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SCROLL DOWN TO READ FULL INDICATION AND IMPORTANT SAFETY INFORMATION
What is EXTAVIA?
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. 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 (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or to mannitol.
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, 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.
Before you take EXTAVIA, tell your HCP about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
EXTAVIA may cause serious side effects including:
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, and 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. 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.
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 healthcare provider right away. You and your healthcare provider should decide if you should continue to take EXTAVIA.
The most common side effects of EXTAVIA include:
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.
What is EXTAVIA?
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. 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 (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or to mannitol.
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, 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.
Before you take EXTAVIA, tell your HCP about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
EXTAVIA may cause serious side effects including:
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, and 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. 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.
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 healthcare provider right away. You and your healthcare provider should decide if you should continue to take EXTAVIA.
The most common side effects of EXTAVIA include:
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.
