Betaseron (Chiron Corp)

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Betaseron (Chiron Corp) - General Information:

Pharmacology:

Betaseron (Chiron Corp) for patients

Instruction on self-injection technique and procedures.

Patients should be instructed in the use of aseptic technique when administering Betaseron. Appropriate instruction for reconstitution of Betaseron and self-injection should be given including careful review of the Betaseron Patient INFORMATION sheet. If possible, the first injection should be performed under the supervision of an appropriately qualified health care professional.

Patients should be cautioned against the re-use of needles or syringes and instructed in safe disposal procedures. A puncture resistant container for disposal of used needles and syringes should be supplied to the patient along with instructions for safe disposal of full containers.

Patients should be advised of the importance of rotating areas of injection with each dose, to minimize the likelihood of severe injection site reactions or necrosis .

Patients should be cautioned not to change the dosage or the schedule of administration without medical consultation.

Betaseron^® (Interferon beta-1b) is intended for use under the guidance and supervision of a physician. Your physician or his/her delegate should instruct you in the preparation of Betaseron for administration and in the technique of self injection. Do not attempt self-administration until you are sure that you understand the requirements for mixing the product and giving an injection to yourself.
Betaseron should be used as prescribed by your physician. However, if you miss a dose, take it as soon as you remember. Your next injection, however, should be scheduled about 48 hours later. While using Betaseron, please keep in mind the following facts:

• Betaseron must be kept cold. Be sure to store it in a refrigerator before and after reconstitution. Do not freeze.
• Keep syringes and needles away from children. Do not reuse needles or syringes. Discard used syringes and needles in a syringe disposal unit as instructed by your physician.
• Women: Betaseron should not be used during pregnancy or if you are trying to become pregnant. If you wish to become pregnant while using Betaseron, discuss the matter with your doctor. While using Betaseron, women of childbearing age should use birth control measures. If you do become pregnant you should discontinue treatment and contact your doctor immediately.
• Injection site reactions are common. They include redness, pain and swelling, and discoloration. Less frequently, injection site necrosis (skin breakdown and tissue destruction) has been observed. To minimize chances for a reaction you should rotate injection sites as described below or as recommended by your physician. Do not make an injection into skin that is tender, red, or hard. If you experience a break in the skin or drainage of fluid from the injection site, you should promptly contact your physician before continuing injections with Betaseron.
• Flu-like symptoms are also common. They include fever, chills, sweating, fatigue, and muscle aches. Taking Betaseron at night may help lessen the impact of flu-like symptoms.
• Depression, including suicide attempts, has been reported by patients. If you experience such symptoms, contact your physician promptly.
• As with any prescription medication, side effects related to therapy can occur. Consult with your physician if you have any problems, whether or not you think they may be related to Betaseron^® (Interferon beta-1b).

SELF-INJECTION PROCEDURE

To mix the contents of one vial

Only the vial of diluent (liquid) that comes inside your prescription package should be used to dissolve the white cake of drug in the Betaseron vial.

1. Wash your hands thoroughly with soap and water.
2. Collect all your equipment before you begin the process.
   You'll need:
3. • vial of Diluent for Betaseron (Sodium Chloride 0.54%)
   • vial of Betaseron
   • 3-mL syringe with 21-gauge needle (1)
   • 1-mL syringe with 27-gauge needle (1)
   • alcohol wipes
   • disposal unit (an opaque, puncture-resistant, sealable container for used syringes/needles)

   NOTE: Be sure needle guards are on the needles tightly.

4. Remove the protective caps from both vials.
5. Use alcohol wipes to clean the tops of the vialsómove in one direction and use one wipe per vial.
   NOTE: Leave an alcohol wipe on top of each vial until you are ready to use it.
6. Resting your hands on a stable surface, remove the needle cover on the 3-mL syringe by pulling the cover straight off the needle.
   
7. Pull back the plunger (on the 3-mL syringe) to the 1.2 mL mark.
   NOTE: Read the labels on the vialsó find the Diluent for Betaseron vial and throw away the alcohol wipe on top of it.
8. Holding the vial of Diluent for Betaseron^® (Interferon beta-1b) on a stable surface, slowly insert the needle straight through the stopper, into the top of the vial. NOTE: When inserting and removing needles from vials, be sure not to touch the needles or the rubber stoppers on the vials with your hands.
   If you do touch a stopper, clean it with a fresh alcohol wipe.
   If you touch a needle, throw away the entire syringe into the disposal unit and start over with a new syringe.
   If the needle touches any surface, throw away the entire syringe into the disposal unit and start over with a new syringe.
9. Push in the plunger all the way to gently inject air into the vial (leave the needle in the vial of Diluent for Betaseron).
10. Turn the vial of Diluent for Betaseron upside down.
    NOTE: Keep the needle tip in the liquid.
11. Resting your hands on a stable surface, hold the vial and syringe in one hand and slowly pull back the plunger on the syringe to the 1.2 mL mark (to draw up that amount of liquid) with your other hand.
    
12. 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.
13. Carefully push in the plunger to eject ONLY THE AIR through the needle.
14. Remove the needle/syringe from the vial of Diluent for Betaseron.
    NOTE: Find the Betaseron vial and throw away the alcohol wipe on top of it.
15. Holding the Betaseron vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 mL of liquid) all the way through the stopper of the vial.
16. Push the plunger down slowly, directing the needle toward the side of the vial to allow the liquid to run down the inside wall (injecting Diluent for Betaseron^® [Interferon beta-1b] directly onto the cake of drug will cause excess foaming).
17. Remove the needle/syringe from the Betaseron vial.
18. Throw away the 3 mL syringe into the disposal unit.
    NOTE: Double-check that you are throwing away the correct syringe into the disposal unit.
19. Roll the vial between your hands gently to completely dissolve the white cake of Betaseron (DO NOT SHAKE).
20. Look closely at the solution (it should be clear).
    NOTE: If the mixture contains particles or is discolored, discard it and start again.

PREPARING THE INJECTION

1. Remove the needle guard of the 1 mL syringe and pull back the plunger to the 1 mL mark.
2. Insert the needle of the 1 mL syringe through the stopper of the vial of Betaseron solution.
3. Gently push the plunger all the way down to inject air into the vial (leave the needle in the vial).
4. Turn the vial of Betaseron^® (Interferon beta-1b) solution upside down. NOTE: Keep the needle tip in the liquid.
5. Pull back the plunger to withdraw 1 mL of liquid into the syringe.
6. Hold the syringe with the needle pointing upward.
7. Tap the syringe gently until any air bubbles that formed rise to the top of the barrel of the syringe.
8. Carefully push in the plunger to eject ONLY THE AIR through the needle.
9. Remove the needle/syringe from the vial.
10. Recap the needle on the syringe.
    NOTE: The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours). Do not freeze.
11. Throw away unused portion of the solution remaining in the vial.

GIVING THE INJECTION

Subcutaneous (under the skin) self-administration

1. Choose an area for injection; use a different area each day.
   
2. • Abdomen
   • Thighs
   • Back of Arms
   • Buttocks

   NOTE: Do not use any area in which you feel lumps, bumps, firm knots, or pain. Do not use any area in which the skin is discolored, depressed, scabbed, or has broken open. Talk to your doctor or healthcare professional about these or any other unusual conditions that you find.
   Hold the syringe like a pencil or dart.

3. Use an alcohol wipe to clean the skin at the injection site; let it air dry.
4. Throw away the wipe.
5. Uncap the needle.
6. Gently pinch the skin together around the site (to lift it up a bit).
7. 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.
8. Inject the drug by using a slow, steady push (push the plunger all the way in until the syringe is empty).
9. Hold a swab on the injection site. Remove the needle from the skin.
10. Gently massage the injection site with a dry cotton ball or gauze.
11. Throw away the 1 mL syringe in the disposal unit.

INJECTION SITE

Picking an Injection Site

Betaseron^® (Interferon beta-1b) should be injected into subcutaneous tissue (into the fat layer between the skin and the muscles beneath). The best areas for injection are where the skin is loose and soft (flabby), away from joints, nerves, bones, and other important structures.
Each day of injection you can choose an injection site from the upper, middle, or lower section of an area shown in the accompanying diagrams. It is a good idea to know where your injection will be given before you prepare your syringe.
If there are any sites that are difficult for you to reach, you can ask your support person (or someone who has been trained to give injections) to help you.

Betaseron (Chiron Corp) Interactions

Interactions between Betaseron and other drugs have not been fully evaluated. Although studies designed to examine drug interactions have not been done, it was noted that corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been administered to patients (N=180) receiving Betaseron.

Betaseron administration to three cancer patients over a dose range of 0.025 mg to 2.2 mg led to a dose-dependent inhibition of antipyrine elimination.¹⁴ The effect of alternate-day administration of 0.25 mg of Betaseron on drug metabolism in MS patients is unknown.

Betaseron (Chiron Corp) Contraindications

Betaseron is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin Human USP, or any other component of the formulation.

Additional information about Betaseron (Chiron Corp)