Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use

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DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

Product Overview

Ibrutinib (IMBRUVICA®) is indicated for the treatment of mantle cell lymphoma (MCL), chronic graft-versus-host disease (cGVHD) and Waldenstrom’s macroglubulinaemia (WM). Ibrutinib also can be given as a single agent or in combination with other agents to treat chronic lymphocytic leukaemia (CLL). For comprehensive information on its approved indications, refer to the detailed package insert.

 

Background of the Safety Issue

The local package insert for IMBRUVICA® has been recently updated with dose modification recommendations for adverse reactions to reduce the occurrence of additional serious events and are intended to improve tolerability for continued IMBRUVICA® treatment. The “Special Warnings and Precautions for Use” section of the IMBRUVICA® package insert has also been revised to provide additional information on cardiac arrhythmias, cardiac failure, and sudden fatal cardiac events, including a description of risk factors and guidelines for assessment and management to assist prescribers better manage patients at risks.

IMBRUVICA® therapy should be withheld for any new onset or worsening Grade 2 cardiac failure, Grade 3 cardiac arrhythmias, Grade ≥ 3 non-haematological toxicities, Grade 3 or greater neutropenia with infection or fever, or Grade 4 haematological toxicities. Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), treatment may be resumed as per new dose modification recommendations.

 

Advice for Healthcare Professionals: 

  • Stay informed about the potential risks of cardiac arrhythmias, cardiac failure, and sudden fatal cardiac events associated with IMBRUVICA®.
  • Review and adhere to the updates to the IMBRUVICA® Malaysian package insert., including the updated dose modification recommendations for adverse reactions.
  • Report any suspected adverse reactions associated with the use of IMBRUVICA® to the NPRA.

 

The local package insert for IMBRUVICA® has been updated with the above-mentioned safety information.

On 3rd August 2023, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Johnson & Johnson Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.

  

Reference:

Direct Healthcare Professional Communication (DHPC). IMBRUVICA® (ibrutinib): Package insert updates to dose modifications for adverse reactions and to special warnings and precautions for use. Johnson & Johnson Sdn. Bhd.; 2023 Aug 7.

 

 

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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