Generic Name: ribavirin (RYE-ba-VYE-rin)
Brand Name: Examples include Copegus and Ribasphere
Copegus may cause serious birth defects and/or fetal death when used during pregnancy. It should not be used by women who are pregnant or by men whose female partners are pregnant. Women of childbearing potential who either take Copegus or are sexual partners of men who take Copegus must:
- have a negative pregnancy test immediately before therapy with Copegus is started.
- avoid becoming pregnant during therapy with Copegus or within the first 6 months after Copegus is stopped.
At least 2 reliable forms of effective birth control must be used during treatment with Copegus and for 6 months after treatment with Copegus is stopped. If you or your sexual partner becomes pregnant while taking Copegus or within 6 months after Copegus is stopped, contact your doctor right away.
Use of Copegus alone is not effective for treating chronic hepatitis C infection. Talk with your doctor.
Copegus may cause a serious blood problem (hemolytic anemia). This blood problem can worsen any heart problems you have and cause you to have a heart attack, which can be fatal. Tell your doctor if you have ever had heart problems. Do not take Copegus if you have a history of serious or uncontrolled heart problems. Call your doctor right away if you have chest pain while taking Copegus.
Copegus is used for:
Treating chronic hepatitis C infection in certain patients. It may also be used for other conditions as determined by your doctor.
Copegus is an antiviral medicine. Exactly how it works to treat hepatitis C is not known.
Do NOT use Copegus if:
- you are allergic to any ingredient in Copegus or have had a severe allergic reaction (eg, red, swollen, blistered, or peeling skin) to ribavirin or any other ingredient in Copegus
- you are pregnant or planning to become pregnant while you take Copegus or within 6 months after you stop taking it
- you are a man with a female sexual partner who is pregnant or planning to become pregnant while you take Copegus or within 6 months after you stop taking it
- you are breast-feeding
- you have certain blood disorders (eg, hemolytic anemia, sickle cell anemia, thalassemia major), autoimmune hepatitis (liver problems caused by your immune system instead of a virus), severely decreased liver function, or inflammation of the pancreas (pancreatitis)
- you have a history of serious or uncontrolled heart problems
- you are taking didanosine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Copegus:
Some medical conditions may interact with Copegus. 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 have a female sexual partner who is of childbearing age
- 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 cancer, heart problems or a heart attack, high blood pressure, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia, spherocytosis), stomach or bowel bleeding, thyroid problems, psoriasis, HIV infection or other immune system problems, or eye or vision problems
- if you have liver problems other than hepatitis C infection (eg, hepatitis B infection), cirrhosis of the liver, or decreased liver function
- if you have kidney problems or are on dialysis. Some brands of this product should not be used in people who have kidney problems
- if you have a history of mood or mental disorders (eg, anxiety, depression, psychosis), thoughts of suicide, or suicidal behavior
- if you have a history of an organ transplant
- if you have a history of drug or alcohol abuse
- if you are dehydrated
Some MEDICINES MAY INTERACT with Copegus. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Didanosine or other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), other antiretroviral medicines for HIV infection, or thiopurines (eg, azathioprine) because serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, bone marrow suppression, lactic acidosis, and severe or fatal liver failure, may be increased by Copegus
- Anticoagulants (eg, warfarin) or certain NRTIs (eg, lamivudine, stavudine, zidovudine) because their effectiveness may be decreased by Copegus
This may not be a complete list of all interactions that may occur. Ask your health care provider if Copegus 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 Copegus:
Use Copegus as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Copegus comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Copegus refilled.
- Take Copegus by mouth with food.
- Drinking extra fluids while you are taking Copegus is recommended. Check with your doctor for instructions.
- Take Copegus on a regular schedule to get the most benefit from it. Taking Copegus at the same times each day will help you remember to take it.
- Continue to take Copegus even if you feel well. Do not miss any doses.
- If you miss a dose of Copegus and you remember the same day, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Check with your doctor if you are unsure of what to do if you miss a dose.
Ask your health care provider any questions you may have about how to use Copegus.
Important safety information:
- Tell your doctor or dentist that you take Copegus before you receive any medical or dental care, emergency care, or surgery.
- Copegus may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Copegus with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
- At least 2 reliable forms of effective birth control must be used during treatment by men and women who take Copegus and for 6 months after Copegus is stopped. Men who take Copegus should use a condom with spermicide as 1 of the 2 forms of birth control.
- Women of childbearing potential who either take Copegus or are sexual partners of men who take Copegus must have a pregnancy test before therapy with Copegus is started, monthly during therapy, and monthly for 6 months after Copegus is stopped.
- Patients who take Copegus may be at increased risk of suicidal thoughts or actions. The risk may be greater in children or teenagers who have had suicidal thoughts or actions in the past. Watch patients who take Copegus closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; aggression, anger, anxiety, nervousness, or irritable behavior; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Copegus 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.
- Copegus may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking it. Brush and floss your teeth and visit the dentist regularly.
- If vomiting occurs while you are taking Copegus, be sure to rinse your mouth and clean your teeth afterwards.
- Serious and sometimes fatal lung problems have happened with Copegus. Call your doctor right away if you have lung or breathing problems (eg, trouble breathing, shortness of breath, a cough that is new or worse).
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Diabetes patients - Copegus may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests may be performed while you use Copegus. These tests may be used to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Have your lung function checked as you have been told by your doctor.
- Have an eye exam as you have been told by your doctor.
- Use Copegus with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia.
- Copegus may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Copegus.
- Some brands of Copegus are not approved for use in CHILDREN younger than 18 years old. Discuss any questions with your doctor.
- If your child is taking Copegus, the dose may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.
- PREGNANCY and BREAST-FEEDING: Do not use Copegus if you are pregnant. It has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Copegus.
Possible side effects of Copegus:
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:
Diarrhea; dizziness; dry mouth; dry skin; hair loss; joint pain; loss of appetite; mild headache, nausea, or vomiting; mild stomach pain; tiredness; trouble sleeping; upset stomach; weakness or fatigue.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); bloating of the stomach; changes in hearing or taste; chest pain; confusion; dark, tarry, or bloody stools; dark urine; decrease in the amount of urine; fainting; hearing loss; irregular heartbeat; menstrual problems; mood or mental problems (eg, agitation, aggression, anger, anxiety, decreased concentration, depression, irritability, memory problems, nervousness); muscle pain or weakness; numbness of an arm or leg; pale skin; pale stools; persistent loss of appetite; rash with blisters or sores in your mouth, nose, or eyes; severe or persistent diarrhea, nausea, or vomiting; severe or persistent headache or dizziness; suicidal thoughts or actions; symptoms of high blood sugar (eg, confusion; drowsiness; flushing; fruit-like breath; increased thirst, hunger, or urination; rapid breathing); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful urination, mouth sores, wound that will not heal); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual or severe tiredness, weakness, or fatigue; vision changes (eg, loss of vision); vomit that looks like coffee grounds; weight loss; worsening psoriasis; 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.Proper storage of Copegus:
Store Copegus between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Copegus out of the reach of children and away from pets.
- If you have any questions about Copegus, please talk with your doctor, pharmacist, or other health care provider.
- Copegus 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 should not be used to decide whether or not to take Copegus or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Copegus. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Copegus. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Copegus.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.