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Avonex (Interferon Beta-1A) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

No formal drug interaction studies have been conducted with AVONEX®. In the placebo-controlled studies in multiple sclerosis, corticosteroids or ACTH were administered for treatment of exacerbations in some patients concurrently receiving AVONEX®. In addition, some patients receiving AVONEX® were also treated with anti-depressant therapy and/or oral contraceptive therapy. No unexpected adverse events were associated with these concomitant therapies.

OVERDOSAGE

Safety of doses higher than 60 mcg once a week have not been adequately evaluated. The maximum amount of AVONEX® that can be safely administered has not been determined.

CONTRAINDICATIONS

AVONEX® is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation.

The lyophilized vial formulation of AVONEX® is contraindicated in patients with a history of hypersensitivity to albumin (human).

REFERENCES

  1. Jacobs LD, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39(3):285-294.
  2. Jacobs LD, et al. Intramuscular interferon beta-1a initiated during a first demyelinating event in multiple sclerosis. NEJM 2000;343:898-904.
  3. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33:1444-1452.

AVONEX® (Interferon beta-1a)

Manufactured by:

BIOGEN, INC.

14 Cambridge Center

Cambridge, MA 02142 USA

©2004 Biogen, Inc. All rights reserved.

1-800-456-2255

U.S. Patent Pending

I61018-4 (Issue date 03/2004)

Rx only

*Micro Pin® is the trademark of B. Braun Medical Inc.

MEDICATION GUIDE

AVONEX®

Interferon beta-1a

(Including appendix with instructions for using AVONEX® Prefilled Syringe or the AVONEX® vials)

Please read this guide carefully before you start to use AVONEX® (a-vuh-necks) and each time your prescription is refilled since there may be new information. The information in this guide does not take the place of talking with your doctor or healthcare professional.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AVONEX®?

AVONEX® will not cure multiple sclerosis (MS) but it has been shown to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. AVONEX® can cause serious side effects, so before you start taking AVONEX®, you should talk with your doctor about the possible benefits of AVONEX® and its possible side effects to decide if AVONEX® is right for you. Potential serious side effects include:

  • Depression-- Some people treated with interferons, including AVONEX®, have become depressed (feeling sad, feeling low or feeling bad about oneself). Some people have thought about killing themselves and a few have committed suicide. Depression is common in people with MS. If you are noticeably sadder or feeling more hopeless, you should tell a family member or friend right away and call your doctor as soon as possible. You should tell the doctor if you have ever had any mental illness, including depression, and if you take any medicines for depression.
  • Risk to pregnancy-- If you become pregnant while taking AVONEX®, you should stop using AVONEX® immediately and call your doctor. AVONEX® 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 AVONEX® is greater than the risks are to your unborn child.
  • Allergic reactions-- Some patients taking AVONEX® have had severe allergic reactions leading to difficulty breathing. Allergic reactions can happen after your first dose or may not happen until after you have taken AVONEX® 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 AVONEX® immediately and call your doctor.
  • Blood problems-- You may have a drop in the levels of infection-fighting blood cells, red blood cells or cells that help to form blood clots. If the drop 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.
  • Seizures-- Some patients have had seizures while taking AVONEX®, including some patients who have never had seizures before. It is not known whether the seizures were related to the effects of their MS, to AVONEX®, or to a combination of both. If you have a seizure while taking AVONEX®, you should stop taking AVONEX® and call your doctor right away.
  • Heart problems-- While AVONEX® is not known to have direct effects on the heart, a few patients who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX®. Some of the symptoms of heart problems are swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, and not being able to lay flat in bed. If you develop these symptoms or any heart problems while taking AVONEX®, you should call your doctor right away.

For more information on possible side effects with AVONEX®, please read the section on "What are the possible side effects of AVONEX®?" in this Medication Guide.

WHAT IS AVONEX®?

AVONEX® is a form of a 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 and slow the occurrence of some of the physical disability that is common in people with MS. MS is a life-long disease that affects your nervous system by destroying the protective covering (myelin) that surrounds your nerve fibers. The way AVONEX® works in MS is not known.

WHO SHOULD NOT TAKE AVONEX®?

Do not take AVONEX® if you have had an allergic reaction (difficulty breathing, itching, flushing or skin bumps spread widely over the body) to interferon beta.

Do not take the vial formulation of AVONEX® if you have a history of hypersensitivity to albumin (human).

If you have ever had any of the following conditions or serious medical problems, you should tell your doctor before taking AVONEX®:

  • Depression (sinking feeling or sadness), anxiety (feeling uneasy or fearful for no reason), or trouble sleeping
  • Problems with your thyroid gland
  • Blood problems such as bleeding or bruising easily and anemia (low red blood cells) or low white blood cells
  • Seizures (for example, epilepsy)
  • Heart problems
  • Liver disease
  • Are 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.

You should tell your doctor if you have had a natural rubber sensitivity since the AVONEX® prefilled syringe cap contains dry natural rubber, which may cause allergic reactions.

HOW SHOULD I TAKE AVONEX®?

To get the most benefit from this medicine, it is important that you take AVONEX® exactly as your doctor tells you.

AVONEX® is given by injection into the muscle (intramuscular injection) once a week, on the same day (for example, every Monday right before bedtime). If you miss a dose, you should take your next dose as soon as you remember. You should continue your regular schedule the following week. Do not take AVONEX® on two consecutive days. Take only the dose your doctor has prescribed for you. Do not change your dose unless you are told to by your doctor. If you take more than your prescribed dose, call your healthcare provider right away. Your doctor may want to monitor you more closely.

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 instructed by your doctor or other healthcare provider in how to prepare and inject your dose of AVONEX®. Do not try to give yourself injections at home until you are sure that you (or the person who will be giving you the injections) fully understands and is comfortable with how to prepare and inject the product. At the end of this guide there are detailed instructions on how to prepare and give yourself an injection of AVONEX® that will help remind you of the instructions from your doctor or healthcare provider.

Always use a new, unopened AVONEX® vial or prefilled syringe for each injection. Never reuse the vials or syringes.

It is important to keep your work area, your hands, and your injection site clean to minimize risk of infection. You should wash your hands prior to handling the syringe.

It is important that you change your injection site each week.

Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. Use the alcohol wipe to thoroughly clean the skin at the injection site you haven chosen. 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 AVONEX.

AVONEX® comes in two different forms (a powder in a single-use vial and a liquid in a prefilled syringe). See the attached appendix for detailed instructions for preparing and giving a dose of AVONEX®. These instructions are specific to the form of AVONEX® chosen for you by your healthcare provider.

WHAT SHOULD I AVOID WHILE TAKING AVONEX®?

  • Pregnancy-- You should avoid becoming pregnant while taking AVONEX® until you have talked with your doctor. AVONEX® 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 AVONEX® gets into the breast milk, or if it could harm your nursing baby.

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