What Is EXTAVIA?

EXTAVIA is one of several MS treatments called interferons that are known as disease-modifying therapies.

Interferon beta-1b is the active ingredient in EXTAVIA and is based on a protein that's found naturally in your body.

EXTAVIA is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with MS. EXTAVIA will not cure MS but may decrease the number of flare-ups of the disease.

Although EXTAVIA is proven effective, the exact mechanism of action is unknown.

BENEFITS OF EXTAVIA

Every patient responds differently to treatment. But treating with EXTAVIA may be beneficial to you for these reasons:

  • EXTAVIA has been shown to decrease the number of relapses
  • EXTAVIA has been shown to help reduce the risk of having a second episode in patients with CIS
  • EXTAVIA has been shown to decrease the number of new MRI lesions and reduce the size of existing MRI lesions

In studies of people taking interferon beta-1b, it has been shown that with this therapy you may:

  • Experience a slower rate of relapse
  • Experience fewer episodes of new or worsening symptoms
  • Experience fewer days of moderate and severe relapsing symptoms

The importance of early treatment

If you've had one episode and MRI findings consistent with MS, EXTAVIA can help reduce your risk of having another clinical attack.

In patients who have had one episode and whose MRI findings are consistent with MS, EXTAVIA has been shown to reduce the risk of having a second clinical attack within 2 years.

side effects of extavia

The most common side effects with EXTAVIA (at least 2% more than placebo) were:

  • Injection site reaction
  • Flu-like symptom complex
  • Excessive fatigue
  • Headache
  • Pain
  • Increases in muscle tension
  • Fever
  • Muscle pain
  • Rash
  • Chills
  • Trouble sleeping
  • Incoordination
  • Abdominal pain
  • Decreased white blood cells
  • Tissue swelling
  • Urinary urgency
  • Skin disorder
  • Chest pain
  • Vaginal bleeding
  • Impotence
  • High blood pressure
  • Malaise
  • Enlarged lymph nodes
  • Shortness of breath
  • Increased liver enzymes
  • Injection site necrosis

NEXT: How Is EXTAVIA Taken?

EXTAVIA also provides access to complimentary support services

through the EXTAVIA®
Go Program™, such as one-on-one injection training.

Learn more

SCROLL DOWN TO READ FULL INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

EXTAVIA® (interferon beta-1b) 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.

Important Safety Information

Do not take EXTAVIA (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin,
or to mannitol.

EXTAVIA can cause serious side effects, including:

Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired,
flu-like symptoms, nausea or vomiting, 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, swelling of the mouth or tongue, rash, itching,
or skin bumps. Also tell your healthcare provider if you have or have had an allergic reaction to rubber or latex. The rubber cap of the
diluent pre-filled syringe contains a natural rubber latex.

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, new or worse depression (sinking feeling or sadness), new or worse anxiety
(feeling uneasy, nervous, or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on
dangerous impulses, hallucinations, other unusual changes in behavior or mood.

Other possible serious side effects with EXTAVIA include:

Heart Problems. EXTAVIA may worsen heart problems including congestive heart failure. Symptoms of heart problems may include
swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night,
not being able to lay flat in bed.

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, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject EXTAVIA as it will lessen the chance of you having a serious skin reaction. Avoid injecting EXTAVIA into an area of the skin that is sore, reddened, infected, or has other problems.

Flu-like Symptoms. EXTAVIA can cause flu-like symptoms including fever, chills, tiredness, sweating, and 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 MS, to EXTAVIA, or to a combination of both. If you have a seizure after taking EXTAVIA call your healthcare provider right away.

Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood
clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish, or cause you to bruise or
bleed easily.

Risk to Pregnancy:
EXTAVIA can harm your unborn baby. EXTAVIA may cause you to lose your baby (miscarry). If you become pregnant while taking
EXTAVIA call your heathcare provider right away. You and your healthcare provider should decide if you should continue to take EXTAVIA.

Most Common Side Effects:
The most common side effects of EXTAVIA include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, and weakness. These are not all the possible side effects of EXTAVIA.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

EXTAVIA® (interferon beta-1b) 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.

Important Safety Information

Do not take EXTAVIA (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or to mannitol.

EXTAVIA can cause serious side effects, including:

Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, 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, swelling of the mouth or tongue, rash, itching, or skin bumps. Also tell your healthcare provider if you have or have had an allergic reaction to rubber or latex. The rubber cap of the
diluent pre-filled syringe contains a natural rubber latex.

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, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous, or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on
dangerous impulses, hallucinations, other unusual changes in behavior or mood.

Other possible serious side effects with EXTAVIA include:

Heart Problems. EXTAVIA may worsen heart problems including congestive heart failure. Symptoms of heart problems may include
swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.

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, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject EXTAVIA as it will lessen the chance of you having a serious skin reaction. Avoid injecting EXTAVIA into an area of the skin that is sore, reddened, infected, or has other problems.

Flu-like Symptoms. EXTAVIA can cause flu-like symptoms including fever, chills, tiredness, sweating, and 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 MS, to EXTAVIA, or to a combination of both. If you have a seizure after taking EXTAVIA call your healthcare provider right away.

Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood
clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish, or cause you to bruise or
bleed easily.

Risk to Pregnancy:
EXTAVIA can harm your unborn baby. EXTAVIA may cause you to lose your baby (miscarry). If you become pregnant while taking
EXTAVIA call your heathcare provider right away. You and your healthcare provider should decide if you should continue to take EXTAVIA.

Most Common Side Effects:
The most common side effects of EXTAVIA include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, and weakness. These are not all the possible side effects of EXTAVIA.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.