July 23, 2016
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Sovaldi

"The US Food and Drug Administration (FDA) has okayed expanded use of the combination antiviral drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) in patients with genotype 4, 5, and 6 chronic hepatitis C virus (HCV) infection and in p"...

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Sovaldi

Indications
Dosage
How Supplied

INDICATIONS

SOVALDI is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Recommended Dosage

The recommended dosage of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [see CLINICAL PHARMACOLOGY].

Administer SOVALDI in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 1.

For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 : Recommended Treatment Regimens and Duration

Patient Population Treatment Regimen Duration
Genotype 1 or 4 SOVALDI + peginterferon alfaa + ribavirinb 12 weeks
Genotype 2 SOVALDI + ribavirinb 12 weeks
Genotype 3 SOVALDI + ribavirinb 24 weeks
a See peginterferon alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV.
b Dosage of ribavirin is weight-based ( < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg). The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤ 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

Patients with Genotype 1 HCV Who are Ineligible to Receive an Interferon-Based Regimen

SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [see Clinical Studies]. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.

Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation

Administer SOVALDI in combination with ribavirin 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].

Dosage Modification

Dosage reduction of SOVALDI is not recommended.

If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dosage should be reduced or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. 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 dosage.

Discontinuation Of Dosing

If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.

Severe Renal Impairment And End Stage Renal Disease

No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 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 and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

SOVALDI is available as a yellow-colored, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “7977” on the other side. Each tablet contains 400 mg sofosbuvir.

Storage And Handling

SOVALDI tablets are yellow, capsule-shaped, film-coated tablets containing 400 mg sofosbuvir debossed with “GSI” on one side and “7977” on the other side. Each bottle contains 28 tablets (NDC 61958-1501-1), a silica gel desiccant and polyester coil with a child-resistant closure.

Store at room temperature below 30 °C (86 °F).

  • Dispense only in original container
  • Do not use if seal over bottle opening is broken or missing

Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Issued: August 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/31/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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