LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis

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Description:

LEMTRADA® (alemtuzumab) is indicated for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies. 

 

New safety information related to alemtuzumab has emerged following post-marketing reports of its use, as below:

(i) Risk of autoimmune hepatitis

Cases of hepatic injury including elevations of serum transaminases and autoimmune hepatitis (including fatal cases) have been reported in patients treated with alemtuzumab.

  • Patients should be informed about the risk of hepatic injury and other related symptoms (including nausea, vomiting, abdominal pain, yellow skin or eyes, and dark urine).
  • Liver function should be checked before starting treatment and then periodically.

 

(ii) Other serious reactions temporally associated with alemtuzumab infusion

Cases of pulmonary alveolar haemorrhage, myocardial ischemia, stroke (including ischaemic and haemorrhagic stroke) and cervicocephalic (e.g. vertebral, carotid) arterial dissection have been reported with the use of alemtuzumab.

  • Cases may occur following any of the doses during the treatment course.
  • In most cases, time to onset was within 1-3 days of alemtuzumab infusion.
  • Patients should have their vital signs monitored, including blood pressure measurement, before and periodically during alemtuzumab infusion.

 

(iii) Haemophagocytic lymphohistiocytosis (HLH)

HLH has been reported in patients treated with alemtuzumab. HLH is a life-threatening syndrome of pathologic immune activation characterised by clinical signs and symptoms of extreme systemic inflammation, including fever, swollen lymph nodes, bruising or skin rash. It has high mortality rates if not recognised and treated early.

  • Symptoms of HLH have been reported to occur within a few months to four years following treatment initiation.
  • Patients who develop disease manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.

 

NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Sanofi-Aventis (M) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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