Interferon, Beta-1b (Systemic)

Brand Names : Betaseron

Proper Use of This Medicine

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 interferon beta-1b 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 interferon beta-1b. If your dose is different, do not change it unless your doctor tells you to do so.

• 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 remembered. The next injection should be scheduled about 48 hours later.

Storage - To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store in the refrigerator. However, keep the medicine from freezing. 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.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.