Infergen

Infergen is a prescription medication used to treat lasting (chronic) hepatitis C virus (HCV) infection in adults. Infergen belongs to a group of drugs called synthetic interferons. These work by helping to prevent the hepatitis C virus from growing inside your body. 

This medication is available in an injectable form to be given directly under the skin (subcutaneously), typically three times per week for 24 weeks. Your doctor will decide wheteher you will take Infergen alone or with ribavirin.

Common side effects of Infergen include flu-like symptoms, stomach problems, and hair thinning.

Infergen can also cause drowsiness. Do not drive or operate heavy machinery until you know how Infergen affects you.

Infergen is a prescription medication used to treat lasting (chronic) hepatitis C virus (HCV) infection in adults with certain levels of hepatitic C antibodies in their blood.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Infergen for the treatment of lasting (chronic) hepatitis C virus (HCV) infection in adults is 9 mcg injected subcutaneously as a single injection three times per week for 24 weeks.

Serious side effects have been reported with Infergen including the following:

• flu-like symptoms. Infergen causes “flu-like” symptoms in most patients. Symptoms include headache, muscle aches, tiredness, chills and fever that usually lessen after the first few weeks of therapy. If you inject your Infergen dose at bedtime, you may be able to sleep through the symptoms. You may also take a fever and pain reducer such as acetaminophen or ibuprofen, to help relieve or reduce the flu-like symptoms.
• blood sugar problems. Infergen may affect blood sugar levels and cause high blood sugar or diabetes. Talk to your physician about before taking Infergen if you have diabetes.
• skin reactions at the injection-site. Redness, rash, itching, swelling, or bruising that does not go away may occur at the site of injection. Call your healthcare provider if these symptoms do not go away after several days.
• neuropsychiatric disorders. Severe psychiatric problems may occur in patients receiving therapy with medications like Infergen including depression, suicidal ideation, suicide attempts, psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and/or relapse of drug addiction. Infergen should be used with extreme caution in patients who report a history of depression. Immediately report any sign or symptom of depression and/or suicidal ideation to your physician.
• bone marrow toxicity. Your physician will monitor your blood levels while you are taking Infergen and adjust your dose if necessary.
• cardiovascular disorders. High blood pressure, abnormally fast heart rate, and palpitations have been reported in patients treated with Infergen. Infergen should be administered with caution to patients with preexisting cardiac disease.
• acute hypersensitivity reactions. Serious acute hypersensitivity reactions have been reported in rare instances following treatment with medications similar to Infergen. Infergen should be discontinued immediately and appropriate medical treatment instituted if you experience the following symptoms
  • swelling of the lips or mouth
  • difficulty breathing
  • hives
• endocrine disorders. Occurrence or aggravation of hyperthyroidism or hypothyroidism have been reported with Infergen. High blood sugar and diabetes have also been observed in patients treated with Infergen. Patients who develop these conditions during treatment that cannot be controlled with medication should not continue Inferger therapy. Talk to your physician about before taking Infergen if you have any endocrine conditions.
• autoimmune disorders. Development of or exacerbation of autoimmune disorders have been reported in patients receiving Infergen. Infergen should not be used in patients with autoimmune hepatitis and should be used with caution in patients with other autoimmune disorders.
• lung disorders. Pneumonia and interstitial pneumonitis, some cases esulting in respiratory failure and/or patient deaths, have been induced or aggravated by Infergen. Talk to your physician about before taking Infergen if you have any lung conditions.
• colitis. Hemorrhagic/ischemic colitis, sometimes fatal, has been observed in patients treated with Infergen. Talk to your physician about before taking Infergen if you have any intestinal conditions.
• eye disorders. Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema may be induced or aggravated by treatment with Infergen. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Infergen therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
• cerebrovascular disorders. Strokes have been observed in patients treated with Infergen. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Talk to your physician about before taking Infergen if you have any history of strokes or heart disease.

Do not take Infergen if you:

• are allergic to Infergen or to any of its ingredients
• have decompensated hepatic disease
• have autoimmune hepatitis

Infergen can also cause drowsiness, dizziness, and/or blurred vision. Do not drive or operate heavy machinery until you know how Infergen affects you.

Serious side effects have been reported with Infergen. See the “Infergen Precautions” section.

Common side effects of Infergen include the following:

• fatigue
• fever
• body pain
• flu-like symptoms
• injection-site redness
• headache
• insomina
• dizziness
• muscle pain
• nausea
• diarrhea
• hair thinning

This is not a complete list of Infergen side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• abacavir
• aldesleukin
• bexarotene
• bupropion
• clozapine
• deferiprone
• eltrombopag
• fingolimod
• iohexol
• iopamidol
• lamivudine
• leflunomide
• lomitapide
• metrizamide
• mipomersen
• natalizumab
• samarium
• telbivudine
• teriflunomide
• tofacitinib
• tramadol
• zidovudine

This is not a complete list of Infergen drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Infergen falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Infergen crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Infergen.