Alemtuzumab

Alemtuzumab

Administration Route: Infusion
Injection site:
Frequency: Two infusions, 12 months apart
TGA approval date: Dec 2013
PBS listed: Yes
Mechanism of action Lemtrada (alemtuzumab) is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab depletes circulating T and B lymphocytes after each treatment course.
Clinical trial results 67% RRR in annual relapes rate,94% RRR for new Gad Lesions, 83% RRR new T2 lesions, 52% RRR disability
Pregnancy Category B3
Safe in Pregnancy There are no adequate and well-controlled studies of Lemtrada in pregnant women. Lemtrada should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Alemtuzumab may cross the placental barrier as well and thus potentially pose a risk to the foetus. It is not known whether Lemtrada can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity. Alemtuzumab crosses the placenta in laboratory models.

Women of child bearing potential should use effective contraceptive measures when receiving a course of treatment with Lemtrada and for 4 months following that course of treatment.

Breastfeeding (information predominatly from  LACTMED database) No information is available on the clinical use of alemtuzumab during breastfeeding. Because alemtuzumab is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, alemtuzumab should be used with caution or avoided during breastfeeding, especially while nursing a newborn or preterm infant.

The manufacturer recommends that breastfeeding be discontinued during alemtuzumab therapy and for 4 months following the last infusion of each treatment course.

Monitoring requirements Full blood counts, serum creatinine tests and a urine tests should be taken before starting treatment and every month until 48 months after the last infusion.

Thyroid function tests should be taken before starting treatment and every 3 months until 48 months after the last infusion.

Potential side effects (not a comprehensive list) Secondary autoimmunity, infections, rash, headache, and fever, nasal congestion, nausea, fatigue
Manufacturer Sanofi Genzyme
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