Ribavirin (ribavirin 200 mg) Dailymed

Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. RIBAVIRIN TABLETS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO PLANNED INITIATION OF THERAPY. Patients should be instructed to use at least two forms of effective contraception during treatment and for six-months after treatment has been stopped. Pregnancy testing should occur monthly during ribavirin tablets therapy and for 6 months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS : Information for Patients and Pregnancy: Category X ).

Patients must be informed that ribavirin may cause birth defects and/or death of the exposed fetus. Ribavirin tablets therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking ribavirin tablets therapy and for 6 months posttherapy. Ribavirin tablets therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months posttherapy.

Patients must be informed that ribavirin may cause birth defects and/or death of the exposed fetus. Ribavirin tablets therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking ribavirin tablets therapy and for 6 months posttherapy. Ribavirin tablets therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months posttherapy. Female patients of childbearing potential and male patients with female partners of childbearing potential must be advised of the teratogenic/embryocidal risks and must be instructed to practice effective contraception during ribavirin tablets therapy and for 6 months posttherapy. Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy (see CONTRAINDICATIONS and WARNINGS ). The most common adverse event associated with ribavirin is anemia, which may be severe (see ADVERSE REACTIONS ). Patients should be advised that laboratory evaluations are required prior to starting ribavirin tablets therapy and periodically thereafter (see Laboratory Tests ). It is advised that patients be well hydrated, especially during the initial stages of treatment. Patients who develop dizziness, confusion, somnolence, and fatigue should be cautioned to avoid driving or operating machinery. Patients should be informed regarding the potential benefits and risks attendant to the use of ribavirin tablets. Instructions on appropriate use should be given, including review of the contents of the enclosed MEDICATION GUIDE, which is not a disclosure of all or possible adverse effects. Patients should be advised to take ribavirin tablets with food.

Before beginning ribavirin tablets therapy, standard hematological and biochemical laboratory tests must be conducted for all patients. Pregnancy screening for women of childbearing potential must be done.

Before beginning ribavirin tablets therapy, standard hematological and biochemical laboratory tests must be conducted for all patients. Pregnancy screening for women of childbearing potential must be done. After initiation of therapy, hematological tests should be performed at 2 weeks and 4 weeks and biochemical tests should be performed at 4 weeks. Additional testing should be performed periodically during therapy. Monthly pregnancy testing should be done during combination therapy and for 6 months after discontinuing therapy. The entrance criteria used for the clinical studies of ribavirin tablets and peginterferon alfa-2a combination therapy may be considered as a guideline to acceptable baseline values for initiation of treatment: Platelet count ≥ 90,000 cells/mm3 (as low as 75,000 cells/mm3 in patients with cirrhosis or 70,000 cells/mm3 in patients with CHC and HIV) Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 TSH and T4 within normal limits or adequately controlled thyroid function ECG (see WARNINGS ) CD4+ cell count ≥ 200 cells/µL or CD4+ cell count ≥100 cells/µL but <200 cells/µL and HIV-1 RNA <5000 copies/mL in patients coinfected with HIV Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men in CHC monoinfected patients Hemoglobin ≥11 g/dL for women and ≥12 g/dL for men in patients with CHC and HIV The maximum drop in hemoglobin usually occurred during the first 8 weeks of initiation of ribavirin tablets therapy. Because of this initial acute drop in hemoglobin, it is advised that a complete blood count should be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated. Additional testing should be performed periodically during therapy. Patients should then be followed as clinically appropriate.

Pregnancy: Category X (see )

Pregnancy: Category X (see CONTRAINDICATIONS ) Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced. In conventional embryotoxicity/teratogenicity studies in rats and rabbits, observed no-effect dose levels were well below those for proposed clinical use (0.3 mg/kg/day for both the rat and rabbit; approximately 0.06 times the recommended human 24-hour dose of ribavirin). No maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (approximately 0.01 times the maximum recommended human 24-hour dose of ribavirin). Treatment and Posttreatment: Potential Risk to the Fetus Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. It is not known whether ribavirin is contained in sperm, and if so, will exert a potential teratogenic effect upon fertilization of the ova. In a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (up to 1.7 times the maximum recommended human dose of ribavirin). However, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners. Ribavirin tablets should not be used by pregnant women or by men whose female partners are pregnant. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin tablets unless the patient and his/her partner are using effective contraception (two reliable forms) during therapy and for 6 months posttherapy. Ribavirin Pregnancy Registry A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies of female patients and female partners of male patients exposed to ribavirin during treatment and for six months following cessation of treatment. Healthcare providers and patients are encouraged to report such cases by calling 1-800-593-2214. Animal Toxicology Long-term study in the mouse and rat (18 to 24 months; dose 20 to 75 and 10 to 40 mg/kg/day, respectively, approximately 0.1 to 0.4 times the maximum human daily dose of ribavirin) have demonstrated a relationship between chronic ribavirin exposure and an increased incidence of vascular lesions (microscopic hemorrhages) in mice. In rats, retinal degeneration occurred in controls, but the incidence was increased in ribavirin-treated rats.

It is not known whether ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with ribavirin tablets, based on the importance of the therapy to the mother.

Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication Guide each time you get more ribavirin tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about ribavirin tablets? 1. Ribavirin tablets may cause birth defects or death of an unborn child. Therefore, if you are pregnant or your partner is pregnant or plans to become pregnant, do not take ribavirin tablets. Female patients and female partners of male  patients being treated with ribavirin tablets must not becomepregnant during treatment and  for 6 months after treatment has stopped. During this time you must have pregnancy tests that show you are not pregnant. You must also use 2 effective forms of birth control during therapy and for 6 months after stopping therapy. Male patients should use a condom with spermicide as one of the two forms. If pregnancy occurs, report the pregnancy to your healthcare provider right away. (See " What should I avoid while taking ribavirin tablets? ") If you or a female sexual partner becomes pregnant, you should tell your healthcare provider. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your healthcare provider are encouraged to contact the Registry at 1-800-593-2214. 2. Ribavirin tablets can cause a dangerous drop in your red blood cell count. Ribavirin tablets can cause anemia, which is a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may cause a worsening of heart (cardiovascular) or circulatory problems. Some patients may get chest pain and rarely, a heart attack. Patients with a history of heart disease have the highest chance of this. Tell your healthcare provider, before taking ribavirin tablets if you have or have ever had any heart or breathing problems. Your healthcare provider should check your red blood cell count before you start treatment with ribavirin tablets and often during the first 4 weeks of treatment. Your red blood cell count may be done more often if you have any heart or breathing problems. 3. Do not take ribavirin tablets alone to treat hepatitis C virus infection. Ribavirin tablet does not treat hepatitis C virus infections by itself. Ribavirin tablets should be used in combination with peginterferon alfa-2a to treat continuing (chronic) hepatitis C virus infections. You should read the Medication Guide for peginterferon alfa-2a because it has additional important information about treatment that is not covered in this Medication Guide. Your healthcare provider or pharmacist should give you a copy of the peginterferon alfa-2a Medication Guide.

Do not use ribavirin tablets if: You are a female and you are pregnant or plan to become pregnant during treatment or during the 6 months after your treatment has ended. (See " What is the most important information I should know about ribavirin tablets? " and " What should I avoid while taking ribavirin tablets?") You are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with ribavirin tablets or during the 6 months after your treatment has ended. (See "What is the most important information I should know about ribavirin tablets?" and "What should I avoid while taking ribavirin tablets?") You are breast feeding. We do not know if ribavirin tablets can pass through your milk and if it can harm your baby. You will need to choose either to breast feed or take ribavirin tablets, but not both. You have a liver disease called autoimmune hepatitis (hepatitis caused by your immune system attacking your liver). You have unstable or severe liver disease. You are allergic to any of the ingredients in ribavirin tablets. The active ingredient in ribavirin tablets is ribavirin. See the end of this Medication Guide for a ul of all the ingredients in ribavirin tablets.

Your healthcare provider will determine the right dose of ribavirin tablets based on your weight. Take ribavirin tablets 1 time in the morning and 1 time at night (2 times a day). Take ribavirin tablets the same 2 times each day. Take ribavirin tablets with food. It is very important to follow your dosing schedule and your healthcare provider's instructions on how to take your medicines. Take ribavirin tablets for as long as it is prescribed, and do not take more than your healthcare provider prescribes. If you miss a dose of ribavirin tablets and remember the same day, take the missed dose as soon as you remember. If the whole day has passed, ask your healthcare provider what to do. Do not take 2 doses at the same time. Your healthcare provider may adjust your dose of ribavirin tablets based on blood tests that show your response to treatment and side effects you may have. Females taking ribavirin tablets or female sexual partners of male patients taking ribavirin tablets must have a pregnancy test: •before treatment begins •every month during treatment •for 6 months after treatment ends to make sure there is no pregnancy It is also important not to use other ribavirin medicines without talking to your healthcare provider. Please see the peginterferon alfa-2a Medication Guide for the proper use of peginterferon alfa-2a injection.

Avoid the following during ribavirin tablets treatment: Do not get pregnant. If you or your sexual partner get pregnant during treatment with ribavirin tablets or in the 6 months after treatment ends, tell your healthcare provider right away. (See " What is the most important information I should know about ribavirin tablets? ")Talk with your healthcare provider about birth control methods and how to avoid pregnancy. You must use extreme care to avoid pregnancy during and for 6 months after treatment in female and male patients. Do not take ribavirin tablets alone to treat your hepatitis C virus infection. Ribavirin tablets should be used in combination with peginterferon alfa-2a to treat chronic hepatitis C virus infections. (See " What is the most important information I should know about ribavirin tablets? ") Do not breast feed. Ribavirin tablets may pass through your milk and may harm your baby. Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse. Do not drive or operate machinery if ribavirin tablet makes you feel tired, dizzy or confused. Do not take other medicines unless your healthcare provider knows about them. Take only medicines prescribed or approved by your healthcare provider. These include prescription and non-prescription medicines, vitamins or herbal supplements. Talk to your healthcare provider before starting any new medicine.