Tsyabri

What is Tsyabri?

Tsyabri is a prescription medicine used to treat adults with:

• relapsing forms of Multiple Sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Tsyabri increases the risk of PML. When starting and continuing treatment with Tsyabri, it is important that you discuss with your doctor whether the expected benefit of Tsyabri is enough to outweigh this risk. See “What is the most important information I should know about Tsyabri?”
• moderate to severe Crohn's disease (CD). Tsyabri is used:
  • to reduce signs and symptoms of CD
  • in people who have not been helped enough by, or cannot use the usual CD medicines and medicines called tumor necrosis factor (TNF) inhibitors.
• It is not known if Tsyabri is safe and effective in children under 18 years of age.

What is the most important information I should know about Tsyabri?

• Tsyabri increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems.
  • There is no known treatment, prevention, or cure for PML.
  • Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for Multiple Sclerosis (MS) and Crohn's disease (CD). You should not take certain medicines that weaken your immune system at the same time you are taking Tsyabri. Even if you use Tsyabri alone to treat your MS or CD, you can still get PML.
  • Your risk of getting PML is higher if you:
    • have received Tsyabri for a long time, especially longer than 2 years
    • have received certain medicines that can weaken your immune system before you start receiving Tsyabri
    • have been infected by the John Cunningham Virus (JCV). JCV is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems, such as people taking Tsyabri. Most people who are infected by JCV do not know it or do not have any symptoms. This infection usually happens in childhood. Before you start receiving Tsyabri or during your treatment, your doctor may do a blood test to check if you have been infected by JCV.
      
      Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors for getting PML during Tsyabri treatment that we do not know about yet. Your doctor should discuss the risks and benefits of Tsyabri treatment with you before you decide to receive Tsyabri. See “What are the possible side effects of Tsyabri?”
  • While you receive Tsyabri, and for 6 months after you stop receiving Tsyabri, it is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days.
    These may be new or sudden and include problems with:
    • thinking
    • balance
    • eyesight
    • weakness on 1 side of your body
    • strength
    • using your arms and legs

Tell all your doctors that you are receiving Tsyabri.

• Because of your risk of getting PML while you receive Tsyabri, Tsyabri is available only through a restricted distribution program called the Touch Prescribing Program. To receive Tsyabri, you must talk to your doctor and understand the risks and benefits of Tsyabri and agree to follow all of the instructions in the Touch Prescribing Program.
• Tsyabri is only:
  • prescribed by doctors who are enrolled in the Touch Prescribing Program
  • given at an infusion center that is enrolled in the Touch Prescribing Program
  • given to people who are enrolled in the Touch Prescribing Program
• Before you receive Tsyabri, your doctor will:
  • explain the Touch Prescribing Program to you
  • have you sign the Touch Prescriber and Patient Enrollment Form

Who should not take Tsyabri?

Do not receive Tsyabri if you:

• have PML
• are allergic to natalizumab or any of the ingredients in Tsyabri. See the end of this Medication Guide for a complete list of ingredients in Tsyabri.

Talk to your doctor before receiving Tsyabri if you have any of these conditions.

What should I tell my healthcare provider before taking Tsyabri?

Before you receive Tsyabri, tell your doctor if you:

• have medical conditions that can weaken your immune system, including:
  • HIV infection or AIDS
  • leukemia or lymphoma
  • an organ transplant
• have other medical conditions that can weaken your immune system
• have any new or worsening medical problems that have lasted several days. These may be new or sudden and include problems with:
  • thinking
  • strength
  • eyesight
  • weakness on 1 side of your body
  • balance
  • using your arms and legs
• have had hives, itching or trouble breathing during or after receiving a dose of Tsyabri
• have a fever or infection (including shingles or any unusually long lasting infection)
• are pregnant or plan to become pregnant. It is not known if Tsyabri can harm your unborn baby.
• are breastfeeding or plan to breastfeed. Tsyabri can pass into your breast milk. It is not known if the Tsyabri that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive Tsyabri.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take medicines that can weaken your immune system. Ask your doctor if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Tsyabri?

• Tsyabri is given 1 time every 4 weeks through a needle placed in your vein (IV infusion).
• Before each Tsyabri dose you will be asked questions to make sure Tsyabri is still right for you.

What are the possible side effects of Tsyabri?

Tsyabri may cause serious side effects, including:

• See “What is the most important information I should know about Tsyabri?”
• Herpes Infections. Tsyabri may increase your risk of getting an infection of the brain or the covering of your brain and spinal cord (encephalitis or meningitis) caused by herpes viruses that may lead to death. Call your doctor right away if you have sudden fever, severe headache, or if you feel confused after receiving Tsyabri. Herpes infections of the eye, causing blindness in some patients, have also occurred. Call your doctor right away if you have changes in vision, eye redness, or eye pain.
• Liver damage. Symptoms of liver damage can include:
  • yellowing of the skin and eyes (jaundice)
  • unusual darkening of the urine
  • nausea
  • feeling tired or weak
  • vomiting

Call your doctor right away if you have symptoms of liver damage. Your doctor can do blood tests to check for liver damage.

• Allergic reactions, including serious allergic reactions. Symptoms of an allergic reaction can include:
  • hives
  • dizziness
  • nausea
  • itching
  • wheezing
  • flushing of skin
  • trouble breathing
  • chills
  • low blood pressure
  • chest pain
  • rash

Serious allergic reactions usually happen within 2 hours of the start of your infusion, but they can happen at any time after you receive Tsyabri.

Tell your doctor right away if you have any symptom of an allergic reaction, even if it happens after you leave the infusion center. You may need treatment if you are having an allergic reaction.

• Infections. Tsyabri may increase your chance of getting an unusual or serious infection because Tsyabri can weaken your immune system. You have a higher risk of getting infections if you also take other medicines that can weaken your immune system.

The most common side effects of Tsyabri include:

• headache
• lung infection
• vaginitis
• stomach area pain
• feeling tired
• depression
• rash
• urinary tract infection
• pain in your arm and legs
• nose and throat infections
• joint pain
• diarrhea
• nausea

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

These are not all the possible side effects of Tsyabri. Ask your doctor for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Tsyabri

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about Tsyabri. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Tsyabri that is written for healthcare professionals.

For more information, go to www.TYSABRI.com or call 1-800-456-2255.

How should I store Tsyabri?

Tsyabri single-dose vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the carton and vial label. DO NOT SHAKE OR FREEZE. Protect from light.

Store diluted Tsyabri solution refrigerated at 2°C to 8°C (36°F to 46°F)

What are the ingredients in Tsyabri?

Active ingredient: natalizumab

Inactive Ingredients: sodium chloride, sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; polysorbate 80, and water for injection