EXTAVIA- interferon beta-1b 
Novartis Pharmaceuticals Corporation

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This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: July 2023
Medication Guide
EXTAVIA
(ex tā vee uh)
interferon beta-1b
(in-ter-feer-on beta-one-be)
for injection, for subcutaneous use
Read this Medication Guide before you start taking EXTAVIA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about EXTAVIA?
EXTAVIA can cause serious side effects, including:

     • liver problems, including liver failure. Symptoms of liver problems may include:
     • yellowing of your eyes
     • flu-like symptoms
• itchy skin
• nausea or vomiting
• feeling very tired
• bruising easily or bleeding problems
Your healthcare provider will do blood tests to check for these problems while you take EXTAVIA.

     • serious allergic reactions. Serious allergic reactions can happen quickly and may happen after your first dose of EXTAVIA or after you have taken EXTAVIA many times. Symptoms may include: difficulty breathing or swallowing or swelling of the mouth or tongue, rash, itching, or skin bumps
     • depression or suicidal thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
     • thoughts about suicide or dying
     • trouble sleeping (insomnia)
     • hallucinations		• new or worse depression
• acting aggressive, being angry, or violent
• other unusual changes in behavior or mood		• new or worse anxiety
• acting on dangerous impulses
What is EXTAVIA?
EXTAVIA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. EXTAVIA is similar to certain interferon proteins that are produced in the body. It is not known if EXTAVIA is safe and effective in children.
Who should not take EXTAVIA?
Do not take EXTAVIA if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. See the end of this leaflet for a complete list of ingredients in EXTAVIA.
What should I tell my healthcare provider before taking EXTAVIA?
Before you take EXTAVIA, tell your healthcare provider if you:
  • have or have had depression (sinking feeling or sadness), anxiety (feeling uneasy, nervous, or fearful for no reason) or trouble sleeping
  • have or have had liver problems
  • have or have had blood problems, such as bleeding or bruising easily, low red blood cells (anemia), or low white blood cells
  • have or have had seizures
  • have or have had heart problems
  • have or have had an allergic reaction to rubber or latex. The rubber cap of the diluent pre-filled syringe contains natural rubber latex
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if EXTAVIA passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take EXTAVIA?
  • See the Instructions for Use at the end of this Medication Guide for complete information on how to use EXTAVIA.
  • EXTAVIA is given by injection under your skin (subcutaneous injection) every other day.
  • Take EXTAVIA exactly as your healthcare provider tells you to take it.
  • If your healthcare provider feels that you or someone else may give you the injections, then you or the other person should be trained by your healthcare provider in how to give an injection.
  • Do not try to give yourself or have another person give you injections until you or both of you understand and are comfortable with how to prepare your dose and give the injection.
  • You may be started on a lower dose when you first start taking EXTAVIA. Your healthcare provider will tell you what dose of EXTAVIA to use.
  • Your healthcare provider may change your dose of EXTAVIA. You should not change your dose without talking to your healthcare provider.
  • If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Your next injection should be taken about 48 hours (2 days) after that dose. Do not take EXTAVIA on 2 consecutive days. If you accidentally take more than your prescribed dose, or take it on 2 consecutive days, call your healthcare provider right away.
  • Always use a new, unopened vial of EXTAVIA and pre-filled diluent syringe for each injection. Throw away any unused medicine. Do not re-use any vials, syringes, or needles.
  • It is important for you to change your injection site each time you inject EXTAVIA. This will lessen the chance of you having a serious skin reaction at the site where you inject EXTAVIA. Avoid injecting EXTAVIA into an area of skin that is sore, reddened, infected, or has other problems.
What are the possible side effects of EXTAVIA?
EXTAVIA may cause serious side effects. Call your healthcare provider right away if you have any of the serious side effects of EXTAVIA, including:
  • See “What is the most important information I should know about EXTAVIA?”
  • heart problems. EXTAVIA may worsen heart problems, including congestive heart failure. Symptoms of heart problems may include:
     • swollen ankles
     • tightness in chest		• shortness of breath
• increased need to urinate at night		• decreased ability to exercise
• not being able to lay flat in bed		• fast heartbeat

     • Injection site problems. Serious skin reactions can happen in some people, including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject EXTAVIA. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, and breaks in your skin or blue-black skin discoloration. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
     • Pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including EXTAVIA. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.
     • flu-like symptoms. EXTAVIA can cause flu-like symptoms, including:
     • fever• chills• tiredness• sweating• muscle aches when you first start to use it
These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using EXTAVIA may help decrease these symptoms.

     • seizures. Some people have had seizures while taking EXTAVIA, including people who have never had seizures before. It is not known if the seizures were related to their MS, to EXTAVIA, or to a combination of both. If you have a seizure after taking EXTAVIA, call your healthcare provider right away.

The most common side effects of EXTAVIA include:
     • low white blood cell count
     • increases in your muscle tension
     • problems sleeping		• increases in your liver enzymes
• pain
• stomach pain		• headache
• rash
• weakness
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 EXTAVIA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EXTAVIA?
  • Before mixing, store EXTAVIA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Before mixing, EXTAVIA may be stored for up to 3 months between 59°F and 86°F (15°C and 30°C).
  • After mixing, you can refrigerate EXTAVIA for up to 3 hours before using. Your EXTAVIA must be used within 3 hours of mixing even if refrigerated.
  • Do not freeze.

Keep EXTAVIA and all medicines out of the reach of children.

General information about the safe and effective use of EXTAVIA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EXTAVIA for a condition for which it was not prescribed. Do not give EXTAVIA to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about EXTAVIA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about EXTAVIA that is written for health professionals.
For more information, go to www.EXTAVIA.com or call the EXTAVIA toll-free medical information line at 1-888-669-6682.
What are the ingredients in EXTAVIA?
Active ingredient: interferon beta-1b
Inactive ingredients: albumin (human), mannitol
Diluent contains sodium chloride solution.

Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
U.S. License No. 1244

T2023-48

Revised: 7/2023
Document Id: 21e70358-f7a8-4b98-8f6c-d2d4cf020a94
Set id: 4cfdb571-ec4c-478f-bedc-e0669eeea504
Version: 25
Effective Time: 20230728
Novartis Pharmaceuticals Corporation