Momentum - Summer 2013

Brief Summary of Medication Guide AVONEX® (a-vuh-necks)

(interferon beta-1a)
Injection for intramuscular use

Read this Medication Guide before you start using AVONEX, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about AVONEX?

AVONEX can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.

1. Behavioral health problems including depression, suicidal thoughts or hallucinations. Some people taking AVONEX may develop mood or behavior problems including:

•;irritability;(getting;upset;easily)

•;depression;(feeling;hopeless;or;feeling;bad;about yourself)

•;nervousness •;anxiety •;aggressive;behavior •;thoughts;of;hurting;yourself;or;suicide •;hearing;or;seeing;things;that;others;do;not;hear;or see;(hallucinations)

2. Liver problems, or worsening of liver problems including liver failure and death. Symptoms may include:

• nausea

•;loss;of;appetite •;tiredness •;dark;colored;urine and pale stools During your treatment with AVONEX you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.

3. Serious allergic reactions and skin reactions. Symptoms may include:

•;itching •;swelling;of;the;face,;eyes,;lips,;tongue;or;throat •;trouble;breathing •;anxiousness •;feeling;faint •;skin;rash,;hives,;sores;in;your;mouth,;or;your;skin blisters and peels

What is AVONEX?

AVONEX is a form of a protein called beta interferon that occurs naturally in the body. AVONEX is a prescription medicine used to treat adults with relapsing forms of

multiple;sclerosis;(MS).;This;includes;people;who;have

had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis.

AVONEX 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.

It is not known if AVONEX is safe and effective in children.

Who should not use AVONEX?

Do not take AVONEX if you:

•;are;allergic;to;interferon;beta,;albumin;(human),;or any of the ingredients in AVONEX. See the end of this Medication Guide for a complete list of ingredients in AVONEX.

What should I tell my healthcare provider before using AVONEX?

Before taking AVONEX, tell your healthcare provider if you:

•;are;being;treated;for;a;mental;illness;or;had;treatment;in the past for any mental illness, including depression and suicidal behavior

•;have;or;had;bleeding;problems;or;blood;clots
•;have;or;had;low;blood;cell;counts
•;have;or;had;liver;problems
•;yellowing;of;your;skin;or
the white part of your eye

•;bleeding;more;easily;than normal

•;confusion
•;sleepiness
•;have;or;had;seizures;(epilepsy)

•;Infections. Some people who take AVONEX may get an infection. Symptoms of an infection may include: ° fever ° chills ° pain or burning with urination ° urinating often ° bloody diarrhea ° coughing up mucus

•;Thyroid problems. Some people taking AVONEX develop changes in their thyroid function. Symptoms of thyroid changes include: ° problems concentrating ° feeling cold or hot all the time °;weight;changes;(gain;or;loss)

° skin changes

Tell your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of AVONEX include:

•;Flu-like;symptoms.;Most;people;who;take;AVONEX;have flu-like symptoms 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 taking;over-the-counter;pain;and;fever;reducers.;For many people, these symptoms lessen or go away over time. Symptoms may include: ° muscle aches ° fever ° tiredness ° chills

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

How should I store AVONEX?

•;Store;AVONEX;in;the;refrigerator;at;36°F;to;46°F;(2°C;to 8°C).

•;Do not;freeze;AVONEX.;Do not use AVONEX that has been;frozen.

•;Do not;store;AVONEX;above;77°F;( 25°C).

•;Keep;AVONEX;away;from;light.

•;Do not;use;AVONEX;past;the;expiration;date.

•;If;you;cannot;refrigerate;your;AVONEX;vials,;you;can store;your;AVONEX;vials;at;77°F;( 25°C);for;up;to;30;days. After;mixing,;the;AVONEX;solution;should;be;used;imme- diately,;within;6;hours;when;stored;refrigerated;at;36°F;to 46°F;(2°C;to;8°C).

•;If;you;cannot;refrigerate;your;AVONEX;PEN;and;AVONEX prefilled syringes, you can store your AVONEX PEN and AVONEX;prefilled;syringes;up;to;77°F;( 25°C);for;up;to;7 days.

Keep AVONEX vials, prefilled syringes, pens and all other medicines out of the reach of children.

General advice about the safe and effective use of AVONEX.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVONEX for a condition for which it was not prescribed. Do not give AVONEX to other people, even if they have the same symptoms that you have, it may harm them.

This;Medication;Guide;summarizes;the;most;important;in-formation about AVONEX. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about AVONEX that is written for healthcare professionals.

What are the ingredients in AVONEX?

Active ingredient:;interferon;beta-1a

Inactive ingredients:

• Vial with freeze-dried (lyophilized) powder:;albumin;(hu-man),;sodium;chloride,;dibasic;sodium;phosphate,;and monobasic sodium phosphate.

•;Single-Use Prefilled Syringe: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20;in;water;for;injection.

•;Single-Use Prefilled Autoinjector Pen: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate;20;in;water;for;injection.