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Rifapentine 150 mg Tablet, Film Coated — NDC 33342-0599-54 package photo

Rifapentine 150 mg Tablet, Film Coated

by Macleods Pharmaceuticals Limited · 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20)
NDC 33342-0599-54
🏷️ FDA NDC (as labeled) 33342-599-54 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 33342-599-54
Product NDC 33342-599
11-digit billing NDC 33342059954
NCPDP billing unit EA — each (per item)
RxCUI 242671
UNII XJM390A33U
Application # ANDA217042
SPL Set ID f95d726e-5a09-48dd-b719-e4400fb91c8f
Established class (EPC) Rifamycin Antimycobacterial
Chemical class Rifamycins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance RIFAPENTINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 33342-599-54 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 33342-0599-54. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Rifamycin Antimycobacterial class.

Pharmacologic class Rifamycin Antimycobacterial
Drug family (ATC) Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMacleods Pharmaceuticals Limited
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA217042 (ANDA)
Labeler code33342
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio385 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Rifapentine is used with other medications to treat active tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body) in adults and children 12 years of age and older. Rifapentine is also used with isoniazid (Laniazid) to treat adults and children 2 years of age and older with latent (resting or nongrowing) TB, including those in close contact with people who have active TB, a positive tuberculin skin test, human immunodeficiency virus (HIV), or those with pulmonary fibrosis (scarring of the lungs with an unknown cause). Rifapentine is in a class of med...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • TB bacteria are remarkably adaptable. If you take only one antibiotic, the bacteria can develop resistance to it and the treatment fails. Using rifapentine alongside other TB medic...
  • Why do I have to take rifapentine with other TB medicines — why can't I just take this one?
  • That's actually a very well-known and harmless effect of rifapentine — it turns body fluids red-orange, including urine, sweat, tears, and saliva. It can be startling the first tim...
  • My urine has turned red-orange. Is something wrong?
📖 Read our full Rifapentine guide →
7
Nutrient depletion considerations

Rifapentine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Rifapentine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Red
ShapeRound
ImprintK;23
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 5Y0974F5PW
    Hydroxypropyl cellulose is a plant-derived thickener and binder made by chemically treating cellulose. In medicines, it helps hold tablets together, thickens liquids, and can form a protective coating on capsules.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Priftin 150 mg 00088-2102-24 sanofi-aventis 8 tablets $4.825 AB Availability likely —
Rifapentine 150 mgthis 33342-0599-54 Macleods 8 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Priftin (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Priftin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$155.1K
Claims incl. refills
811
Beneficiaries
582
Spend / beneficiary
$266.50
Spend / claim
$191.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Rifapentine — the ingredient across all brands.

Top reported reactions

Drug Interaction67
Pyrexia66
Nausea52
Fatigue42
Hypertension40
Vomiting40
Headache32

Age at onset

Neonate1
Infant1
Child2
Adolescent2
Adult143
Elderly21

Reporter sex

509 reports

Serious outcomes

Hospitalization164
Life-threatening26
Death14
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 73 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
33342-0599-54 You're viewing this 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20) 2026-06-23 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 33342-599-54, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 33342-0599-54, written without dashes as 33342059954. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 33342-0599-54, the first segment (33342) is the labeler code FDA assigned to Macleods Pharmaceuticals Limited; the middle segment (0599) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Macleods Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Macleods Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE • Rifapentine tablets are a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) • Rifapentine tablets are indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease.

( 1.2 ) • See Full Prescribing Information for Limitations of Use. ( 1.1 , 1.2 )

1.1Active Pulmonary Tuberculosis Rifapentine tablets are indicated in adults and pediatric patients 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis. Rifapentine tablets must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.1 )]. Limitations of Use Do not use rifapentine tabletsmonotherapy in either the initial or the continuation phases of active antituberculous treatment.

Rifapentine tablets 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 [see Warnings and Precautions ( 5.4 ) and Clinical Studies ( 14.1 )]. Rifapentine tablets have not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis.

1.2Latent Tuberculosis Infection Rifapentine tablets are indicated in adults and pediatric patients 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) [see Clinical Studies ( 14.2 )]. Limitations of Use Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection.

Rifapentine tablets must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )]. •Rifapentine tablets in combination with isoniazid are not recommended for individuals presumed to be exposed to rifamycin-resistant or isoniazid-resistant M. tuberculosis.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION • Active pulmonary tuberculosis: Rifapentine tablets should be used in regimens consisting of an initial 2 month phase followed by a 4 month continuation phase. ( 2.1 ) Initial phase (2 Months): 600 mg twice weekly for two months as directly observed therapy (DOT), with no less than 72 hours between doses, in combination with other antituberculosis drugs. ( 2.1 ) Continuation phase (4 Months): 600 mg once weekly for 4 months as directly observed therapy with isoniazid or another appropriate antituberculosis agent.

( 2.1 ) • Latent tuberculosis infection: Rifapentine tablets should be administered in combination with isoniazid once weekly for 12 weeks as directly observed therapy. ( 2.2 ) Adults and pediatric patients ≥12 years: Rifapentine tablets (based on weight, see table below) and isoniazid 15 mg/kg (900 mg maximum). ( 2.2 ) Pediatric patients 2 to 11 years: Rifapentine tablets (based on weight, see table below) and isoniazid 25 mg/kg (900 mg maximum).

( 2.2 ) Weight range Rifapentine Tablets dose Number of Rifapentine tablets 10-14 kg 300 mg 2 14.1-25 kg 450 mg 3 25.1-32 kg 600 mg 4 32.1-50 kg 750 mg 5 >50 kg 900 mg 6 For Latent Tuberculosis Infection, the maximum recommended dose of rifapentine tablets is 900 mg once weekly for 12 weeks. ( 2.2 ) •Take with food. Tablets may be crushed and added to semi-solid food.

( 2.3 )

2.1Dosage in Active Pulmonary Tuberculosis Rifapentine tablets are 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. Rifapentine tablets should not be used in the treatment of active pulmonary tuberculosis caused by rifampin-resistant strains. Initial phase (2 Months): Rifapentine tablets 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 antituberculosis 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 rifapentine tablets 600 mg once weekly for 4 months in combination with isoniazid or another appropriate antituberculosis agent for susceptible organisms administered as directly observed therapy.

2.2Dosage in Latent Tuberculosis Infection Rifapentine tablets should be administered once weekly in combination with isoniazid for 12 weeks as directly observed therapy. Adults and pediatric patients 12 years and older: The recommended dose of rifapentine tablets 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 100 mg) up to a maximum of 900 mg once weekly for 12 weeks.

Pediatric Patients 2 to 11 years: The recommended dose of rifapentine tablets 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 100 mg) up to a maximum of 900 mg once weekly for 12 weeks. Table 1: Weight Based Dose of Rifapentine Tablets in the Treatment of Latent Tuberculosis Infection Weight range Rifapentine tablets dose Number of Rifapentine tablets 10-14 kg 300 mg 2 14.1-25 kg 450 mg 3 25.1-32 kg 600 mg 4 32.1-50 kg 750 mg 5 >50 kg 900 mg 6

2.3Administration Take rifapentine tablets with meals. Administration of rifapentine tablets with a meal increases oral bioavailability and may reduce the incidence of gastrointestinal upset, nausea, and/or vomiting [see Clinical Pharmacology ( 12.3 )]. 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 b…

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS & STRENGTHS Rifapentine tablets are supplied as 150 mg reddish brown colored, round, beveled edge, biconvex, film-coated tablets debossed with "K" and "23" on one side and plain on other side. Tablets: 150 mg ( 3 )

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to any rifamycin. ( 4.1 )

4.1Hypersensitivity Rifapentine tablets are contraindicated in patients with a history of hypersensitivity to rifamycins.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS •Hepatotoxicity: Monitor for symptoms of liver injury and discontinue rifapentine tablets if signs or symptoms or liver injury occur. ( 5.1 ) •Hypersensitivity: Discontinue rifapentine tablets if signs or symptoms of hypersensitivity reaction occur. ( 5.2 ) •Severe cutaneous adverse reactions: Discontinue rifapentine tablets at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

( 5.3 ) •Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regimen with isoniazid in HIV-infected patients. Monitor for signs or symptoms of relapse in patients with cavitary lesions or bilateral disease. ( 5.4 , 14.1 ) • Paradoxical Drug Reactions: If worsening of symptoms or signs occur during antimycobacterial treatment, consider paradoxical drug reaction in the differential diagnosis, and monitor or treat accordingly.

( 5.5 ) •Drug Interactions: May interact with drugs metabolized by CYP450. ( 5.6 , 7.1 , 7.4 ) •Discoloration of body fluids: May permanently stain contact lenses or dentures red-orange. ( 5.7 ) • Clostridioides difficile– associated diarrhea: Evaluate if diarrhea occurs.

( 5.8 ) •Porphyria: Avoid use in patients with porphyria. ( 5.9 )

5.1Hepatotoxicity Elevations of liver transaminases may occur in patients receiving rifapentine tablets [see Adverse Reactions ( 6.1 )]. Patients on rifapentine tablets should be monitored for symptoms of liver injury. Patients with abnormal liver tests and/or liver disease or patients initiating treatment for active pulmonary tuberculosis should only be given rifapentine tablets in cases of necessity and under strict medical supervision.

In such patients, obtain serum transaminase levels prior to therapy and every 2 to 4 weeks while on therapy. Discontinue rifapentine tablets if evidence of liver injury occurs.

5.2Hypersensitivity and Related Reactions Hypersensitivity reactions may occur in patients receiving rifapentine tablets. Signs and symptoms of these reactions may include hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia or flu-like syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, fever, chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest pain, cough, syncope, palpitations). There have been reports of anaphylaxis [see Patient Counseling Information ( 17 )].

Monitor patients receiving rifapentine tablets therapy for signs and/or symptoms of hypersensitivity reactions. If these symptoms occur, administer supportive measures and discontinue rifapentine tablets.

5.3Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in association with the use of rifapentine tablets treatment regimens in patients with active and latent tuberculosis. Discontinue rifapentine tablets at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Patient Counseling Information ( 17 )].

5.4Relapse in the Treatment of Active Pulmonary Tuberculosis Rifapentine tablets have not been evaluated as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary TB. Do not use rifapentine tablets as a once-weekly continuation phase regimen in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin-resistant organisms [see Clinical Studies ( 14.1 )]. Higher relapse rates may occur in patients with cavitary pulmonary lesions and/or positive sputum cultures after the initial phase of active tuberculosis treatment and in patients with evidence of bilateral pulmonary disease.

Monitor for signs and symptoms of TB relapse in these patients [see Clinical Studies ( 14.1 )]. Poor adherence to therapy is associated with high relapse rat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: •Hepatotoxicity [see Warnings and Precautions ( 5.1 )] •Hypersensitivity [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.2 )] •Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] •Paradoxical Drug Reactions [see Warnings and Precautions ( 5.5 )] •Discoloration of Body Fluids [see Warnings and Precautions ( 5.7 )] • Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions ( 5.8 )] •Porphyria [see Warnings and Precautions ( 5.9 )] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache.

The most common adverse reaction (3% and greater) with the regimen for latent tuberculosis infection is hypersensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Active Pulmonary Tuberculosis Rifapentine tablets were studied in a randomized, open label, active-controlled trial of HIV-negative patients with active pulmonary tuberculosis. The population consisted primarily of male subjects with a mean age of 37 ± 11 years.

In the initial 2-month phase of treatment, 361 patients received rifapentine tablets 600 mg twice a week in combination with daily isoniazid, pyrazinamide, and ethambutol and 361 subjects received rifampin in combination with isoniazid, pyrazinamide and ethambutol all administered daily. Ethambutol was discontinued when drug susceptibly testing was known. During the 4-month continuation phase, 317 patients in the rifapentine tablets group continued to receive rifapentine tablets 600 mg dosed once weekly with isoniazid and 304 patients in the rifampin group received twice weekly rifampin and isoniazid.

Both treatment groups received pyridoxine (Vitamin B6) over the 6-month treatment period. Because rifapentine tablets were administered as part of a combination regimen, the adverse reaction profile reflects the entire regimen. Twenty-two deaths occurred in the study, eleven in the rifampin combination therapy group and eleven in the rifapentine tablets combination therapy group.

18/361 (5%) rifampin combination therapy patients discontinued the study due to an adverse reaction compared to 11/361 (3%) rifapentine tablets combination therapy patients. Three patients (two rifampin combination therapy patients and one rifapentine tablets combination therapy patient) were discontinued in the initial phase due to hepatotoxicity. Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine.

All three recovered without sequelae. Five patients had adverse reactions associated with rifapentine tablets overdose. These reactions included hematuria, neutropenia, hyperglycemia, ALT increased, hyperuricemia, pruritus, and arthritis.

Table 2 presents selected treatment-emergent adverse reactions associated with the treatment regimens which occurred in at least 1% of patients during treatment and post treatment through the first three months of follow-up. Table 2: Selected Treatment Emergent Adverse Reactions during Treatment of Active Pulmonary Tuberculosis and through Three Months Follow-up System Organ Class Adverse Reaction Initial Phase 1 Continuation Phase 2 Rifapentine Tablets Combination (N=361) N (%) Rifampin Combination (N=361) N…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Protease Inhibitors and Reverse Transcriptase Inhibitors. ( 5.2 , 7.1 ) • Hormonal Contraceptives: Use an effective non-hormonal method of contraception or add a barrier method of contraception during treatment with rifapentine tablets. ( 7.3 ) • May increase metabolism and decrease the activity of drugs metabolized by cytochrome P450 3A4 and 2C8/9. Dosage adjustments may be necessary if given concomitantly. ( 7.4 )

7.1Protease Inhibitors and Reverse Transcriptase Inhibitors Rifapentine is an inducer of CYP450 enzymes. Concomitant use of rifapentine tablets with other drugs metabolized by these enzymes, such as protease inhibitors and certain reverse transcriptase inhibitors, may cause a significant decrease in plasma concentrations and loss of therapeutic effect of the protease inhibitor or reverse transcriptase inhibitor [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 )].

7.2Fixed-Dose Combination of Efavirenz, Emtricitabine, and Tenofovir Once-weekly coadministration of 900 mg rifapentine tablets with the antiretroviral fixed-dose combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in HIV-infected patients did not result in any substantial change in steady state exposures of efavirenz, emtricitabine, and tenofovir. No clinically significant change in CD4 cell counts or viral loads were noted [see Clinical Pharmacology ( 12.3 )].

7.3Hormonal Contraceptives Rifapentine tablets may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with rifapentine tablets [see Use in Specific Populations ( 8.3 ) and Clinical Pharmacology ( 12.3 )].

7.4Cytochrome P450 3A4 and 2C8/9 Rifapentine is an inducer of cytochromes P450 3A4 and P450 2C8/9. Therefore, rifapentine tablets may increase the metabolism of other coadministered drugs that are metabolized by these enzymes. Induction of enzyme activities by rifapentine tablets occurred within 4 days after the first dose.

Enzyme activities returned to baseline levels 14 days after discontinuing rifapentine tablets. Rifampin has been reported to accelerate the metabolism and may reduce the activity of the following drugs; hence, rifapentine tablets may also increase the metabolism and decrease the activity of these drugs. Dosage adjustments of the drugs in Table 4 or of other drugs metabolized by cytochrome P450 3A4 or P450 2C8/9 may be necessary if they are given concurrently with rifapentine tablets.

Table 4: Drug Interactions with Rifapentine Tablets: Dosage Adjustment May be Necessary Drug Class Examples of Drugs Within Class Antiarrhythmics Disopyramide, mexiletine, quinidine, tocainide Antibiotics Chloramphenicol, clarithromycin, dapsone, doxycycline; Fluoroquinolones (such as ciprofloxacin) Oral Anticoagulants Warfarin Anticonvulsants Phenytoin Antimalarials Quinine Azole Antifungals Fluconazole, itraconazole, ketoconazole Antipsychotics Haloperidol Barbiturates Phenobarbital Benzodiazepines Diazepam Beta-Blockers Propranolol Calcium Channel Blockers Diltiazem, nifedipine, verapamil Cardiac Glycoside Preparations Digoxin Corticosteroids Prednisone Fibrates Clofibrate Oral Hypoglycemics Sulfonylureas (e.g., glyburide, glipizide) Hormonal Contraceptives/Progestins Ethinyl estradiol, levonorgestrel Immunosuppressants Cyclosporine, tacrolimus Methylxanthines Theophylline Narcotic analgesics Methadone Phosphodiesterase-5 (PDE-5) Inhibitors Sildenafil Thyroid preparations Levothyroxine Tricyclic antidepressants Amitriptyline, nortriptyline

7.5Other Interactions The conversion of rifapentine tablets to 25-desacetyl rifapentine is mediated by an esterase enzyme. There is minimal potential for rifapentine tablets metabolism to be inhibited or induced by another drug, based upon the characteristics of the esterase enzymes. Since rifapentine…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS •Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) •Lactation: Monitor infants exposed to rifapentine tablets through breast milk for irritability, prolonged unexplained crying, yellowing of the eyes, changes in color of the urine or stool. ( 8.2 ) •Pediatrics: Safety and effectiveness in treating active pulmonary tuberculosis in pediatric patients under the age of 12 years have not been established. ( 8.4 )

8.1Pregnancy Risk Summary Based on animal data, rifapentine tablets may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with rifapentine tablets use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant.

Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data). There are risks associated with active tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, rifapentine tablets may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see Clinical Considerations).

In animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see Data). Based on animal data, advise pregnant women of the risk for fetal harm. As rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Labor or delivery When administered during the last few weeks of pregnancy, rifapentine tablets may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. Monitor prothrombin time of pregnant women and neonates who are exposed to rifapentine tablets during the last few weeks of pregnancy.

Treatment with Vitamin K may be indicated. Data Human data Fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including rifapentine tablets became pregnant during clinical studies. Six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was HIV-infected), one had an elective abortion, and outcome was unknown in three patients.

These data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. In the trial that compared the safety and effectiveness of rifapentine tablets in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the rifapentine t…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on animal data, rifapentine tablets may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with rifapentine tablets use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant.

Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data). There are risks associated with active tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, rifapentine tablets may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see Clinical Considerations).

In animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see Data). Based on animal data, advise pregnant women of the risk for fetal harm. As rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Labor or delivery When administered during the last few weeks of pregnancy, rifapentine tablets may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. Monitor prothrombin time of pregnant women and neonates who are exposed to rifapentine tablets during the last few weeks of pregnancy.

Treatment with Vitamin K may be indicated. Data Human data Fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including rifapentine tablets became pregnant during clinical studies. Six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was HIV-infected), one had an elective abortion, and outcome was unknown in three patients.

These data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. In the trial that compared the safety and effectiveness of rifapentine tablets in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the rifapentine tablets / isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. Among the 46 total pregnancies in the rifapentine tablets /isoniazid arm, there were 31 live births, 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes.

Of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. The rate of spontaneous abortion in the rifapentine tablets/ isoniazid arm (15%) and the…

🧒 Pediatric Use 169 words ▾

8.4Pediatric Use The safety and effectiveness of rifapentine tablets in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. The safety and effectiveness of rifapentine tablets in combination with isoniazid once-weekly regimen has been evaluated in pediatric patients (2 to 17 years of age) for the treatment of latent tuberculosis infection. In clinical studies, the safety profile in pediatric patients was similar to that observed in adult patients [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.2 )].

In a pharmacokinetic study conducted in 2 to 11-year-old pediatric patients with latent tuberculosis infection, rifapentine tablets were administered once weekly based on weight (15 mg/kg to 30 mg/kg, up to a maximum of 900 mg). Exposures (AUC) in pediatric patients 2 to 11 years old with latent tuberculosis infection were higher (average 31%) than those observed in adults receiving rifapentine tablets 900 mg once weekly [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Clinical studies with rifapentine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In a pharmacokinetic study with rifapentine tablets, no substantial differences in the pharmacokinetics of rifapentine and 25-desacetyl metabolite were observed in the elderly compared to younger adults [see Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 108 words ▾

10 OVERDOSAGE While there is no experience with the treatment of acute overdose with rifapentine tablets, clinical experience with rifamycins suggests that gastric lavage to evacuate gastric contents (within a few hours of overdose), followed by instillation of an activated charcoal slurry into the stomach, may help adsorb any remaining drug from the gastrointestinal tract. Rifapentine and 25-desacetyl rifapentine are 97.7% and 93.2% plasma protein bound, respectively. Rifapentine and related compounds excreted in urine account for only 17% of the administered dose, therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifapentine from the body of a patient with rifapentine tablets overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology ( 12.4 )].

12.3Pharmacokinetics When oral doses of rifapentine tablets were administered once daily or once every 72 hours to healthy volunteers for 10 days, single dose AUC (0-∞) of rifapentine was similar to its steady-state AUC ss (0-24h) or AUC ss (0-72h) values, suggesting no significant auto-induction effect on steady-state pharmacokinetics of rifapentine. Steady-state conditions were achieved by day 10 following daily administration of rifapentine tablets 600 mg. No plasma accumulation of rifapentine and 25-desacetyl rifapentine (active metabolite) is expected after once weekly administration of rifapentine tablets.

The pharmacokinetic parameters of rifapentine and 25-desacetyl rifapentine on day 10 following oral administration of 600 mg rifapentine tablets every 72 hours to healthy volunteers are described in Table 5. Table 5: Pharmacokinetics and Rifapentine and 25-Desacetyl Rifapentine in Healthy Volunteers Parameter Rifapentine 25-desacetyl Rifapentine Mean ± SD (n=12) C max (μg/mL) 15.05 ± 4.62 6.26 ±

2.06AUC (0-72h) (μg·h/mL) 319.54 ± 91.52 215.88 ±

85.96T 1/2 (h) 13.19 ± 1.38 13.35 ±

2.67T max (h) 4.83 ± 1.80 11.25 ±

2.73Cl/F (L/h) 2.03 ± 0.60 -- The pharmacokinetic parameters of rifapentine and 25-desacetyl rifapentine following single-dose oral administration of 900 mg rifapentine tabletsin combination with 900 mg isoniazid in fed conditions are described in Table 6. Table 6: Mean ± SD Pharmacokinetic Parameters of Rifapentine and 25-Desacetyl Rifapentine in Healthy Volunteers When Rifapentine Tablets is Coadministered with Isoniazid Under Fed Conditions (N=16) Parameter Rifapentine 25-desacetyl Rifapentine C max (μg/mL) 25.8 ± 5.83 13.3 ±

4.83AUC (μg·h/mL) 817 ± 128 601 ± 187 T 1/2 (h) 16.6 ± 5.02 17.5 ±

7.42T max (h)* 8 (3-10) 24 (10-36) Cl/F (L/h) 1.13 ± 0.174 NA** * Median (Min-Max). ** Not Applicable. Absorption The absolute bioavailability of rifapentine tablets has not been determined. The relative bioavailability (with an oral solution as a reference) of rifapentine tablets after a single 600 mg dose to healthy adult volunteers was 70%.

The maximum concentrations were achieved from 5 hours to 6 hours after administration of the 600 mg rifapentine tablets dose. The administration of rifapentine tablets with a high fat meal increased rifapentine C max and AUC by 40% to 50% over that observed when rifapentine tablets were administered under fasting conditions. The administration of rifapentine tablets(900 mg single dose) and isoniazid (900 mg single dose) with a low fat, high carbohydrate breakfast, led to a 47% and 51% increase in rifapentine C max and AUC, respectively.

In contrast, the ingestion of the same meal decreased isoniazid C max and AUC by 46% and of 23%, respectively. Distribution In a population pharmacokinetic analysis in 351 tuberculosis patients who received 600 mg rifapentine tablets in combination with isoniazid, pyrazinamide and ethambutol, the estimated apparent volume of distribution was 70.2 ±

9.1L. In healthy volunteers, rifapentine and 25-desacetyl rifapentine were 97.7% and 93.2% bound to plasma proteins, respectively. Rifapentine was mainly bound to albumin.

Similar extent of protein binding was observed in healthy volunteers, asymptomatic HIV-infected subjects and hepatically impaired subjects. Metabolism/Excretion Following a single 600 mg oral dose of radiolabeled rifapentine to healthy volunteers (n=4), 87% of the total 14 C-rifapentine was recovered in the urine (17%) and feces (70%). Greater than 80% of the total 14 C-rifapentine dose was excreted from the body within 7 days.

Rifapentine was hydrolyzed by an esterase enzyme to form a microbiologically active 25-desacetyl rifapentine. Rifapentine and 25-desacetyl rifapentine accounted for 99% of the total radioactivity in plasma. Plasma AUC (0-∞) and C max values of the 25-desacetyl…

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Rifapentine tablets is supplied as 150 mg reddish brown colored, round, beveled edge, biconvex, film-coated tablets debossed with "K" and "23" on one side and plain on other side of tablets packaged in blister strips. Carton of 24 tablets (3 strips of 8 tablets) NDC 33342-599-54 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.

📋 Description 123 words ▾

11 DESCRIPTION Rifapentine tablets for oral administration contains 150 mg of the active ingredient rifapentine per tablet. The 150 mg tablets also contain, as inactive ingredients: calcium stearate, colloidal silicon dioxide, disodium EDTA, hydroxypropyl cellulose, iron oxide red, low substituted hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and polyvinyl alcohol - part. hydrolyzed.

Rifapentine is a rifamycin derivative antimicrobial and has a similar profile of microbiological activity to rifampicin. The molecular weight is 877.04. The molecular formula is C 47 H 64 N 4 O 12 .

The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]- or 3-[N-(4-cyclopentyl - 1-piperazinyl)formimidoyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure: 202

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patient to read FDA-approved patient labeling (Medication Guide). Treatment Adherence Emphasize the importance of compliance with the full course of therapy, and the importance of not missing any doses of rifapentine tablets or companion medications in the treatment of active pulmonary tuberculosis or the treatment of latent tuberculosis infection. Hypersensitivity Reactions Inform patients that rifapentine tablets may cause hypersensitivity reactions.

Signs and symptoms of this reaction may include a flu-like illness, hypotension, urticaria, angioedema, bronchospasm, conjunctivitis, thrombocytopenia or neutropenia. Anaphylaxis may also occur [see Warnings and Precautions ( 5.2 )]. Inform patients of signs and symptoms of hypersensitivity reactions and advise them to stop the medication and contact their healthcare provider if they experience any of these symptoms.

Severe Cutaneous Adverse Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking rifapentine tablets immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions ( 5.3 )]. Hepatitis Instruct patients to stop the medication and notify their physician promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, and pain or swelling of the joints [see Warnings and Precautions ( 5.1 )].

Paradoxical Drug Reactions Advise patients to seek medical advice immediately if their symptoms of tuberculosis reappear or worsen [see Warnings and Precautions ( 5.5 )]. Drug Interactions Rifapentine may increase the metabolism and decrease the activity of other drugs that are metabolized by the P450 3A4 and 2C8/9 pathways. Dosage adjustments of the coadministered drugs may be necessary.

Advise patients to discuss with their physician any other medications they are taking before starting treatment with rifapentine tablets [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 , 7.4 )]. Concomitant use of rifapentine tablets with protease inhibitors or reverse transcriptase inhibitors may cause a significant decrease in plasma concentrations and loss of therapeutic effect of the protease inhibitor or reverse transcriptase inhibitor [see Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7.4 )].

Discoloration of Body Fluids Inform the patient that rifapentine tablets produce a red-orange discoloration of the urine, sweat, sputum, tears, and breast milk. Contact lenses or dentures may be permanently stained [see Warnings and Precautions ( 5.7 )]. Administration with Food Advise patients to take rifapentine tablets with food [see Dosage and Administration ( 2.3 )].

Lactation Monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity to include irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, and changes in color of the urine (darkening) or stool (lightening, pale or light brown) [see Use in Specific Populations ( 8.2 )]. Contraception Advise patients that use of rifapentine tablets may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment [see Warning and Precautions ( 5.6 ), Drug Interactions ( 7.3 ), and Use in Specific Populations ( 8.3 )].

Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh-174101, India All trademarks are the property of their respective owners. Dispense the Medication Guide available at www.macleodspharma.com/usa Revised: June 2026

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE SECTION Medication Guide Rifapentine (RIF a PEN teen) Tablets Read this Medication Guide before you start taking rifapentine tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about rifapentine tablets? Rifapentine tablets may cause serious side effects, including: •Liver problems. Rifapentine tablets may cause serious liver problems.

Your doctor may do a blood test to check your liver function before and while you take rifapentine tablets. Stop taking rifapentine tablets and call your doctor right away if you have any of the following signs and symptoms of liver problems: nausea vomiting stomach pain loss of appetite tiredness, yellowing skin or whites of your eyes dark urine •Allergic reactions and flu-like symptoms. Allergic reactions and flu-like symptoms have happened in some people taking rifapentine tablets.

Signs and symptoms of an allergic reaction may include: low blood pressure (hypotension) difficulty breathing hives red eyes (conjunctivitis) cough with wheezing lower blood platelet levels Signs and symptoms of a flu-like reaction may include: weakness tiredness muscle pain nausea and vomiting headache fever chills aches rash itching sweats dizziness shortness of breath chest pain cough fainting fast heartbeat •Severe skin reactions. Serious skin reactions such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have happened in some people taking rifapentine tablets.

Stop taking rifapentine tablets right away and call your doctor or get emergency help if you have any of the following symptoms: rash peeling or bleeding skin swollen face, lips, mouth tongue or throat red and painful skin sores or blisters on the inside of your mouth or lips flu-like symptoms What are rifapentine tablets? Rifapentine tablets are a prescription medicine used with other anti-tuberculosis (TB) medicines to: •treat active tuberculosis disease of the lung in people age 12 years and older. •prevent progression of inactive (latent) tuberculosis infection to active tuberculosis disease in people age 2 years and older.

Rifapentine tablets should not be used: •alone to treat people with active or latent TB •in people with active TB who had taken the medicines rifampin or isoniazid in the past and did not respond (resistant) •in people who had been exposed to patients with TB that cannot be treated with isoniazid or rifampin Rifapentine tablets are safe and effective in children older than 2 years of age who have inactive (latent TB), but it is not known if rifapentine tablets are safe and effective for use in the treatment of active TB in children under 12 years of age.

Who should not take rifapentine tablets? •Do not take rifapentine tablets if you are allergic to a group of medicines called rifamycins. What should I tell my doctor before taking rifapentine tablets? Before taking rifapentine tablets, tell your doctor about all of your medical conditions, including if you: •have active TB disease. •know that you have TB that is resistant to treatment with some medicines. •have HIV infection or taking medicines to treat HIV infection. • have liver problems. •have a condition called porphyria. •are pregnant or planning to become pregnant.

It is not known if rifapentine tablets will harm your unborn baby. •are breastfeeding or plan to breastfeed. It is not known if rifapentine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking rifapentine tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using rifapentine tablets with other medicines may affect each other causing serious side effects. Rifapentine tablets may affect the way other medic…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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