Betaseron (interferon beta-1b)

Betaseron generic or biosimilar

Betaseron is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

A biologic is a drug made using living cells, whereas traditional drugs are made using chemicals. It’s possible to make exact copies of brand-name drugs made from chemicals. These are called generics. It’s not possible to make exact copies of brand-name biologic drugs. However, manufacturers can sometimes make biosimilars. These are considered to be as safe and effective as the parent biologic drug.

Generics and biosimilars usually cost less than brand-name drugs.

Betaseron side effects

Betaseron can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during Betaseron treatment. These lists do not include all possible side effects.

For more information about the possible side effects of Betaseron, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Betaseron, you can do so through MedWatch.

Mild side effects

Here is a partial list of mild side effects of Betaseron. To learn about other mild side effects, talk with your doctor or pharmacist, or view Betaseron’s prescribing information.

Mild side effects of Betaseron can include:

• injection site reactions, such as swelling, discoloration, or pain
• flu-like symptoms
• muscle pain or stiffness
• headache
• insomnia (difficulty sleeping)
• abdominal pain
• weakness
• rash
• fever or chills
• swelling of the lower legs or feet
• weight gain

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Betaseron aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• skin necrosis (severe skin damage) at the injection site, which may include symptoms such as:
  • severe pain and swelling
  • breaks in the skin
  • discharge of fluid
  • blue-black discoloration
• liver damage, which may include symptoms such as:
  • raised liver enzymes
  • nausea, vomiting, or abdominal pain
  • jaundice (yellowing of your skin or whites of your eyes)
• depression and suicidal thoughts, which may include symptoms such as:
  • new or worsening depression or anxiety
  • unusual thoughts or behavior
  • new or worsening insomnia
  • thoughts about harming yourself
• congestive heart failure
  • swelling of your lower legs or feet
  • shortness of breath
  • weight gain
• decreased levels of white blood cells, which may include symptoms such as:
  • fever or chills
  • sore throat, cough, or other signs of infection
• thrombotic microangiopathy (blood clots in small blood vessels), which may include symptoms such as:
  • unusual bruising or bleeding
  • fatigue
  • decreased urination
• pulmonary arterial hypertension (high blood pressure in the artery carrying blood to your lungs), which may include symptoms such as:
  • shortness of breath
  • fatigue
  • dizziness
• drug-induced lupus erythematosus, which may include symptoms such as:
  • rash
  • joint pain
  • cold, pale, or numb fingers or toes
• seizures

ALLERGIC REACTION

For some people, Betaseron injection can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Betaseron injection, your doctor may recommend a different medication instead.

Betaseron dosage

Your doctor will typically increase your Betaseron dosage gradually over the first 6 weeks of treatment.

The following information describes dosages that are commonly used or recommended. However, be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Betaseron comes as a powder in a single-dose vial. Each vial contains 0.3 milligrams (mg) of Betaseron.

Betaseron comes with a prefilled syringe containing a 0.54% sodium chloride solution. This is mixed with the Betaseron powder to make a liquid solution, which is given as a subcutaneous injection.

Dosage for multiple sclerosis

The recommended dosages of Betaseron are as follows:

• Weeks 1 and 2: 0.0625 mg (0.25 milliliters [mL] of mixed solution) injected subcutaneously every other day
• Weeks 3 and 4: 0.125 mg (0.5 mL) injected subcutaneously every other day
• Weeks 5 and 6: 0.1875 mg (0.75 mL) injected subcutaneously every other day
• Week 7 and onward: 0.25 mg (1 mL) injected subcutaneously every other day

How to inject

A healthcare professional may administer Betaseron injections. Alternatively, your doctor or another healthcare professional can teach you or your caregiver how to prepare Betaseron injections and administer them at home.

You can find complete instructions on how to use Betaseron in the medication guide and instructions for use that come with Betaseron. If you have questions about using Betaseron, talk with your doctor, nurse, or pharmacist. You can also contact Betaplus, the patient support program for Betaseron, by calling 800-788-1467.

Betaseron injection sites

Betaseron can be injected in the following sites:

• left or right side of your abdomen, avoiding the two inches around your navel
• front of your left or right thigh
• back of your right or left upper arm
• left or right buttock

The injection should be given in a different place each time. It’s helpful to note the injection site used each time you receive a dose. The same injection site should not be used for two injections in a row.

The injection should only be given in places where the skin is healthy. It should not be given in areas of skin that are red, discolored, bruised, infected, swollen, damaged, or painful.

About taking Betaseron

Here, you’ll find information about key dosage issues.

• When to use: You should use Betaseron every other day. Taking the medication around the same time every other day helps keep a steady level of the drug in your body. This helps Betaseron work effectively.
• If you miss a dose: If you miss a dose, take the missed dose as soon as possible. Take your next dose 48 hours later, then continue taking your dose every other day around that same time. Do not take any extra doses and do not take a dose 2 days in a row.
• Using Betaseron with food: As Betaseron is taken by injection, it is not affected by food. You can take Betaseron with or without food.
• Length of use: Betaseron is meant to be a long-term treatment. If you and your doctor determine that Betaseron is safe and effective for you, you’ll likely continue with it long term.
• Length of time to work: Betaseron starts working as soon as you start taking it, but you might not notice it working. The medication helps to slow the progression (worsening) of multiple sclerosis and reduce the number of relapses you have. (A relapse is a period of time when your symptoms get worse.)

Overdose

Do not use more Betaseron than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Betaseron

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Betaseron uses

The Food and Drug Administration (FDA) approves prescription drugs such as Betaseron to treat certain conditions.

Betaseron for multiple sclerosis

Betaseron is FDA approved to treat relapsing forms of multiple sclerosis (MS) in adults.

MS is a long-term autoimmune condition in which the immune system mistakenly attacks nerves in your brain and spinal cord. The resulting nerve damage makes it harder for your brain to communicate with other parts of your body.

MS can cause various symptoms, depending on which nerves are affected. Examples include tingling, numbness, pain, vision problems, bladder or bowel problems, muscle weakness or spasms, and difficulty walking.

MS is a progressive (gradually worsening) condition. However, you may have periods when your symptoms relapse (worsen) and periods when your symptoms stabilize or improve.

Relapsing forms of MS that Betaseron treats include:

• Relapsing-remitting MS (RRMS): With RRMS, you have periods of relapse where your symptoms get worse. You also have periods of remission where your symptoms go away partially or completely.
• Active secondary progressive MS (SPMS): With active SPMS, your symptoms get gradually worse without remission. You may also have periods where your symptoms suddenly relapse and are much worse for a time.

Betaseron is also FDA approved to treat clinically isolated syndrome (CIS). With CIS, you have one episode of MS-like symptoms lasting at least 24 hours. In some people, CIS may develop into MS. (Because CIS and MS cause similar symptoms, these conditions are often grouped as MS.)

Betaseron helps slow the progression of MS. It can reduce the number of lesions (damaged areas) that form in your brain and the number of relapses you have. It can also slow the development of disabilities, such as difficulty walking.

To learn more about your condition, visit our MS hub.

Betaseron and children

Betaseron is not FDA approved for use in children. It hasn’t been studied for use in children.

Betaseron interactions

The manufacturer of Betaseron didn’t look at interactions in clinical trials of the drug.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Betaseron.

Before starting Betaseron treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Alcohol interaction

Betaseron is not known to interact with alcohol. However, Betaseron and alcohol can cause some similar side effects, such as headaches and liver problems. So you may be more likely to have these side effects if you drink alcohol during Betaseron treatment.

If you drink alcohol and have questions about drinking it during your Betaseron treatment, talk with your doctor.

Betaseron cost and coupons

As with all medications, the cost of Betaseron can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Betaseron, or if you need help understanding your insurance coverage, help is available.

To learn more about saving money on prescriptions, check out this article.

Biosimilar version: Betaseron is a brand-name biologic drug (a drug made using living cells). It’s not available in a biosimilar form. Biosimilars are like generics for brand-name biologic drugs. Like generics, biosimilars tend to cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Betaseron, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Betaseron:

• dimethyl fumarate (Tecfidera)
• fingolimod (Gilenya)
• glatiramer acetate (Copaxone, Glatopa)
• interferon beta-1a (Avonex, Rebif)
• interferon beta-1b (Extavia)
• peginterferon beta-1a (Plegridy)
• natalizumab (Tysabri)
• ocrelizumab (Ocrevus)
• ofatumumab (Kesimpta)
• siponimod (Mayzent)
• teriflunomide (Aubagio)

Things to consider when taking Betaseron

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Betaseron and pregnancy

It’s not known whether Betaseron should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Betaseron and birth control

It’s not known whether Betaseron is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options while you’re taking Betaseron.

Betaseron and breastfeeding

It’s not known whether Betaseron should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

How Betaseron works

Betaseron is used to treat multiple sclerosis (MS). With MS, your immune system becomes overactive and mistakenly attacks and damages nerves in your brain and spinal cord. This causes symptoms such as tingling, numbness, pain, vision problems, bladder or bowel problems, muscle weakness or spasms, and difficulty walking. You may have periods when your symptoms relapse (get worse) and periods when they stabilize or improve. However, the condition worsens over time.

Doctors don’t fully understand how Betaseron works to treat MS. However, the drug may reduce inflammatory responses produced by your overactive immune system. It may also stop certain immune cells from entering your brain and spinal cord. These actions may stop or reduce damage to the nerves in your brain and spinal cord.

Betaseron helps slow the progression of MS. It can reduce the number of lesions (damaged areas) that form in your brain and the number of relapses you have. It can also slow the development of disabilities, such as difficulty walking.