Avonex

DRUG DESCRIPTION

AVONEX® (Interferon beta-1a) is a 166 amino acid glycoprotein with a predicted
molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into
which the human interferon beta gene has been introduced. The amino acid sequence
of AVONEX® (interferon beta-1a) is identical to that of natural human interferon beta.

Using the World Health Organization (WHO) natural interferon beta standard,
Second International Standard for Interferon, Human Fibroblast (Gb-23-902-531),
AVONEX® (interferon beta-1a) has a specific activity of approximately 200 million international
units (IU) of antiviral activity per mg of Interferon beta-1a determined specifically
by an in vitro cytopathic effect bioassay using lung carcinoma cells
(A549) and Encephalomyocarditis virus (ECM). AVONEX® (interferon beta-1a) 30 mcg contains approximately
6 million IU of antiviral activity using this method. The activity against other
standards is not known. Comparison of the activity of AVONEX® (interferon beta-1a) with other
Interferon betas is not appropriate, because of differences in the reference
standards and assays used to measure activity.

30 mcg Lyophilized Powder Vial

A vial of AVONEX® (interferon beta-1a) is formulated as a sterile, white to off-white lyophilized
powder for intramuscular injection after reconstitution with supplied diluent
(Sterile Water for Injection, USP). Each vial of reconstituted AVONEX® contains
30 mcg of Interferon beta-1a; 15 mg Albumin (Human), USP; 5.8 mg Sodium Chloride,
USP; 5.7 mg Dibasic Sodium Phosphate, USP; and 1.2 mg Monobasic Sodium Phosphate,
USP, in 1.0 mL at a pH of approximately 7.3.

30 mcg Prefilled Syringe

A prefilled syringe of AVONEX® (interferon beta-1a) is formulated as a sterile liquid for intramuscular
injection. Each 0.5 mL (30 mcg dose) of AVONEX® (interferon beta-1a) in a prefilled glass syringe
contains 30 mcg of Interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP;
0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025
mg Polysorbate 20 in Water for Injection, USP at a pH of approximately 4.8.

What are the possible side effects of interferon beta-1a (Avonex, Avonex Prefilled Syringe, Rebif)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;


• easy bruising or bleeding, weakness;


• seizure (convulsions);


• numbness or tingling in your hands or feet;


• pain or...

Read All Potential Side Effects and See Pictures of Avonex »

What are the precautions when taking interferon beta-1a (Avonex)?

Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

There is a risk of contracting a virus from using this medication because it contains albumin from human blood. Careful screening of blood donors, special manufacturing methods, and FDA-approved tests are all used to reduce such a risk. For more details, talk to your doctor.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), heart disease (e.g., angina,...

Read All Potential Precautions of Avonex »

Avonex Consumer (continued)

SIDE EFFECTS: Pain, swelling, or redness at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Flu-like symptoms such as headache, fatigue, fever, chills, and muscle aches may occur when you first start this medication. These symptoms usually last about a day after the shot and improve or go away after a few months of continued use. You can minimize these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen or ibuprofen before each dose. Consult your doctor or pharmacist for more information.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., depression, thoughts of suicide, new or worsening psychiatric symptoms), hair loss, vision changes, persistent fatigue, numbness/tingling/swelling of the hands/ankles/feet, muscle weakness, trouble breathing, sudden weight gain, gradual change in weight (without a change in diet or exercise), cold or heat intolerance, slow/fast/irregular heartbeat, easy bleeding or bruising, signs of infection (e.g., fever, persistent sore throat), yellowing eyes or skin, persistent nausea/vomiting, stomach/abdominal pain, dark urine.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

There is a risk of contracting a virus from using this medication because it contains albumin from human blood. Careful screening of blood donors, special manufacturing methods, and FDA-approved tests are all used to reduce such a risk. For more details, talk to your doctor.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), heart disease (e.g., angina, congestive heart failure, arrhythmia), seizures, thyroid disease, liver disease, decreased bone marrow function.

Limit your intake of alcohol while on this medication. Ask your doctor or pharmacist about the safe use of alcohol while using this drug.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Avonex Patient Information Including Side Effects

Brand Names: Avonex, Avonex Prefilled Syringe, Rebif

Generic Name: interferon beta-1a (Pronunciation: in ter FEAR on BAY ta)

• What is interferon beta-1a (Avonex)?


• What are the possible side effects of interferon beta-1a (Avonex)?


• What is the most important information I should know about interferon beta-1a (Avonex)?


• What should I discuss with my healthcare provider before using interferon beta-1a (Avonex)?


• How should I use interferon beta-1a (Avonex)?


• What happens if I miss a dose (Avonex)?


• What happens if I overdose (Avonex)?


• What should I avoid while using interferon beta-1a (Avonex)?


• What other drugs will affect interferon beta-1a (Avonex)?


• Where can I get more information?

What is interferon beta-1a (Avonex)?

Interferon beta-1a is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1a is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1a may also be used for other purposes not listed in this medication guide.

What are the possible side effects of interferon beta-1a (Avonex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;


• easy bruising or bleeding, weakness;


• seizure (convulsions);


• numbness or tingling in your hands or feet;


• pain or burning when you urinate;


• pain, swelling, or skin changes where the injection was given;


• fever, chills, body aches, flu symptoms; or


• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache, dizziness;


• stomach pain; or


• runny or stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about interferon beta-1a (Avonex)?

This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1a if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1a, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, heart disease, chest pain (angina), congestive heart failure, a heart rhythm disorder, or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1a if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

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