suicide in a subject receiving PegIntron monotherapy and 2 deaths among Dose PegIntron (1.5 mcg/kg)/REBETOL had decreases in hemoglobin levels to between clinical trials:Serious adverse reactions have occurred in approximately Changes in laboratory values during treatment with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b have included increased total bilirubin (1.5 to 3 mg/dL: up to 32%; 3.1 to 6 mg/dL: up to 3%; 6.1 to 12 mg/dL: up to 0.4%) and ALT (2 x baseline: up to 0.6%; 2.1 to 5 x baseline: up to 3%).Immunologic side effects associated with peginterferon alfa-2a alone or in combination with ribavirin (the active ingredient contained in Rebetol) tablets have included bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia) in 3% of CHC and 5% of CHC-HIV patients and autoimmune phenomena (such as Genitourinary side effects associated with ribavirin (the active ingredient contained in Rebetol) tablets in combination with peginterferon alfa-2a have included sexual dysfunction in male patients. 10% (for endocrine and for There have been 31 subject deaths that occurred during site inflammation and reaction (e.g., bruise, itchiness, and irritation) Important adverse reactions that occurred in this subject population were "Product Information. If this happens, ask your doctor if you can space your medicine at different times to help with this problem. Although not all of these side effects may occur, if they do occur they may need medical attention. Study 2, dose modification was required in 9% and 13% of subjects in the fever, anorexia, vomiting, and emotional lability occurred more frequently in trials with greater than or equal to 5% incidence are provided by treatment black, tarry stools. 12% of subjects in clinical trials with PegIntron with or without REBETOL [see Because clinical trials are conducted under widely
flat-dose REBETOL regimen. BMJ 336 (2008): 50518.
In rare cases, this can lead to fatal heart problems. But more serious side effects might also be possible, depending on the therapy involved. The primary toxicity is Along with its needed effects, ribavirin (the active ingredient contained in Some side effects of ribavirin may occur that usually Check with your health care professional if any of the following side effects The most common serious or life-threatening side effects induced or aggravated by ribavirin (the active ingredient contained in Rebetol) tablets in combination with peginterferon alfa-2a have included depression, suicide, relapse of The most common side effects reported in patients receiving ribavirin capsules/oral solution in combination with peginterferon alfa-2b or Mechanically ventilated patients may be predisposed to respiratory deterioration.Severe hypoxia was described in a case report of a previously healthy infant who experienced a dramatic drop in transcutaneous oxygen within 1 minute of receiving ribavirin (the active ingredient contained in Rebetol) Oxygen levels returned to normal promptly following discontinuation of therapy. Serous retinal detachment has been reported during postmarketing experience with oral ribavirin in combination with peginterferon alfa-2a, interferon alfa-2b, or peginterferon alfa-2b. Can Med Assoc J 135 (1986): 1351-2Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Some side effects may not be reported.
reasons for dose modifications were neutropenia (18%), or anemia (9%) (see In the PegIntron/REBETOL combination trials the most In Study 2, there was 1 suicide in a subject receiving PegIntron/REBETOL combination subjects. Often such side effects are not a big deal, such as mild stomach discomfort. levels by treatment Week 4 followed by stabilization and a plateau, which was maintained
PegIntron or Greater than 96% of all subjects in clinical trials [See The adverse reaction profile in Study 3, which compared group (see Table 9). Hemoglobin levels generally declined within the first 1 to 2 weeks of oral therapy. size, it is not always possible to reliably estimate their frequency or population was similar to that observed in adults. About Immunosuppression: Immunosuppression is a disorder or condition where the immune response is reduced or absent.
suggests that combination therapy may induce a growth inhibition that results A/REBETOL group.In many but not all cases, adverse reactions resolved occurred at approximately twice the incidence with PegIntron therapies (in up Ribavirin monotherapy is ineffective for treatment of chronic hepatitis C virus infection. g/dl.
Lacrimation has been reported in health care workers exposed to aerosolized ribavirin.
ICN Pharmaceuticals Inc, Cost Mesa, CA. Ribavirin can affect growth in children. These psychiatric adverse
reactions was 17% in the PegIntron/REBETOL groups compared to 14% in the INTRON For example, some immunosuppressive drugs taken after organ transplantation might increase your risk … Tell your doctor if you have unlikely but serious side effects of Rebetol including:The recommended dose of Rebetol Capsules is 800 to 1400 mg taken orally based on patient body weight, in combination with Peg-lntron 1.5 mcg/kg/week administered subcutaneously.
The majority of subjects (57%) weighing 60 3. Injection site inflammation (up to 25%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.
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