Efavirenz, emtricitabine and tenofovir disoproxil fumarate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, in combination with other antiretrovirals.
Efavirenz, emtricitabine, and tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of efavirenz, emtricitabine, and tenofovir disoproxil fumarate have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emcitrabine or tenofovir disoproxil fumarate, which are components of efavirenz, emtricitabine, and tenofovir disoproxil fumarate. 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 efavirenz, emtricitabine, and tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
|
Overview
Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor, human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor that is FDA approved for the treatment of HIV-1 infection. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, diarrhea, nausea, decreased bone mineral density, dizziness, headache, anxiety, depression, sleep disorder, increased creatine kinase level, sinusitis, upper respiratory tract infection, fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Adults and pediatric patients 12 years of age and older with body weight at least 40 kg (at least 88 lbs): The dose of efavirenz, emtricitabine and tenofovir disoproxil fumarate is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms.
- Renal Impairment: Because efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (estimated creatinine clearance below 50 mL/min).
- Rifampin Coadministration: When efavirenz, emtricitabine and tenofovir disoproxil fumarate is administered with rifampin to patients weighing 50 kg or more, an additional 200 mg/day of efavirenz is recommended
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Efavirenz, emtricitabine and tenofovir disoproxil fumarate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Efavirenz, emtricitabine and tenofovir disoproxil fumarate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Efavirenz, emtricitabine and tenofovir disoproxil fumarate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
- Condition 1
- Condition 2
- Condition 3
- Condition 4
- Condition 5
Warnings
|
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B
See full prescribing information for complete Boxed Warning.
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, in combination with other antiretrovirals.
Efavirenz, emtricitabine, and tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of efavirenz, emtricitabine, and tenofovir disoproxil fumarate have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emcitrabine or tenofovir disoproxil fumarate, which are components of efavirenz, emtricitabine, and tenofovir disoproxil fumarate. 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 efavirenz, emtricitabine, and tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
|
Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Condition 2
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
(Description)
Labor and Delivery
(Description)
Nursing Mothers
(Description)
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Y-Site
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Admixture
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Efavirenz, emtricitabine and tenofovir disoproxil fumarate
| |
| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | ? |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
(Description)
Condition 3
(Description)
How Supplied
(Description)
Storage
There is limited information regarding Efavirenz, emtricitabine and tenofovir disoproxil fumarate Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Efavirenz, emtricitabine and tenofovir disoproxil fumarate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Efavirenz, emtricitabine and tenofovir disoproxil fumarate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Efavirenz, emtricitabine and tenofovir disoproxil fumarate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Efavirenz, emtricitabine and tenofovir disoproxil fumarate Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.