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For US Healthcare Professionals Sanofi Genzyme

LEMTRADA Resources

It's important to prepare and educate your patients before and during their treatment journey with LEMTRADA. The resources below are available in digital and print formats. You can download the materials directly or order printed materials to be shipped directly to your practice. Select a category to find the resource you need.

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Resources

LEMTRADA Patient Brochure

An educational brochure that provides information for patients considering LEMTRADA treatment.

LEMTRADA Patient Brochure

Profiles of Determination

Real LEMTRADA patients and their treatment experiences.

Profiles of Determination

Getting Started Guide

Step-by-step guide for patients with everything they need to know before, during, and after LEMTRADA treatment.

Getting Started Guide

Patient Stories Magazine

Patients can find in-depth information to get ready for the second round of LEMTRADA infusions.

Patient Stories Magazine

Central Lab Brochure

Information on the monitoring assistance available through the LEMTRADA Central Lab Program.

Central Lab Brochure

Infusion Essentials Brochure

Information you need before your patients start the LEMTRADA infusion process.

Infusion Essentials Brochure

LEMTRADA Services Form

To enroll in patient support services, this form should be completed by patients and their healthcare providers.

LEMTRADA Services Form

Central Lab Brochure

Information on the monitoring assistance available through the LEMTRADA Central Lab Program.

Central Lab Brochure

Infusion Essentials Brochure

Information you need before your patients start the LEMTRADA infusion process.

Infusion Essentials Brochure

LEMTRADA Services Form

To enroll in patient support services, this form should be completed by patients and their healthcare providers.

LEMTRADA Services Form

LEMTRADA Patient Brochure

An educational brochure that provides information for patients considering LEMTRADA treatment.

LEMTRADA Patient Brochure

Profiles of Determination

Real LEMTRADA patients and their treatment experiences.

Profiles of Determination

Getting Started Guide

Step-by-step guide for patients with everything they need to know before, during, and after LEMTRADA treatment.

Getting Started Guide

Patient Stories Magazine

Patients can find in-depth information to get ready for the second round of LEMTRADA infusions.

Patient Stories Magazine

Frequently Asked Questions

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for the treatment of MS.1

LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.1

CARE-MS II was a 2-year, randomized, open-label, rater-blinded, phase III study that included RMS patients (N=628) with Expanded Disability Status Scale (EDSS) scores of ≤5.0, who had experienced ≥2 relapses in the previous 2 years, with at least 1 relapse in the prior year and at least 1 relapse while on interferon beta or glatiramer acetate therapy after at least 6 months of treatment.1,2

The primary endpoint was the annualized relapse rate (ARR) over 2 years.1

The precise mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown but is presumed to involve binding to CD52, a cell surface antigen present on T and B lymphocytes, and on natural killer cells, monocytes, and macrophages. Following cell surface binding to T and B lymphocytes, alemtuzumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.1

The clinical outcomes measured were the annualized relapse rate (ARR) over two years and time to confirmed disability progression defined as at least a 1-point increase above baseline EDSS (1.5-point increase for patients with baseline EDSS of 0) sustained for 6 months. Additional endpoints included evaluation of the measurement of T2 lesion volume by MRI.1

Treatment with LEMTRADA can result in the formation of autoantibodies and increase the risk of serious autoimmune-mediated conditions, which may be life threatening. Measure the urine protein to creatinine ratio prior to initiation of treatment. Obtain complete blood counts with differential, serum creatinine levels, and urinalysis with cell counts before starting treatment and then monitor at monthly intervals until 48 months after the last dose of LEMTRADA, or longer, if clinically indicated.

LEMTRADA causes cytokine release syndrome resulting in infusion reactions. In clinical studies, 92% of LEMTRADA-treated patients experienced infusion reactions. Serious reactions occurred in 3% of these patients and included anaphylaxis in 2 patients (including anaphylactic shock), angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), transient neurologic symptoms, hypertension, headache, pyrexia, and rash. In some patients, infusion reactions were reported more than 24 hours after LEMTRADA infusion. Postmarketing cases of pulmonary alveolar hemorrhage, myocardial ischemia, and myocardial infarction have been reported with time to onset of 1-3 days from LEMTRADA infusion in the majority of cases. Patients should be informed about the signs and symptoms and advised to seek immediate medical attention if any of these symptoms occur. Cases of severe, including fatal, neutropenia have been reported within 2 months of LEMTRADA infusion. Mild to moderate decreases in platelet counts, starting at the time of alemtuzumab infusion have been reported. Consider additional monitoring in patients with medical conditions which predispose them to cardiovascular or pulmonary compromise.

Premedicate patients with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days of each treatment course. Consider pretreatment with antihistamines and/or antipyretics. Infusion reactions may occur despite pretreatment.

LEMTRADA can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage infusion reactions (including anaphylaxis and cardiac and respiratory emergencies).

To check for the development of autoimmune conditions, your patient will have to be monitored monthly by having their blood and urine tested. Order blood and urine tests in the month before you start your patient on LEMTRADA treatment, and these tests will continue each month until 4 years after their last LEMTRADA infusion. Monitoring may need to continue for longer if your patient has signs or symptoms of autoimmune conditions. Autoimmune conditions include1:

  • Immune thrombocytopenia (ITP, or low platelets)
  • Other blood disorders (including neutropenia, hemolytic anemia, and pancytopenia)
  • Certain types of kidney diseases
  • Thyroid disorders
  • Liver disorders

It is very important that your patient continues to have these tests until 4 years after their last LEMTRADA infusion, even if they are feeling well (no symptoms or side effects). Side effects may occur many months to years after LEMTRADA infusion and may be life-threatening.1

Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under Risk Evaluation and Mitigation Strategy (REMS). Call 1-855-676-6326 to enroll and learn more about the LEMTRADA REMS. See the LEMTRADA REMS page of this site to get registered.1

INDICATION

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

CONTRAINDICATIONS

LEMTRADA is contraindicated in patients:

WARNINGS AND PRECAUTIONS

Most Common Adverse Reactions

In controlled clinical trials, the most common adverse reactions (incidence ≥10% and >interferon beta-1a) with LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache (52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%), nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue (18% vs 13%), insomnia (16% vs 15%), upper respiratory tract infection (16% vs 13%), herpes viral infection (16% vs 3%), urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia (12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%), diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain (11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%), abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10% vs 3%).

Use in Specific Populations

Physicians are encouraged to register patients in the pregnancy exposure registry by calling 1-866-758-2990. Antibodies, including anti-CD52 and autoantibodies, may be transferred from the mother to the fetus during pregnancy. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity and infusion reactions, stroke, and because it may increase the risk of malignancies.

Please see full Prescribing Information, including Boxed WARNING.

References:

  1. LEMTRADA [prescribing information]. Cambridge, MA: Genzyme Corporation.
  2. Coles AJ, Twyman CL, Arnold DL, et al; for CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1829-1839. doi:10.1016/S0140-6736(12)61768-1

Indication

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

  • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane (anti-GBM) disease. Monitor complete blood counts with differential, serum
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