April 29, 2017
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Sovaldi

"BOSTON ” Direct-acting antiviral agents do not appear to increase risk for liver cancer in patients with hepatitis C infection and cirrhosis, but the drugs could make existing but previously undetected cancers worse and harder to treat, acco"...

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Sovaldi

Indications
Dosage
How Supplied

INDICATIONS

Adult Patients

SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see DOSAGE AND ADMINISTRATION, and Clinical Studies]

  • genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin
  • genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Pediatric Patients

SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see DOSAGE AND ADMINISTRATION and Clinical Studies].

DOSAGE AND ADMINISTRATION

Testing Prior To The Initiation Of Therapy

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with SOVALDI [see WARNINGS AND PRECAUTIONS].

Recommended Dosage In Adults

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 coinfection, follow the dosage recommendations in Table1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 Recommended Treatment Regimen and Duration in Adult Patients with Genotype 1, 2, 3, or 4 HCV

  Patient Population Treatment Regimen and Duration
Genotype 1 or 4 Treatment-naïve without cirrhosis or with compensated cirrho SOVALDI + peginterferon alfaa + ribavirinb 12 weeks
Genotype 2 Treatment-naïve and treatment-experiencedc without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirinb 12 weeks
Genotype 3 Treatment-naïve and treatment-experiencedc without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirinb24 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.
c.Treatment-experienced patients have failed an interferon based regimen with or without ribavirin.

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].

Recommended Dosage In Pediatric Patients 12 Years Of Age And Older Or Weighing At Least 35 kg

The recommended dosage of SOVALDI in pediatric patients 12 years of age and older or weighing at least 35 kg is one 400 mg tablet taken orally once daily with or without food in combination with ribavirin [see CLINICAL PHARMACOLOGY and Clinical Studies].

The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 2. Table 3 provides the weight-based dosage of ribavirin when used in combination with SOVALDI for pediatric patients. For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 2 and Table 3. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 2 Recommended Treatment Regimen and Duration in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

  Patient Population Treatment Regimen and Duration
Genotype 2 Treatment-naïve and treatmentexperienceda without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirinb 12 weeks
Genotype 3 Treatment-naïve and treatmentexperienceda without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirinb 24 weeks
a.Treatment-experienced patients have failed an interferon based regimen with or without ribavirin.
b.See Table 3 for weight-based ribavirin dosing recommendations.

Table 3 Recommended Dosing for Ribavirin in Combination Therapy with SOVALDI for Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

Body Weight kg Ribavirin Daily Dosagea
less than 47 15 mg/kg/day
47–49 600 mg/day
50–65 800 mg/day
66–80 1000 mg/day
greater than 80 1200 mg/day
a. The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.

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. Revised: April 2017.

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

Last reviewed on RxList: 4/20/2017

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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