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Drugs & Medications - Roferon-A Inj

Roferon-A Inj

Important Note

INTERFERON ALFA(CON) - INJECTION

Pronunciation: (in-ter-FEER-on AL-fuh)

Brand Name(s): Alferon N, Infergen, Intron A, Roferon-A

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Roferon-A Inj Warnings

This medication can infrequently cause or worsen serious (rarely fatal) medical conditions, including mental/mood conditions (e.g., depression), immune system problems (autoimmune conditions such as lupus or rheumatoid arthritis), circulation problems, or infections. If your medical history includes any of these conditions, tell your doctor promptly. Also, tell your doctor immediately if any serious symptoms or side effects occur (see Side Effects section).

Roferon-A Inj Uses

This medication is used to treat various cancers (e.g., leukemia, melanoma, AIDS-related Kaposi's sarcoma). It is also used to treat virus infections (e.g., chronic hepatitis B, chronic hepatitis C, condylomata acuminata). This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer or virus infections.

How to use Roferon-A Inj

Read the Medication Guide available from your pharmacist before you start using this drug and each time you get a refill. Learn all preparation and usage instructions given by the manufacturer. If you have any questions, consult your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not shake the medication container (vial or syringe). Doing so may decrease the effectiveness of the drug.

This medication is given by injection into a muscle or under the skin as directed by your doctor. Rotate the injection site each time you inject this medication to prevent soreness. It may also be given by injection into a vein or directly into a lesion, usually by a health care professional. If you are using this medication at home, it is best used in the evening before bedtime to reduce side effects.

Drink plenty of fluids while using this medication unless otherwise directed by your doctor.

Dosage is based on your medical condition and response to therapy. Do not change the dose or how often you use this medication without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each evening that you have a scheduled dose.

Different brands of interferon alfa can result in different amounts of medication in the blood. This medication comes in different forms (a powder in a vial, a solution in a vial, and a multidose pen). The way you inject this medication depends on the form you are using. Follow your doctor's directions carefully. Do not switch brands without your doctor's permission.

Learn how to store and discard needles and medical supplies safely. Never reuse single-use syringes or needles. It is okay to reuse the multidose pen (see Storage section). Consult your pharmacist for details.

Roferon-A Inj Side Effects

Injection site reactions (pain/swelling/redness), diarrhea, upset stomach, loss of appetite, back pain, dizziness, dry mouth, taste changes, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few weeks of continued use. You can reduce these side effects by injecting this medicine at bedtime and using a fever reducer/pain reliever such as acetaminophen before each dose. Consult your doctor or pharmacist for more information.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, depression, irritability, thoughts of suicide), feeling too hot or cold (more than others around you), fast/irregular heartbeat, menstrual changes (absent/delayed/irregular periods), numbness/tingling of hands/feet, persistent tiredness, swelling (especially of face/hands/feet), trouble sleeping, trouble walking, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), stomach/abdominal pain, sudden decrease in amount of urine, dark urine, black/tarry stools, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, weakness on one side of the body, slurred speech.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Roferon-A Inj Precautions

Before using interferon alfa, tell your doctor or pharmacist if you are allergic to it; or to albumin; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver conditions (e.g., autoimmune hepatitis, decompensated liver disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), cancer, diabetes, eye problems, heart disease (e.g., angina, irregular heartbeat), high blood pressure, HIV infection, immune system diseases (e.g., lupus, psoriasis, rheumatoid arthritis), intestinal disease (e.g., colitis), kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, asthma, pneumonia), mental/mood disorders (e.g., anxiety, depression), pancreatitis, seizure disorder, thyroid disease, use/abuse of drugs/alcohol.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

If you use both interferon and ribavirin, you may quickly develop a certain serious blood problem (anemia). Talk with your doctor immediately if you feel sudden increased tiredness or fast/pounding heartbeat while taking interferon along with ribavirin.

If you use both interferon and ribavirin, tooth and gum problems may sometimes occur. Dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or by using a saliva substitute. Brush your teeth well at least twice daily and see your dentist regularly. If you experience vomiting during treatment, rinse out your mouth afterwards to reduce tooth and gum problems.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially dizziness, mental/mood changes, and effects on the heart.

This medication is not recommended for use during pregnancy due to possible harm to an unborn baby and the risk of serious side effects for the pregnant woman. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug must use reliable form(s) of birth control (e.g., condoms, birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Roferon-A Inj Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: barbiturates (e.g., phenobarbital), colchicine, drugs that may affect your immune system (e.g., cancer chemotherapy, aldesleukin, cyclosporine), hydroxyurea, stavudine, telbivudine, theophyllines (e.g., aminophylline, theophylline), zidovudine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Roferon-A Inj Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, persistent nausea/vomiting, stomach/abdominal pain, dark urine.

NOTES:

Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, blood chemistry, liver or thyroid function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

If you miss a dose, use it as soon as you remember, then contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE:

Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. The multidose pen may be used for up to 4 weeks after the first injection. After 4 weeks of use, discard the pen, even if it still contains unused solution. Keep all medicines away from children and pets.

Do not leave this medicine outside of the refrigerator for more than 24 hours. For storage instructions for your particular brand, check the package storage information or ask your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.

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