Ribavirin package insert

Common Questions and Answers about Ribavirin package insert

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Avatar n tn In my package insert it says that there is a 1 - 10% chance that people might experience decreased libido and/or temporary impotence.
Avatar f tn Here is the information from the package insert for Ribavirin: Warnings and Precautions Pregnancy Ribavirin Capsules may cause birth defects and death of the unborn child. Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two forms of contraception and have monthly pregnancy tests during treatment and during the 6-month period after treatment has been stopped.
Avatar m tn .The package insert simply says take with food , no designation as to how much or what, follow the link to see more on the subject. http://www.medhelp.org/posts/Hepatitis-C/Starting-Week-12-on-INC---THEN-WHAT-/show/1637168 .
2030686 tn?1351692148 See PEGASYS Package Insert for all instructions regarding PEGASYS dosing and administration. 2.1 Chronic Hepatitis C Monoinfection Adult Patients The recommended dose of COPEGUS tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses.
Avatar m tn to *really* increase bioavailabilty never mind peanut butter - dissolve the tablets (they are water soluble) and inject them! There is a simple way to confirm whether you need to take your rbv pills with a given amount of fat: check the "Patient Information" section of the package insert. The FDA tightly regulates the language in the package insert that accompanies medication.
Avatar n tn I weigh 79 kg, (170#) How much Ribavirin are you taking? Anyone have concerns that in the package insert it says that Ribavirin MAY be a carcinogen? What's with that?
Avatar n tn Ask your pharmacist about the proper dosing of these drugs, or ask for the package insert.
Avatar n tn Ribavirin is a Federal Drug Administration Pregnancy Category X product, indicating that its use is contraindicated in women who are pregnant. The package insert also states that ribavirin is contraindicated in men whose partners may become pregnant. The Ribavirin Pregnancy Registry operates in the United States and actively monitors pregnancy exposures to ribavirin.
Avatar m tn 124 129. 22. Pegasys [package insert]. Nutley, NJ: Roche; January 2004. 23. PegIntron [package insert]. Kenilworth, NJ: Schering Corporation; February 2007. 23. Shiffman ML, Ghany MG, Morgan TR, et al. Impact of reducing peginterferon alfa 2a and ribavirin dose during retreatment in patients with chronic hepatitis C. Gastroenterology. 2007;132:103 112. 24. Shiffman ML, Salvatore J, Hubbard S, et al.
Avatar f tn Willing (a forum member) posted this in a comment on another thread today about new PI data coming out of The Liver Meeting: "Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen." Which comes from the package insert. Who knows? The meds, aging, HCV... regardless, you need to take care of yourself and get well. Sure hope things go well. Keep us posted.
Avatar f tn The package insert in the riba pack says to wait 6 months, but I think Trish has a good point. The little person you are wanting is going to live with you for a long time, so a little more waiting just to be safe would be a good idea.
Avatar f tn 10 g/dl is considered anemia. The dosage of riba was reduced to 600 mg/per day according to “package insert directions”. Time of first Ribavirin dose modification appeared not to affect SRV rates. 7 days was considered “dose interruption” 76% (24 weeks) and 73% (48 weeks) with “dose interruptions” achieved SVR.
Avatar f tn How can these new doctors state that I should only be taking 800 mg of riba because I weigh 115 lbs?! This is very upsetting to me. I will post the riba package insert information as a separate post as it exceeds adding it to this post - I read it over, and there is a section that does say that the dose is 800 mg – but not sure if it applies to me. If anyone is familiar enough with this insert information – can you please clarify ? Thanks.
1838299 tn?1403496143 If you doc reads the ribavirin package insert directions it says that for anemia the standard protocol is to reduce ribavirin to 600 mg per day if hemoglobin <10 g/dl, first. If < 8.5 g/dL interrupt dose. Then see if hemoglobin level rise. In the clinical trial most patients did rise. Only 4% stopped treatment owing to anemia. 1. The proper protocol is to reduce ribavirin to 600 mg when hemoglobin is less than <10 g/dl.
Avatar m tn The package insert simply says take with food , no designation as to how much or what, follow the link to see more on the subject. http://www.medhelp.
Avatar f tn there's a good reason you can't find it : it's not there! Merck did not include null-responders in its phase3 re-tx trials. Nevertheless they applied for FDA approval for nulls based on their other data and received it. The situation is very similar to Vertex asking for approval of 24w for cEVR relapsers though they never tested that. That was also granted. In both cases approval seems well justified, though it's clearly less desirable than something already measured.
190885 tn?1333029491 //www.drugs.com/pro/ribavirin.html Look at the section "Dose Modifications" ------------------------------------------------------------------------------------------------- Sulkowski MS, Reddy R, Afdhal NH, Di Bisceglie AM, Zeuzem S, Poordad F, et al. Anemia had no effect on efficacy outcomes in treatment- naive patients who received telaprevir-based regimen in the ADVANCE and ILLUMINATE phase 3 studies. J Hepatol 2011; 54(suppl 1):S195.
446474 tn?1446351282 The following sections of the package insert were updated. A new contraindication was added to section 4: Patients with a history of a hypersensitivity reaction to boceprevir Section 5.4 Hypersensitivity was added to Warnings and Precautions to include the following: Serious acute hypersensitivity reactions (e.g.
Avatar m tn org/posts/Hepatitis-C/Harvoni-Package-Insert/show/2339634 Good luck all Lynn
446474 tn?1446351282 good summary but a couple of details don't look right. The actual response rates confirmed by the FDA are in the staff review summaries. For boce: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252341.pdf and for tela http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252561.pdf For boce's P05216(SPRINT-2) the staff summary (Table 1) gives 63 and 66.
Avatar m tn You posted this info 5 days ago. "UND for tx wk 12 ; tx wk 16 begins tomorrow. WBC-2.4; HGB 9.6, alt/ast now in center of normal range for 2nd set of labs on liver function. Losing my hair enough to be cutting, no dose reductions on riba or peg, no rescue meds." How could your doctor say "If your anemia gets worse we may have to discontinue therapy"? You anemia is HGB less a little less than 10. You have had no dose reductions and no Procrit.
Avatar f tn Results from the 300-subject study showed that treating HCV-4 patients with sofosbuvir 400 mg and ravidasvir 200 mg once daily for 12 weeks resulted in cure rates (SVR12) of 98% overall (n=255/261) and 100% (n=163/163) in non-cirrhotic patients, suggesting that ribavirin in unnecessary for these patients even if they failed to respond to treatment with interferon. No relapses were observed.
Avatar m tn It's actually listed on the ribavirin package insert, not to mention that a lot of our liver specialists have told us to take ribavirin with meals that have some fat in them.
Avatar n tn The package insert says that Ribavirin should be considered a potential carcinogen. The package also says that further studies are being conducted; however, the package insert is copyrighted 1998, and bears a revision date of 8/01. If studies were underway in 1998, is there any more recent information available?
Avatar n tn You should tell your relative " Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy". This is a very serious issue "ribavirin may cause birth defects and/or death of the exposed fetus" to quote from the ribavirin package insert. It doesn't get much clearer then this. From the package insert on Incivek... http://pi.vrtx.com/files/uspi_telaprevir.
299628 tn?1208386198 Hopefully there is some reasonable explanation for this - either the wrong package insert getting put into the meds or a newly hired asst. pharmacist reading a doctors scrawl wrong. The thought that any doctor would Rx that stuff or any licensed pharmacist fill the 'script without questioning it in this day and age is sorta chilling. I didn't know they even still made Inron A or Roferon..
Avatar m tn I'm on triple therapy treatment (Incivek) and my doctor has prescribed 1000 mg of ribavarin, 600 mg in the morning, 400 mg in the evening. I weigh 80 kg. The ribavarin package insert and the triple therapy study using Incivek indicate that 75 kg is the point where dosage is increased from 1000 mg to 1200 mg. I called my doctor and spoke with the nurse and she said their information said that 183 lbs (83 kg) was the point at which dosage is increased to 1200 mg.
1995824 tn?1330382649 The updated AASLD guidelines refer clinicians to the drugs’ labeling, or detailed package insert, for information on managing side effects, although the guidelines authors do provide their own guidance on managing anemia. Anemia is a common side effect from ribavirin and the HCV protease inhibitors. During hepatitis C treatment, if anemia develops, people are either treated with a red blood cell growth factor, such as Procrit (erythropoietin), or given a lower dose of ribavirin.
683231 tn?1467326617 I got that from reading the package insert says take with food. Guess I will have to skip my disease on 13 Feb when I have my upper endoscopy because nothing to eat or drink after midnight.
Avatar n tn correct? my first try i had a doc prescribe pegasys then use another brand's package insert to guage my platelet count. pegasys allowed a drop to 50 and the other brand only 80 - so the doc put me on half doses of interferon for 12 weeks out of the 24 (my platelet count never went below 70) and vl made an upward turn at week 24. he also did not tell me about the depression side effect and the first 10 weeks without "daddy's little helper" fully working were pure hell!