Alectinib (Alecensa®): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance)

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Product Overview

Alectinib (Alecensa®) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) as well as for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.

In Malaysia, there is currently only one (1) product containing alectinib registered with the Drug Control Authority (DCA).

 

Background of the Safety Issue

Cases of haemolytic anaemia have been reported with alectinib use in clinical trials, with an uncommon frequency, and in the post-marketing setting. A recent cumulative analysis of cases revealed that modification of dosing led to improvement of the majority of the haemolytic anaemia events.

 

Advice for Healthcare Professionals:

  • When haemolytic anaemia is suspected and the haemoglobin concentration is below 10 g/dl, withhold Alecensa® and initiate appropriate laboratory testing.
  • If haemolytic anaemia is confirmed, consider resuming Alecensa® at a reduced dose upon resolution, or permanently discontinuing Alecensa®.
  • Report all suspected adverse events associated with the use of Alecensa® to the NPRA.

The local package insert for Alecensa® (alectinib) is being updated to reflect the latest safety information.

On 30 May 2022, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter to be distributed by Roche (Malaysia) Sdn. Bhd. to highlight the new warning and precaution and dose modification guidance for management of haemolytic anaemia for alectinib. For further information, please contact your local salesperson for a copy of the DHPC.

 

Reference:

  • Direct Healthcare Professional Communication (DHPC). Alecensa® (alectinib): Warning and Precaution and Specific Dose Modification Guidance for Management of Haemolytic Anaemia. Roche (Malaysia) Sdn Bhd; 2022 May 22.

 

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.

National Pharmaceutical Regulatory Agency (NPRA)

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

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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