Peginterferon Beta-1a Solution for injection

What is this medicine?

PEGINTERFERON BETA-1a (peg in ter FEER on BAY ta) helps to decrease the number of multiple sclerosis attacks and to slow disability in people with relapsing forms of the disease. This medicine does not cure multiple sclerosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• heart disease

• history of irregular heartbeat

• if you often drink alcohol

• immune system problems

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• mental illness

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• thyroid disease

• an unusual or allergic reaction to interferon, peginterferon, or other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Remove the injection from the refrigerator about 30 minutes prior to use so it can warm to room temperature. Do not use heat sources such as hot water to warm the injection. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.

Flu-like symptoms are common with the medicine. Ask your doctor or healthcare professional about taking acetaminophen or ibuprofen before your dose and for 24 hours after you receive your injection.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• a skin sore with a black-blue color, swelling, or drainage

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or palpitations

• depressed mood

• dizziness

• feeling faint or lightheaded

• suicidal thoughts or other mood changes

• seizures

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• stomach pain

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• fever

• general ill feeling or flu-like symptoms

• headache

• joint pain

• missed menstrual periods

• muscle pain

• pain, redness, or irritation at site where injected

• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Keep this medicine in the original carton. Protect from light. Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. If refrigeration is not available, store at cool room temperature between 2 and 25 degrees C (36 and 77 degrees F) for a period up to 30 days. The injection can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days. Make sure you do not expose the injection to heat and do not store it at temperatures warmer than those listed. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.