Tenofovir: Difference between revisions
Ahmed Zaghw (talk | contribs) No edit summary |
No edit summary |
||
Line 1: | Line 1: | ||
{{DrugProjectFormSinglePage | |||
{{ | |authorTag= | ||
{{VP}} | |||
<!--Overview--> | |||
= | |genericName= | ||
Tenofovir | |||
|aOrAn= | |||
a | |||
|drugClass= | |||
HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor | |||
[[ | |indication= | ||
[[Category: | |||
HIV-1 infection in adults and pediatric patients 2 years of age and older, chronic hepatitis B in adults and pediatric patients 12 years of age and older | |||
|hasBlackBoxWarning= | |||
Yes | |||
|adverseReactions= | |||
rash, diarrhea, headache, pain, depression, asthenia, and nausea | |||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle= | |||
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS | |||
|blackBoxWarningBody= | |||
<i><span style="color:#FF0000;"> </span></i> | |||
*Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD. | |||
*Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely in these patients. If appropriate, resumption of anti-hepatitis B therapy may be warranted. | |||
<!--Adult Indications and Dosage--> | |||
<!--FDA-Labeled Indications and Dosage (Adult)--> | |||
|fdaLIADAdult= | |||
=====HIV-1 Infection===== | |||
* Dosing Information | |||
:* The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. | |||
=====Chronic Hepatitis B===== | |||
* Dosing Information | |||
:* The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. | |||
<!--Off-Label Use and Dosage (Adult)--> | |||
<!--Guideline-Supported Use (Adult)--> | |||
|offLabelAdultGuideSupport= | |||
=====HIV infection - Type B viral hepatitis, chronic===== | |||
* Developed by: The Department of Health and Human Services Panel on Antiretroviral Guidelines and the American Association for the Study of Liver Diseases (AASLD) | |||
* Class of Recommendation: Adult, Class IIa | |||
* Strength of Evidence: Adult, Category B | |||
* Dosing Information | |||
:* Tenofovir 300 mg/day<ref name="pmid18771054">{{cite journal| author=Lacombe K, Gozlan J, Boyd A, Boelle PY, Bonnard P, Molina JM et al.| title=Comparison of the antiviral activity of adefovir and tenofovir on hepatitis B virus in HIV-HBV-coinfected patients. | journal=Antivir Ther | year= 2008 | volume= 13 | issue= 5 | pages= 705-13 | pmid=18771054 | doi= | pmc=PMC2665195 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18771054 }} </ref> | |||
<!--Non–Guideline-Supported Use (Adult)--> | |||
|offLabelAdultNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Pediatric Indications and Dosage--> | |||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | |||
|fdaLIADPed= | |||
=====HIV-1 Infection===== | |||
*Pediatric Patients 12 Years of Age and Older (35 kg or more) | |||
*The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. | |||
*For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of VIREAD is 8 mg of tenofovir disoproxil fumarate per kilogram of body weight (up to a maximum of 300 mg) once daily administered as oral powder or tablets. | |||
*VIREAD oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder which contains 40 mg of tenofovir disoproxil fumarate. VIREAD oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing (e.g., applesauce, baby food, yogurt). The entire mixture should be ingested immediately to avoid a bitter taste. Do not administer VIREAD oral powder in a liquid as the powder may float on top of the liquid even after stirring. Further patient instructions on how to administer VIREAD oral powder with the supplied dosing scoop are provided in the FDA-approved patient labeling (Patient Information). | |||
*VIREAD is also available as tablets in 150, 200, 250 and 300 mg strengths for pediatric patients who weigh greater than or equal to 17 kg and who are able to reliably swallow intact tablets. The dose is one tablet once daily taken orally, without regard to food. | |||
*Tables 1 and 2 contain dosing recommendations for VIREAD oral powder and tablets based on body weight. Weight should be monitored periodically and the VIREAD dose adjusted accordingly. | |||
=====Chronic Hepatitis B===== | |||
*Pediatric Patients 12 Years of Age and Older (35 kg or more) | |||
*The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. | |||
<!--Off-Label Use and Dosage (Pediatric)--> | |||
<!--Guideline-Supported Use (Pediatric)--> | |||
|offLabelPedGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | |||
|offLabelPedNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | |||
|contraindications= | |||
* Condition1 | |||
<!--Warnings--> | |||
|warnings= | |||
* Description | |||
====Precautions==== | |||
* Description | |||
<!--Adverse Reactions--> | |||
<!--Clinical Trials Experience--> | |||
|clinicalTrials= | |||
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |||
=====Body as a Whole===== | |||
=====Cardiovascular===== | |||
=====Digestive===== | |||
=====Endocrine===== | |||
=====Hematologic and Lymphatic===== | |||
=====Metabolic and Nutritional===== | |||
=====Musculoskeletal===== | |||
=====Neurologic===== | |||
=====Respiratory===== | |||
=====Skin and Hypersensitivy Reactions===== | |||
=====Special Senses===== | |||
=====Urogenital===== | |||
=====Miscellaneous===== | |||
<!--Postmarketing Experience--> | |||
|postmarketing= | |||
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |||
=====Body as a Whole===== | |||
=====Cardiovascular===== | |||
=====Digestive===== | |||
=====Endocrine===== | |||
=====Hematologic and Lymphatic===== | |||
=====Metabolic and Nutritional===== | |||
=====Musculoskeletal===== | |||
=====Neurologic===== | |||
=====Respiratory===== | |||
=====Skin and Hypersensitivy Reactions===== | |||
=====Special Senses===== | |||
=====Urogenital===== | |||
=====Miscellaneous===== | |||
<!--Drug Interactions--> | |||
|drugInteractions= | |||
* Drug | |||
:* Description | |||
<!--Use in Specific Populations--> | |||
|useInPregnancyFDA= | |||
* '''Pregnancy Category''' | |||
|useInPregnancyAUS= | |||
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | |||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | |||
|useInLaborDelivery= | |||
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |||
|useInNursing= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers. | |||
|useInPed= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | |||
|useInGeri= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |||
|useInGender= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |||
|useInRace= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | |||
|useInRenalImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | |||
|useInHepaticImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | |||
|useInReproPotential= | |||
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | |||
|useInImmunocomp= | |||
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |||
<!--Administration and Monitoring--> | |||
|administration= | |||
* Oral | |||
* Intravenous | |||
|monitoring= | |||
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |||
* Description | |||
<!--IV Compatibility--> | |||
|IVCompat= | |||
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |||
<!--Overdosage--> | |||
|overdose= | |||
===Acute Overdose=== | |||
====Signs and Symptoms==== | |||
* Description | |||
====Management==== | |||
* Description | |||
===Chronic Overdose=== | |||
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | |||
<!--Pharmacology--> | |||
<!--Drug box 2--> | |||
|drugBox= | |||
<!--Mechanism of Action--> | |||
|mechAction= | |||
* | |||
<!--Structure--> | |||
|structure= | |||
* | |||
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | |||
<!--Pharmacodynamics--> | |||
|PD= | |||
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label. | |||
<!--Pharmacokinetics--> | |||
|PK= | |||
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
<!--Nonclinical Toxicology--> | |||
|nonClinToxic= | |||
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
<!--Clinical Studies--> | |||
|clinicalStudies= | |||
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
<!--How Supplied--> | |||
|howSupplied= | |||
* | |||
<!--Patient Counseling Information--> | |||
|fdaPatientInfo= | |||
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
<!--Precautions with Alcohol--> | |||
|alcohol= | |||
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
<!--Brand Names--> | |||
|brandNames= | |||
* ®<ref>{{Cite web | title = | url = }}</ref> | |||
<!--Look-Alike Drug Names--> | |||
|lookAlike= | |||
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | |||
<!--Drug Shortage Status--> | |||
|drugShortage= | |||
}} | |||
<!--Pill Image--> | |||
{{PillImage | |||
|fileName=No image.jpg|This image is provided by the National Library of Medicine. | |||
|drugName= | |||
|NDC= | |||
|drugAuthor= | |||
|ingredients= | |||
|pillImprint= | |||
|dosageValue= | |||
|dosageUnit= | |||
|pillColor= | |||
|pillShape= | |||
|pillSize= | |||
|pillScore= | |||
}} | |||
<!--Label Display Image--> | |||
{{LabelImage | |||
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine. | |||
}} | |||
{{LabelImage | |||
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine. | |||
}} | |||
<!--Category--> | |||
[[Category:Drug]] |
Revision as of 15:07, 12 August 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [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
See full prescribing information for complete Boxed Warning.
|
Overview
Tenofovir is a HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor that is FDA approved for the {{{indicationType}}} of HIV-1 infection in adults and pediatric patients 2 years of age and older, chronic hepatitis B in adults and pediatric patients 12 years of age and older. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, diarrhea, headache, pain, depression, asthenia, and nausea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
HIV-1 Infection
- Dosing Information
- The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
Chronic Hepatitis B
- Dosing Information
- The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
HIV infection - Type B viral hepatitis, chronic
- Developed by: The Department of Health and Human Services Panel on Antiretroviral Guidelines and the American Association for the Study of Liver Diseases (AASLD)
- Class of Recommendation: Adult, Class IIa
- Strength of Evidence: Adult, Category B
- Dosing Information
- Tenofovir 300 mg/day[1]
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenofovir in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
HIV-1 Infection
- Pediatric Patients 12 Years of Age and Older (35 kg or more)
- The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
- For the treatment of HIV-1 in pediatric patients 2 years of age and older, the recommended oral dose of VIREAD is 8 mg of tenofovir disoproxil fumarate per kilogram of body weight (up to a maximum of 300 mg) once daily administered as oral powder or tablets.
- VIREAD oral powder should be measured only with the supplied dosing scoop. One level scoop delivers 1 g of powder which contains 40 mg of tenofovir disoproxil fumarate. VIREAD oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing (e.g., applesauce, baby food, yogurt). The entire mixture should be ingested immediately to avoid a bitter taste. Do not administer VIREAD oral powder in a liquid as the powder may float on top of the liquid even after stirring. Further patient instructions on how to administer VIREAD oral powder with the supplied dosing scoop are provided in the FDA-approved patient labeling (Patient Information).
- VIREAD is also available as tablets in 150, 200, 250 and 300 mg strengths for pediatric patients who weigh greater than or equal to 17 kg and who are able to reliably swallow intact tablets. The dose is one tablet once daily taken orally, without regard to food.
- Tables 1 and 2 contain dosing recommendations for VIREAD oral powder and tablets based on body weight. Weight should be monitored periodically and the VIREAD dose adjusted accordingly.
Chronic Hepatitis B
- Pediatric Patients 12 Years of Age and Older (35 kg or more)
- The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tenofovir in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenofovir in pediatric patients.
Contraindications
- Condition1
Warnings
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS
See full prescribing information for complete Boxed Warning.
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Tenofovir in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tenofovir in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tenofovir in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tenofovir during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tenofovir with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tenofovir with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tenofovir with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tenofovir with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tenofovir with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tenofovir in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tenofovir in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tenofovir in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tenofovir in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Tenofovir in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Tenofovir in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Tenofovir in the drug label.
Pharmacology
There is limited information regarding Tenofovir Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tenofovir in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tenofovir in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tenofovir in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Tenofovir in the drug label.
How Supplied
Storage
There is limited information regarding Tenofovir Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Tenofovir |?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::Tenofovir |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tenofovir in the drug label.
Precautions with Alcohol
- Alcohol-Tenofovir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[2]
Look-Alike Drug Names
- A® — B®[3]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Lacombe K, Gozlan J, Boyd A, Boelle PY, Bonnard P, Molina JM; et al. (2008). "Comparison of the antiviral activity of adefovir and tenofovir on hepatitis B virus in HIV-HBV-coinfected patients". Antivir Ther. 13 (5): 705–13. PMC 2665195. PMID 18771054.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
|title=
(help)
{{#subobject:
|Page Name=Tenofovir |Pill Name=No image.jpg |Drug Name= |Pill Ingred=|+sep=; |Pill Imprint= |Pill Dosage= |Pill Color=|+sep=; |Pill Shape= |Pill Size (mm)= |Pill Scoring= |Pill Image= |Drug Author= |NDC=
}}
{{#subobject:
|Label Page=Tenofovir |Label Name=Tenofovir11.png
}}
{{#subobject:
|Label Page=Tenofovir |Label Name=Tenofovir11.png
}}