Avonex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• To treat relapsing forms of multiple sclerosis (MS), to slow

  progression of disability, decrease the frequency of exacerbations, and reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.

• To delay the onset of MS in patients who have experienced a

  single clinical attack accompanied by abnormal MRI scans, to delay the onset of clinically definite MS (as determined by a second demyelinating event), and to decrease the number and volume of active brain lesions and overall disease burden (as identified by MRI scans).

Intended for use under the guidance and supervision of a physician.

What it does:

AVONEX and AVONEX PS will not cure MS but have 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.

When it should not be used:

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

Pregnancy: You should avoid becoming pregnant while taking AVONEX or AVONEX PS until you have talked with your doctor. AVONEX and AVONEX PS may 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 and AVONEX PS gets into breast milk, but because of the potential to cause a serious adverse reaction in an infant, a decision should be made to either discontinue breast-feeding or discontinue AVONEX or AVONEX PS.

What the medicinal ingredient is:

Interferon beta-1a is a form of a protein that occurs naturally in the body.

What the important nonmedicinal ingredients are:

Human serum albumin is included in the AVONEX vial.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

AVONEX is a powder for reconstitution in a single-use vial. AVONEX PS is a liquid for injection in a 30 µg prefilled syringe.

WARNINGS AND PRECAUTIONS

BEFORE you use AVONEX or AVONEX PS talk to your doctor or pharmacist if:

• You have ever had, or currently experience depression

  (sinking feeling or sadness), anxiety (feeling uneasy or fearful for no reason), or trouble sleeping

• You have problems with your thyroid gland
• You have blood problems such as bleeding or bruising easily and anemia (low red blood cells) or low white blood cells
• You have experienced seizures (for example, epilepsy)
• You have heart problems
• You have liver disease
• You are planning to become pregnant

INTERACTIONS WITH THIS MEDICATION

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

PROPER USE OF THIS MEDICATION

Usual dose:

AVONEX or AVONEX PS is given by injection into the muscle (intramuscular injection) once a week on the same day (e.g. every Monday right before bedtime).

Your AVONEX kit already includes a needle for injection. It may be possible for your doctor to prescribe you a shorter and thinner needle depending on your body type. Talk to your doctor to see if this is appropriate for you.

Relapsing remitting MS or to delay Clinically Definite MS: usual dose is 30 micrograms once a week.

Secondary progressive/relapsing progressive MS: usual dose is up to 60 micrograms once a week.

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 or AVONEX PS. 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 or AVONEX PS. This will help remind you of the instructions from your doctor or healthcare provider.

Overdose:

Take only the dose your doctor has prescribed for you. If you take more than your prescribed dose, call your healthcare provider right away. Your doctor may want to monitor you more closely.

Missed Dose:

If you miss a dose, take your next dose as soon as possible. You should continue your regular schedule the following week. Do not take AVONEX or AVONEX PS on two consecutive days.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Flu-like symptoms: Most people who take AVONEX or AVONEX PS have flu-like symptoms (fever, chills, sweating, muscle aches and tiredness) early during the course of therapy. Usually these symptoms last for a day after the injection. You may be able to manage these flu-like symptoms by injecting your AVONEX or AVONEX PS dose at bedtime and taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Talk to your doctor if these symptoms continue longer than the first few months of therapy, or if they are difficult to manage.

Depression: Some patients taking interferons have become severely depressed and/or anxious. If you feel sad or hopeless you should tell a friend or family member right away and call your doctor immediately. Your doctor or healthcare provider may ask that you stop taking AVONEX or AVONEX PS and/or may recommend that you take a medication to treat your depression.

Blood problems: A drop in the levels of white (infection-fighting) blood cells, red blood cells, or a part of your blood that helps to form blood clots (platelets) can happen. If this drop in blood levels is severe, it can lessen your ability to fight infections, make you feel very tired or sluggish, or cause you to bruise or bleed easily.

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.

Thyroid problems: Some people taking AVONEX or AVONEX PS develop changes in the function of their thyroid. Symptoms of these changes include feeling cold or hot all the time, a change in your weight (gain or loss) without a change in your diet or amount of exercise you get, or feeling emotional.

Seizures: Some patients have had seizures while taking AVONEX or AVONEX PS including 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 AVONEX PS, or to a

combination of both. If you have a seizure while taking AVONEX or AVONEX PS, you should call your doctor right away.

Heart problems: While AVONEX or AVONEX PS is not known to have any direct effects on the heart, a few patients who did not have a history of heart problems developed muscle heart 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 or AVONEX PS, you should call your doctor right away.

Your doctor may want to monitor you more closely or may ask you to have periodic blood, liver function and thyroid tests.

This is not a complete list of side effects. For any unexpected effects while taking AVONEX or AVONEX PS, contact your doctor or pharmacist.

HOW TO STORE IT

AVONEX: The vial of AVONEX powder should be kept in the refrigerator at 2°C to 8°C. If refrigeration is not available, AVONEX can be kept for up to 30 days at room temperature (25°C). After mixing the AVONEX powder with the diluent (see below for instructions on how to prepare a dose of AVONEX), the AVONEX solution should be used right away or within 6 hours when it is stored in the refrigerator at 2°C to 8°C. Do not freeze AVONEX solution.

AVONEX PS:The prefilled syringe of AVONEX PS should be stored in a refrigerator at 2°C to 8°C. Before your injection, the

syringe should be taken out of the refrigerator and allowed to warm to room temperature over 30 minutes. Do not use external heat sources, such as hot water, to warm the prefilled syringe. AVONEX PS can be stored at room temperature (15°C to 30°C) for up to one week.

Do not expose the vial of AVONEX or the prefilled syringe of AVONEX PS to high temperatures or freezing. Protect from light.

Find a well-lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or to receive an injection. You may want to take one AVONEX administration dose pack out of the refrigerator about 30 minutes before you plan on injecting your dose to allow it to reach room temperature. A room temperature solution is more comfortable to inject.

You will need the following supplies:

• vial of AVONEX (white to off-white powder or cake)
• vial of diluent, single-use (Sterile Water for Injection)
• syringe
• blue MICRO PIN^® (vial access pin)
• sterile needle

• alcohol wipes

• gauze pad
• adhesive bandage

• a puncture resistant container for disposal of used needle, and

  MICRO PIN^®.

Preparing the solution of AVONEX

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 preparing the medication.

1. 1.

   Check the expiration date on the vial of AVONEX and the

   vial of diluent; do not use if the medication or diluent is expired.

2. 2.

   Remove the caps from the vial of AVONEX and the vial of

   diluent, and clean the rubber stopper on the top of each vial with an alcohol wipe.

3. 3.

   Attach the blue MICRO PIN^® to the syringe by turning

   clockwise until secure. NOTE: Over-tightening can make the MICRO PIN^® difficult to remove.

   1. 4. Pull the MICRO PIN^® cover straight off; do not twist. Save the cover for later use.
   2. 5. Pull back the syringe plunger to the 1.1 mL mark.
   3. 6. Firmly push the MICRO PIN^® down through the centre of the rubber stopper of the diluent vial.
   4. 7. Inject the air in the syringe into the diluent vial by pushing down on the plunger until it cannot be pushed any further.
   5. 8. Keeping the MICRO PIN^® in the vial, turn the diluent vial and syringe upside down.
   6. 9. While keeping the MICRO PIN^® in the fluid, slowly pull back on the plunger to withdraw 1.1 mL of diluent into the syringe.
   7. 10. Gently tap the syringe with your finger to make any air bubbles rise to the top. If bubbles are present, slowly press the plunger in (to push just the bubbles out through the

needle). Make sure there is still 1.1 mL of diluent in the syringe.

1. 11. Slowly pull the MICRO PIN^® out of the diluent vial.
2. 12.

   Carefully insert the MICRO PIN^® through the centre of the

   rubber stopper of the vial of AVONEX. NOTE: Off-centre punctures can push the stopper into the vial. If the stopper falls into the vial, do not use.

3. 13.

   Slowly inject the diluent into the vial of AVONEX. DO NOT

   aim the stream of diluent directly on the AVONEX powder. Too direct or forceful a stream of diluent onto the powder may cause foaming, and make it difficult to withdraw AVONEX.

4. 14.

   Without removing the syringe, gently swirl the vial until the

   AVONEX is dissolved. DO NOT SHAKE.

5. 15.

   Check to see that all of the AVONEX is dissolved. Check the

   solution in the vial of AVONEX. It should be clear to slightly yellow in colour and should not have any particles. Do not use the vial if the solution is cloudy, has particles in it or is a colour other than clear to slightly yellow.

6. 16.

   Turn the vial and syringe upside down. Slowly pull back on

   the plunger to withdraw 1.0 mL of AVONEX. If bubbles appear, push solution slowly back into the vial and withdraw the solution again.

   1. 17. With the vial still upside down, tap the syringe gently to make any air bubbles rise to the top. Then press the plunger in until the AVONEX is at the top of the syringe. Check the volume (should be 1.0 mL) and withdraw more medication if necessary. Withdraw the MICRO PIN^® and syringe from the vial.
   2. 18. Replace the cover on the MICRO PIN^® and remove from the syringe with a counterclockwise turn.
   3. 19. Attach the sterile needle for injection to the syringe turning clockwise until the needle is secure. A secure attachment will prevent leakage during the injection.

Find a well-lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or to receive an injection. You should take one AVONEX administration dose pack out of the refrigerator about 30 minutes before you plan on injecting your dose to allow it to reach room temperature. A room temperature solution is more comfortable to inject.

You will need the following supplies:

• single-use prefilled syringe
• sterile needle
• alcohol wipe
• gauze wipe
• adhesive bandage
• a puncture resistant container for disposal of used syringes and needles

Preparing the prefilled syringe of AVONEX PS for injection

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.

1. 1.

   Check the expiration date. The expiration date is printed on

   the prefilled syringe of AVONEX PS, syringe package and the carton. Do not use if the medication is expired.

2. 2.

   Check the contents of the syringe. The solution in the syringe

   should be clear and colourless. If the solution is coloured or cloudy, do not use the syringe. Get a new syringe.

3. 3.

   Check to make sure the amount of liquid in the syringe is the

   same or very close to the 0.5 mL mark. If the syringe does not have the correct amount of liquid, DO NOT USE THAT SYRINGE. Call your pharmacist.

4. 4.

   The syringe has a tamper evident cap. Check the cap on the

   end of the syringe to confirm it is attached and has not been opened. If the cap is not securely attached or appears to have been opened, DO NOT USE THAT SYRINGE. Call your pharmacist.

5. 5.

   Hold the prefilled syringe of AVONEX PS upright (so that the

   cap is pointing up).

   1. 6. Remove the cap by bending it at a 90° angle until it snaps free.
   2. 7.

      Open the package with the needle. Attach the needle by pressing it onto the syringe and turning it clockwise until it locks in place. NOTE: If you do not firmly attach the needle to the syringe, it may leak so you may not get your full dose of AVONEX PS. Be careful not to push the plunger while attaching the needle.

      SELECTING AN INJECTION SITE

The best sites for intramuscular injection are the thigh and upper arm:

• thigh • upper arm

You should rotate injection sites each week. This can be as simple as switching between thighs (if you are always injecting yourself). If another person is helping you, you can rotate among your thighs and upper arms. Make sure that the site you choose is free from any skin irritations.

1. 1.

   Use a new alcohol wipe to clean the skin at one of the

   recommended intramuscular injection sites. Then, pull the protective cover straight off the needle; do not twist the cover off.

2. 2.

   With one hand, stretch the skin out around the injection site.

   Hold the syringe like a pencil with the other hand, and using a quick motion insert the needle at a 90° angle, through the skin and into the muscle.

3. 3.

   Once the needle is in, let go of the skin and slowly push the

   plunger down until the syringe is empty.

4. 4.

   Hold a gauze pad near the needle at the injection site and pull

   the needle straight out. Use the pad to apply pressure to the site for a few seconds or rub gently in a circular motion.

5. 5.

   If there is bleeding at the site, wipe it off and, if necessary,

   apply an adhesive bandage.

6. 6.

   Dispose of the used needle and blue MICRO PIN^® in your

   puncture resistant container. DO NOT USE a syringe, MICRO PIN^® or needle more than once. The AVONEX vial, syringe, and diluent vial should be put in the trash.

Disposal of syringes and needles

Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used needles and syringes. DO NOT throw used needles into the household trash and DO NOT RECYCLE.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the MS Alliance at: 1-888-456-2263.

AVONEX is a registered trademark of Biogen Idec and AVONEX PS is a trademark of Biogen Idec.

MICRO PIN is a registered trademark of B. Braun Medical Inc.

Last revised: 01 May 2008