SANOFI GENZYME RELAPSING MS TREATMENTS
SANOFI GENZYME RELAPSING MS TREATMENTS

People and science are at the center of everything we do. Since 2012, we have introduced two treatments for relapsing MS, expanding therapeutic options for patients. We have also worked to improve MS care through partnerships with healthcare professionals, advocates, and researchers for relapsing multiple sclerosis patients. Please take a moment to learn about Sanofi Genzyme's treatment options.

INFUSION TREATMENT
LEMTRADA® (alemtuzumab) logo

INDICATION

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.

Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).

ORAL TREATMENT
AUBAGIO® (teriflunomide) logo

INDICATION

AUBAGIO (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis.

LEMTRADA

IMPORTANT SAFETY INFORMATION

LEMTRADA can cause serious side effects including:

Serious autoimmune problems: Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include:

  • Immune thrombocytopenia, which is when reduced platelet counts in your blood cause severe bleeding that, if not treated, may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; heavier menstrual periods than normal; bleeding from your gums or nose that is new or takes longer than usual to stop; small, scattered spots on your skin that are red, pink, or purple
  • Kidney problems called anti-glomerular basement membrane disease, which can, if untreated, lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: blood in the urine (red or tea-colored urine); swelling of legs or feet; coughing up blood

It is important for you to have blood and urine tests before you receive, while you are receiving and every month, for 4 years or longer, after you receive your last LEMTRADA infusion.

Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.

  • You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.

Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:

  • swelling in your mouth or throat
  • trouble breathing
  • weakness
  • fast, slow, or irregular heartbeat
  • chest pain
  • rash

To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them after they happen.

Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:

  • new lump
  • swelling in your neck
  • pain in front of neck
  • hoarseness or other voice changes that do not go away
  • trouble swallowing or breathing
  • cough that is not caused by a cold

Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.

Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:

  • excessive sweating
  • unexplained weight loss
  • eye swelling
  • nervousness
  • fast heartbeat
  • unexplained weight gain
  • feeling cold
  • worsening tiredness
  • constipation

Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as:

  • weakness
  • chest pain
  • yellowing of the skin or whites of the eyes (jaundice)
  • dark urine
  • fast heartbeat

Serious infections: LEMTRADA may cause you to have a serious infection while you receive and after receiving a course of treatment. Serious infections may include:

  • Herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take any medicines as prescribed by your healthcare provider to reduce your chances of getting these infections.
  • Tuberculosis. Your healthcare provider should check you for tuberculosis before you receive LEMTRADA.
  • Hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.
  • Listeria. People who receive LEMTRADA have an increased chance of getting a bacterial infection called listeria, which can lead to significant complications or death. Avoid foods that may be a source of listeria or make sure foods that may contain listeria are heated well.

These are not all the possible infections that could happen while on LEMTRADA. Call your healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.

Inflammation of the gallbladder without gallstones (acalculous cholecystitis): LEMTRADA may increase your chance of getting inflammation of the gallbladder without gallstones, a serious medical condition that can be life-threatening. Call your healthcare provider right away if you have any of the following symptoms:

  • stomach pain or discomfort
  • fever
  • nausea or vomiting

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:

  • shortness of breath
  • cough
  • wheezing
  • chest pain or tightness
  • coughing up blood

Before receiving LEMTRADA, tell your healthcare provider if you:

  • are taking a medicine called Campath® (alemtuzumab)
  • have bleeding, thyroid, or kidney problems
  • have HIV
  • have a recent history of infection
  • have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine
  • are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby. You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should receive LEMTRADA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.

The most common side effects of LEMTRADA include:

  • rash
  • headache
  • thyroid problems
  • fever
  • swelling of your nose and throat
  • nausea
  • urinary tract infection
  • feeling tired
  • trouble sleeping
  • upper respiratory infection
  • herpes viral infection
  • hives
  • itching
  • fungal infection
  • joint pain
  • pain in your arms or legs
  • back pain
  • diarrhea
  • sinus infection
  • mouth pain or sore throat
  • tingling sensation
  • dizziness
  • stomach pain
  • sudden redness in face,
    neck, or chest
  • vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.

You are encouraged to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

AUBAGIO (teriflunomide)

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:

  • Have severe liver problems. AUBAGIO may cause serious liver problems, which can be life-threatening. Your risk may be higher if you take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your healthcare provider right away if you develop any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of your skin or whites of your eyes, or dark urine.
  • Are pregnant. AUBAGIO may harm an unborn baby. You should have a pregnancy test before starting AUBAGIO. After stopping AUBAGIO, continue to use effective birth control until you have made sure your blood levels of AUBAGIO are lowered. If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2.
  • Are of childbearing potential and not using effective birth control.

It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed — you should not do both at the same time.

If you are a man whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your healthcare provider about reducing the levels of AUBAGIO in your blood. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

  • Have had an allergic reaction to AUBAGIO or a medicine called leflunomide.
  • Take a medicine called leflunomide for rheumatoid arthritis.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine that can remove AUBAGIO from your blood quickly.

Before taking AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or infection, or if you are unable to fight infections; numbness or tingling in your hands or feet that is different from your MS symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; or high blood pressure. Your healthcare provider will check your blood cell count and TB test before you start AUBAGIO. Talk with your healthcare provider if you take or are planning to take other medicines (especially medicines for treating cancer or controlling your immune system), vitamins or herbal supplements.

AUBAGIO may cause serious side effects, including: reduced white blood cell count — this may cause you to have more infections; numbness or tingling in your hands or feet that is different from your MS symptoms; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

Tell your doctor if you have any side effect that bothers you or does not go away.

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results. These are not all the side effects of AUBAGIO. Tell your healthcare provider about any side effect that bothers you.

Consult your healthcare provider if you have questions about your health or any medications you may be taking, including AUBAGIO.

You are encouraged to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

Always talk to your healthcare provider before deciding on a relapsing MS treatment.
It's important to work together to find a treatment option that is right for you. If you need more assistance, contact the MS One to One® support program at 1-855-676-6326 to speak with a Nurse at any time.

IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including serious autoimmune problems. Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death.