Infergen

DRUG DESCRIPTION

Interferon alfacon-1 is a wholly synthetic type-I interferon. The 166-amino
acid sequence of interferon alfacon-1 was derived by scanning the sequences
of several natural interferon alpha subtypes and assigning the most frequently
observed amino acid in each corresponding position resulting in a consensus
sequence. Four additional amino acid changes were made to facilitate the molecular
construction, and a corresponding synthetic DNA sequence was constructed using
chemical synthesis methodology. Interferon alfacon-1 differs from interferon
alfa-2b at 19/166 amino acids (88% homology), and with Interferon alfa-2a at
18/166 amino acids (88% homology). Comparison with interferon-beta shows identity
at over 30% of the amino acid positions. Interferon alfacon-1 is produced in
Escherichia coli (E. coli) cells that have been genetically altered by
insertion of a synthetically constructed sequence that codes for interferon
alfacon-1. Prior to final purification, interferon alfacon-1 is allowed to oxidize
to its native state, and its final purity is achieved by sequential passage
over a series of chromatography columns. This protein has a molecular weight
of 19,434 daltons.

INFERGEN (interferon alfacon-1) is a sterile, clear, colorless, preservative-free liquid formulated
with 100 mM sodium chloride and 27 mM sodium phosphate at pH 7.0 ± 0.2. The
product is available in single-use vials containing 9 mcg and 15 mcg interferon
alfacon-1 at a fill volume of 0.3 mL and 0.5 mL, respectively. INFERGEN vials
contain 0.03 mg/mL interferon alfacon-1, sodium chloride (5.9 mg/mL), and sodium
phosphate (3.8 mg/mL) in Water for Injection, USP. INFERGEN (interferon alfacon-1) is to be administered
undiluted by subcutaneous injection.

What are the possible side effects of interferon alfacon-1 (Infergen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon alfacon-1 and call your doctor at once if you have a serious side effect such as:

• severe depression, aggressive behavior, or thoughts of hurting yourself;


• fever, chills, sore throat, body aches, flu symptoms;


• pale skin, easy bruising or bleeding, unusual weakness;


• cough with yellow or green mucus,...

Read All Potential Side Effects and See Pictures of Infergen »

Infergen Patient Information Including Side Effects

Brand Names: Infergen

Generic Name: interferon alfacon-1 (Pronunciation: IN ter FEER on AL fa kon 1)

• What is interferon alfacon-1 (Infergen)?


• What are the possible side effects of interferon alfacon-1 (Infergen)?


• What is the most important information I should know about interferon alfacon-1 (Infergen)?


• What should I discuss with my healthcare provider before using interferon alfacon-1 (Infergen)?


• How should I use interferon alfacon-1 (Infergen)?


• What happens if I miss a dose (Infergen)?


• What happens if I overdose (Infergen)?


• What should I avoid while using interferon alfacon-1 (Infergen)?


• What other drugs will affect interferon alfacon-1 (Infergen)?


• Where can I get more information?

What is interferon alfacon-1 (Infergen)?

Interferon alfacon-1 is made from human proteins. Interferons help the body fight viral infections.

Interferon alfacon-1 is used to treat chronic hepatitis C.

Interferon alfacon-1 may also be used for other purposes not listed in this medication guide.

What are the possible side effects of interferon alfacon-1 (Infergen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon alfacon-1 and call your doctor at once if you have a serious side effect such as:

• severe depression, aggressive behavior, or thoughts of hurting yourself;


• fever, chills, sore throat, body aches, flu symptoms;


• pale skin, easy bruising or bleeding, unusual weakness;


• cough with yellow or green mucus, feeling short of breath;


• chest pain, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;


• sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;


• black, bloody, or tarry stools;


• urinating less than usual or not at all;


• fast, pounding, or uneven heartbeats;


• vision or hearing problems;


• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);


• high blood sugar (increased thirst, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting); or


• worsening liver symptoms such as severe stomach pain, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dizziness;


• mild headache, tired feeling, sleep problems (insomnia);


• joint or muscle pain, back pain;


• mild nausea, vomiting, diarrhea, upset stomach;


• temporary hair loss;


• mild itching or skin rash; or


• redness, pain, bruising, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about interferon alfacon-1 (Infergen)?

You should not use this medication if you are allergic to interferons, if you are pregnant, or if you have autoimmune hepatitis or severe liver problems from causes other than hepatitis C.

Before using interferon alfacon-1, tell your doctor if you have other liver problems (including hepatitis B), kidney disease, diabetes, cancer, bone marrow suppression, HIV or AIDS, a bleeding or blood clotting disorder, a thyroid disorder, sleep problems, a breathing disorder, heart problems, high blood pressure, an autoimmune disorder, a history of heart attack or stroke, or a history of depression, mental illness, suicidal thoughts, or drug or alcohol addiction.

Tell your doctor if you use any medications that weaken your immune system, such as cancer medicine, steroids, medicines to treat autoimmune disorders, or medicines to prevent organ transplant rejection.

Interferon alfacon-1 can cause serious side effects, some of which may be life-threatening. However, the benefits of treating your condition may outweigh any risks posed by using interferon alfacon-1. Talk to your doctor about the risks and benefits of using this medication.

Stop using interferon alfacon-1 and call your doctor at once if you have a serious side effect such as severe depression, behavior changes, thoughts of hurting yourself, fast or pounding heartbeats, signs of infection (fever, chills, flu symptoms), pale skin, easy bruising or bleeding, cough with yellow or green mucus, feeling short of breath, chest pain, sudden numbness or weakness, severe stomach pain, increased thirst, urinating less than usual, or worsening liver symptoms.

To be sure this medication is not causing harmful effects, your blood may need to be tested before you start using interferon alfacon-1, and then on a regular basis during treatment. Do not miss any follow-up visits to your doctor.

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