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|Infergen

Infergen

Infergen is used for:

Treating long-term hepatitis C virus infection in patients 18 years of age or older. It may also be used for other conditions as determined by your doctor.

Infergen is an interferon. How interferon alfacon-1 works against the hepatitis C virus is not fully understood. It may directly kill the virus, prevent the virus from reproducing, or alter the body"s natural defense against the virus.

Do NOT use Infergen if:

• you are allergic to any ingredient in Infergen or products taken from Escherichia coli
• you are pregnant, planning to become pregnant, or are breast-feeding
• you have autoimmune hepatitis (inflammation of the liver)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Infergen :

Some medical conditions may interact with Infergen . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart disease, decompensated liver disease, diabetes, high blood pressure, difficulty sleeping, heart problems, liver problems, thyroid problems, cancer, bowel problems, hepatitis B, HIV, kidney problems, a blood disorder, disease, or a weakened immune system, or have received a transplant
• if you have a history of low blood cell counts, autoimmune or endocrine disorders, psychotic disorders (eg, anxiety, depression), or a history of suicidal thoughts or behavior
• if you have a history of alcoholism or substance abuse

Some MEDICINES MAY INTERACT with Infergen . However, no specific interactions with Infergen are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Infergen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Infergen :

Use Infergen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Infergen comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Infergen refilled.
• Infergen is sometimes used at home as an injection. Before using Infergen , a health care professional will provide detailed instructions for its appropriate use.
• Carefully follow the injection procedures taught to you by your health care provider.
• Do not shake the vial before using.
• Infergen may be allowed to reach room temperature before it is injected.
• If Infergen contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Infergen , check with your doctor for further instructions. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Infergen .

Important safety information:

• Infergen may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Infergen . Using Infergen alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Infergen . Infergen will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Flu-like symptoms (eg, headache, tiredness, fever, rigors, muscle aches, increased sweating, joint pain) are very common with Infergen . While fever may be related to flu-like symptoms, other causes of persistent fever should be ruled out. Contact your health care provider if fever recurs or does not go away.
• Vision exams are recommended before starting Infergen and during therapy, especially in patients with diabetes or high blood pressure. Stop using Infergen and contact your health care provider at once if vision problems (eg, blurred or double vision) occur.
• Do not change from one brand or generic version of Infergen to another without consulting your pharmacist or doctor. Products manufactured by different companies may not be equally effective.
• Do not share razors or toothbrushes with other people. Infergen does not prevent the spread of hepatitis C. If you have questions about how to prevent the spread of hepatitis C, ask your doctor or pharmacist.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Infergen .
• You should receive an eye exam before using Infergen . If you have an eye disease or are at risk for eye disease (eg, diabetes), you should have periodic eye exams while using Infergen .
• Contraceptive (birth control) measures are recommended for use with men and women while taking Infergen .
• LAB TESTS, including liver function, serum albumin, platelet counts, and blood cholesterol, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Infergen is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Infergen if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Infergen is excreted in breast milk. Do not breast-feed while taking Infergen .

Possible side effects of Infergen :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; arm or leg pain; bad taste in mouth; body pain; bronchitis; confusion; constipation; cough; decreased salivation; decreased sex drive; diarrhea; dizziness; drowsiness; dry skin; earache; eye inflammation; eye pain; flu-like symptoms (eg, fever, headache, increased sweating, joint pain, muscle aches, rigors, tiredness); flushing; gas; general body discomfort; hair loss; headache; hemorrhoids; hot flashes; increased sweating; indigestion; infection; injection site pain; itching; joint pain; loss of appetite; menstrual disorder; mood swings; mouth sores; muscle aches; nausea; neck pain; nervousness; nosebleed; painful menstruation; runny nose; sinus inflammation; sleepiness; sore throat; stuffy nose; swelling of the hands and feet; toothache; trouble sleeping; upper respiratory tract infection; vaginal inflammation; vomiting; weakness; weight loss; wounds.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavioral, emotional, or mood changes; changes in vision; chills; confusion; depression; dizziness; fast heartbeat; fatigue; fever; headache; joint or muscle aches; lack of interest; nervousness; numbness of an arm or leg; pain, redness, or swelling at the injection site; pounding in the chest; ringing in the ears; severe headache; severe stomach pain; sharp or crushing chest pain; stomach bloating; stomach or lower back pain; sudden fainting; sudden leg pain; sudden shortness of breath; sweating; thinning hair; thoughts of suicide; unusual bleeding or bruising; vision problems; vomiting; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chills; fever; loss of appetite; muscle pain.

Store Infergen in refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Avoid vigorous shaking and exposure to direct sunlight. Use only 1 dose per vial. Do not use solution from the same vial again. Throw away any unused portion. Keep Infergen , as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Infergen , please talk with your doctor, pharmacist, or other health care provider.
• Infergen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Infergen . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.