Generic Name: interferon alfacon-1 (IN-ter-FEER-on AL-fa-kon-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:
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. Exactly how interferon alfacon-1 works against the hepatitis C virus is not known. 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) or severe or worsening liver problems
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 pregnant, planning to become pregnant, or are breast-feeding
- 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 diabetes, high blood triglycerides, high blood pressure, difficulty sleeping, heart problems (eg, irregular heartbeat, heart muscle problems), liver problems, thyroid problems, eye problems, lung or breathing problems (eg, pulmonary hypertension, chronic obstructive pulmonary disease [COPD]), pneumonia, cancer, bowel problems (eg, colitis), hepatitis B, HIV, kidney problems, or you have never been treated for hepatitis C before
- if you have a weakened immune system, have received a transplant, or you are taking medicines that weaken the immune system (eg, tacrolimus)
- if you have a history of low blood cell counts, autoimmune disorders (eg, rheumatoid arthritis, psoriasis, lupus), bleeding problems, blood clots, heart attack, pancreas problems (eg, pancreatitis), mental or mood 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. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Telbivudine because the risk of nerve problems (peripheral neuropathy) may be increased
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 not 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.
- Patients who take Infergen may be at increased risk of new or worsening mental or mood changes or suicidal thoughts or actions. Watch all patients who take Infergen closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- 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 of eye disease (eg, diabetes), you should have periodic eye exams while using Infergen.
- Men and women should use effective forms of birth control while taking Infergen.
- Lab tests, including liver and kidney function, serum albumin, complete blood cell counts, blood cholesterol, and eye exams, 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.
- Use Infergen with caution in the ELDERLY; they may be more sensitive to its effects.
- Infergen should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these 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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thinking; black, tarry, or bloody stools or diarrhea; chest, jaw, or left arm pain; confusion; dark urine; decreased or increased urination; fainting; fast or irregular heartbeat; high or persistent fever, chills, or sore throat; loss of coordination; new or worsening mental or mood changes (eg, depression, irritability, nervousness, anxiety, agitation; aggressive behavior); new or worsening vision problems or loss of vision; numbness of an arm or leg; one-sided weakness; pain or burning while urinating; persistent feeling of hot or cold; severe or persistent dizziness or headache; severe stomach or lower back pain; shortness of breath; slurred speech; sudden, severe vomiting; swelling of the stomach; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts or behaviors of killing or hurting yourself or others; unusual bleeding or bruising; unusual tiredness or weakness; unusual weight changes; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Infergen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Infergen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Infergen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Infergen.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.