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Overview: Betaseron is injected under the skin to treat certain forms of multiple sclerosis. Common side effects include flu-like symptoms, and pain, itching, swelling, or redness near where the needle went in. Serious side effects are less common, but may include liver, heart, skin, blood vessel, or mental health problems. Let your health care provider know right away if you have new or worsening depression, anxiety, or thoughts of suicide.

Uses

What is Betaseron used for?

Betaseron (interferon beta-1b) is commonly used to treat certain forms of multiple sclerosis, such as clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.

Betaseron may also be used for other conditions as determined by your health care provider.

How does Betaseron work (mechanism of action)?

Multiple sclerosis (MS) is a condition where the immune system attacks the central nervous system (CNS), causing inflammation, damage to the protective covering of nerves, and loss of nerve function. Betaseron is similar to a natural protein called interferon beta. It seems to help people with MS by reducing inflammation in your body by changing the balance of cytokines (chemical messengers that guide cell growth and activity). 

How is Betaseron supplied (dosage forms)?

Brands and other names

  • Betaseron

Dosage forms and strengths

  • 0.3 mg vial

How should I store Betaseron?

Before preparing (mixing) Betaseron, store it in the refrigerator or at room temperature, between 36 F and 86 F (2 C and 30 C). After mixing Betaseron, you can use it right away or store it in the refrigerator for up to three hours. You must use prepared Betaseron within three hours of mixing, even if you put it in the refrigerator. Do not freeze it.

Side Effects

What are the most common side effects of Betaseron?

The most common side effects of Betaseron are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Reactions where the needle went in (see below)
  • Flu-like symptoms (see below)
  • Muscle pain or increased muscle tension
  • Blood disorders (see below) 
  • Changes in liver function tests
  • Headache
  • Pain, including stomach pain
  • Rash
  • Trouble sleeping
  • Feeling unusually weak or tired

There may be other side effects of Betaseron that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Betaseron?

While less common, the most serious side effects of Betaseron are described below, along with what to do if they happen.

Severe Allergic Reactions. Betaseron may cause allergic reactions, which can be serious. Stop using Betaseron and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • A racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Betaseron. This can be serious and may lead to liver failure. The risk may be higher if you have certain other medical conditions or take other medicines. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever or other flu-like symptoms
  • Easy bruising or bleeding 
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Depression, Suicidal Thoughts, or Other Mental Health Conditions. Betaseron may cause depression or suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide and Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety or depression
  • Other mood or behavior changes
  • Trouble sleeping
  • Aggressiveness, anger, or violence
  • Acting dangerously or impulsively
  • Seeing or hearing things that others do not see or hear, also called hallucinations

Heart Problems. Betaseron may cause or worsen heart problems, including heart failure and a heart muscle problem (cardiomyopathy). Tell your health care provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Chest pain or tightness
  • A hard time exercising
  • Swelling in your feet, ankles, or legs
  • Peeing frequently, especially at night
  • Unusually fast weight gain
  • Unusual tiredness
  • Fast or abnormal heart beat

Injection Site Reactions. Pain, itching, swelling, or redness near where the needle went in are common with Betaseron. Betaseron may also rarely cause severe damage to the skin and tissue near the injection site. You should not inject Betaseron into an area where skin is red, bruised, infected, scabbed, broken, painful, or has lumps or bumps. Avoid injection Betaseron in the same spot over and over. Call your health care provider right away if you have any of the following symptoms. 

  • Swelling, redness, or pain where the needle went in
  • Fluid draining from the injection site
  • Breaks in your skin with discolored skin (blue/black)

Pulmonary Arterial Hypertension. Betaseron may cause pulmonary arterial hypertension, which is high blood pressure in the arteries of the lungs. This can happen soon after or even years after you start using Betaseron. Call your health care provider right away if you have shortness of breath or tiredness that is new or getting worse.

Flu-Like Symptoms. Betaseron can commonly cause flu-like symptoms, which can be severe. These symptoms may decrease over time. If you have flu-like symptoms that bother you, ask your health care provider if you can take over-the-counter fever or pain medicines on the days you use Betaseron. Call your health care provider if you have symptoms that bother you or do not go away, including any of the following symptoms. 

  • Fever, chills, or sweating
  • Tiredness
  • Achy muscles

Seizures. Some people who have used Betaseron have reported having seizures, even if they never had seizures before. There are many types of seizures, and some of them are not easy to recognize. Call your health care provider right away if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Immune System Reactions. Betaseron can cause inflammation of your liver, blood vessels, or lymph vessels and cause symptoms that look like a condition called lupus. Stop using Betaseron and call your health care provider right away if you get any of the following symptoms.

  • Rash
  • Joint pain
  • Fever
  • Weakness or unusual tiredness
  • Swollen glands
  • A reduced need to pee, or pink, red, or brown pee 
  • Swelling
  • Fingers or toes feeling numb, cool, painful, sensitive to cold, or changing color 
  • Unexplained wounds on fingers or toes
  • Chest discomfort or painful breathing

Small Blood Vessel Injury. Betaseron can lead to a serious problem with blood clotting, called thrombotic thrombocytopenic purpura (TTP). TTP is when blood clots form in some parts of your bloodstream, which reduces platelets in the rest of the blood (thrombocytopenia). If the blood vessel damage happens in your kidneys it can lead to hemolytic uremic syndrome (HUS). This can lead to kidney failure. These conditions need to be treated right away in the hospital or they can lead to death. Get emergency help if you have any of the following symptoms without another explanation.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin, or your skin or the whites of your eyes turn yellowish (also called jaundice)
  • Changes in your vision
  • Unusual weakness or tiredness
  • Headache, confusion, or slurred speech
  • Fast heartbeat, chest pain, or chest pressure
  • Purplish spots (purpura) on the skin or in the mouth due to bleeding under the skin
  • A reduced need to pee, a low amount of pee, or pee that is pink or has blood in it
  • Swelling in your feet, ankles, or legs
  • Nausea
  • Seizures

Blood Disorders. Betaseron can cause blood disorders, such as low white blood cell levels (leukopenia). Keep all appointments, including those for lab work, while you are using Betaseron. Tell your health care provider right away if you have any of the following symptoms of low white blood cell levels.

  • Fever
  • Tiredness
  • Frequent infection
  • Sores or wounds that will not heal

Warnings & Precautions

Who should not use Betaseron?

Allergies to Ingredients. People who are allergic to any of the following should not use Betaseron.

  • Interferon beta-1b or any other interferon beta
  • Betaseron
  • Human albumin 
  • Mannitol
  • Any other medicine known as an interferon beta
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Betaseron.

What should I know about Betaseron before using it?

Do not use Betaseron unless it has been prescribed to you by a health care provider. Use it as prescribed. Do not change your Betaseron dose or schedule unless your health care provider says that’s OK. This medicine is injected under the skin. Read and follow the instructions. Make sure that you or a caregiver understands how to properly prepare and use Betaseron. If you have any questions, talk to your health care provider.

Do not share Betaseron with other people, even if they have the same condition as you. It may harm them.

Keep Betaseron out of the reach of children. When this medicine is kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

You should use a different injection site each time you inject this medicine. Do not inject Betaseron into skin that is red, bruised, infected, scabbed, broken, painful, or has lumps or bumps. Tell your health care provider if you have any of these skin reactions. 

You can use Betaseron with the prefilled syringe or optional injection device. The optional injection device is available through the drugmaker. If you have any questions, talk to your health care provider.

Betaseron is for single use only. Throw away any unused medicine after injecting your dose. Do not reuse needles or syringes. Throw them away in a sharps container.

What should I tell my health care provider before using Betaseron?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Betaseron is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Betaseron. Tell your health care provider about any vaccines you have recently received or have scheduled.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Depression, anxiety, suicidal thoughts, or other mental health problems
  • Trouble sleeping (insomnia)
  • Pulmonary arterial hypertension
  • Heart problems, including heart failure
  • Blood disorders, such as easy bruising or bleeding, low red blood cells (anemia), or low white blood cells
  • Seizures

Pregnancy. It is not known if or how Betaseron could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Betaseron while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Betaseron passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Betaseron while breastfeeding.

How can I get more information about Betaseron?

For more information about Betaseron, you can visit the drugmaker’s website at www.betaseron.com or call them at 800-788-1467.

Interactions

Does Betaseron interact with foods or drinks?

There are no known interactions between Betaseron and foods or drinks.

It is unknown if drinking alcohol will affect Betaseron. The risk of liver damage may be increased if you drink alcohol while using Betaseron.

Does Betaseron interact with other medicines (drug interactions)?

There are no known interactions between Betaseron and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Betaseron?

If you or someone else has used too much Betaseron, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Betaseron?

If you miss a dose, use it as soon as you remember. Then, your next shot should be about 48 hours (two days) after you inject the missed dose. Do not use Betaseron two days in a row. Do not use double or extra doses. Call your health care provider if you are not sure what to do if you miss a dose of Betaseron.

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