Do you have questions about getting a COVID-19 vaccine?

If you are on treatment for multiple sclerosis (MS) and have questions about COVID-19 or the COVID-19 vaccines, contact your healthcare provider for answers and guidance. It is very important to continue taking your MS medicine as prescribed and to follow your healthcare provider’s treatment directions.

For additional information, there are helpful online resources that address the question of whether people with MS should get a COVID-19 vaccine, including the National MS Society and the The Consortium of Multiple Sclerosis Centers. To learn more about your vaccination options, talk with your healthcare provider.

US-REB-00324 04/2021

FAMILY PLANNING WHILE TAKING REBIF® (interferon beta-1a)

Family planning with RMS

If you have relapsing multiple sclerosis (RMS) and are thinking about starting a family, it’s important to plan ahead. Talk with your healthcare provider about your options for treating RMS while you are trying to become pregnant, and ask if Rebif® may be a good choice for you.

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Family planning with RMS

If you have relapsing multiple sclerosis (RMS) and are thinking about starting a family, it’s important to plan ahead. Talk with your healthcare provider about your options for treating RMS while you are trying to become pregnant, and ask if Rebif® may be a good choice for you.

Based on the pregnancy registry data described below, Rebif® is thought to be appropriate to continue taking while family planning up until you become pregnant, but you should tell your healthcare provider right away if you suspect you’ve become pregnant. The study did not identify an increased risk of major birth defects associated with use of interferon beta during early pregnancy, but it is not known if Rebif® may harm your unborn baby.

 

Before you take Rebif®, tell your healthcare provider if:

  • You are pregnant or plan to become pregnant. It is not known if Rebif® will harm your unborn baby

  • You are breastfeeding or plan to breastfeed. Rebif® may pass into breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif®

MS pregnancy study data

The possible effects of interferon beta during pregnancy were evaluated in a pregnancy registry. This registry tracked the outcomes of 2,831 pregnancies of women with multiple sclerosis in Finland from 1996 to 2014 and Sweden from 2005 to 2014.

Early in their pregnancies, some women were exposed to interferon beta, including Rebif® (n=797 pregnancies), while others were not exposed to any disease-modifying drugs (n=1,647 pregnancies).

 

THE STUDY DID NOT IDENTIFY:

a drug-associated risk of major birth defects among the women exposed to interferon beta in early pregnancy

– OR –

an increased risk of miscarriage or ectopic pregnancy. However, limitations in obtaining complete data capture for these outcomes made the interpretation of these findings more difficult

 

 

Before, during, and after pregnancy

If you are planning to get pregnant, it is important to talk with your healthcare provider about managing your risk of RMS relapses (flare-ups) before, during, and after pregnancy.

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Pre-pregnancy

Based on the study data discussed above, Rebif® may be able to treat your RMS while you’re trying to become pregnant. If you’re thinking about becoming pregnant, ask your healthcare provider whether Rebif® may be an option for you.

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Pregnancy

Tell your healthcare provider right away if you become pregnant. Although the study data did not identify a drug-associated risk of major birth defects with interferon beta use during early pregnancy, it is not known if Rebif® may harm your unborn baby.

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Post-pregnancy

You may also wonder about breastfeeding your baby post-partum. There is limited published data on this topic. Some data has shown interferon may be present at low levels in breastmilk. Other data has shown that it is poorly absorbed into the baby’s bloodstream. Talk with your healthcare provider about the best way to feed your baby if you take Rebif®.

 

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Learn more about family planning with Rebif®

A free brochure gives you a list of questions to ask your healthcare provider, background on Rebif®, and other helpful information if you have RMS and are thinking about starting a family.


IMPORTANT SAFETY INFORMATION AND INDICATION

Important Safety Information

Before beginning treatment, you should discuss the potential benefits and risks associated with Rebif with your healthcare provider.

Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.

  • Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide
  • Liver problems or worsening of liver problems including liver failure. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects
  • Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels
  • Injection site problems. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
  • Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems
  • Seizures. Some people have had seizures while taking Rebif

Rebif will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

  • mental illness, including depression and suicidal behavior
  • liver problems, bleeding problems or blood clots, low blood cell counts, seizures (epilepsy), or thyroid problems
  • you drink alcohol
  • you are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby
  • you are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

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

The most common side effects of Rebif include:

  • flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills
  • stomach pain
  • change in liver blood tests

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 Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. 

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

Indication

Rebif® (interferon beta-1a) is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.