Rx Item-Emtriva 200MG 30 CAP-KEEP REFRIG- by Gilead Sciences USA , Clinical Information:
Generic Code And Description: 52802 Emtricitabine Oral Capsule 200 Mg
Strength: 200 Mg
Dose Form: Capsule
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 8180820 Hiv Nucleoside Nucleotide Rt Inhibitors
Active Ingredients: 1321 Emtricitabine 143491570
Inactive Ingredients: 10138 Blue Dye
2549 Gelatin 9000708 Drug Class: Drug Class: 8180820 H I V Nucleoside Nucleotide Rt Inhibitors, OMP Family: , Temparature Zone: 30 Refrige./DoNot Freez, Unit Dose Indicator: NO, Item Size: 30 , Brand Label Flag: BRAND , Storage Temperature Zone: 30 Refrige./DoNot Freez, Item Size Code:30 , Item Strength Code:200MG , Item Abbreviation: Emtriva , Generic Form: CAP
These highlights do not include all the information needed to use EMTRIVA safely and effectively. See full prescribing information for EMTRIVA.
EMTRIVA ® (emtricitabine) capsule, for oral use
EMTRIVA ® (emtricitabine) oral solution
Initial U.S. Approval: 2003
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warning.
Severe acute exacerbations of Hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued EMTRIVA. Hepatic function should be monitored closely in patients coinfected with HIV-1 and HBV who discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration
Testing Prior to Initiation of Treatment with EMTRIVA (2.1) 12/2018
Warnings and Precautions
Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV (5.1) 12/2018
Coadministration with Related Products Removed 12/2018
INDICATIONS AND USAGE
EMTRIVA, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating EMTRIVA test for hepatitis B virus infection. (2.1)
EMTRIVA may be taken without regard to food. (2.2)
Adult Patients (18 years of age and older) (2.3):
EMTRIVA capsules: One 200 mg capsule administered once daily orally.
EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.
Pediatric Patients (0�"3 months of age) (2.4):
EMTRIVA oral solution: 3 mg/kg administered once daily orally.
Pediatric Patients (3 months through 17 years of age) (2.5):
EMTRIVA capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.
EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally.
Dose interval adjustment in adult patients with renal impairment (2.6):
Creatinine Clearance (mL/min)
Formulation ≥50 mL/min 30�"49 mL/min 15�"29 mL/min <15 mL/min or on hemodialysis*
*
Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis.
Capsule
(200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours
Oral Solution
(10 mg/mL) 240 mg every 24 hours
(24 mL) 120 mg every 24 hours
(12 mL) 80 mg every 24 hours
(8 mL) 60 mg every 24 hours
(6 mL)
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg (3)
Oral solution: 10 mg per mL (3)
CONTRAINDICATIONS
EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. (4)
WARNINGS AND PRECAUTIONS
Immune reconstitution syndrome: May necessitate further evaluation and treatment. (5.2)
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Skin hyperpigmentation was very common (≥10%) in pediatric patients. (6)
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.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended. (8.2)
Pediatrics: Dose adjustment based on age and weight. (2.4, 2.5, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2018
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Table of Contents
Table of Contents
BOXED WARNING (What is this?)
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued EMTRIVA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue EMTRIVA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].
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1 INDICATIONS AND USAGE
EMTRIVA® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to Initiation of Treatment with EMTRIVA - Prior to or when initiating EMTRIVA, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)]. 2.2 ...
3 DOSAGE FORMS AND STRENGTHS
EMTRIVA is available as capsules or as an oral solution. 200 mg Capsules: 200 mg of emtricitabine (FTC): size 1 hard gelatin capsules with a blue cap and white body, printed with "200 mg" in ...
4 CONTRAINDICATIONS
EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products.
5 WARNINGS AND PRECAUTIONS
5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV - All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when ...
6 ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions ...
7 DRUG INTERACTIONS
The potential for drug interactions with EMTRIVA has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug ...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMTRIVA during pregnancy. Healthcare providers are ...
10 OVERDOSAGE
If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Hemodialysis treatment removes approximately 30% of the FTC ...
11 DESCRIPTION
EMTRIVA is the brand name of emtricitabine (FTC), a synthetic nucleoside analog with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase. The chemical name of FTC is ...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Emtricitabine is an antiretroviral drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Adults - The pharmacokinetic properties of FTC were evaluated in ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In long-term oral carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 ...
14 CLINICAL STUDIES
14.1 Overview of Clinical Trials - The efficacy and safety of EMTRIVA were evaluated in the trials summarized in Table 10. Table 10 Trials Conducted with EMTRIVA in Adult and Pediatric ...
16 HOW SUPPLIED/STORAGE AND HANDLING
EMTRIVA capsules are available in bottles containing 30 capsules with child-resistant closure as follows: 200 mg of FTC capsules are size 1 hard gelatin capsules with a blue cap and white body and ...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV - Inform patients that ...
SPL UNCLASSIFIED SECTION
© 2018 Gilead Sciences, Inc. All rights reserved. Manufactured for and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 - EMTRIVA and TRUVADA are trademarks of Gilead Sciences, Inc., or ...
PATIENT PACKAGE INSERT
This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: December/2018 - Patient Information - EMTRIVA® (em-treev'-ah) (emtricitabine) capsules and oral ...
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - Representative Bottle Label - NDC 61958-0601-1 - Emtriva ® (emtricitabine) Capsules, 200 mg - 30 capsules - Rx only
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 170 mL Bottle Carton - NDC-61958-0602-1 - Emtriva ® (emtricitabine) Oral Solution - 10 mg/mL - 170 mL - Rx only - Each mL contains - 10 mg of emtricitabine - GILEAD
INGREDIENTS AND APPEARANCE
Product Information
