Alferon N

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.

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use interferon alfa-n3:

• heart disease, congestive heart failure, angina (chest pain);

• severe lung disease such as COPD (chronic obstructive pulmonary disease);

• diabetes;

• bone marrow suppression;

• a seizure disorder; or

• a bleeding or blood clotting disorder such as hemophilia.

FDA pregnancy category C. It is not known whether interferon alfa-n3 is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether interferon alfa-n3 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.

Interferon alfa-n3 is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of an interferon alfa-n3 overdose are not known.

• If you have an allergy to alpha interferon or any other part of Alferon N (interferon alfa-n3).
• 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.

This medicine may interact with other drugs or health problems.

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Alferon N as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• Your doctor will give this medicine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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 Alferon N. 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.

Data not available

Data not available

Interferon alfa-n3 is contraindicated in patients who have anaphylactic sensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.

Due to fever and other influenza-like symptoms associated with interferon alfa-n3 therapy, caution should be taken when administering to patients with debilitating medical conditions such as cardiovascular disease, severe pulmonary disease, or diabetes mellitus with ketoacidosis.

Patients with coagulation disorders, severe myelosuppression, or seizure disorders should receive interferon alfa-n3 with caution.

Acute, serious hypersensitivity reactions have not been reported in patients administered interferon alfa-n3. However, if such reactions develop, drug administration should be discontinued immediately and appropriate medical therapy should be instituted.

Caution is recommended if interferon alfa-n3 is to be used in fertile men. Fertile women should be encouraged to use effective contraception during treatment.

Since interferon alfa-n3 (human leukocyte derived) is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease agent.

Patients being treated with interferon alfa-n3 should be informed of the benefits and risks associated with this therapy. Since the manufacturing process, strength, and type of interferon (e.g., natural, human leukocyte interferon versus single-species recombinant interferon) may vary for different interferon formulations, changing brands may require a change in dosage. Therefore, prescribers are cautioned not to change from one interferon product to another without considering these factors.

Resolution of warts has occurred during the 3 months after treatment cessation. No further therapy (interferon alfa-n3 or conventional therapy) should be administered for 3 months after the initial 8-week course of treatment unless the warts enlarge or new warts appear. Studies to determine the safety and efficacy of a second course of treatment of warts with interferon alfa-n3 (human leukocyte derived) have not been conducted.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Data not available