betaseron

Betaseron (interferon) is made from human proteins. Interferons help the body fight viral infections.

Betaseron is used to treat relapsing multiple sclerosis (MS). Betaseron will not cure MS, it will only decrease the frequency of relapse symptoms.

Betaseron may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Betaseron?

Betaseron may be harmful to an unborn baby, or may cause a miscarriage. Do not use Betaseron if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using Betaseron, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using Betaseron if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Betaseron is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure Betaseron is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using Betaseron?

Do not use Betaseron if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using Betaseron if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Before using Betaseron, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• a thyroid disorder;

• epilepsy or other seizure disorder;

• a bleeding or blood-clotting disorder, such as hemophilia;

• anemia (lack of red blood cells); or

• a history of depression or suicidal behavior.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Betaseron.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use Betaseron if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether Betaseron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

Interferon beta-1b is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Betaseron?

Betaseron is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Betaseron is injected into a skin area of the thigh, stomach, buttocks, or back of the upper arm. Betaseron comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Betaseron is usually given as one injection at bedtime every 48 hours (2 days). Follow the directions on your prescription label. Try to use your injections at the same time each dosing day.

Betaseron is a powder that comes in a single-use vial (bottle) with a liquid (diluent) that must be mixed with the powder in the vial. Gently swirl but do not shake the vial after mixing the medicine. Allow any bubbles or foam to settle before drawing the medicine into a syringe.

If the medicine has changed colors or has any particles in it, call your doctor for a new prescription.

Do not draw your Betaseron dose into a syringe until you are ready to give yourself an injection. Use a different place on your skin each time you inject this medication. Do not inject Betaseron into the same skin area two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure Betaseron is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store Betaseron vials at room temperature away from moisture and heat. After mixing the medicine you should use it right away, or within 3 hours after mixing if you store it in a refrigerator. Do not freeze.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. Then wait at least 48 hours before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours (2 days).

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Betaseron overdose are not known.

What should I avoid?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity while you are using Betaseron.

Interferons can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Betaseron side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Betaseron and call your doctor at once if you have any of these serious side effects:

• depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

• bruising, swelling, oozing, or skin changes where the injection was given;

• weight changes, pounding heartbeats, feeling too hot or cold;

• fever, chills, body aches, flu symptoms; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Betaseron side effects may include:

• weakness;

• headache;

• muscle pain or weakness;

• sleep problems (insomnia);

• stomach pain;

• swelling in your hands or feet;

• skin rash; or

• irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Betaseron?

There may be other drugs that can affect Betaseron. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.