admin
Admin
عدد المساهمات : 9696
تاريخ التسجيل : 06/08/2009
 | موضوع: What you want to know about SOVALDI, the novel drug used for treatment of chronic hepatitis C  الأربعاء يوليو 16, 2014 5:13 pm | |
| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI.
SOVALDITM (sofosbuvir) tablets, for oral use
Initial U.S. Approval: 2013
-------------------------------INDICATIONS AND USAGE-------------------------
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. (1)
SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. (1)
------------------------DOSAGE AND ADMINISTRATION----------------------
One 400 mg tablet taken once daily with or without food. (2.1)
Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC. Recommended combination therapy: (2.1)
SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. (2.1)
Should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first. (2.1)
A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease. (2.4, 8.6)
-----------------------DOSAGE FORMS AND STRENGTHS--------------------
Tablets: 400 mg. (3)
--------------------------------CONTRAINDICATIONS------------------------------
„h When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to SOVALDI combination therapy. (4)
„h Because ribavirin may cause birth defects and fetal death, SOVALDI in combination with peginterferon alfa/ribavirin or ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4)
-------------------------WARNINGS AND PRECAUTIONS----------------------
„h Pregnancy: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective non-hormonal methods of contraception and have monthly pregnancy tests. (5.1)
--------------------------------ADVERSE REACTIONS-----------------------------
The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache. The most common adverse events observed with SOVALDI in combination with peginterferon alfa and ribavirin were fatigue, headache, nausea, insomnia and anemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
---------------------------------DRUG INTERACTIONS-----------------------------
Drugs that are potent intestinal P-gp inducers (e.g., rifampin, St. John¡¦s wort) may alter the concentrations of sofosbuvir. Consult the full prescribing information prior to use for potential drug-drug interactions. (5.2, 7, 12.3)
---------------------------USE IN SPECIFIC POPULATIONS--------------------
„h Patients with HCV/HIV-1 co-infection: Safety and efficacy have been studied. (8.8, 14.4)
„h Patients with hepatocellular carcinoma awaiting liver transplantation: Safety and efficacy have been studied. (8.9)
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose in Adults
2.2 Dose Modification
2.3 Discontinuation of Dosing
2.4 Severe Renal Impairment and End Stage Renal Disease
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin
5.2 Use with Potent P-gp Inducers
6 ADVERSE REACTIONS
6.1 Adverse Reactions from Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Potential for Drug Interactions
7.2 Potentially Significant Drug Interactions
7.3 Drugs without Clinically Significant Interactions with SOVALDI
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Patients with HCV/HIV-1 Co-infection
8.9 Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation
8.10 Post-Liver Transplant Patients
8.11 CHC Patients with Genotype 5 or 6 HCV Infection
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Description of Clinical Trials
14.2 Clinical Trials in Subjects with Genotype 1 or 4 CHC
14.3 Clinical Trials in Subjects with Genotype 2 or 3 CHC
14.4 Clinical Trials in Subjects Co-infected with HCV and HIV-1
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
====================================================
FOR FULL READING DOWNLOAD THIS FILE
Dr Khaled
 | |
|
