Interferon Alfa N3

Interferon alfa-n3 is made from human proteins. Interferons help the body fight viral infections.

Interferon alfa-n3 is used to treat genital warts that occur on the outside of the body. This medication is for use only in people who are at least 18 years old.

Interferon alfa-n3 is usually given after other medications have been tried without successful treatment of genital warts.

Interferon alfa-n3 may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to interferons, or if you are allergic to eggs or mouse proteins.

Before receiving interferon alfa-n3, tell your doctor if you have heart disease, congestive heart failure, angina (chest pain), severe lung disease (such as COPD), diabetes, bone marrow suppression, a bleeding or blood clotting disorder, or a seizure disorder.

Call your doctor if you have flu symptoms (fever, chills, and body aches), or if your genital warts do not completely clear up within 3 months after your last injection of interferon alfa-n3.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest tightness, wheezing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have flu symptoms such as fever, chills, and body aches.

Less serious side effects may include:

• headache, tired feeling;

• dizziness;

• joint or muscle pain, back pain;

• mild nausea; or

• sleep problems (insomnia).

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.

(in ter FEER on AL fa en three)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Alferon N: 5,000,000 units/mL (1 mL)

Hypersensitivity to human interferon alpha proteins or any component of the formulation; anaphylactic sensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.

Concerns related to adverse effects:

• Flu-like symptoms: Flu-like symptoms are common; may aggravate debilitating conditions.

• Hypersensitivity reactions: Discontinue use if signs/symptoms of hypersensitivity reactions occur (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis).

Disease-related concerns:

• Bone marrow suppression: Use with caution in patients with severe myelosuppression.

• Cardiovascular disease: Use with caution in patients with preexisting cardiovascular disease (eg, unstable angina, uncontrolled CHF). In a scientific statement from the American Heart Association, interferon has been determined to be an agent that may either cause reversible direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: moderate/major) (AHA [Page 2016]).

• Coagulation disorders: Use with caution in patients with coagulation disorders (eg, thrombophlebitis, pulmonary embolism, hemophilia).

• Diabetes: Use with caution in patients with diabetes with ketoacidosis.

• Pulmonary disease: Use with caution in patients with severe pulmonary disease (eg, chronic obstructive pulmonary disease).

• Seizure disorder: Use with caution in patients with seizure disorders.

Dosage form specific issues:

• Albumin: Contains albumin, which may carry a remote risk of transmitting Creutzfeldt-Jakob or other viral diseases.

• Product variability: Due to differences in manufacturing, strength, and type of interferon, do not change from one brand of interferon to another; a change in dosage may be required.

Other warnings/precautions:

• Appropriate use: Patients should be selected for therapy based on a number of factors: the locations and sizes of the lesions, past treatment and response, and the patient's ability to comply with the treatment regimen. Therapy is particularly useful for patients who have not responded satisfactorily to other treatment modalities (eg, podophyllin resin, surgery, laser or cryotherapy).

Commonly reported side effects of interferon alfa-n3 include: fever, headache, myalgia, arthralgia, flu-like symptoms, vomiting, and chills. Other side effects include: back pain. See below for a comprehensive list of adverse effects.

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.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Blurred eyesight.
• Low white blood cell counts have rarely happened with this drug. This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Muscle or joint pain.
• Back pain.
• Not able to sleep.
• Feeling tired or weak.
• Feeling sleepy.
• Irritation where the shot is given.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Mouth irritation or mouth sores.
• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.