Interferon Alfa-2a (E. Coli) Solution for injection

What is this medicine?

INTERFERON ALFA-2a (in ter FEER on AL fa 2 a) (Roferon-A) helps the immune system fight viral infections such as chronic hepatitis C, and certain cancers like Philadelphia chromosome positive chronic myelogenous leukemia, and hairy cell leukemia.

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:

• alcoholism or other drug abuse or addiction
• autoimmune disease like psoriasis, Raynaud's phenomenon, rheumatoid arthritis, or systemic lupus erythematosus
• blood or bleeding disorders
• depression or mental disorders
• diabetes
• heart disease
• high blood pressure
• immune system problems like HIV infection
• kidney disease
• liver disease
• lung disease
• seizures
• stomach problems
• thyroid disease
• transplant recipient
• an unusual or allergic reaction to interferons, other medicines, benzyl alcohol, E. coli proteins, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

The medicine is for injection under the skin. Do not shake the prefilled syringes. Shaking can destroy the medicine. If you are giving yourself the injections, make sure you follow the directions carefully. If you have any questions about how to give your medicine, call your health care provider. If you experience flu-like effects, inject the dose at bedtime to decrease these effects. Do not reuse syringes or needles.

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.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have 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 or take more than one dose in a day unless told to do so by your doctor. If you forget a dose for more than 2 days, call your health care professional. If you accidentally take too much, call your doctor immediately.

What may interact with this medicine?

• alcohol
• antiviral medicines for HIV or AIDS
• theophylline

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?

Visit your doctor or health care professional for regular checks on your progress. You will need regular blood checks.

Do not change brands of medicine without consulting your doctor or health care professional. Different brands of medicine can act differently in your body. Check with your pharmacist if your refills do not look like your original product.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can make you more drowsy or dizzy, increase confusion and lightheadedness. Avoid alcoholic drinks.

This medicine can cause flu-like symptoms and make you feel generally unwell. Report any side effects, but continue your medicine even though you feel ill, unless your doctor or health care professional tells you to stop. If you get a fever or sore throat that does not go away after the first few weeks of treatment, do not treat yourself. Call your doctor or health care professional as soon as you can if you think you have an infection. Other signs of infection include cough, lower back or side pain, and pain or difficulty passing urine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This medicine can cause blood problems and may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise, or injure yourself because you may get an infection and bleed more than usual.

Be careful brushing and flossing your teeth or using a toothpick while receiving this medicine because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain or palpitations
• depression
• fast, irregular heartbeat
• seizures
• severe abdominal pain
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of the eyes or skin

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

• hair loss
• headaches
• joint, leg, muscle, or back aches
• nausea, vomiting
• tiredness
• weight loss

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.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or expose to light. Throw away any unused medicine after the expiration date.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.