LEMTRADA IS
GIVEN AND
MONITORED
LEMTRADA IS AN INFUSION TREATMENT FOR RELAPSING MS.
THE LEMTRADA TREATMENT SCHEDULE
LEMTRADA is given by intravenous (IV) infusion through a needle placed in your vein. When starting LEMTRADA, you will have 8 days of infusion, spread over two rounds of treatment that are about 12 months apart. Concurrent monitoring starts after your first infusion and continues until 4 years after the last round
of treatment.
Additional infusion rounds and longer-term monitoring may occur if needed, as determined by your healthcare provider.
round 1
- 1 infusion a day
- Given 5 days in a row
monthly
Monthly monitoring for potential side effects starts upon completion of ROUND 1 and includes:
- monthly blood and urine tests
- self-checks
- yearly skin checks
round 2
- 1 infusion a day
- Given 3 days in a row
Additional round(s)
- 1 infusion a day
- Given 3 days in a row
- Initiated no earlier than 1 year after your last treatment
monthly
Monitoring will continue until 4 years or longer after the last round of treatment to help detect side effects like:
- autoimmune problems
- certain cancers
What to expect during an infusion
You will receive your infusions at a lab or healthcare provider’s office with equipment and staff trained to manage infusion reactions:
- It will take approximately 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.
- Be aware that administration time can vary, and you can expect to be at the infusion facility for up to 8 hours or more per day.
- 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.
of patients did not require additional rounds of LEMTRADA or any other disease-modifying therapy (DMT)*†
*192 out of 387 patients
†Information beyond 3 treatment courses is limited
WHY IS MONTHLY MONITORING NEEDED?
MONITORING IS JUST AS IMPORTANT AS GETTING TREATMENT.
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. You will need:
Monthly blood and
urine tests
Ongoing symptom
self-checks
Yearly skin exams
Certain side effects of LEMTRADA can happen months and even years after treatment. These can be, but are not limited to, autoimmune side effects and some kinds of cancers, including skin cancer (melanoma). That is why it is very important to have your blood and urine tested even if you’re feeling well and do not have any symptoms from LEMTRADA and relapsing MS.
THE LEMTRADA REMS
Because of risks associated with autoimmune diseases, certain cancers, and infusion reactions, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS). A REMS program is required by the FDA for certain medications to help ensure that the potential benefits of a drug outweigh its potential risks.
During an appointment, your healthcare provider will tell you more about the program and how to enroll..
Confirms patients are enrolled and educated about treatment and ongoing monitoring requirements.
Trains and certifies healthcare providers to prescribe LEMTRADA.
Verifies healthcare facilities are enrolled in the program and have on-site access to equipment and personnel trained to manage infusion reactions.
Makes sure approved pharmacies are certified with the program and working with trained facilities.
