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For US Healthcare Professionals Sanofi Genzyme

The Importance of Monitoring

Monitoring patients before, during, and long after infusion is just as important as getting the treatment itself. It can help find potential side effects early.1

Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use.1

  • Pharmacies, prescribers, healthcare facilities, and patients must be enrolled and comply with all program requirements.
  • Healthcare facilities must have onsite access to equipment and personnel trained to manage infusion reactions.
  • Call 1-855-676-6326 to enroll and learn more about the LEMTRADA REMS.

Initiate monitoring at baseline and after the first treatment course, and continue until 48 months after the last course of LEMTRADA, or longer, if clinically indicated.

Before, during, and after infusion

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).

Patients should always be monitored before, during, and after their infusion.1

MONITOR

Vital signs should be monitored before the infusion and periodically during the infusion

Observe

Observe patients for infusion reactions during and for at least 2 hours after each LEMTRADA infusion

advise

Encourage patients to report symptoms during and after each infusion because prompt medical
intervention may be needed

consider

Additional monitoring in patients with medical conditions that predispose them to cardiovascular or
pulmonary compromise should be considered. Consider pretreatment with antihistamines and/or antipyretics. Infusion reactions may occur despite pretreatment. Physicians should alert patients that an infusion reaction
could occur within 48 hours of infusion

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Certain side effects of LEMTRADA can happen months and even years after treatment. That’s why it’s important to help patients begin monitoring after their first infusion and continue regular monitoring until 4 years or longer after the last round of treatment.1

Monitoring includes:

Be sure that your patients understand the importance of blood and urine testing even if they’re feeling well and do not have any symptoms from LEMTRADA and relapsing MS.1

Monthly blood and
urine lab tests

Ongoing symptom
self-checks

Recommended yearly
skin exams

Monitoring & Lab Collection Assistance:

Patients can receive monthly blood and urine testing at no cost.

Sanofi Genzyme covers the cost of lab services and testing until 48 months after the last treatment course and offers 2 ways to complete monitoring. Lab samples can be drawn:

Lab

Any local LabCorp® or Quest Diagnostics® patient service center

HCP OFFICE

Patients can give samples at their HCP’s office. Copays may incur*, the cost of analyzing the samples will
be covered by the LEMTRADA Central Lab Program.

Patients will determine which option is best for their individual needs

*For HCP office samples, patients may incur a co-pay to cover the cost of the lab draw and office visit, which is not covered by Sanofi Genzyme.

Proactive Monitoring

Proactive monitoring may help identify potential adverse events early.1 The following laboratory tests and potential treatment strategies apply to possible autoimmune events associated with the treatment of LEMTRADA.

 

Laboratory Tests1

Potential Treatment Strategies2-7

ITP*

Laboratory Tests1

  • Monthly complete blood count (CBC) with differential*

Potential Treatment Strategies2-7

  • Corticosteroids, IVIG, anti-D immunoglobulin, anti-CD20 monoclonal antibodies, splenectomy2

Glomerular Nephropathies

Laboratory Tests1

  • Urine protein-to-creatinine ratio prior to initiation of treatment
  • Monthly serum creatinine levels
  • Monthly urinalysis with urine cell counts

Potential Treatment Strategies3-8

  • Corticosteroids, diuretics, anti-hypertensive agents, plasmapheresis, and immunosuppressants3,4

Thyroid Disorders

Laboratory Tests1

  • Quarterly thyroid function test

Potential Treatment Strategies3-8

  • Hormone/drug therapy, thyroid ablation, thyroidectomy5,6

Autoimmune Hepatitis

Laboratory Tests1

  • Serum transaminases (ALT and AST) and total bilirubin levels prior to treatment initiation and periodically thereafter

Potential Treatment Strategies3-8

  • Anti-inflammatory agents and immunosuppressants7

*Use CBC results to monitor for autoimmune cytopenias.1

For urine dipstick results of 1+ protein or greater during monthly monitoring, measure the urine protein-to-creatinine ratio. For urine protein-to-creatinine ratio greater than 200 mg/g, increase in serum creatinine greater than 30%, or unexplained hematuria, perform further evaluation for nephropathies.1

  • Monitor for symptoms of thyroid cancer1
  • Perform baseline and yearly skin exams to monitor for melanoma1
Learn About REMS

Connect With LEMTRADA LabWatch

LabWatch, as part of the Central Lab Program, is an automated monitoring hub that relays information about a patient’s monitoring with real-time results and lab adherence data.

Track

LabWatch provides lab results directly to you in real time from LabCorp® or Quest Diagnostics™ facilities.

Alert

LabWatch generates alerts for all results that fall outside predefined LabCorp or Quest Diagnostics reference ranges related to the identified autoimmune risks associated with LEMTRADA. Alerts are sent to HCPs and their teams via email or text message upon detection of abnormal results.

Manage

HCPs access an online portal and/or mobile application where their LEMTRADA patients’ contact information, lab results, and infusion details are displayed. This may allow for faster access to potentially time-sensitive information.

Get Started

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. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207. doi:10.1182/blood-2010-08-302984
  3. Phelps RG, Turner AN. Chapter 22. Antiglomerular basement membrane disease and Goodpasture’s disease. In: Floege J, Johnson RJ, Feehally J, authors. Comprehensive Clinical Nephrology. 4th ed. Elsevier; 2010:282-291.
  4. Fervenza FC, Sethi S, Specks U. Idiopathic membranous nephropathy: diagnosis and treatment. Clin J Am Soc Nephrol. 2008;3(3):905-919. doi:10.2215/CJN.04321007
  5. Brent GA. Graves’ disease. N Engl J Med. 2008;358(24):2594-2605. doi:10.1056/NEJMcp0801880
  6. Garber JR, Cobin RH, Gharib H, et al; for American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on Hypothyroidism in Adults. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocrine Pract. 2012;18(6):988-1028. doi:10.4158/EP12280.GL
  7. Krawitt EL. Autoimmune hepatitis. N Engl J Med. 2006;354(1):54-66. doi:10.1056/NEJMra050408

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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