Interferon alfacon-1

What is Interferon alfacon-1?

• Interferon alfacon-1 (Infergen) an analogue of consensus interferon which contains an additional methionyl amino acid residue.
• Consensus interferon (also known as interferon alfacon-1, rCon-IFN, and CIFN) is a genetically engineered synthetic interferon created from the most common amino acid sequences from the naturally occurring alpha interferons.

What are the uses of this medicine?

• Infergen (Interferon alfacon-1) is a medicine used to treat adults with lasting (chronic) hepatitis C virus (HCV) infection.
• HCV is a liver disease that is caused by the hepatitis C virus and is spread by contact with the blood of a person carrying the hepatitis C virus.
• Most people who get HCV carry the virus in their blood for the rest of their lives.
• Most of these people will have some liver damage, but many do not feel sick from the disease.
• Some people will develop a badly damaged or scarred liver (cirrhosis).
• Cirrhosis can cause the liver to stop working.

Limitations of use:

• It is not known if Infergen can cure HCV (permanently get rid of the virus) or if it can prevent liver failure or liver cancer that is caused by HCV infection.
• Infergen therapy alone or in combination with other treatments will not prevent a person with HCV from giving another person the HCV infection.

How does this medicine work?

• Consensus interferon (also known as interferon alfacon-1, rCon-IFN, and CIFN) is a genetically engineered synthetic interferon created from the most common amino acid sequences from the naturally occurring alpha interferons.
• Alpha interferons bind to specific cell-surface receptors, resulting in the transcription and translation of genes whose protein products have antiviral, antiproliferative, anticancer, and immune-modulating effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant or breast feeding or planning to become pregnant
• have autoimmune hepatitis (hepatitis caused by your immune system attacking your liver)
• had an allergic reaction to another alpha-interferon medicine or are allergic to any of the ingredients in Infergen

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with INFERGEN.
• INFERGEN should be used cautiously in patients who are receiving agents that are known to cause myelosuppression.

Is this medicine FDA approved?

• Initial U.S. Approval: 1997

How should this medicine be used?

Recommended dosage: Monotherapy:

• INFERGEN 9 mcg three times weekly for 24 weeks (as initial treatment) or 15 mcg three times weekly for up to 48 weeks (as retreatment).

Combination treatment: INFERGEN 15 mcg daily with ribavirin 1,000 or 1,200 mg (for body weight < 75 kg and ≥ 75 kg) daily for up to 48 weeks (as retreatment).

• Dose reduction is recommended in patients experiencing serious adverse reactions.

Administration:

• Infergen is given as an injection under your skin. Your healthcare provider will inject your Infergen when you first start using it. Your healthcare provider will decide if you, a family member, or a friend is able to inject your Infergen at home. Your healthcare provider will teach you or the person that will be giving your injections, the right way to prepare and inject Infergen. Make sure you understand the instructions before you inject Infergen at home.
• Infergen comes in ready-to-use vials. There is one dose of medicine in each vial. Your healthcare provider will tell you the amount (your dose) to inject. Do not change your dose unless your healthcare provider tells you to change it. It is important that you take Infergen exactly as your healthcare provider tells you. Too little Infergen may not be effective in treating your HCV infection and too much Infergen may cause side effects.
• Inject your dose of Infergen three times a week, at the same time of day.
• If you miss a dose of Infergen, give yourself an injection as soon as you remember and then call your healthcare provider. Do not take your next scheduled dose until you have been told what you should do by your healthcare provider.
• If you take more than your prescribed amount of Infergen, call your healthcare provider right away. Your healthcare provider may want to examine you.
• Once you start treatment with Infergen, do not switch to another brand of interferon without talking to your healthcare provider. Other interferons may not have the same effect on the treatment of your disease. Switching brands will also require a change in your dose.
• You must get regular blood tests to help your healthcare provider check to see how the treatment is working and to check for side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As injection for subcutaneous use:

• 9 mcg/0.3 mL INFERGEN in sterile, colorless liquid
• 15 mcg/0.5 mL INFERGEN in sterile, colorless liquid

This medicine is available in fallowing brand namesː

• INFERGEN

What side effects can this medication cause?

The most common side effects of this medicine include:

• Flu-like symptoms
• Tiredness (fatigue)
• Upset stomach
• Blood sugar problems
• Skin reactions at the injection site
• Hair thinning

Infergen can cause serious side effects including:

• mental health problems
• blood problems
• heart problems
• autoimmune problems
• allergic reactions

What special precautions should I follow?

• Avoid becoming pregnant while taking Infergen. Infergen may cause harm to an unborn child or cause you to lose your baby (miscarry).
• Do not breastfeed your baby while taking Infergen.
• Treatment with INFERGEN and combination treatment with INFERGEN/ribavirin should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse reactions requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
• Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferon alphas, including INFERGEN. In severe cases, INFERGEN should be stopped immediately and psychiatric intervention instituted.
• Cardiovascular events, which include hypotension, arrhythmia, tachycardia, cardiomyopathy, angina pectoris, and myocardial infarction, have been observed in patients treated with INFERGEN. Patients with a history of significant or unstable cardiac disease should not be treated with INFERGEN/ribavirin combination therapy.
• Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis, some resulting in respiratory failure and/or patient deaths, may be induced or aggravated by interferon alpha therapy, including INFERGEN. INFERGEN treatment should be suspended in patients who develop pulmonary infiltrates or pulmonary function impairment. Patients who resume interferon treatment should be closely monitored.
• Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with interferon alphas, including INFERGEN. INFERGEN treatment should be immediately
• discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin are observed.
• Increases in serum creatinine levels, including renal failure, have been observed in patients receiving INFERGEN.
• Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including INFERGEN.
• Interferon alphas suppress bone marrow function and may result in severe cytopenias including Hemorrhagic/ischemic colitis, sometimes fatal, has been observed within 12 weeks of interferon alpha therapies and has been reported in patients treated with INFERGEN. INFERGEN treatment should be discontinued immediately in patients who develop signs and symptoms of colitis.
• Pancreatitis, sometimes fatal, has been observed in patients treated with interferon alphas, including INFERGEN.
• Serious acute hypersensitivity reactions have been reported following treatment with interferon alphas. INFERGEN should be discontinued immediately and appropriate medical treatment instituted.
• Peripheral neuropathy has been reported when interferon alphas were given in combination with telbivudine. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
• INFERGEN should be administered with caution to patients with a history of endocrine disorders.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• anorexia, chills, fever, and myalgia
• Increases in ALT (15 IU/L to 127 IU/L), aspartate transaminase (AST) (15 to 164 IU/L), and lactic dehydrogenase (LDH) (183 IU/L to 281 IU/L) were reported.

Treatment of overdosage:

• These laboratory values returned to normal or to the subjects baseline values within 30 days.

Can this medicine be used in pregnancy?

• INFERGEN should not be used during pregnancy.
• If a woman becomes pregnant or plans to become pregnant while taking INFERGEN, she should be informed of the potential hazards to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of INFERGEN have not been established in patients below the age of 18 years.
• INFERGEN therapy is not recommended in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: interferon alfacon-1
• Inactive ingredients: sodium chloride, and sodium phosphate in Water for Injection.

Who manufactures and distributes this medicine?

Manufactured by: Boehringer Ingelheim Pharma GmbH & Co. Biberach, Germany Manufactured for: Three Rivers Pharmaceuticals, LLC Warrendale, PA 15086, USA

What should I know about storage and disposal of this medication?

• Store INFERGEN in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC)‚
• Do not freeze INFERGEN. Do not use a vial of INFERGEN that has been frozen.
• Keep INFERGEN away from direct sunlight
• Do not use a vial of INFERGEN past the expiration date stamped on the label.
• Do not shake INFERGEN. If INFERGEN is shaken too hard, it will not work properly.

• Dailymed label info on Interferon alfacon-1
• FDA Interferon alfacon-1

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