Interferon Alfacon 1

Interferon Alfacon-1 is available in the following forms:

• Injectable Solution

You should not use this medication if you are allergic to interferons, or if you have autoimmune hepatitis, severe liver problems from causes other than hepatitis C, severe kidney disease, or a hemoglobin blood cell disorder such as sickle cell anemia or thalasssemia.

Interferon alfacon-1 is sometimes used together with another drug called ribavirin. Ribavirin can cause birth defects or death in an unborn baby. If you are a woman, do not take ribavirin if you are pregnant. If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

Before using interferon alfacon-1, tell your doctor if you have other liver problems (including hepatitis B), kidney disease, diabetes, pancreatitis, cancer, bone marrow suppression, HIV or AIDS, a bleeding or blood clotting disorder, numbness or circulation problems, a thyroid disorder, problems with your eyes, a breathing disorder, an intestinal disorder, high triglycerides, heart problems, high blood pressure, an autoimmune disorder, a history of organ transplant, 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.

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.

Interferon alfacon-1 is sometimes used together with another drug called ribavirin (Copegus, Rebetol, Ribasphere). Ribavirin can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.
• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking ribavirin.
• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

You should not use interferon alfacon-1 if you are allergic to interferons, or if you have:

• autoimmune hepatitis;
• severe liver problems from causes other than hepatitis C;
• severe kidney disease; or
• a hemoglobin blood cell disorder such as sickle cell anemia or thalasssemia.

To make sure you can safely use interferon alfacon-1, tell your doctor if you have any of these other conditions:

• hepatitis B or liver problems other than hepatitis C;
• kidney disease;
• diabetes, pancreatitis;
• cancer;
• bone marrow suppression;
• HIV or AIDS;
• a bleeding or blood clotting disorder;
• numbness or circulation problems;
• a thyroid disorder;
• problems with your eyes;
• a breathing disorder;
• a history of depression, mental illness, suicidal thoughts, or drug or alcohol addiction;
• heart disease, high blood pressure, a heart rhythm disorder, or history of a heart attack or stroke;
• high triglycerides (a type of fat in the blood);
• an autoimmune disorder such as psoriasis, arthritis, or lupus;
• colitis or other intestinal disorder;
• if you have had an organ transplant; or
• if you use any medications that weaken your immune system.

FDA pregnancy category C. It is not known whether interferon alfacon-1 used without ribavirin is harmful to an unborn baby. Tell your doctor if you become pregnant during treatment with interfon alfacon-1.

It is not known whether interferon alfacon-1 passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• If you have an allergy to this medicine or any part of interferon alfacon-1.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take interferon alfacon-1 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Not able to pass urine or change in how much urine is passed.
• Any unexplained bruising or bleeding.
• A burning, numbness, or tingling feeling that is not normal.
• Memory problems or loss.
• Not able to focus.
• Not able to handle heat or cold.
• A change in weight without trying.
• Skin irritation.
• This medicine may cause eye problems that may lead to loss of eyesight or blindness. Tell your doctor if you have or have ever had eye problems. Call your doctor right away if you have any changes in eyesight.

(in ter FEER on AL fa con one)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Injectable, Subcutaneous [preservative free]:

Infergen: 9 mcg/0.3 mL (0.3 mL [DSC]); 15 mcg/0.5 mL (0.5 mL [DSC])

Note: Infergen has been discontinued in the US for more than 1 year.

Chronic HCV infection: SubQ: 9 mcg 3 times/week for 24 weeks; allow 48 hours between doses.

Combination therapy with ribavirin: SubQ: 15 mcg/day with ribavirin for up to 48 weeks

Patients who have previously tolerated interferon therapy but did not respond or relapsed: 15 mcg 3 times/week week for up to 48 weeks

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dyspepsia, nausea, diarrhea, alopecia, insomnia, arthralgia, myalgia, lack of appetite, headache, hot flashes, injection site irritation, or flu-like symptoms. Have patient report immediately to prescriber signs of bowel problems (black, tarry, or bloody stools; fever; mucus in stools; vomiting; vomiting blood; severe abdominal pain; constipation; or diarrhea), signs of a pancreas problem (pancreatitis; severe abdominal pain, severe back pain, severe nausea, vomiting), signs of a severe pulmonary disorder (lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of infection, signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking, hallucination, psychosis, suicidal ideation), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), severe dizziness, passing out, angina, tachycardia, arrhythmia, urinary retention, change in amount of urine passed, bruising, bleeding, burning or numbness feeling, vision changes, blindness, memory impairment, difficulty focusing, temperature sensitivity, weight gain or loss, or skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.