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Medication Guide

Betaseron (interferon beta-1b) ^®
(bay-ta-seer-on)

Interferon beta-1b
(in-ter-feer-on beta-one-be)

Please read this leaflet carefully before you start to use Betaseron® (interferon beta-1b) and each time your prescription is refilled since there may be new information. The information in this medication guide does not take the place of talking with your doctor or healthcare professional.

What is the most important information I should know about Betaseron (interferon beta-1b) ?

Betaseron (interferon beta-1b) will not cure multiple sclerosis (MS) but it has been shown to decrease the number of flare-ups of the disease. Betaseron (interferon beta-1b) can cause serious side effects, so before you start taking Betaseron (interferon beta-1b) , you should talk to your doctor about the possible benefits of Betaseron (interferon beta-1b) and its possible side effects to decide if Betaseron (interferon beta-1b) is right for you. Potential serious side effects include:

• Depression.Some patients treated with interferons, including Betaseron (interferon beta-1b) , have become seriously depressed (feeling sad). Some patients have thought about or have attempted to kill themselves. Depression (a sinking of spirits or sadness) is not uncommon in people with multiple sclerosis. However, if you are feeling noticeably sadder or helpless, or feel like hurting yourself or others, you should tell a family member or friend right away and call your doctor or health care provider as soon as possible. Your doctor may ask that you stop using Betaseron (interferon beta-1b) . Before starting Betaseron (interferon beta-1b) , you should also tell your doctor if you have ever had any mental illness, including depression, and if you take any medications for depression.
• Risk to pregnancy. If you become pregnant while taking Betaseron (interferon beta-1b) you should stop using Betaseron (interferon beta-1b) immediately and call your doctor. Betaseron (interferon beta-1b) may cause you to lose your baby (miscarry) or may cause harm to your unborn child. You and your doctor will need to decide whether the potential benefit of taking Betaseron (interferon beta-1b) is greater than the potential risks to your unborn child.
• Allergic reactions. Some patients taking Betaseron (interferon beta-1b) have had severe allergic reactions leading to difficulty breathing and swallowing; these reactions can happen quickly. Allergic reactions can happen after your first dose or may not happen until after you have taken Betaseron (interferon beta-1b) many times. Less severe allergic reactions such as rash, itching, skin bumps or swelling of the mouth and tongue can also happen. If you think you are having an allergic reaction, stop using Betaseron (interferon beta-1b) immediately and call your doctor.
• Injection site problems. Betaseron (interferon beta-1b) may cause redness, pain or swelling at the place where an injection was given. A few patients have developed skin infections or areas of severe skin damage (necrosis). If one of your injection sites becomes swollen and painful or the area looks infected and it doesn't heal within a few days, you should call your doctor.

What is Betaseron (interferon beta-1b) ?

Betaseron (interferon beta-1b) is a type of protein called beta interferon that occurs naturally in the body. It is used to treat relapsing forms of multiple sclerosis. It will not cure your MS but may decrease the number of flare-ups of the disease. MS is a life-long disease that affects your nervous system by destroying the protective covering (myelin) that surrounds your nerve fibers. The way Betaseron (interferon beta-1b) works in MS is not known.

Who should not take Betaseron (interferon beta-1b) ?

Do not take Betaseron (interferon beta-1b) if you:

• Have had allergic reactions such as difficulty breathing, flushing or hives to another interferon beta or to human albumin.

If you have any of the following conditions or serious medical problems, you should tell your doctor before taking Betaseron (interferon beta-1b) :

• Depression (a sinking feeling or sadness), anxiety (feeling uneasy, nervous, or fearful for no reason), or trouble sleeping
• Liver diseases
• Problems with your thyroid gland
• Blood problems such as bleeding or bruising easily and anemia (low red blood cells) or low white blood cells
• Epilepsy
• Are pregnant, breast feeding, or planning to become pregnant

You should tell your doctor if you are taking any other prescription or nonprescription medicines. This includes any vitamin or mineral supplements, or herbal products.

How should I take Betaseron (interferon beta-1b) ?

Betaseron (interferon beta-1b) is given by injection under the skin (subcutaneous injection) every other day. Your injections should be approximately 48 hours (two days) apart, so it is best to take them at the same time each day, preferably in the evening just before bedtime.

You may be started on a lower dose when you first start taking Betaseron (interferon beta-1b) . Your doctor will tell you what dose of Betaseron (interferon beta-1b) to use, and that dose may change based on how your body responds. You should not change your dose without talking with your doctor.

If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Your next injection should be taken about 48 hours (two days) after that dose. Do not take Betaseron (interferon beta-1b) on two consecutive days. If you accidentally take more than your prescribed dose, or take it on two consecutive days, call your doctor right away.

You should always follow your doctor's instructions and advice about how to take this medication. If your doctor feels that you, or a family member or friend may give you the injections, then you and/or the other person should be trained by your doctor or healthcare provider in how to give an injection. Do not try to give yourself (or have another person give you) injections at home until you (or both of you) understand and are comfortable with how to prepare your dose and give the injection.

Always use a new, unopened, vial of Betaseron (interferon beta-1b) and syringe for each injection. Never reuse vials or syringes.

It is important that you change your injection site each time Betaseron (interferon beta-1b) is injected. This will lessen the chance of your having a serious skin reaction at the spot where you inject Betaseron (interferon beta-1b) . You should always avoid injecting Betaseron (interferon beta-1b) into an area of skin that is sore, reddened, infected or otherwise damaged.

At the end of this leaflet there are detailed instructions on how to prepare and give an injection of Betaseron (interferon beta-1b) . You should become familiar with these instructions and follow your doctor's orders before injecting Betaseron (interferon beta-1b) .

What should I avoid while taking Betaseron (interferon beta-1b) ?

• Pregnancy. You should avoid becoming pregnant while taking Betaseron (interferon beta-1b) until you have talked with your doctor. Betaseron (interferon beta-1b) can cause you to lose your baby (miscarry).
• Breast feeding. You should talk to your doctor if you are breast feeding an infant. It is not known if the interferon in Betaseron (interferon beta-1b) can be passed to an infant in mother's milk, and it is not known whether the drug could harm the infant if it is passed to an infant.

What are the possible side effects of Betaseron (interferon beta-1b) ?

• Flu-like symptoms. Most patients have flu-like symptoms (fever, chills, sweating, muscle aches and tiredness). For many patients, these symptoms will lessen or go away over time. You should talk to your doctor about whether you should take an over the counter medication for pain or fever reduction before or after taking your dose of Betaseron (interferon beta-1b) .
• Skin reactions. Soreness, redness, pain, bruising or swelling may occur at the place of injection. (see “What is the most important information I should know about Betaseron (interferon beta-1b) ?”).
• Depression and anxiety. Some patients taking interferons have become very depressed and/or anxious. There have been patients taking interferons who have had thoughts about killing themselves. If you feel sad or hopeless you should tell a friend or family member right away and call your doctor immediately. (see “What is the most important information I should know about Betaseron (interferon beta-1b) ?”).
• Liver problems. Your liver function may be affected. Symptoms of changes in your liver include yellowing of the skin and whites of the eyes and easy bruising.
• 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.
• Thyroid problems. Your thyroid function may change. Symptoms of changes in the function of your thyroid include feeling cold or hot much of the time or change in your weight (gain or loss) without a change in your diet or amount of exercise you are getting.
• Allergic reaction. Some patients have had hives, rash, skin bumps or itching while they were taking Betaseron (interferon beta-1b) . There is also a rare possibility that you can have a life-threatening allergic reaction. (see “What is the most important information I should know about Betaseron (interferon beta-1b) ?”).

Whether you experience any of these side effects or not, you and your doctor should periodically talk about your general health. Your doctor may want to monitor you more closely and ask you to have blood tests done more frequently.

General Information About Prescription Medicines

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This medication has been prescribed for your particular medical condition. Do not use it for another condition or give this drug to anyone else. If you have any questions you should speak with your doctor or health care professional. You may also ask your doctor or pharmacist for a copy of the information provided to them with the product. Keep this and all drugs out of the reach of children.

Instructions for Preparing and Giving Yourself an Injection of Betaseron (interferon beta-1b)

1. Find a clean, flat working surface that is well-lit and collect all the supplies you will need to give yourself an injection. You will need:
   • One tray containing Betaseron (interferon beta-1b) . Make sure the tray contains: A pre-filled diluent syringe
   • A vial of Betaseron (interferon beta-1b)
   • Two (2) alcohol prep pads
   • A vial adapter with a 27 gauge needle attached (in the blister pack)
   • A puncture-resistant sealable container to dispose of used syringes/needles
2. Check the expiration date on the tray label to make sure that it has not expired. Do not use it if the medication has expired.
3. Wash your hands thoroughly with soap and water.
4. Open the tray by peeling off the label and take out all the contents. Make sure the blister pack containing the vial adapter is sealed. Check to make sure the rubber cap on the diluent syringe is firmly attached.
5. Turn the tray over, place the Betaseron (interferon beta-1b) vial in the well (vial holder) and place the prefilled diluent syringe in the U-shaped trough.

Reconstituting Betaseron (interferon beta-1b)

1. Remove the Betaseron (interferon beta-1b) vial from the well and take the cap off the vial.

2. Place the vial back into the vial holder. Use an alcohol prep pad to clean the top of the vial. Move the prep pad in one direction. Leave the alcohol prep pad on top of the vial until step 5.

3. Peel the label off the blister pack with the vial adapter in it, but do not remove vial adapter. The vial adapter is sterile; avoid touching the vial adapter.

4. Remove the alcohol prep pad from the top of the Betaseron (interferon beta-1b) vial. Keeping the vial adapter in the blister pack, place the adapter on top of the Betaseron (interferon beta-1b) vial and push down on the adapter until it pierces the rubber top of the Betaseron (interferon beta-1b) vial and snaps in place (Figure 1). Remove the blister packaging from the vial adapter.

5. Remove the rubber cap from the diluent syringe using a twist and pull motion. Discard the rubber cap.

6. Keeping the syringe assembly attached to the vial, remove the vial from the tray. Be careful not to pull the vial adapter off the top of the vial.

7. Connect the syringe to the vial adapter by turning clockwise and tighten carefully. This will form the syringe assembly (Figure 2).

8. Slowly push the plunger of the diluent syringe all the way in. This will transfer all of the diluent in the syringe to the Betaseron (interferon beta-1b) vial (Figure 3). The plunger may return to its original position after you release it.

9. Gently swirl the vial to completely dissolve the white cake of Betaseron (interferon beta-1b) . Do not shake. Shaking can cause Betaseron (interferon beta-1b) to foam; even gently mixing the solution can cause foaming. If there is foam, allow the vial to sit undisturbed until the foam settles.

10. After the cake is dissolved, look closely at the solution to make sure the solution is clear and colorless and does not contain particles. If the mixture contains particles, or is discolored, do not use. Repeat the steps to prepare your dose using a new tray of Betaseron (interferon beta-1b) , prefilled syringe, vial adapter and alcohol prep pads. Contact Bayer HealthCare Pharmaceuticals Inc.at 1-800-788-1467 to obtain replacement product.

Preparing the Injection

You have completed the steps to reconstitute your Betaseron (interferon beta-1b) and are ready for the injection. The injection should be given immediately after mixing and allowing any foam in the solution to settle. If you must delay giving yourself the injection, you may refrigerate the solution and use within three hours of reconstitution. Do not freeze.

1. Push the plunger in and hold it there; then turn the syringe assembly so that the vial is on top. (The syringe is horizontal.) (Figure 4).

2. Slowly pull the plunger back to withdraw the entire contents of the Betaseron (interferon beta-1b) vial into the syringe.

NOTE: The syringe barrel is marked with numbers from 0.25 to 1.0. If the solution in the vial cannot be drawn up to the 1.0 mark, discard the vial and syringe and start over with a new tray containing a Betaseron (interferon beta-1b) vial, prefilled diluent syringe, vial adapter and alcohol prep pads.

3. Turn the syringe assembly so that the needle end is pointing up. Remove any air bubbles by tapping the outer wall of the syringe with your fingers. Slowly push the plunger to the 1 mL mark on the syringe (or to the amount prescribed by your doctor).

NOTE: If too much solution is pushed into the vial, repeat steps 1, 2, and 3.

4. Remove the vial adapter and the vial from the syringe by twisting the vial adapter as shown in Figure 5. This will remove the vial adapter and the vial from the syringe, but will leave the needle on the syringe (Figure 5).

Picking an Injection Site

Betaseron (Interferon beta-1b) is injected under the skin and into the fat layer between the skin and the muscles (subcutaneous tissue). The best areas for injection are where the skin is loose and soft and away from the joints, nerves, and bones. Do not use the area near your navel or waistline. If you are very thin, use only the thigh or outer surface of the arm for injection.

You should pick a different site each time you give yourself an injection. The diagrams show different areas for giving injections. You should not choose the same area for two injections in a row. Keeping a record of your injections will help make sure you rotate your injection sites. You should decide where your injection will be given before you prepare your syringe for injection. If there are any sites that are difficult for you to reach, you can ask someone who has been trained to give injections to help you.

Do not inject in a site where the skin is red, bruised, infected, or scabbed, has broken open, or has lumps, bumps, or pain. Tell your doctor or health-care provider if you find skin conditions like the ones mentioned here or any other unusual looking areas where you have been given injections.

Using a circular motion, and starting at the injection site and moving outward, clean the injection site with an alcohol wipe. Let the skin area dry before you inject the Betaseron (interferon beta-1b) .

Remove the cap from the needle.

Hold the syringe like a pencil or dart in one hand.

Gently pinch the skin around the site with the thumb and forefinger of the other hand.

While holding your skin, stick the needle straight into the skin at a 90° angle with a quick, firm motion. Once in your skin, slowly pull back on the plunger. If blood appears in the syringe it means that you have entered a blood vessel. Do not inject Betaseron (interferon beta-1b) . Withdraw the needle and repeat the steps to prepare your dose. Choose and clean a new injection site. You should not use the same syringe; discard it in your puncture-proof container.

If no blood appears, slowly push the plunger all the way in until the syringe is empty.

Remove the needle from the skin; then place a dry cotton ball or gauze pad over the injection site.

Gently massage the injection site for a few moments with the dry cotton ball or gauze pad.

Throw away the syringe in the disposal container.

Disposing of syringes and needles

Used needles and syringes may be placed in a container made specially for disposing of used syringes and needles (called a “Sharps” container), or a hard plastic container with a screw-on cap or metal container with a plastic lid labeled &lequo;Used Syringes”. Do not use glass or clear plastic con-tainers.You should always check with your healthcare provider for instructions on how to properly dispose of used vials, needles and syringes. You should follow any special state or local laws regarding the proper disposal of needles and syringes.

DO NOT throw the needle or syringe in the household trash or recycle.

Always keep the disposal container out of the reach of children.

How Should I Store Betaseron (interferon beta-1b) ?

Betaseron (interferon beta-1b) should be stored at room temperature 25°C (77°F). Excursions of 15 to 30°C (59 to 86°F) are permitted. Avoid freezing.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.