Alpha interferons, including interferon alfa-2b, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping interferon alfa-2b therapy .
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely with periodic clinical and laboratory evaluations. Discontinue therapy with persistently severe or worsening signs or symptoms of these conditions .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immunological Agent
Pharmacologic Class: Interferon, Alfa (class)
Interferon alfa-2b injection is used to treat hepatitis B and C, lymphoma, malignant melanoma (skin cancer), genital warts, hairy cell leukemia, and Kaposi's sarcoma (in people with AIDS). Interferons are substances produced by cells in the body to help fight infections and tumors. Interferon alfa-2b is a synthetic (man-made) version of these substances.
interferon alfa-2b is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For interferon alfa-2b, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to interferon alfa-2b or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of interferon alfa-2b injection in children 1 to 17 years of age with hepatitis B or children 3 to 16 years of age with hepatitis C. .
Appropriate studies have not been performed on the relationship of age to the effects of interferon alfa-2b injection in children with lymphoma, malignant melanoma, genital warts, hairy cell leukemia, and Kaposi's sarcoma. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of interferon alfa-2b injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, bone marrow, or heart problems, which may require an adjustment in the dose for patients receiving interferon alfa-2b injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using interferon alfa-2b with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of interferon alfa-2b. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you interferon alfa-2b. You may also be taught how to give your medicine at home. interferon alfa-2b is given as a shot under your skin, into a muscle or vein, or directly into a skin lesion.
If you are injecting interferon alfa-2b yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
Use only the brand of interferon alfa-2b that your doctor prescribed. Different brands may not work the same way.
Use a new needle and syringe each time you inject your medicine.
Drink extra fluids so you will pass more urine while you are using interferon alfa-2b. This will keep your kidneys working well and help prevent kidney problems.
Each package of interferon alfa-2b injection contains a medication guide and patient instruction sheet. Read this sheet carefully and make sure you understand:
If you have any questions about any of this, check with your doctor.
interferon alfa-2b needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
It is very important that your doctor check the progress of you or your child at regular visits to make sure interferon alfa-2b is working properly. Blood tests may be needed to check for unwanted effects.
Using interferon alfa-2b injection together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.
A negative pregnancy test is needed in women who are of childbearing age before starting combination treatment with interferon alfa-2b injection and ribavirin. Two forms of birth control must be used during treatment and for six months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with these medicines and after your treatment ends.
interferon alfa-2b may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using interferon alfa-2b and call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth.
Interferon alfa-2b injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you or your child can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
For some children and teenagers, interferon alfa-2b can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts of hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.
The powder form of interferon alfa-2b contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.
Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
interferon alfa-2b may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to interferon alfa-2b before you drive, operate machinery, or do anything else that could be dangerous if you are dizzy or not alert.
Interferon alfa-2b injection and ribavirin combination may cause a dry mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Some patients who have used interferon alfa-2b with ribavirin have had vomiting. If you vomit during or after your treatment, rinse your mouth out with water. This may also help prevent damage to your teeth and gums.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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