Betaseron

Generic Name: interferon beta-1b (Subcutaneous route)

in-ter-FEER-on BAY-ta-1b

Commonly used brand name(s):

In the U.S.

• Betaseron
• Extavia

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Beta (class)

Uses For Betaseron

Interferon beta-1b is used to treat the relapsing-remitting form of multiple sclerosis (MS). This medicine will not cure MS, but may decrease the number of relapses of the disease.

This medicine is available only with your doctor's prescription.

Before Using Betaseron

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of interferon beta-1b in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of interferon beta-1b in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Mental depression or thoughts of suicide—This medicine may make the condition worse

Proper Use of interferon beta-1b

This section provides information on the proper use of a number of products that contain interferon beta-1b. It may not be specific to Betaseron. Please read with care.

Use this medicine exactly as directed by your doctor in order to help your condition as much as possible.

Taking interferon beta-1b at bedtime may help lessen the flu-like symptoms.

Special patient directions come with interferon beta-1b. Read the directions carefully before using this medicine.

It is important to follow several steps to prepare your interferon beta-1b injection correctly. Before injecting the medication, you need to:

• Collect the items you will need before you begin.
• Wash your hands thoroughly with soap and water. Do not touch your hair or skin afterwards.
• Make sure the needle guards are on the needles tightly.
• Remove the plastic cap from the interferon beta-1b and the diluent vial. Use an alcohol wipe to clean the tops of the vials. Move the alcohol wipe in one direction and use one wipe per vial. Leave the alcohol wipe on top of each vial until you are ready to use it.

In order to keep everything sterile, it is important that you do not touch the tops of the vials or the needles. If you do touch a stopper, clean it with a fresh alcohol wipe. If you touch a needle, or if the needle touches any surface, throw away the entire syringe and start over with a new syringe. Also, use only the diluent (sodium chloride 0.54%) provided with the interferon beta-1b to dilute the medicine for injection.

To mix the contents of one vial:

• Resting your hands on a stable surface, remove the needle cover on the 3-mL syringe by pulling the cover straight off the needle. Do not touch the needle itself.
• Pull back the plunger of the syringe back to the 1.2-mL mark.
• Holding the vial of diluent for interferon beta-1b on a stable surface, slowly insert the needle straight through the stopper into the top of the vial.
• Push in the plunger all the way to gently inject 1.2 mL of air into the vial. Leave the needle in the vial of diluent.
• Turn the vial upside down using one hand and make sure the tip of the needle is covered by solution. With your other hand, slowly pull back the plunger of the syringe to withdraw 1.2 mL of diluent into the syringe.
• Keeping the vial upside down, gently tap the syringe until any air bubbles that formed rise to the top of the barrel of the syringe.
• Carefully push in the plunger to eject only the air through the needle. Remove the needle/syringe from the vial of diluent.
• Holding the interferon beta-1b vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 mL of diluent) all the way through the stopper of the vial.
• Push the plunger down slowly, directing the needle toward the side of the vial to allow the diluent to run down the inside wall. Injecting the diluent directly onto the white cake of medicine will cause excess foaming.
• Remove the needle/syringe from the vial of interferon beta-1b.
• Roll the vial between your hands gently to completely dissolve the white cake of medicine.
• Check the solution to make sure it is clear. If you can see anything solid in the solution or if the solution is discolored, discard it and start again.

To prepare the injection syringe:

• Remove the needle guard from the 1-mL syringe and pull back the plunger to the 1-mL mark.
• Insert the needle of the 1-mL syringe through the stopper of the vial of interferon beta-1b solution.
• Gently push the plunger all the way down to inject air into the vial.
• Turn the vial of interferon beta-1b solution upside down, keeping the needle tip in the liquid.
• Pull back the plunger of the syringe to withdraw 1 mL of liquid into the syringe.
• Hold the syringe with the needle pointing upward. Tap the syringe gently until any air bubbles that formed rise to the top of the barrel of the syringe.
• Carefully push in the plunger to eject only the air through the needle.
• Remove the needle/syringe from the vial. Replace the needle guard on the syringe.
• Throw away the unused portion of the solution remaining in the vial.

The injection should be administered immediately after mixing. If the injection is delayed, refrigerate the solution and inject it within 3 hours.

To give yourself the injection:

Before you self-inject the interferon beta-1b dose, decide where you will inject yourself. There are eight areas for injection, and each area has an upper, a middle, and a lower injection site. To help prevent injection site reactions, select a site in an area different from the area where you last injected yourself. 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 areas.

Do not self-inject into any area in which you feel lumps, bumps, firm knots, or pain. Do not use any area in which the skin is discolored, depressed, red, scabbed, tender, or has broken open. Talk to your doctor or other health care professional about these or any other unusual conditions that you find. If you experience a break in the skin or drainage of fluid from the injection site, contact your doctor before continuing injections with interferon beta-1b.

• Clean the injection site with a fresh alcohol wipe, and let it air dry.
• Pick up the 1-mL syringe you already filled with interferon beta-1b. Hold the syringe as you would a pencil or dart. Remove the needle guard from the needle, but do not touch the needle itself.
• Gently pinch the skin together around the site, to lift it up a bit.
• Resting your wrist on the skin near the site, stick the needle straight into the skin at a 90° angle with a quick, firm motion.
• Using a slow steady push, inject the medicine by pushing the plunger all the way in until the syringe is empty.
• Hold a swab on the injection site. Remove the needle by pulling straight out.
• Gently massage the injection site with a dry cotton ball or gauze.

To dispose of needles and syringes:

Needles, syringes, and vials should be used for only one injection. Place all used syringes, needles, and vials in a syringe disposal unit or in a hard-walled plastic container, such as a liquid laundry detergent container. Keep the cover closed tightly, and keep the container out of the reach of children. When the container is full, check with your physician or nurse about proper disposal, as laws vary from state to state.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For multiple sclerosis (MS):
    • Adults—0.25 milligrams (mg) every other day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

The next injection should be scheduled about 48 hours later.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If refrigeration is not available, vials may be kept for up to 7 days at room temperature, as long as the temperature does not go above 86 °F.

Betaseron Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal pain
• break in the skin at place of injection, with blue-black discoloration, swelling, or drainage of fluid
• flu-like symptoms including chills, fever, generalized feeling of discomfort or illness, increased sweating, and muscle pain
• headache or migraine
• hives, itching, or swelling at place of injection
• hypertension (high blood pressure)
• irregular or pounding heartbeat
• pain at place of injection
• redness or feeling of heat at place of injection
• stuffy nose

• Breast pain
• bloody or cloudy urine
• changes in vision
• cold hands and feet
• difficult, burning, or painful urination
• fast or racing heartbeat
• frequent urge to urinate
• pain
• pelvic pain
• swollen glands
• troubled breathing
• unusual weight gain

• Abnormal growth in breast
• benign lumps in breast
• bleeding problems
• bloating or swelling
• changes in menstrual periods
• confusion
• convulsions (seizures)
• cyst (abnormal growth filled with fluid or semisolid material)
• decreased sexual ability in males
• dry, puffy skin
• feeling cold
• hyperactivity
• increased muscle tone
• increased urge to urinate
• loss of memory
• mental depression with thoughts of suicide
• problems in speaking
• red, itching, or swollen eyes
• swelling of front part of neck
• unusual weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• diarrhea
• dizziness
• laryngitis (loss of voice)
• menstrual pain or other changes
• unusual tiredness or weakness

• Anxiety
• drowsiness
• hair loss
• nervousness
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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