May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of these conditions. Ribavirin may cause birth defects and fetal death, and extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia, which may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Interferon, Alfa (class)
Peginterferon alfa-2b is a synthetic (man-made) version of substances normally produced in the body to fight infection. Peginterferon alfa-2b is used alone or together with ribavirin to treat chronic hepatitis C infection. It is used for patients who have never been treated by alpha interferons. The combination treatment of peginterferon alfa-2b and ribavirin is used to treat adults and children 3 years of age and older who show symptoms of liver damage.
peginterferon 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 peginterferon alfa-2b, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to peginterferon 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 have not been performed on the relationship of age to the effects of peginterferon alfa-2b in children below 3 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of peginterferon alfa-2b in the elderly. However, elderly patients are more likely to have age-related stomach, liver, lung, kidney, or heart problems, which may require caution in patients receiving peginterferon alfa-2b.
|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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 peginterferon alfa-2b. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional may give you peginterferon alfa-2b. peginterferon alfa-2b is given as a shot under your skin. You may be taught how to give peginterferon alfa-2b at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
Each package of peginterferon alfa-2b contains a 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.
peginterferon alfa-2b should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
The dose of peginterferon alfa-2b will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of peginterferon alfa-2b. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
peginterferon 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 unopened vials of peginterferon alfa-2b at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.
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.
Store the medicine that has been mixed in the refrigerator. You may use it immediately but also may be stored in the refrigerator for 24 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution.
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 your progress at regular visits to make sure that peginterferon alfa-2b is working properly. Blood tests may be needed to check for unwanted effects.
Using peginterferon alfa-2b 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. Do not breastfeed while you are using these medicines.
A negative pregnancy test is needed in women who are of childbearing age before starting treatment with peginterferon alfa-2b 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.
Peginterferon alfa-2b may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.
Serious allergic reactions can occur with peginterferon alfa-2b. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; fever or chills; hives or welts; red skin lesions; severe acne or skin rash; or sores or ulcers on the skin while you are using peginterferon alfa-2b.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Peginterferon alfa-2b when used together with ribavirin may cause teeth and gum problems. These medicines may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these medicines for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.
peginterferon alfa-2b when used together with ribavirin may affect your child's growth. Your doctor may need to check your child's height and weight during and after treatment with these medicines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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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