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Tembexa Brincidofovir 100 mg Tablet, Film Coated, 4-count — NDC 64678-0010-01 package photo

Tembexa Brincidofovir 100 mg Tablet, Film Coated, 4-count

by Emergent BioDefense Operations Lansing LLC · 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-01)
NDC 64678-0010-01
🏷️ FDA NDC (as labeled) 64678-010-01 billing pads the product segment with a zero
This package
Contains4-count Pack sizes2 compare ↓
Also comes in: 4 tablets 64678-0010-02
Rx only Brand 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) 64678-010-01
Product NDC 64678-010
11-digit billing NDC 64678001001
RxCUI 2599535, 2599539, 2599540, 2599541
UNII 6794O900AX
Application # NDA214461
SPL Set ID 209aa94b-c613-4880-ad89-41be83d12c0a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance BRINCIDOFOVIR
Why two NDCs? The FDA registers this code as 64678-010-01 — 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 → 64678-0010-01. 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 Nucleosides and nucleotides excl. reverse transcriptase inhibitors class.

Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
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

LabelerEmergent BioDefense Operations Lansing LLC
Application holderEMERGENT BIODEFENSE OPERATIONS LANSING INC
FDA applicationNDA214461 (NDA)
Labeler code64678
First marketedApr 2022
Product typeHuman Prescription Drug
Portfolio3 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

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 Blue
ShapeOval
ImprintBCV;100
Size14 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 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.
Try another pack size: 4 tablets
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
Tembexa 100 mgthis 64678-0010-01 Emergent 4 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2021
First FDA approval
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 4, 2021 RLD RS ⏳ ~8.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10112909 — method of use (U-3165)
US 9303051 — drug substance (U-3165)
US 10487061 — method of use (U-3165)
US 8962829 — drug substance
US 9371344 — drug product
Exclusivity ODE-354
2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)
PatentTypeUse codeExpires
US 10112909 ↗ Method of use U-3165 Oct 10, 2034
US 9303051 ↗ Drug substance U-3165 Jul 30, 2034
US 10487061 ↗ Method of use U-3165 Oct 10, 2034
US 8962829 ↗ Drug substance — Oct 10, 2034
US 9371344 ↗ Drug product — Oct 10, 2034
FDA exclusivity
CodeWhat it grantsExpires
ODE-354Orphan Drug Exclusivity (7-year)Jun 4, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2034 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🔬 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 Tembexa (this brand).

Top reported reactions

Acute Kidney Injury27
Adenovirus Infection15
Drug Resistance12
Graft Versus Host Disease In Gastrointestinal Tract11
Hypotension11
Immune Reconstitution Inflammatory Syndrome11
Multiple Organ Dysfunction Syndrome11

Age at onset

Child1
Adult18
Elderly1

Reporter sex

137 reports
Male · 68%
Female · 32%

Serious outcomes

Hospitalization41
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 23 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
64678-0010-01 You're viewing this 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-01) 2022-04-20 Active
64678-0010-02 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-02) 2022-04-20 Active

Pack size FAQ

What quantity is in NDC 64678-0010-01?
NDC 64678-0010-01 is a 4-count package — 4 tablet, film coated in 1 blister pack.
What is the difference between NDC 64678-0010-01 and NDC 64678-0010-02?
Both are Tembexa Brincidofovir 100 mg Tablet, Film Coated — the drug itself is identical. NDC 64678-0010-01 is the 4-count package, while NDC 64678-0010-02 is the 4 tablets package.
What NDC number is used to bill for this package of Tembexa Brincidofovir 100 mg Tablet, Film Coated?
Bill NDC 64678-0010-01 — the 11-digit billing format is 64678001001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 64678-010-01, 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: 64678-0010-01, written without dashes as 64678001001. 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 64678-0010-01, the first segment (64678) is the labeler code FDA assigned to Emergent BioDefense Operations Lansing LLC; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Emergent BioDefense Operations Lansing LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 4 tablets (64678-0010-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Emergent BioDefense Operations Lansing LLC 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.
🚨 Boxed Warning 🎯 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
🚨 Boxed Warning 95 words ▾

WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )]. WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION See full prescribing information for complete boxed warning. An increased incidence of mortality was seen in TEMBEXA- treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )].

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. ( 1.1 ) Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. ( 1.2 ) • The effectiveness of TEMBEXA for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical.

( 1.2 ) • TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. ( 1.2 )

1.1Treatment of Human Smallpox Disease TEMBEXA ® is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.

1.2Limitations of Use TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease [see Warnings and Precautions ( 5.1 , 5.2 )] . The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical [see Clinical Studies ( 14 )] . TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Testing: Before initiation and during treatment with TEMBEXA perform hepatic laboratory testing and pregnancy testing. ( 2.1 ) • See full prescribing information for details on important administration instructions. ( 2.2 ) • Adult and pediatric patients weighing 48 kg or above: 200 mg (two 100 mg tablets or 20 mL oral suspension for patients who cannot swallow tablets) once weekly for 2 doses.

( 2.3 ) • Adult and pediatric patients weighing 10 kg to less than 48 kg: 4 mg/kg oral suspension once weekly for 2 doses. ( 2.3 ) • Pediatric patients weighing less than 10 kg: 6 mg/kg oral suspension once weekly for 2 doses. ( 2.3 )

2.1Testing Before Initiating and During Treatment with TEMBEXA Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.7 )] . Perform pregnancy testing before initiation of TEMBEXA in individuals of childbearing potential to inform risk [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.3 )] .

2.2Important Administration Instructions Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see Warnings and Precautions ( 5.6 )] . TEMBEXA Tablets TEMBEXA tablets can be taken on an empty stomach or with a low-fat meal (approximately 400 calories, with approximately 25% of calories from fat) [see Clinical Pharmacology ( 12.3 )] .

Swallow TEMBEXA tablets whole. Do not crush or divide TEMBEXA tablets. TEMBEXA Oral Suspension Take TEMBEXA oral suspension on an empty stomach [see Clinical Pharmacology ( 12.3 )] .

Shake oral suspension before use. Use an appropriate oral dosing syringe to correctly measure the total prescribed dose [see Patient Counseling Information ( 17 )] . Discard unused portion after completion of 2 prescribed doses.

For patients who cannot swallow, TEMBEXA oral suspension can be administered by enteral tube (naso-gastric or gastrostomy tubes) as follows: • Draw up prescribed dose with a calibrated catheter-tip syringe, and utilize this syringe to administer the dose via the enteral tube. • Refill the catheter-tip syringe with 3 mL of water, shake, and administer the contents via the enteral tube. • Flush with water before and after enteral administration.

2.3Recommended Dosage The recommended dosage of TEMBEXA in pediatric and adult patients is displayed in Table 1 [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14 )] . Table 1: Recommended Dosage in Pediatric and Adult Patients Patient’s Weight (kg) TEMBEXA Oral Suspension (10 mg/mL) TEMBEXA Tablet (100 mg) Less than 10 kg 6 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 10 kg to less than 48 kg 4 mg/kg once weekly for 2 doses (on Days 1 and 8) N/A 48 kg and above 200 mg (20 mL) once weekly for 2 doses (on Days 1 and 8) 200 mg (two 100 mg tablets) once weekly for 2 doses (on Days 1 and 8)

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets TEMBEXA tablets are blue, modified-oval shape, film-coated tablets debossed with BCV on one side and 100 on the other side. Each tablet contains 100 mg of brincidofovir. Oral Suspension TEMBEXA oral suspension is an aqueous based, preserved white to off-white opaque, lemon lime flavored suspension containing 10 mg/mL of brincidofovir. • Tablets: 100 mg ( 3 ) • Oral Suspension: 10 mg/mL ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment. ( 5.2 ) • Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur.

Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA. ( 5.3 ) • Coadministration with Related Products: TEMBEXA should not be coadministered with intravenous cidofovir. ( 5.4 ) • Embryo-fetal Toxicity: May cause fetal harm.

Advise individuals of childbearing potential of the potential risk to the fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) • Carcinogenicity: TEMBEXA should be considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets.

( 5.6 , 13.1 ) • Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential. ( 5.7 , 8.3 )

5.1Increased Risk for Mortality When Used for Longer Duration TEMBEXA is not indicated for use in diseases other than human smallpox. An increase in mortality was observed in a randomized, placebo-controlled Phase 3 trial when TEMBEXA was evaluated in another disease. An increased risk in mortality is possible if TEMBEXA is used for a duration longer than at the recommended dosage on Days 1 and 8 [see Indications and Usage ( 1.2 ) and Dosage and Administration ( 2.3 )] .

Study 301 (CMX001-301) evaluated TEMBEXA versus placebo for the prevention of cytomegalovirus infection. A total of 303 subjects received TEMBEXA (100 mg twice weekly) and 149 subjects received matching placebo for up to 14 weeks. The primary endpoint was evaluated at Week 24.

All-cause mortality at Week 24 was 16% in the TEMBEXA group compared to 10% in the placebo group. Safety and effectiveness of TEMBEXA have not been established for diseases other than human smallpox disease.

5.2Elevations in Hepatic Transaminases and Bilirubin Elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin have been observed, including cases of concurrent increases in ALT and bilirubin. During the first 2 weeks of TEMBEXA therapy in 392 subjects, ALT elevations >3x the upper limit of normal were reported in 7% of subjects and bilirubin elevations >2x the upper limit of normal were reported in 2% of subjects; these elevations in hepatic laboratory tests were generally reversible and did not require discontinuation of TEMBEXA [see Adverse Reactions ( 6.1 ) and Nonclinical Toxicology ( 13.2 )] .

Severe hepatobiliary adverse events including hyperbilirubinemia, acute hepatitis, hepatic steatosis, and venoocclusive liver disease have been reported in less than 1% of subjects. Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate. Monitor patients who develop abnormal hepatic laboratory tests during TEMBEXA therapy for the development of more severe hepatic injury.

Consider discontinuing TEMBEXA if ALT levels remain persistently >10x the upper limit of normal. Do not give the second and final dose of TEMBEXA on Day 8 if ALT elevation is accompanied by clinical signs and symptoms of liver inflammation or increasing direct bilirubin, alkaline phosphatase, or International Normalized Ratio (INR) [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.1 )] .

5.3Diarrhea and Other Gastrointestinal Adverse Events During the first 2 weeks of TEMBEXA therapy in 392 subjects, a composite term of diarrhea (all grade, all cause) occurred in 40% of TEMBEXA-treated subjects compared with 25% of subjects in the placebo control group. Treatment with TEMBEXA was discontinued in 5% of subjects for diarrhea (composite term) compared with 1% in the placebo control group. Additional gastroi…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Elevations in hepatic transaminases and bilirubin [see Warnings and Precautions ( 5.2 )] • Diarrhea and other GI adverse events [see Warnings and Precautions ( 5.3 )] Common adverse reactions (occurring in at least 2% of TEMBEXA-treated subjects) were diarrhea, nausea, vomiting, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioDefense Operations Lansing LLC at 1‑877-246-8472 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. The safety of TEMBEXA has not been studied in patients with smallpox disease. The safety of TEMBEXA was evaluated in 392 adult subjects aged 18 to 77 years in Phase 2 and 3 randomized, placebo-controlled clinical trials.

Of the subjects who received a 200 mg total weekly dose of TEMBEXA, 54% were male, 85% were White, 7% were Black/African American, 6% were Asian, and 10% were Hispanic or Latino. Twenty-one percent of subjects in the studies were age 65 or older. Of these 392 subjects, 85% received a 200 mg total weekly dose of TEMBEXA for at least 2 weeks.

Common Adverse Reactions The most common adverse reactions (adverse events assessed as causally related by the investigator) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea and nausea. Adverse reactions that occurred in at least 2% of subjects in the TEMBEXA treatment group are shown in Table 2 . Table 2: Adverse Reactions (All Grades) Reported in ≥2% of Subjects Note: Only adverse reactions with onset in the first 2 weeks of treatment are presented. a.

Composite term includes: bowel movement irregularity, defecation urgency, diarrhea, fecal incontinence, and frequent bowel movements. b. Composite term includes: vomiting and retching. c. Composite term includes: abdominal discomfort, abdominal distention, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.

Adverse Reaction TEMBEXA 200 mg N=392 % Placebo N=208 % Diarrhea a 8 3 Nausea 5 1 Vomiting b 4 1 Abdominal pain c 3 2 Adverse Reactions Leading to Discontinuation of TEMBEXA Fifteen subjects (4%) had their treatment with TEMBEXA discontinued due to adverse reactions. One subject had two adverse reactions; the other subjects had one reaction each. These adverse reactions were: • Diarrhea (n=9) • Nausea (n=3) • Vomiting (n=1) • Enteritis (n=1) • ALT increased (n=1) • Dyspepsia (n=1) These adverse reactions were mild (Grade 1, n=1), moderate (Grade 2, n=7) or severe (Grade 3, n=8) in severity and resolved upon discontinuation of TEMBEXA.

Less Common Adverse Reactions Clinically significant adverse reactions that were reported in <2% of subjects (and also occurred in 2 or more subjects) exposed to TEMBEXA and at rates higher than in subjects who received placebo are listed below: • General and administration site: peripheral edema • Metabolism and nutrition: decreased appetite • Musculoskeletal and connective tissue: muscular weakness • Nervous system: dysgeusia • Skin and subcutaneous tissue: rash (includes rash, maculo-papular rash, pruritic rash) Selected treatment-emergent laboratory values occurring during the first 2 weeks of treatment with TEMBEXA are presented in Table 3 .

Table 3: Frequencies of Selected Laboratory Abnormalities ULN = upper limit of normal a. Frequencies are based on treatment-emergent laboratory abnormalities. Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity grading criteria. b.

ALT >10x ULN occurred in one subject in the TEMBEXA group and no subjects in the placebo group. c. No subjects reported AST >10x ULN. Laboratory…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Concomitant use with OATP1B1 and 1B3 inhibitors increase TEMBEXA exposure which may increase TEMBEXA-associated adverse reactions. Consider alternative medication that are not OATP1B1 or 1B3 inhibitors. If concomitant use is necessary, increase monitoring for adverse reactions associated with TEMBEXA and postpone the dosing of OATP1B1 or 1B3 inhibitors at least 3 hours after TEMBEXA administration. ( 7.1 )

7.1Effect of Other Drugs on TEMBEXA Inhibitors for Organic Anion Transporting Polypeptide (OATP) 1B1 and 1B3 Concomitant use of TEMBEXA with OATP1B1 and 1B3 inhibitors (clarithromycin, cyclosporine, erythromycin, gemfibrozil, human immunodeficiency virus [HIV] and hepatitis C virus [HCV] protease inhibitors, rifampin [single dose]) increase brincidofovir AUC and C max which may increase TEMBEXA-associated adverse reactions [see Clinical Pharmacology ( 12.3 )] . Where possible, consider alternative medications that are not OATP1B1 or 1B3 inhibitors.

If concomitant use with TEMBEXA is necessary, increase monitoring for adverse reactions associated with TEMBEXA (elevations in transaminases and bilirubin, diarrhea, or other GI adverse events) [see Warnings and Precautions ( 5.2 , 5.3 )] and postpone the dosing of OATP1B1 or 1B3 inhibitors for at least 3 hours after TEMBEXA administration.

7.2Vaccine Interactions No vaccine-drug interaction studies have been performed in human subjects. Animal studies have indicated that coadministration of TEMBEXA at the same time as live smallpox vaccine (vaccinia virus) may reduce the immune response to the vaccine. It is also possible that TEMBEXA may reduce the immune response to replication-defective smallpox vaccine (modified vaccinia virus Ankara).

The clinical impacts of these potential interactions on vaccine efficacy are unknown.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Use an alternative therapy to treat smallpox during pregnancy, if feasible. There are no available data on the use of brincidofovir in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage, and other adverse maternal and fetal outcomes.

In animal reproduction studies, oral administration of brincidofovir to pregnant rats and rabbits during the period of organogenesis resulted in embryotoxicity and structural malformations. These effects occurred in animals at systemic exposures less than the expected human exposure based on the recommended dose of TEMBEXA ( see Data ). The estimated background risk of major birth defects for the indicated population is unknown, and the estimated background risk of miscarriage for the indicated population is higher than the general population.

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% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals were administered oral doses of brincidofovir up to 4.5 mg/kg/day from gestation days 7 to 20.

Maternal toxicity in rats, characterized by decreases in food consumption and decreased body weight gain, was observed at doses of 1.5 and 4.5 mg/kg/day. These effects correlated with decreased fetal weights in rats given 4.5 mg/kg/day. Brincidofovir administration in rats was not associated with effects on intrauterine growth or survival at any dose, and there were no external malformations or developmental variations.

In rabbits, 4.5 mg/kg/day brincidofovir was associated with decreased maternal body weight and food consumption, decreased fetal body weight, increased late resorptions and morphological changes which included external, visceral and skeletal malformations and variations. In the pre-/post-natal development study, administration of brincidofovir at doses of 0, 0.25, 1, and 4 mg/kg/day and 15 mg/kg twice weekly to pregnant rats from gestation day 7 to lactation day 20 resulted in pup toxicity at maternally toxic doses (4 mg/kg/day and 15 mg/kg twice weekly).

Pup body weight and viability were decreased, and reproductive function of the pups was impaired as evidenced by a delay in sexual maturation, decreased testes and epididymal size, reduced mating and an increase in the number of days to mating as well as preimplantation loss. All effects were observed at systemic exposures less than the expected human exposure based on the recommended dose of TEMBEXA.

8.2Lactation Risk Summary Because of the potential for variola virus transmission through direct contact with the breastfed infant, breastfeeding is not recommended in patients with smallpox. There are no data on the presence of brincidofovir in human milk, the effects of the drug on the breastfed infant, or on milk production. Brincidofovir is present in animal milk ( see Data ).

Data When brincidofovir was administered to lactating rats (4 mg/kg/day or 15 mg/kg twice weekly), brincidofovir was detected in milk but not in the plasma of nursing pups.

8.3Females and Males of Reproductive Potential Based on animal data, TEMBEXA may cause fetal harm [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Perform pregnancy testing in individuals of childbearing potential before initiation of TEMBEXA [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.5 )] . Contraception Females Advise individuals of childbearing potential to use effective contraception during treatment and for at least 2 months after the last dose of TEMBEXA [see Warnings and Precautio…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Use an alternative therapy to treat smallpox during pregnancy, if feasible. There are no available data on the use of brincidofovir in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage, and other adverse maternal and fetal outcomes.

In animal reproduction studies, oral administration of brincidofovir to pregnant rats and rabbits during the period of organogenesis resulted in embryotoxicity and structural malformations. These effects occurred in animals at systemic exposures less than the expected human exposure based on the recommended dose of TEMBEXA ( see Data ). The estimated background risk of major birth defects for the indicated population is unknown, and the estimated background risk of miscarriage for the indicated population is higher than the general population.

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% to 4% and 15% to 20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals were administered oral doses of brincidofovir up to 4.5 mg/kg/day from gestation days 7 to 20.

Maternal toxicity in rats, characterized by decreases in food consumption and decreased body weight gain, was observed at doses of 1.5 and 4.5 mg/kg/day. These effects correlated with decreased fetal weights in rats given 4.5 mg/kg/day. Brincidofovir administration in rats was not associated with effects on intrauterine growth or survival at any dose, and there were no external malformations or developmental variations.

In rabbits, 4.5 mg/kg/day brincidofovir was associated with decreased maternal body weight and food consumption, decreased fetal body weight, increased late resorptions and morphological changes which included external, visceral and skeletal malformations and variations. In the pre-/post-natal development study, administration of brincidofovir at doses of 0, 0.25, 1, and 4 mg/kg/day and 15 mg/kg twice weekly to pregnant rats from gestation day 7 to lactation day 20 resulted in pup toxicity at maternally toxic doses (4 mg/kg/day and 15 mg/kg twice weekly).

Pup body weight and viability were decreased, and reproductive function of the pups was impaired as evidenced by a delay in sexual maturation, decreased testes and epididymal size, reduced mating and an increase in the number of days to mating as well as preimplantation loss. All effects were observed at systemic exposures less than the expected human exposure based on the recommended dose of TEMBEXA.

🧒 Pediatric Use 164 words ▾

8.4Pediatric Use As in adults, the effectiveness of TEMBEXA in smallpox infected pediatric patients, including neonates, is based solely on efficacy studies in animal models of orthopoxvirus disease. The recommended pediatric dosing regimen is expected to produce brincidofovir exposures that are comparable to those in adults based on a population pharmacokinetic modeling and simulation approach. The dosage for pediatric patients is based on weight [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] .

There have been 23 pediatric subjects aged 7 months to 17 years who received TEMBEXA in a randomized, placebo-controlled clinical trial. The safety in adult and pediatric subjects treated with TEMBEXA were similar [see Adverse Reactions ( 6.1 )] . An additional 166 pediatric subjects aged 3 months to 18 years of age received TEMBEXA from uncontrolled studies and expanded access.

The dosage of TEMBEXA in pediatric patients <3 months of age was based on modeling and simulations [see Clinical Pharmacology ( 12.3 )] .

🧓 Geriatric Use 61 words ▾

8.5Geriatric Use Of the 392 subjects in the controlled clinical studies, 21% were ≥65 years of age and 1% were ≥75 years of age. The nature and severity of adverse events was comparable between subjects older and younger than 65 years. No alteration of dosing is recommended for patients ≥65 years of age [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 27 words ▾

10 OVERDOSAGE There is no clinical experience with overdosage of TEMBEXA. In the event of an overdose, monitor patients for adverse effects and provide appropriate supportive care.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brincidofovir is an antiviral drug against variola (smallpox) virus [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics Brincidofovir and its active metabolite cidofovir diphosphate exposure-response relationships and time course of pharmacodynamic responses are unknown. Cardiac Electrophysiology TEMBEXA does not prolong the QT interval at the anticipated therapeutic exposure.

12.3Pharmacokinetics Brincidofovir is a prodrug that is converted intracellularly to cidofovir, which is subsequently phosphorylated to cidofovir diphosphate, the active antiviral moiety, following oral administration. Brincidofovir plasma exposures do not accumulate after repeat doses. The metabolite cidofovir diphosphate reaches maximum concentration at 47 hours (23 to 311 hours) following administration of the recommended dose, with a mean (CV%) half-life of 113 hours (34.2%).

The pharmacokinetic properties of brincidofovir following administration of TEMBEXA are provided in Table 4 . The pharmacokinetic parameters of brincidofovir and cidofovir diphosphate following administration of TEMBEXA at the recommended dose are provided in Table 5 . Table 4: Pharmacokinetic Properties of Brincidofovir a a.

Healthy adults. b. Administered under fasted conditions. c. Low-fat meal: ~400 calories, with ~25% calories from fat.

No clinically meaningful change in intracellular concentrations of cidofovir diphosphate were seen when TEMBEXA Tablet was administered with a low-fat meal. The effect of food on TEMBEXA oral suspension has not been studied. d. Following administration of radiolabeled brincidofovir.

Absorption Bioavailability Oral suspension 16.8% Tablet 13.4% T max b 3 hours (2 to 8 hours) Effect of food on TEMBEXA Tablet (relative to fasting) c • AUC inf decreased by 31% • C max decreased by 49% Distribution % Bound to human plasma proteins >99.9% Blood-to-plasma ratio (drug or drug-related materials) d 0.48 to

0.61 Apparent Volume of distribution, L 1230 Elimination Apparent Clearance, L/hr

44.1 Mean terminal half-life (t 1/2 ), hr

19.3Metabolism Metabolic pathways hydrolysis, CYP4F2 Metabolites cidofovir and cidofovir diphosphate (active) Excretion % of dose excreted in urine d 51%, as metabolites % of dose excreted in feces d 40%, as metabolites Table 5: Single-Dose Pharmacokinetic Parameters of Brincidofovir and Cidofovir Diphosphate a AUC = area under the time concentration curve; C max = maximum concentration; CV = coefficient of variation. a. Healthy adults. PK Parameter Geometric Mean (%CV) Brincidofovir Cidofovir diphosphate C max 480 ng/mL (70%) 9.7 pg/10 6 cells (75%) AUC tau 3400 ng·hr/mL (58%) 1200 pg·hr/10 6 cells (75%) Metabolism Brincidofovir is metabolized by hydrolysis of the phosphoester bond to form cidofovir.

Cidofovir is subsequently phosphorylated to form cidofovir diphosphate. Brincidofovir is also carboxylated at the terminal carbon by Cytochrome P450 (CYP) 4F2, followed by subsequent CYP-mediated oxidations and multiple cycles of fatty acid beta-oxidation. The major inactive metabolites formed via these pathways are CMX103 (3-hydroxypropyl ester of cidofovir) and CMX064 (4‑(3-propoxy)butanoic acid ester of cidofovir).

Genetic and chemical inhibition of acid sphingomyelinase enzyme activity in multiple human cell lines resulted in substantially lower concentrations of cidofovir and cidofovir diphosphate (the active drug), compared to controls with functional acid sphingomyelinase enzyme activity. Findings show acid sphingomyelinase plays a major role in the hydrolysis of brincidofovir to cidofovir in these cell lines. Based on in vitro data, acid sphingomyelinase deficiency may reduce the ability to convert brincidofovir to cidofovir and cidofovir diphosphate; however, the clinical relevance of this finding is unknown.

Comparison of Animal and Human Pharmacokinetic Data to Support Effective Human Dose Selection Because the effectiveness of TEMBEXA cannot be tested in humans, a com…

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Brincidofovir is an antiviral drug against variola (smallpox) virus [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TEMBEXA Tablets: Tablets are blue, modified-oval shape, film-coated tablets debossed with BCV on one side and 100 on the other side and packaged into blister cards. Each blister cavity contains one film-coated tablet containing 100 mg of brincidofovir. The blister card is placed in a child-resistant wallet.

Each wallet (NDC 64678-010-01) contains one (1) blister card with a total of 4 film-coated tablets. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Do not divide, break, or crush the tablets.

Avoid direct contact with broken or crushed tablets. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see Warnings and Precautions ( 5.6 )] . TEMBEXA Oral Suspension: Aqueous based, preserved white to off-white opaque, lemon lime flavored suspension containing 10 mg/mL of brincidofovir packaged into a high density polyethylene bottle with a low density polyethylene press-in bottle adaptor (PIBA) inserted into the bottle.

The bottle is capped by a child-resistant closure. Each bottle is filled to deliver 65 mL (NDC 64678-012-01) and 45 mL (NDC 64678-012-03) of brincidofovir. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

Do not freeze. Avoid direct contact with oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see Warnings and Precautions ( 5.6 )] .

📋 Description 188 words ▾

11 DESCRIPTION TEMBEXA (brincidofovir) tablets, 100 mg, for oral use are immediate release film-coated tablets containing the following inactive ingredients: Colloidal Silicon Dioxide, Crospovidone, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Purified Water, Silicified Microcrystalline Cellulose, Talc and Titanium Dioxide. TEMBEXA (brincidofovir) oral suspension, 10 mg/mL, is an aqueous based, preserved, orally dosed suspension.

The inactive ingredients are: Citric Acid Anhydrous, Lemon Lime Flavor, Microcrystalline Cellulose and Carboxymethyl Cellulose Sodium, Purified Water, Simethicone 30% Emulsion, Sodium Benzoate, Sucralose, Trisodium Citrate Anhydrous, and Xanthan Gum. Brincidofovir is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and a lipid conjugate of the nucleotide analog cidofovir and is indicated for the treatment of human smallpox disease. The full chemical name is: Phosphonic acid, P -[[(1 S )-2-(4-amino-2-oxo-1(2 H )-pyrimidinyl)-1- (hydroxymethyl)ethoxy]methyl]-, mono[3-(hexadecyloxy)propyl] ester.

The molecular formula of brincidofovir is C 27 H 52 N 3 O 7 P and the relative molecular mass is 561.70. The structure is shown below. Brincidofovir is a white to off-white crystalline powder as a free acid and practically insoluble in water.

Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Efficacy Based on Animal Models Alone Inform patients that the efficacy of TEMBEXA is based solely on efficacy studies demonstrating a survival benefit in animals and that the effectiveness of TEMBEXA has not been tested in humans with smallpox disease [see Clinical Studies ( 14) ] . Elevations of Hepatic Transaminases and Bilirubin Inform patients of the need for liver monitoring before treatment with TEMBEXA and during treatment if signs or symptoms of liver injury occur.

Advise patients to report symptoms that may indicate liver injury, including right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions ( 5.2 )] . Diarrhea and Other Gastrointestinal Adverse Events Inform patients of the risk of diarrhea and other GI adverse events (nausea, vomiting, and abdominal pain) while taking TEMBEXA. Advise patients to inform their healthcare provider if they develop severe diarrhea or other severe GI symptoms [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.1 )] .

Important Drug Interactions Inform patients that TEMBEXA may interact with some drugs. If concomitant use of OATP1B1 and 1B3 inhibitors with TEMBEXA is necessary, advise patients to postpone the dosing of these medicines for at least 3 hours after TEMBEXA administration [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . Embryo-fetal Toxicity Advise pregnant individuals and individuals of childbearing potential of the risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.

Advise individuals of childbearing potential to use effective contraception during treatment with TEMBEXA and for at least 2 months after the last dose. Due to animal findings of testicular toxicity, advise individuals of reproductive potential with partners of childbearing potential to use condoms during treatment with TEMBEXA and for at least 4 months after the last dose [see Warnings and Precautions ( 5.5 , 5.7 ) and Use in Specific Populations ( 8.3 )] . Infertility Advise individuals of reproductive potential that treatment with TEMBEXA may deplete sperm, resulting in infertility [see Use in Specific Populations ( 8.3 ) and Nonclinical Toxicology ( 13.1 )] .

Lactation Instruct individuals with smallpox not to breastfeed their infant because of the risk of passing variola virus to the breastfed infant [see Use in Specific Populations (8.2 )] . Important Administration Instructions for Oral Suspension Instruct patients or caregivers to use an oral dosing syringe to correctly measure the prescribed amount of medication. Oral dosing syringes may be obtained from the pharmacy.

Refer to instructions above for administration of TEMBEXA oral suspension through enteral tubes [see Dosage and Administration ( 2.2 )] . Advise patients taking the oral suspension to discard unused portion after completion of the 2 prescribed doses. Handling Advise patients not to divide, break, or crush tablets.

Advise patients to avoid direct contact with broken or crushed tablets and oral suspension. If contact with skin or mucous membranes occurs, inform patients to wash thoroughly with soap and water, and rinse eyes thoroughly with water [see Dosage and Administration ( 2.2 ) and How Supplied/Storage and Handling ( 16 )] . Manufactured for Emergent BioDefense Operations Lansing LLC 3500 North Martin Luther King Jr Blvd Lansing, MI 48906

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