LEMTRADA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
LEMTRADA is given by intravenous (IV) infusion through a needle placed in your vein.
One infusion a day on 5 consecutive days
ROUND 2 (1 YEAR LATER)
One infusion a day on 3 consecutive days
ADDITIONAL ROUNDS IF NEEDED
You and your healthcare provider may decide that you need one or more additional rounds of treatment. If so, this would occur at least 1 year after your last round. Any additional rounds would consist of one infusion a day on 3 consecutive days.
HOW LEMTRADA WAS STUDIED
LEMTRADA was studied in two 2-year clinical trials against Rebif® (interferon beta-1a) 44 mcg. Patients were treated with LEMTRADA for 2 years and were then, if eligible, invited to continue in an Extension Study for an additional 4 years, for a total of 6 years in the studies.
patients in the 2-year study (Study 1) with 426 taking LEMTRADA, and 202 taking Rebif
of patients treated with LEMTRADA (387) entered the Study 1 Extension
of patients treated with LEMTRADA (332) that began Study 1 remained through Year 6
Of the 387 patients who entered the Study 1 Extension of LEMTRADA:
(192 patients) did not receive additional rounds of LEMTRADA
or any other disease-modifying therapy (DMT).
29% (114 patients) received 1 additional round of LEMTRADA
13% (50 patients) received 2 additional rounds of LEMTRADA
2% (9 patients) received 3 additional rounds of LEMTRADA
1% (4 patients) received 4 additional rounds of LEMTRADA
5% (18 patients) received another DMT and no additional LEMTRADA rounds
Information beyond 3 treatment courses is limited.
Monthly monitoring to detect potential side effects starts after your first infusion and continues until 4 years or longer after the last round of treatment.
WHAT HAPPENS DURING TREATMENT?
It will take at least 4 hours to receive 1 dose of LEMTRADA
You will be monitored closely during the infusion and for at least 2 hours following the completion of the infusion to watch for any infusion reactions
You will be given certain medications prior to treatment
LEMTRADA can cause serious side effects during infusion or up to 24 hours or longer after you receive LEMTRADA. Tell your healthcare provider immediately if you experience any discomfort during or after your infusion. You may also be given other medicines before, during, or after the infusion to try to reduce your chances of getting these reactions or to treat them if they happen
WHAT HAPPENS AFTER TREATMENT?
You will need monthly blood and urine tests, self-checks, and yearly skin checks. These help to monitor for possible side effects that can show up months or even years after your last infusion, including autoimmune side effects and some kinds of cancers, including skin cancer (melanoma). It is important to have your blood and urine tested, even if you are feeling well and do not have any symptoms from LEMTRADA or your MS. This may help your healthcare provider find side effects early