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Generic Name: interferon alfa-2a (IN-ter-FEER-on AL-fa)
Brand Name: Roferon-A
Roferon-A solution can cause or worsen certain life-threatening or fatal medical conditions. These include mental or mood problems (eg, depression), autoimmune problems (eg, lupus or rheumatoid arthritis), circulation problems (eg, blood vessel or heart problems), and infections. Be sure to tell your doctor if you have a history of these conditions. Lab tests may be performed while you use Roferon-A solution to check for side effects. Tell your doctor if you notice any new, worsening, or severe symptoms. You may need to stop Roferon-A solution if they occur. In many, but not all, cases these conditions get better after you stop the medicine.
Roferon-A solution is used for:
Treating chronic hepatitis C and certain types of leukemia. It may also be used for other conditions as determined by your doctor.
Roferon-A solution is an immunomodulator. Exactly how Roferon-A solution works is not known. It may work directly against tumor cells and viruses, and help the immune system fight them.
Do NOT use Roferon-A solution if:
- you are allergic to any ingredient in Roferon-A solution or to other alpha interferons
- you are allergic to any product made from Escherichia coli (E. coli)
- you have certain liver problems (eg, autoimmune hepatitis, liver decompensation)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Roferon-A solution:
Some medical conditions may interact with Roferon-A solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of heart problems (eg, fast or irregular heartbeat), heart attack, blood vessel problems, high blood pressure, or high blood triglycerides
- if you have a history of autoimmune disease (eg, lupus, rheumatoid arthritis), kidney problems, liver problems (eg, hepatitis B), lung or breathing problems, stomach or bowel problems (eg, inflammation), thyroid problems, diabetes, seizures, pancreas problems, or vision or eye problems (eg, retinopathy)
- if you have low white blood cell or platelet levels, anemia, or a history of bone marrow problems, blood or bleeding problems, or organ transplant
- if you have severe drowsiness or trouble sleeping
- if you have an infection, including chickenpox or HIV, or you have a history of herpes simplex
- if you have a history of mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or other substance abuse or dependence
Some MEDICINES MAY INTERACT with Roferon-A solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Zidovudine because the risk of bone marrow problems may be increased
- Interleukin-2 because the risk of kidney problems or high blood sugar may be increased
- Fluorouracil or theophylline because the risk of its side effects may be increased by Roferon-A solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Roferon-A solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Roferon-A solution:
Use Roferon-A solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Roferon-A solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Roferon-A solution refilled.
- Roferon-A solution is sometimes given as an injection at your doctor's office, hospital, or clinic. If you are using Roferon-A solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Roferon-A solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have questions.
- Inject Roferon-A solution deep under the skin, NOT into muscle.
- Do NOT shake Roferon-A solution.
- Do not use Roferon-A solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Roferon-A solution may cause flu-like side effects. Talk to your doctor if these effects become bothersome. Use it at bedtime or take a fever reducer to help decrease these effects.
- Drinking extra fluids while you are using Roferon-A solution is recommended. Check with your doctor for instructions.
- Keep this product, as well as syringes and needles, out the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of the medicine, use the missed dose as soon as you remember then go back to your regular dosing schedule. If several days go by after you miss a dose, check with your doctor about what to do. Do not use 2 doses at once. Do not use more than 1 dose per week without talking to your doctor.
Ask your health care provider any questions you may have about how to use Roferon-A solution.
Important safety information:
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. If you use more than your prescribed dose, contact your doctor right away.
- Roferon-A solution may cause dizziness, drowsiness, or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use Roferon-A solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Roferon-A solution without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Roferon-A solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Roferon-A solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Roferon-A solution.
- Roferon-A solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Do not change the type of interferon that you are using without checking with your doctor. Other types of interferon may not have the same effect on your condition.
- Women who use Roferon-A solution should avoid becoming pregnant. Female partners of men who use Roferon-A solution should also not become pregnant. To avoid pregnancy, be sure to use an effective method of birth control. Talk with your doctor if you have questions about effective birth control.
- Lab tests, including liver function, complete blood cell counts, and triglyceride levels, may be performed while you use Roferon-A solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Roferon-A solution with caution in the ELDERLY; they may be more sensitive to its effects.
- Roferon-A solution has benzyl alcohol in it. Do not use is in NEWBORNS and INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
- PREGNANCY and BREAST-FEEDING: Do not become pregnant while you are using Roferon-A solution. If you think you may be pregnant, contact your doctor You will need to discuss the benefits and risks of using Roferon-A solution while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using Roferon-A solution.
Possible side effects of Roferon-A solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; bone pain; coughing; diarrhea; dizziness; dry mouth, throat, or skin; hair loss; headache; increased sweating; irritability; loss of appetite; mild flu-like symptoms (eg, fever, chills, joint and muscle pain); nausea; pain, swelling, or redness at the site of injection; stomach pain; taste changes; tiredness or weakness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; bloody or black, tarry stools; bloody vomit; change in amount of urine produced; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; heart attack symptoms (eg, chest, shoulder, jaw, or neck pain; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting); memory problems; mental or mood changes (eg, depression, severe or persistent irritability or anxiety); numbness or tingling; pale, blue, or very cold fingers or toes; seizures; severe or persistent fever, chills, coughing, or sore throat; severe or persistent joint and muscle pain; severe or persistent stomach pain; severe or persistent tiredness or weakness; shortness of breath; suicidal thoughts or attempts; trouble concentrating or thinking; unexplained weight gain; unusual bleeding or bruising; vision loss or other vision problems; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; extreme sluggishness or fatigue.Proper storage of Roferon-A solution:
Store Roferon-A solution in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not leave outside the refrigerator for more than 24 hours. Store away from heat, moisture, and light. Keep Roferon-A solution out of the reach of children and away from pets.
- If you have any questions about Roferon-A solution, please talk with your doctor, pharmacist, or other health care provider.
- Roferon-A solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Roferon-A solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.