Rifapentin

Rifapentin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, 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.

Overview

Rifapentin is an antimycobacterial drug that is FDA approved for the treatment of active pulmonary tuberculosis and latent tuberculosis. Common adverse reactions include anemia, lymphopenia, neutropenia, increased ALT, arthralgia, conjunctivitis, headache, vomiting, nausea, diarrhea, rash, pruritus, anorexia and lymphadenopathy.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Active Pulmonary Tuberculosis

• PRIFTIN® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis. PRIFTIN must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible.

Limitations of Use

• Do not use PRIFTIN monotherapy in either the initial or the continuation phases of active antituberculous treatment.

• PRIFTIN should not be used once-weekly in the continuation phase regimen in combination with isoniazid (INH) in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (RIF)-resistant organisms.

• PRIFTIN has not been studied as part of the initial phase treatment regimen in HIV- infected patients with active pulmonary tuberculosis.

Latent Tuberculosis Infection

• PRIFTIN is indicated in adults and children 2 years and older for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in patients at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph).

Limitations of Use

• Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection.

• PRIFTIN must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection.

• PRIFTIN in combination with isoniazid is not recommended for Individuals presumed to be exposed to rifamycin- or - isoniazid resistant M. tuberculosis.

Dosage

Dosage in Active Pulmonary Tuberculosis

• PRIFTIN is only recommended for the treatment of active pulmonary tuberculosis caused by drug-susceptible organisms as part of regimens consisting of a 2 month initial phase followed by a 4 month continuation phase.

• PRIFTIN should not be used in the treatment of active pulmonary tuberculosis caused by rifampin-resistant strains.

• Initial phase (2 Months): PRIFTIN should be administered at a dose of 600 mg twice weekly for two months as directly observed therapy (DOT), with an interval of no less than 3 consecutive days (72 hours) between doses, in combination with other anti- tuberculosis drugs as part of an appropriate regimen which includes daily companion drugs such as isoniazid (INH), ethambutol (EMB) and pyrazinamide (PZA).

• Continuation phase (4 Months): Following the initial phase (2 months), continuation phase (4 months) treatment consists of PRIFTIN 600 mg once-weekly for 4 months in combination with isoniazid or another appropriate anti- tuberculosis agent for susceptible organisms administered as directly observed therapy.

Dosage in Latent Tuberculosis Infection

• PRIFTIN should be administered once-weekly in combination with isoniazid for 12 weeks as directly observed therapy.

• Adults and children 12 years and older: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once-weekly (see TABLE 1). The recommended dose of isoniazid is 15 mg/kg (rounded to the nearest 50 mg or 100mg) up to a maximum of 900 mg once-weekly for 12 weeks.

• Children 2–11 years: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once- weekly (see TABLE 1). The recommended dose of isoniazid is 25 mg/kg (rounded to the nearest 50 mg or 100mg) up to a maximum of 900 mg once-weekly for 12 weeks.

File:XXXXX.png

This image is provided by the National Library of Medicine.

DOSAGE FORMS AND STRENGTHS

• PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "Priftin" on top and "150" on the bottom.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Rifapentin in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Rifapentin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• There is limited information regarding FDA-Labeled Use of Rifapentin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Rifapentin in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Rifapentin in pediatric patients.

Contraindications

Hypersensitivity

• PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.

Warnings

There is limited information regarding Rifapentin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Rifapentin 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 Rifapentin 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 (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rifapentin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Rifapentin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Rifapentin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Rifapentin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Rifapentin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Rifapentin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rifapentin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Rifapentin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Rifapentin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rifapentin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rifapentin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Take PRIFTIN with meals. Administration of PRIFTIN with a meal increases oral bioavailability and may reduce the incidence of gastrointestinal upset, nausea, and/or vomiting.

• For patients who cannot swallow tablets, the tablets may be crushed and added to a small amount of semi-solid food, all of which should be consumed immediately.

Monitoring

There is limited information regarding Monitoring of Rifapentin in the drug label

IV Compatibility

There is limited information regarding IV Compatibility of Rifapentin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Rifapentin in the drug label.

Pharmacology

There is limited information regarding Rifapentin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Rifapentin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Rifapentin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Rifapentin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Rifapentin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Rifapentin in the drug label.

How Supplied

Storage

There is limited information regarding Rifapentin Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Rifapentin |?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::Rifapentin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Rifapentin in the drug label.

Precautions with Alcohol

• Alcohol-Rifapentin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Rifapentin
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Rifapentin
 |Label Name=Rifapentin11.png

}}

{{#subobject:

 |Label Page=Rifapentin
 |Label Name=Rifapentin11.png

}}