Our Therapies

LEMTRADA® Infusion Therapy

Violet Health Outpatient Specialty Infusion Care

About LEMTRADA® Infusion Therapy

LEMTRADA® (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody. CD52 is a protein carried on the surface of T and B lymphocytes, the immune cells that drive the inflammatory attacks of multiple sclerosis. LEMTRADA® binds CD52 and depletes those cells from circulation. Over the following months the immune system repopulates, and the cells that come back appear to do so in a different balance, with fewer of the ones that attack myelin.

That mechanism makes LEMTRADA® fundamentally different from the other MS therapies offered here. OCREVUS®, BRIUMVI®, and TYSABRI® are continuous treatments: you come in every few weeks or months, indefinitely, and the effect depends on staying on schedule. LEMTRADA® is given as two short courses a year apart, and then, for many patients, nothing. It is an immune reconstitution therapy rather than a maintenance one. The trade-off is that the risks do not stop when the infusions do, and monitoring continues for four years after the last dose.

This is a reserved therapy

Because of its safety profile, LEMTRADA® should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of multiple sclerosis. It is not a first-line option, and it is not recommended for patients with clinically isolated syndrome. LEMTRADA® is available only through the restricted LEMTRADA® REMS program, which means the prescriber, the patient, the pharmacy, and the infusion center all have to be certified and enrolled before the first dose.

Dosing and administration

First course: 12 mg per day by intravenous infusion over 4 hours, on 5 consecutive days, for a total of 60 mg.
Second course: 12 mg per day on 3 consecutive days, for a total of 36 mg, given 12 months after the first course.
Subsequent courses, if needed: 12 mg per day on 3 consecutive days (36 mg total), given at least 12 months after the last dose of the previous course.
The dose is fixed at 12 mg. It is not calculated from your weight, and it is not stepped down.

The shape of that schedule is the thing to hold onto. The first course is a treatment week, not a treatment day. Five consecutive days of four-hour infusions, plus premedication and observation, means five long days in a row. Then nothing for a year, then three days, then potentially nothing again. Many patients are still relapse-free years after two courses without any ongoing MS medication.

Premedication and prophylaxis

High-dose corticosteroids (1,000 mg methylprednisolone or equivalent) immediately before the infusion on each of the first 3 days of every course.
Antihistamines and antipyretics are commonly added before each infusion.
An antiviral agent for herpes prophylaxis, started on the first day of each course and continued for a minimum of 2 months after the course finishes, or until the CD4+ lymphocyte count recovers to at least 200 cells per microliter, whichever is later.

Vaccinations need to be completed at least 6 weeks before treatment starts, and patients without varicella zoster antibodies are tested and vaccinated beforehand, with the same 6-week gap. Tuberculosis screening and hepatitis B and C testing are done before the first course.

Monitoring continues for four years

This is the part patients most often underestimate. A complete blood count with differential, serum creatinine, and urinalysis with microscopy are required before starting and then monthly, every month, until 48 months after the last infusion. Thyroid function is checked every 3 months over the same period. Annual skin examinations for melanoma and, for female patients, annual HPV screening are also recommended. The infusions are brief by comparison with the commitment that follows them.

Conditions treated by this therapy

LEMTRADA® is FDA approved for adults with relapsing forms of multiple sclerosis:

Relapsing-remitting multiple sclerosis (RRMS)
Active secondary progressive multiple sclerosis (SPMS), meaning progressive disease with continued relapses or new inflammatory activity on MRI

Who this therapy is not for

Patients at an earlier point in their treatment path. LEMTRADA® should generally be reserved for those with an inadequate response to two or more MS therapies, so the prior treatment history is as much a part of eligibility as the diagnosis.
Clinically isolated syndrome. LEMTRADA® is not recommended for a first demyelinating event.
Primary progressive MS, which is not an approved indication. OCREVUS® is the therapy approved in that setting.
Patients with HIV infection, an active infection, or known hypersensitivity to alemtuzumab. These are contraindications, not cautions.
Children. Safety and effectiveness have not been established under 17 years of age, and use is not recommended in pediatric patients.

One naming note that causes real confusion: alemtuzumab is also sold as CAMPATH® for B-cell chronic lymphocytic leukemia. Same molecule, different product, different dose, different distribution program. A referral should name LEMTRADA® specifically.

LEMTRADA® Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

Remember, many resources exist to help patients access necessary medications. Don't hesitate to ask for help if you're struggling with medication costs. No patient should go without necessary treatment due to financial limitations. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During LEMTRADA® Infusion Therapy

LEMTRADA® is a prescription infusion therapy first approved by the FDA for multiple sclerosis in 2014. At Violet Health we're proud to offer it in our spa-like infusion center, a comfortable alternative to traditional hospital settings. Given the length of a treatment course, that difference is felt more here than almost anywhere else on our schedule.

Plan on a full day, five days in a row, for your first course. Here is how each of those days runs:

Labs are drawn before treatment, including a complete blood count with differential, serum creatinine, and urinalysis.
Premedication comes first: high-dose intravenous methylprednisolone on each of the first 3 days, usually with an antihistamine and a fever reducer. The steroid alone takes time to run.
The LEMTRADA® infusion itself runs over approximately 4 hours through a peripheral IV.
You are observed for at least 2 hours after each infusion finishes, with vital signs checked throughout. Pulse and blood pressure are monitored during the infusion and for the observation period after.
Including premedication, infusion, and observation, each day typically runs 7 to 8 hours. Arrange a ride. Steroids and antihistamines together leave most people in no condition to drive home.

Infusion-related reactions are expected rather than exceptional here. Roughly 9 in 10 patients have some reaction, most often headache, rash, fever, flushing, nausea, hives, itching, or chills, and most of them happen while you are still in the chair or within 24 hours. The infusion can be slowed or paused and then restarted. Your care team will give you a plan for managing symptoms at home over the following day or two.

Eat and drink normally before each day, and come well hydrated. Bring something to occupy the time. Patients who treat the week as five scheduled appointments rather than five medical events generally have an easier time of it.

After the course ends

This is where LEMTRADA® differs most from every other MS therapy. There is no next appointment in three weeks. There is a year. What there is instead is a monthly blood and urine test, every month, for four years after your final infusion, plus thyroid testing every three months. Those tests are not a formality. They are how serious autoimmune conditions get caught early enough to treat, and they are the reason a patient who feels completely well still needs to keep showing up.

You will also stay on an antiviral for at least two months after each course, and you should carry the patient safety information card you are given. If you need urgent care anywhere else, the treating clinician needs to know you have received LEMTRADA®, because the conditions it can cause are easy to miss without that context.

Benefit is measured over years rather than weeks. Relapse rates and MRI activity are the markers, and many patients need no further MS treatment after two courses. Roughly a third to a half go on to receive a third course.

Boxed Warning and REMS Requirements

LEMTRADA® carries one of the most extensive boxed warnings of any therapy offered here. It covers four distinct risks, and it is the reason the drug sits behind a restricted program rather than on a standard formulary.

Autoimmunity

LEMTRADA® can cause serious, sometimes fatal autoimmune conditions. Immune thrombocytopenia, a dangerous drop in platelets, occurred in about 2% of patients. Anti-glomerular basement membrane disease and other kidney conditions occurred in about 0.3% and can lead to kidney failure requiring dialysis or transplant if not caught early. Autoimmune hepatitis, acquired hemophilia A, and thrombotic thrombocytopenic purpura have also been reported. These can appear years after the last infusion, which is why monthly blood and urine testing continues for 48 months.

Infusion reactions

Serious and sometimes fatal infusion reactions have occurred, which is why infusions are given in a setting with resuscitation equipment on hand and why observation continues for at least 2 hours afterward. Some serious reactions have occurred more than 24 hours after an infusion.

Stroke and arterial dissection

Ischemic and hemorrhagic stroke, and tears in the arteries supplying the head and neck, have been reported within 1 to 3 days of infusion. Seek emergency care immediately for sudden weakness or numbness on one side, trouble speaking, a sudden severe headache, or neck pain. Tell the emergency team you recently received LEMTRADA®.

Malignancies

LEMTRADA® may increase the risk of certain cancers, including thyroid cancer, melanoma, and lymphoproliferative disorders. Skin examinations are recommended before treatment and yearly afterward.

The LEMTRADA® REMS program

LEMTRADA® is available only through a restricted distribution program. Prescribers, patients, pharmacies, and infusion centers all have to be certified and enrolled before treatment can begin. Enrollment is a prerequisite, not a formality, and it needs to be in place before scheduling.

LEMTRADA® Side Effects

The most common side effects, reported in 10% or more of patients in clinical trials, were:

Rash, hives, itching, and flushing
Headache and fever
Nausea, vomiting, diarrhea, and abdominal pain
Infections: nasopharyngitis, upper respiratory and urinary tract infections, sinusitis, herpes viral infections, and fungal infections
Thyroid gland disorders
Fatigue and insomnia
Joint pain, back pain, and pain in the arms or legs
Tingling or numbness, dizziness, and throat pain

Thyroid problems are the most frequent serious issue

Autoimmune thyroid disease affected roughly a third to 40% of patients in long-term follow-up, most often Graves' disease or an underactive thyroid, and it typically appears one to three years after treatment rather than during it. Most cases are managed with medication, though some patients need thyroid surgery or radioactive iodine. Report unexplained weight change, fast or irregular heartbeat, heat or cold intolerance, sweating, nervousness, or new neck swelling. Thyroid function is tested every 3 months for 48 months after the last infusion specifically to catch this.

Infection risk

Lymphocyte counts fall sharply after each course and recover slowly over months, so infections are more common and can be more serious. Herpes infections, including shingles, are frequent enough that antiviral prophylaxis is routine. Listeria infections have been reported, so avoid unpasteurized dairy, deli meats, and undercooked meat from two weeks before a course until at least one month after. Cervical HPV infection has been reported, and annual screening is recommended for female patients. Tuberculosis and hepatitis B or C reactivation have both occurred, and progressive multifocal leukoencephalopathy has been reported.

Other serious reactions

Hemophagocytic lymphohistiocytosis, a rare and life-threatening overactivation of the immune system, which can appear months to years after treatment. It presents with prolonged fever, swollen lymph nodes, an enlarged liver or spleen, and abnormal blood counts.
Pneumonitis, including inflammatory lung disease. Report shortness of breath, cough, wheezing, chest pain, or coughing up blood.
Gallbladder inflammation without gallstones, which has occurred within days of infusion.
Autoimmune hepatitis and other liver injury. Report yellowing of the skin or eyes, dark urine, unusual bruising or bleeding, or severe fatigue.

Call your care team right away if you experience:

Easy bruising, pinpoint red spots on the skin, bleeding gums, nosebleeds, or heavier than usual periods
Swelling of the legs or feet, blood in the urine, reduced urine output, or coughing up blood
Sudden weakness or numbness on one side, drooping of the face, trouble speaking, severe headache, or neck pain
Fever that will not resolve, swollen glands, or persistent unexplained illness
New weakness, worsening balance, changes in vision, confusion, or personality change
A new or changing mole, or any new skin lesion

Important Safety Information

Unlike most therapies on this site, LEMTRADA® has firm contraindications rather than cautions alone.

HIV infection. LEMTRADA® causes prolonged reductions in CD4+ lymphocyte counts and must not be given to patients with HIV.
Active infection. Treatment is delayed until the infection has fully resolved.
Known hypersensitivity or anaphylactic reaction to alemtuzumab or any component of the formulation.

Vaccines

Complete all needed immunizations at least 6 weeks before treatment. Live or live-attenuated vaccines should not be given during treatment or shortly after, since the immune response may not be adequate and the risk is higher. Patients without a history of chickenpox or vaccination are tested for varicella zoster antibodies, and those without antibodies are vaccinated before treatment, again with a 6-week gap.

Pregnancy and breastfeeding

Females of reproductive potential should use effective contraception during each course of treatment and for 4 months after that course. Thyroid disease carries additional risk in pregnancy, and the antibodies LEMTRADA® can trigger may cross the placenta and affect the baby's thyroid. Alemtuzumab has been detected in breast milk in animal studies. Discuss any pregnancy plan with your neurologist before starting, since the course-based schedule can sometimes be planned around it.

Before you start, tell your care team if you

Have any bleeding or blood disorder, or kidney or thyroid disease
Have a history of stroke, TIA, uncontrolled high blood pressure, or heart disease
Have had cancer, particularly thyroid cancer or melanoma
Have had tuberculosis, hepatitis B, or hepatitis C, or recent exposure to any of them
Are taking any other medication that affects the immune system, or an antiplatelet or anticoagulant drug

Keep the Medication Guide and carry the patient safety information card you are given. Carry it for four years after your last infusion, not four weeks. The conditions this drug can cause tend to arrive long after anyone would connect them to a treatment you finished years ago.

What Your Referral Should Include

LEMTRADA® referrals take longer to clear than most, because REMS enrollment, baseline screening, and a documented treatment history all have to be in place before a date can be held. A complete referral moves this along considerably. Please include:

MS diagnosis and subtype, specifying relapsing-remitting or active secondary progressive, with supporting MRI and relapse history
Prior disease-modifying therapies with dates, doses, and reason for discontinuation. At least two with inadequate response need to be documented, and this is the single item that most often stalls a referral
Washout status from the prior therapy, particularly natalizumab, fingolimod, or another anti-CD20 agent such as ocrelizumab, ofatumumab, or ublituximab, with the last dose date
Confirmation of prescriber and patient enrollment in the LEMTRADA® REMS program
Which course is being scheduled, first or subsequent, and the date of the last LEMTRADA® infusion if there has been one
Baseline labs: complete blood count with differential, serum creatinine, and urinalysis with microscopy
Baseline thyroid function with TSH, and liver function tests
HIV status, which is a contraindication, along with hepatitis B and C serology and tuberculosis screening
Varicella zoster antibody status, and if negative, the vaccination date with confirmation that 6 weeks have passed
Full vaccination record, with confirmation that any needed immunizations were completed at least 6 weeks before the planned start
Baseline skin examination for melanoma, and for female patients, HPV screening status
Cardiovascular history including stroke, TIA, or arterial dissection, and baseline blood pressure
History of thyroid disease, bleeding or platelet disorders, kidney disease, or autoimmune conditions, personal or family
Prior or current malignancy, particularly thyroid cancer, melanoma, or a lymphoproliferative disorder
The prescribed antiviral prophylaxis plan, and the corticosteroid premedication order
Pregnancy status for females of reproductive potential, and the contraception plan covering the course plus 4 months
Who will manage the 48-month monitoring schedule after the course, and where those labs will be drawn
Venous access notes, including any history of difficult sticks, since this is five consecutive days of infusion
Confirmation that LEMTRADA® is intended rather than CAMPATH®, since both are alemtuzumab