurotoxicity syndrome (ICANS), which may be fatal or life-threatening, occurred concurrently with CRS, after CRS resolution or in the absence of CRS following treatment with BREYANZI. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.

• BREYANZI administration: under the supervision of healthcare professionals experienced in hematological malignancies at a qualified treatment centre.

Other relevant warnings and precautions:

• BREYANZI is intended solely for autologous use.

• BREYANZI is for intravenous use only.

• Do not use a leukodepleting filter.

• Patients treated with BREYANZI should not donate blood, organs, tissues and cells for transplantation.

• There is no experience of use of BREYANZI in patients with primary central nervous system (CNS) lymphoma.

• Risk of secondary malignancies.

• Patients should refrain from driving or operating heavy or potentially dangerous machines for at least 8 weeks.

• Risk of tumour lysis syndrome (TLS).

• Risk of hypogammaglobulinemia.

• The safety of the use of live vaccines with BREYANZI has not been established.

• Risk of hypersensitivity.

• Risk of prolonged cytopenias.

• Risk of viral reactivation, febrile neutropenia, serious, life-threatening or fatal infections.

• Life-threatening and opportunistic infections in immunosuppressed patients.

• Pregnancy status of women of child-bearing age should be verified using a pregnancy test prior to starting BREYANZI treatment.

• Sexually active men and women who receive BREYANZI should use appropriate contraceptives.

• The safety and efficacy of BREYANZI in pregnant women has not been established. BREYANZI is not recommended for women who are pregnant and pregnancy after BREYANZI should be discussed with treating physician.

• Fetal/neonatal adverse reactions.

• It is unknown whether BREYANZI cells are excreted in human milk. Women who are breast-feeding should be advised of the potential risk to the breast-fed child.

For more information:

Please consult the BREYANZI Product Monograph for important information relating to adverse reactions, drug interactions, and dosing. The Product Monograph is also available by calling BMS Medical Information at 1-866-463-6267 or by email at medical.canada@bms.com.

Reference:

1. BREYANZI Product Monograph. Bristol-Myers Squibb Company