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| __NOTOC__
| | #redirect [[Sofosbuvir#Adult Indications and Dosage]] |
| {{Sofosbuvir}}
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| {{CMG}}
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| ==Dosage And Administration==
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| ===Recommended Dose in Adults===
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| The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [See Clinical Pharmacology (12.3)].
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| SOVALDI should be used in combination with [[ribavirin]] or in combination with pegylated interferon and [[ribavirin]] for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.
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| SOVALDI in combination with [[ribavirin]] for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [See Use in Specific Populations (8.8) and Clinical Studies (14.4)]. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.
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| Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation
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| SOVALDI in combination with [[ribavirin]] is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant [[HCV]] reinfection [See Use in Specific Populations (8.9)].
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| ===Dose Modification===
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| Dose reduction of SOVALDI is not recommended.
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| ====Genotype 1 and 4====
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| If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or [[ribavirin]], the peginterferon alfa and/or [[ribavirin]] dose should be reduced or discontinued. Refer to the peginterferon alfa and [[ribavirin]] prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or [[ribavirin]] dose.
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| ====Genotype 2 and 3====
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| If a patient has a serious adverse reaction potentially related to [[ribavirin]], the [[ribavirin]] dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.
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| ===Discontinuation of Dosing===
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| If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.
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| ===Severe Renal Impairment and End Stage Renal Disease===
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| No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [See Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=80beab2c-396e-4a37-a4dc-40fdb62859cf#nlm43685-7 | publisher = | date = | accessdate = 7 January 2014 }}</ref></div></div>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Antiviral]]
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| [[Category:Wikinfect]]
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