Consumer Drug Information

Infergen

Generic Name: Interferon Alfacon-1 Injection (IN-ter-FEER-ahn AL-fuh-con-1)
Brand Name: Infergen

Infergen may cause or aggravate fatal or life-threatening autoimmune (eg, lupus), neuropsychiatric (eg, depression), ischemic (eg, heart problems), or infectious disorders. Contact your health care provider if persistent or worsening symptoms of these conditions occur.

Infergen is used for:

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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.

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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Infergen refilled.
If you will be using Infergen at home, a health care provider will teach you how to use it. Be sure you understand how to use Infergen . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not shake the vial before using.
Infergen may be allowed to reach room temperature before it is injected.
Do not use Infergen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Infergen , contact your doctor right away. 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. These effects may be worse if you take it with alcohol or certain medicines. Use Infergen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Infergen ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
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.
Infergen may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right 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.
Tell your doctor or dentist that you take Infergen before you receive any medical or dental care, emergency care, or surgery.
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 while you use Infergen . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Infergen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Infergen if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Infergen is found 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:

Diarrhea; dizziness; flu-like symptoms (eg, chills; headache; mild, temporary fever); hair thinning; increased sweating; joint or muscle aches; loss of appetite; mild bruising, itching, lump, redness, or swelling at the injection site; nausea; stomach upset; tiredness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or blood stools; blood diarrhea; chest pain; confusion; dark urine; decreased urination; fainting; fast or irregular heartbeat; high or persistent fever, chills, or sore throat; mental or mood changes (eg, depression, irritability, nervousness, anxiety, aggressive behavior); numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or headache; severe stomach or lower back pain; shortness of breath; slurred speech; sudden severe vomiting; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts of killing or hurting yourself or others; unusual bleeding or bruising; vision problems or changes; 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 / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include chills; fever; loss of appetite; muscle pain.

Proper storage of Infergen :

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.

Issue Date: August 6, 2008

Database Edition 08.3.1.002