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SOVALDI® (Sofosbuvir)

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SOVALDI® (Sofosbuvir) HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------------------CONTRAINDICATIONS-----------------------------­ These highlights do not include all the information needed to use • When used in combination with peginterferon alfa/ribavirin or SOVALDI safely and effectively. See full prescribing information ribavirin alone, all contraindications to peginterferon alfa and/or for SOVALDI. ribavirin also apply to SOVALDI combination therapy. (4) ® SOVALDI (sofosbuvir) tablets, for oral use -------------------------WARNINGS AND PRECAUTIONS---------------------­ Initial U.S. Approval: 2013 • Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking ------------------------------RECENT MAJOR CHANGES-----------------------­ amiodarone and SOVALDI in combination with another direct Indications and Usage (1) 08/2015 acting antiviral (DAA), particularly in patients also receiving beta Dosage and Administration (2.1, 2.2) 08/2015 blockers, or those with underlying cardiac comorbidities and/or Contraindications (4) 08/2015 advanced liver disease. Coadministration of amiodarone with Warnings and Precautions (5.1) 03/2015 SOVALDI in combination with another DAA is not recommended. Warnings and Precautions (5.2, 5.3, 5.4) 08/2015 In patients without alternative, viable treatment options, cardiac -------------------------------INDICATIONS AND USAGE------------------------­ monitoring is recommended. (5.1, 6.2,7.1) SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B • Use with other drugs containing sofosbuvir is not recommended polymerase inhibitor indicated for the treatment of genotype 1, 2, 3 or 4 (5.4) chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen. (1) --------------------------------ADVERSE REACTIONS----------------------------­ The most common adverse events (incidence greater than or equal to ------------------------DOSAGE AND ADMINISTRATION---------------------­ 20%, all grades) observed with SOVALDI in combination with ribavirin • One 400 mg tablet taken once daily with or without food. (2.1) were fatigue and headache. The most common adverse events • Should be used in combination with ribavirin or in combination observed with SOVALDI in combination with peginterferon alfa and with pegylated interferon and ribavirin for the treatment of HCV. ribavirin were fatigue, headache, nausea, insomnia and anemia. (6.1) Recommended combination therapy: (2.1) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or Patient Population Treatment Duration www.fda.gov/medwatch. SOVALDI + peg- Genotype 1 or 4 12 weeks ---------------------------------DRUG INTERACTIONS----------------------------­ interferon alfa + ribavirin • Coadministration of amiodarone with SOVALDI in combination Genotype 2 SOVALDI + ribavirin 12 weeks with another DAA may result in serious symptomatic bradycardia. (5.1, 6.2, 7.1) Genotype 3 SOVALDI + ribavirin 24 weeks • Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John’s wort) may alter the concentrations of sofosbuvir. (5.2, 7, 12.3) • HCV/HIV-1 co-infection: For patients with HCV/HIV-1 co-infection, • follow the dosage recommendations in the table above. (2.1) Consult the full prescribing information prior to use for potential drug-drug interactions. (5.1, 5.2, 7, 12.3) • SOVALDI in combination with ribavirin for 24 weeks can be considered for patients with genotype 1 infection who are ---------------------------USE IN SPECIFIC POPULATIONS-------------------­ interferon ineligible. (2.1) • Patients with HCV/HIV-1 co-infection: Safety and efficacy have been studied. (14.4) • Should be used in combination with ribavirin for treatment of HCV in patients with hepatocellular carcinoma awaiting liver • Patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, transplantation: Safety and efficacy have been studied. (8.8) whichever occurs first. (2.1) • A dosage recommendation cannot be made for patients with See 17 for PATIENT COUNSELING INFORMATION and severe renal impairment or end stage renal disease. (2.4, 8.6) FDA-approved patient labeling. -----------------------DOSAGE FORMS AND STRENGTHS-------------------­ Revised: 08/2015 Tablets: 400 mg. (3) FULL PRESCRIBING INFORMATION: CONTENTS* 7.2 Drugs without Clinically Significant Interactions with 1 INDICATIONS AND USAGE SOVALDI 2 DOSAGE AND ADMINISTRATION 8 USE IN SPECIFIC POPULATIONS 2.1 Recommended Dosage 8.1 Pregnancy 2.2 Dosage Modification 8.3 Nursing Mothers 2.3 Discontinuation of Dosing 8.4 Pediatric Use 2.4 Severe Renal Impairment and End Stage Renal Disease 8.5 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 8.6 Renal Impairment 4 CONTRAINDICATIONS 8.7 Hepatic Impairment 5 WARNINGS AND PRECAUTIONS 8.8 Patients with Hepatocellular Carcinoma Awaiting Liver 5.1 Serious Symptomatic Bradycardia When Coadministered Transplantation with Amiodarone and Another HCV Direct Acting Antiviral 8.9 Post-Liver Transplant Patients 5.2 Risk of Reduced Therapeutic Effect Due to Use with P-gp 8.10 Patients with Genotype 5 or 6 HCV Infection Inducers 10 OVERDOSAGE 5.3 Risks Associated with Combination Treatment 11 DESCRIPTION 5.4 Related Products Not Recommended 12 CLINICAL PHARMACOLOGY 6 ADVERSE REACTIONS 12.1 Mechanism of Action 6.1 Clinical Trials Experience 12.2 Pharmacodynamics 6.2 Postmarketing Experience 12.3 Pharmacokinetics 7 DRUG INTERACTIONS 12.4 Microbiology 7.1 Potentially Significant Drug Interactions 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 1 Reference ID: 3808716 14.1 Description of Clinical Trials 16 HOW SUPPLIED/STORAGE AND HANDLING 14.2 Clinical Trials in Subjects with Genotype 1 or 4 HCV 17 PATIENT COUNSELING INFORMATION 14.3 Clinical Trials in Subjects with Genotype 2 or 3 HCV * Sections or subsections omitted from the full prescribing information are not 14.4 Clinical Trials in Subjects Co-infected with HCV and listed. HIV-1 Gilead Sciences 2 Reference ID: 3808716 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 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 (14)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [see Clinical Pharmacology (12.3)]. 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 a SOVALDI + peginterferon alfa Genotype 1 or 4 b 12 weeks + ribavirin 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. Dos age 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 (14.4)]. 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 (8.8)]. Gilead Sciences 3 Reference ID: 3808716 2.2 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. 2.3 Discontinuation of Dosing If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued. 2.4 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 (8.6) and Clinical Pharmacology (12.3)]. 3 DOSAGE FORMS AND STRENGTHS SOVALDI is available as a yellow-colored, capsule-shaped, film-coated tablet debossed
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