Ribasphere

Pronunciation: RYE-ba-VYE-rin
Generic Name: Ribavirin
Brand Name: Examples include Copegus and Ribasphere

Ribasphere is used for:

Treating chronic hepatitis C infection in certain patients when used in combination with peginterferon. It may also be used for other conditions as determined by your doctor.

Ribasphere is an antiviral medicine. Exactly how it works to treat hepatitis C is not known.

Do NOT use Ribasphere if:

• you are allergic to any ingredient in Ribasphere or have had a severe allergic reaction (eg, red, swollen, blistered, or peeling skin) to ribavirin or any other ingredient in Ribasphere
• you are pregnant or planning to become pregnant while you take Ribasphere 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 Ribasphere 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), a history of serious or uncontrolled heart problems, or inflammation of the pancreas (acute pancreatitis)
• you have autoimmune hepatitis (liver problems caused by your own body instead of a virus) or severely decreased liver function
• you are taking didanosine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ribasphere:

Some medical conditions may interact with Ribasphere. 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, kidney problems or if you are on dialysis, 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 a history of mood or mental disorders (eg, anxiety, depression, psychosis), thoughts of suicide, or suicidal behavior
• if you have used interferon before to treat hepatitis C and it did not work
• if you have a history of an organ transplant
• if you have a history of drug or alcohol abuse

Some MEDICINES MAY INTERACT with Ribasphere. 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 Ribasphere
• Anticoagulants (eg, warfarin) or certain NRTIs (eg, lamivudine, stavudine, zidovudine) because their effectiveness may be decreased by Ribasphere

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ribasphere 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 Ribasphere:

Use Ribasphere as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ribasphere comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ribasphere refilled.
• Take Ribasphere by mouth with food.
• Drinking extra fluids while you are taking Ribasphere is recommended. Check with your doctor for instructions.
• Take Ribasphere on a regular schedule to get the most benefit from it. Taking Ribasphere at the same times each day will help you remember to take it.
• Continue to take Ribasphere even if you feel well. Do not miss any doses.
• If you miss a dose of Ribasphere 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 Ribasphere.

Important safety information:

• Ribasphere may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ribasphere 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 Ribasphere and for 6 months after Ribasphere is stopped. Men who take Ribasphere should use a condom with spermicide as 1 of the 2 forms of birth control.
• Women of childbearing potential who either take Ribasphere or are sexual partners of men who take Ribasphere must have a pregnancy test before therapy with Ribasphere is started, monthly during therapy, and monthly for 6 months after Ribasphere is stopped.
• Patients who take Ribasphere 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 Ribasphere 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.
• Ribasphere 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.
• Ribasphere 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 Ribasphere, be sure to rinse your mouth and clean your teeth afterwards.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Diabetes patients - Ribasphere may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including pregnancy; complete blood cell counts; hemoglobin or hematocrit levels; heart, liver, kidney, thyroid, and lung function; and eye exams, may be performed while you use Ribasphere. These tests may be used to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Ribasphere with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia.
• Ribasphere may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Ribasphere.
• Ribasphere should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Ribasphere 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 Ribasphere is found in breast milk. Do not breast-feed while taking Ribasphere.

Possible side effects of Ribasphere:

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:

Cough; diarrhea; dizziness; dry mouth; dry skin; hair loss; joint pain; loss of appetite; mild headache, nausea, or vomiting; mild stomach pain; sinus problems; tiredness; trouble sleeping; upset stomach; weakness or fatigue.

Seek medical attention right away if any of these SEVERE side effects occur:

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, taste, or vision; chest pain; confusion; dark, tarry, or bloody stools; dark urine; decrease in the amount of urine; fainting; fever, chills, or sore throat; 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 stools; persistent loss of appetite; rapid breathing; rash with blisters or sores in your mouth, nose, or eyes; red, swollen, blistered, or peeling skin; severe or persistent diarrhea, nausea, or vomiting; severe or persistent headache or dizziness; severe stomach or back pain; shortness of breath; suicidal thoughts or actions; unusual bruising or bleeding; unusual or severe tiredness, weakness, or fatigue; 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.

See also: Ribasphere side effects (in more detail)

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 Ribasphere:

Store Ribasphere 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 Ribasphere out of the reach of children and away from pets.

General information:

• If you have any questions about Ribasphere, please talk with your doctor, pharmacist, or other health care provider.
• Ribasphere 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 Ribasphere. 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.