DARZALEX (daratumumab) and Hepatitis B Virus Reactivation

Healthcare professionals including haematologists, oncologists, oncology nurses, oncology pharmacists, and other healthcare professionals providing care to cancer patients, including those who work in hospitals, cancer centres, oncology clinics and hospital pharmacies

• Cases of hepatitis B virus (HBV) reactivation, some with a fatal outcome, have been reported in patients treated with DARZALEX.
• Healthcare professionals are advised to:
  • Perform HBV screening in all patients before starting DARZALEX treatment.
  • Monitor patients with evidence of positive HBV serology for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of, DARZALEX treatment. Manage patients according to clinical guidelines.
  • Suspend DARZALEX, any concomitant steroids and chemotherapy treatment in patients who develop reactivation of HBV and start appropriate treatment.
  • Discuss with physicians who have expertise in managing HBV before resuming DARZALEX treatment in patients with adequately controlled HBV reactivation.
• Health Canada is currently working with the manufacturer to include the risk of HBV reactivation in the DARZALEX Canadian Product Monograph.

Cases of HBV reactivation, some with a fatal outcome, have been reported in patients treated with DARZALEX. As of December 14, 2018, there were 15 cases of HBV reactivation in patients treated with DARZALEX.  No Canadian cases of HBV reactivation related to DARZALEX treatment have been reported.

DARZALEX (daratumumab), concentrate for infusion solution, 20 mg / mL, in 5mL and 20mL single use vials

DARZALEX has received market authorization in Canada for use in the following clinical settings:

• In combination with bortezomib, melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
• For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD. 

A recent cumulative review of clinical trial and post-marketing data identified 15 cases of HBV reactivation in patients treated with DARZALEX. Ten of the 15 cases were reported as serious. Of the 10 serious cases, 2 cases had a fatal outcome.  No Canadian cases of HBV reactivation related to DARZALEX treatment have been reported at the time of the cumulative analysis. As of November 15, 2018, DARZALEX has been received by approximately 4,407 patients in clinical trial settings, and an estimated world-wide post-marketing exposure of 34,316 person-years. The estimated patient exposure in Canada is 390 person-years.  The overall frequency of HBV reactivation in DARZALEX clinical trials, including serious and non-serious reports, is uncommon (0.2%). The majority of clinical trial cases were considered non-serious, although fatal HBV reactivation cases have been reported in clinical trials and in the post-market setting.

DARZALEX is used in adults 18 years or older to treat a type of cancer called multiple myeloma. This is a cancer of plasma cells which are found in bone marrow.

DARZALEX could cause the hepatitis B virus to become active again (hepatitis B virus reactivation) in patients with previously stable or undetectable levels. Patients should tell their doctor if they have ever had or might now have a hepatitis B infection.

Patients should contact their healthcare professional for more details on this new safety information.

Patients should immediately tell their healthcare professional if they get worsening tiredness or yellowing of the skin or white part of the eyes, as these may be symptoms of hepatitis B virus reactivation.

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