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Xofluza BALOXAVIR MARBOXIL 40 mg Tablet, Film Coated, 1 tablet — NDC 50242-0860-86 package photo

Xofluza BALOXAVIR MARBOXIL 40 mg Tablet, Film Coated, 1 tablet

by Genentech, Inc. · 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC 50242-0860-86
🏷️ FDA NDC (as labeled) 50242-860-86 billing pads the product segment with a zero
This package
Contains1 tablet Pack sizes2 compare ↓
Also priced by: Part D plans $169.17/unit — full pricing hub ↓
Also comes in: 1 tablet 50242-0860-01
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) 50242-860-86
Product NDC 50242-860
11-digit billing NDC 50242086086
RxCUI 2100008, 2100010, 2467537, 2467539, 2536740, 2536742, 2716798, 2716800
UNII 505CXM6OHG
Application # NDA210854
SPL Set ID e49e1a61-1b7c-4be5-ac84-af6240b511e7
Established class (EPC) Polymerase Acidic Endonuclease Inhibitor
Mechanism of action Chelating Activity; Polymerase Acidic Endonuclease Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance BALOXAVIR MARBOXIL
GPI-14 1250202020B745
GPI class Xofluza (40 MG Dose)
GCN Seq No 079191
GCN 45639
HICL code 045394
Ingredient (HICL) Baloxavir Marboxil
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5A
Therapeutic class — specific (HIC3) Antivirals, General
AHFS code 08:18.30.00
AHFS class Endonuclease Inhibitors
FDB label name XOFLUZA 40 MG TABLET
FDB brand name Xofluza
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50242-860-86 — 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 → 50242-0860-86. 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 Other antivirals class.

Drug family (ATC) Other antivirals
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

LabelerGenentech, Inc.
Application holderGENENTECH INC
FDA applicationNDA210854 (NDA)
Labeler code50242
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio93 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

Label name XOFLUZA 40 MG TABLET Ingredient Baloxavir Marboxil
📗 Our plain-language guide HelloPharmacist
  • Yes — Xofluza is designed as a single-dose treatment. Because baloxavir stays active in your body for a long time (it has a half-life of about 79 hours), one dose is enough to do i...
  • Does Xofluza really work with just one dose?
  • You can take Xofluza with or without food, but there's one important catch: avoid dairy products, calcium-fortified juices or drinks, and any supplements or antacids containing cal...
  • Most people do very well with Xofluza. The most common side effects reported in adults and teens were diarrhea, nausea, headache, bronchitis, and sinusitis — and these were actuall...
📖 Read our full Baloxavir Marboxil guide →
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 Yellow / White
ShapeOval
ImprintBXM80
Size16 mm
ScoringNot scored
FlavorStrawberry
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 K0KQV10C35
    Povidone K25 is a synthetic polymer made from vinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach for better absorption.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.

8 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 · Q2 2026 $169.17 $169.17 / 1 tablet
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
Xofluza 40 mgthis 50242-0860-86 Genentech, 1 tablet — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
Mar 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 18, 2021 AB TE-rated RLD RS ⏳ ~13.1 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 10633397 — method of use (U-3000)
US 10633397 — method of use (U-2816)
US 11306106 — method of use (U-2816)
US 11306106 — method of use (U-2816)
US 11306106 — method of use (U-2816)
US 11306106 — method of use (U-3000)
US 11306106 — method of use (U-3000)
US 11306106 — method of use (U-3000)
US 10633397 — method of use (U-2816)
US 10633397 — method of use (U-2816)
US 10633397 — method of use (U-3000)
US 10633397 — method of use (U-3000)
US 8927710 — drug product
US 9815835 — drug product
US 8927710 — drug product
US 8987441 — drug substance
US 8927710 — drug product
US 11261198 — drug product
US 10759814 — drug substance
US 8987441 — drug substance
US 10392406 — drug substance
US 10759814 — drug substance
US 11261198 — drug product
US 8987441 — drug substance
US 12064438 — drug product
US 10392406 — drug substance
US 9815835 — drug product
US 12064438 — drug product
US 10392406 — drug substance
US 10759814 — drug substance
US 11261198 — drug product
US 12064438 — drug product
US 9815835 — drug product
Exclusivity M-187
Exclusivity M-187
Exclusivity M-187
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
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 (33)
PatentTypeUse codeExpires
US 10633397 ↗ Method of use U-3000 Apr 27, 2036
US 10633397 ↗ Method of use U-2816 Apr 27, 2036
US 11306106 ↗ Method of use U-2816 Aug 9, 2037
US 11306106 ↗ Method of use U-2816 Aug 9, 2037
US 11306106 ↗ Method of use U-2816 Aug 9, 2037
US 11306106 ↗ Method of use U-3000 Aug 9, 2037
US 11306106 ↗ Method of use U-3000 Aug 9, 2037
US 11306106 ↗ Method of use U-3000 Aug 9, 2037
US 10633397 ↗ Method of use U-2816 Apr 27, 2036
US 10633397 ↗ Method of use U-2816 Apr 27, 2036
US 10633397 ↗ Method of use U-3000 Apr 27, 2036
US 10633397 ↗ Method of use U-3000 Apr 27, 2036
US 8927710 ↗ Drug product — May 5, 2031
US 9815835 ↗ Drug product — Jun 14, 2030
US 8927710 ↗ Drug product — May 5, 2031
US 8987441 ↗ Drug substance — Oct 24, 2032
US 8927710 ↗ Drug product — May 5, 2031
US 11261198 ↗ Drug product — Sep 25, 2038
US 10759814 ↗ Drug substance — Aug 9, 2037
US 8987441 ↗ Drug substance — Oct 24, 2032
US 10392406 ↗ Drug substance — Apr 27, 2036
US 10759814 ↗ Drug substance — Aug 9, 2037
US 11261198 ↗ Drug product — Sep 25, 2038
US 8987441 ↗ Drug substance — Oct 24, 2032
US 12064438 ↗ Drug product — Oct 9, 2039
US 10392406 ↗ Drug substance — Apr 27, 2036
US 9815835 ↗ Drug product — Jun 14, 2030
US 12064438 ↗ Drug product — Oct 9, 2039
US 10392406 ↗ Drug substance — Apr 27, 2036
US 10759814 ↗ Drug substance — Aug 9, 2037
US 11261198 ↗ Drug product — Sep 25, 2038
US 12064438 ↗ Drug product — Oct 9, 2039
US 9815835 ↗ Drug product — Jun 14, 2030
FDA exclusivity
CodeWhat it grantsExpires
M-187New indication / labeling change (3-year)Dec 19, 2027
M-187New indication / labeling change (3-year)Dec 19, 2027
M-187New indication / labeling change (3-year)Dec 19, 2027
Common questions
Is there a generic version of XOFLUZA 40 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for XOFLUZA 40 MG TABLET. See the alternatives section for substitutable, lower-cost products.
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tablet50242-0860-01 13,095 Rx · $2,198,481
1 tablet this page50242-0860-86 No Medicaid data
Drug total (last 4 qtrs): 13,095 Rx · 13,178 units · $2,198,481 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Xofluza — 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 Xofluza. 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
$1.57M
Claims incl. refills
9.3K
Beneficiaries
9.1K
Spend / beneficiary
$171.84
Spend / claim
$168.49
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 Xofluza (this brand).

Top reported reactions

Diarrhoea136
Vomiting132
Pneumonia114
Nausea75
Rash68
Hyperpyrexia67
Headache64

Reporter sex

2,301 reports

Serious outcomes

Hospitalization449
Death136
Life-threatening87
Disabling19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 814 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 Per unit Per pack Marketing startStatus
50242-0860-01 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK $161.95 / ea $161.95 2021-03-26 Active
50242-0860-86 You're viewing this 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK — — 2021-08-31 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 50242-0860-86?
NDC 50242-0860-86 contains 1 tablet — 1 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack.
What is the difference between NDC 50242-0860-86 and NDC 50242-0860-01?
Both are Xofluza BALOXAVIR MARBOXIL 40 mg Tablet, Film Coated — the drug itself is identical. NDC 50242-0860-86 is the 1 tablet package, while NDC 50242-0860-01 is the 1 tablet package.
What NDC number is used to bill for this package of Xofluza BALOXAVIR MARBOXIL 40 mg Tablet, Film Coated?
Bill NDC 50242-0860-86 — the 11-digit billing format is 50242086086. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 50242-860-86, 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: 50242-0860-86, written without dashes as 50242086086. 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 50242-0860-86, the first segment (50242) is the labeler code FDA assigned to Genentech, Inc.; the middle segment (0860) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (86) 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 Genentech, Inc.. 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 1 tablet (50242-0860-01). 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?
Genentech, Inc. 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications . ( 1.1 ) Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. ( 1.2 ) Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs.

Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA. ( 1.3 )

1.1Treatment of Influenza XOFLUZA is indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications 1 [see Clinical Studies (14.1 , 14.2 , and 14.3 ].

1.2Post-Exposure Prophylaxis of Influenza XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 5 years of age and older following contact with an individual who has influenza [see Clinical Studies (14.4) ].

1.3Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Warnings and Precautions (5.2) , Microbiology (12.4) and Clinical Studies (14) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Treatment and Post-Exposure Prophylaxis of Influenza Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. XOFLUZA may be taken with or without food. ( 2.1 , 2.2 ) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older (Tablets) 20 kg to less than 80 kg One 40 mg tablet (blister card contains one 40 mg tablet) At least 80 kg One 80 mg tablet (blister card contains one 80 mg tablet) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Packets) 15 kg to less than 20 kg One 30 mg packet 20 kg to less than 80 kg One 40 mg packet At least 80 kg 80 mg (two 40 mg packets) Patient Body Weight Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Bottles) Less than 20 kg 2 mg/kg 20 kg to less than 80 kg 40 mg (20 mL) At least 80 kg 80 mg (40 mL) Refer to the Full Prescribing Information for additional information on the recommended dosage and preparation of XOFLUZA for oral suspension (bottles) or for oral suspension (packets) for both for oral or enteral use in patients 5 years of age and older.

( 2.2 , 2.3 )

2.1Dosage and Administration Overview XOFLUZA is available in two dosage forms: XOFLUZA tablets (40 mg and 80 mg). XOFLUZA for oral suspension is available in two different presentations: packets (30 mg and 40 mg) and bottles (2 mg/mL). If the patient weighs less than 15 kg, XOFLUZA for oral suspension in bottle is the recommended presentation.

Both presentations of the for oral suspension are intended for patients who are unable to or have difficulty swallowing tablets, or those who require enteral administration [see Dosage and Administration (2.2 , 2.3 , 2.4) ] . Take XOFLUZA as soon as possible after influenza symptom onset or exposure to influenza [see Dosage and Administration (2.2) ] . XOFLUZA may be taken with or without food.

However, concomitant use of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) should be avoided [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ].

2.2Recommended Dosage Treatment of Acute Uncomplicated Influenza or Post-Exposure Prophylaxis in Adults, and Pediatric Patients (5 Years of Age and Older) Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. The recommended dosage of XOFLUZA in patients 5 years of age or older is a single weight-based dose displayed in Tables 1 , 2 and 3 . Table 1 XOFLUZA Tablets: Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older Patient Body Weight Recommended Single Oral Dose (Tablets) Recommended XOFLUZA dosage is based on the patient's weight.

20 kg to less than 80 kg One 40 mg tablet (blister card contains one 40 mg tablet) At least 80 kg One 80 mg tablet (blister card contains one 80 mg tablet) Table 2 XOFLUZA for Oral Suspension (Packets): Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older Patient Body Weight Recommended Single Oral Dose (Packets) Recommended XOFLUZA dosage is based on the patient's weight. 15 kg Patients who weigh less than 15 kg should receive XOFLUZA for oral suspension (bottles). to less than 20 kg One 30 mg packet 20 kg to less than 80 kg One 40 mg packet At least 80 kg 80 mg (two 40 mg packets) Table 3 XOFLUZA for Oral Suspension (Bottles): Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older Patient Body Weight Recommended Single Oral Dose Recommended XOFLUZA dosage is based on the patient's weight. , Use a measuring device (oral syringe) to measure the prescribed dose for use.

(For Ora…

💊 Dosage Forms and Strengths 166 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 40 mg and 80 mg. ( 3 ) For oral suspension (packets): 30 mg and 40 mg per packet in about 15-20 mL of drinking water. ( 3 ) For oral suspension (bottles): 40 mg/20 mL (2 mg/mL) after reconstitution.

( 3 ). XOFLUZA Tablets: 40 mg: white to light yellow, oblong-shaped, film-coated, debossed with "BXM40" on one side. 80 mg: white to light yellow, oblong shaped, film-coated, debossed with "BXM80" on one side.

XOFLUZA for Oral Suspension (Packets): 30 mg: white to light yellow granules with strawberry flavor (each packet contains 30 mg baloxavir marboxil). 40 mg: white to light yellow granules with strawberry flavor (each packet contains 40 mg baloxavir marboxil). XOFLUZA for Oral Suspension (Bottles): 40 mg/20 mL (2 mg/mL) of baloxavir marboxil after reconstitution with 20 mL of drinking water or sterile water.

The granules are white to light yellow. The reconstituted product is a greyish white, white to light yellow opaque suspension with strawberry flavor.

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme [see Warnings and Precautions (5.1) ]. XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected. ( 5.1 ) Increased incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age: XOFLUZA is not indicated in patients less than 5 years of age due to increased incidence of treatment-emergent resistance in this age group . In clinical trials, incidence of virus with treatment-emergent substitutions associated with reduced susceptibility to baloxavir (resistance) was higher in pediatric subjects younger than 5 years of age than older subjects.

( 5.2 ) Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. XOFLUZA has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

( 5.3 )

5.1Hypersensitivity Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in postmarketing experience with XOFLUZA. Appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected. The use of XOFLUZA is contraindicated in patients with known hypersensitivity to XOFLUZA [see Contraindications (4) and Adverse Reactions (6.2) ].

5.2Increased Incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age XOFLUZA is not indicated in patients less than 5 years of age due to increased incidence of treatment-emergent resistance in this age group. In clinical trials, the incidence of virus with treatment-emergent substitutions associated with reduced susceptibility to baloxavir (resistance) was higher in pediatric subjects younger than 5 years of age (40%, 38/96) than in pediatric subjects ≥ 5 years to < 12 years of age (16%, 19/117) or subjects ≥ 12 years of age (7%, 60/842).

The potential for transmission of resistant strains in the community has not been determined [see Indications and Usage (1) , Use in Specific Populations (8.4) , and Microbiology (12.4) ].

5.3Risk of Bacterial Infections There is no evidence of efficacy of XOFLUZA in any illness caused by pathogens other than influenza viruses. Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. XOFLUZA has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with XOFLUZA included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). ( 6.1 ) Adverse events reported in at least 5% of pediatric subjects (5 to < 12 years) treated with XOFLUZA included vomiting (5%) and diarrhea (5%). To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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 overall safety profile of XOFLUZA is based on data from 2,079 subjects, 5 years of age and older in 5 controlled clinical trials who received XOFLUZA. Of these subjects, 1,943 were adults and adolescents (≥ 12 years of age) and 136 were in the pediatric age group (5 to < 12 years of age) [see Clinical Studies (14) ] .

Treatment of Acute Uncomplicated Influenza Adult and Adolescent Subjects (≥ 12 Years of Age): The safety of XOFLUZA in adult and adolescent subjects is based on data from 3 placebo-controlled trials in which a total of 1,640 subjects received XOFLUZA: 1,334 (81%) subjects were 18 to 64 years of age, 209 (13%) subjects were adults 65 years of age or older, and 97 (6%) subjects were adolescents 12 to 17 years of age. These trials included otherwise healthy adults and adolescents (N=910) and subjects at high risk of developing complications associated with influenza (N=730).

Of these, 1,440 subjects received XOFLUZA at the recommended dose [see Clinical Studies (14.1 , 14.2) ]. Trial T0821 was a phase 2 dose-finding placebo-controlled trial where otherwise healthy adult subjects 20 to 64 years of age received single oral dose of XOFLUZA or placebo. Trial T0831 was a placebo- and active-controlled trial in otherwise healthy adults and adolescents 12 to 64 years of age; subjects received weight-based XOFLUZA or placebo as a single oral dose on Day 1 or oseltamivir twice a day for 5 days.

Trial T0832 was a randomized, double-blind, placebo- and active-controlled trial where adults and adolescents at high risk of influenza complications 12 years of age and older received either XOFLUZA, placebo or oseltamivir. Table 4 displays the most common adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects who received XOFLUZA at the recommended dose in Trials T0821, T0831, and T0832. Table 4 Incidence of Adverse Events Occurring in at Least 1% of Adult and Adolescent Subjects Receiving XOFLUZA in the Acute Uncomplicated Influenza Trials T0821, T0831, and T0832 Adverse Event XOFLUZA (N=1,440) Placebo (N=1,136) Diarrhea 3% 4% Bronchitis 3% 4% Nausea 2% 3% Sinusitis 2% 3% Headache 1% 1% Pediatric Subjects (5 to < 12 Years of Age): In an active-controlled, double-blind trial Trial CP40563 in pediatric subjects, a total of 79 subjects 5 to less than 12 years of age, received the recommended weight-based dosage of XOFLUZA, and 39 subjects received oseltamivir.

Of the 118 subjects 5 to less than 12 years of age in Trial CP40563, 15 subjects in the XOFLUZA arm and 4 subjects in the oseltamivir arm were at high risk of developing influenza complications. The most frequently reported AEs (≥ 5%) in all subjects in the XOFLUZA treatment arm were vomiting (5%) and diarrhea (5%). Vomiting was reported in 18% of subjects in the oseltamivir arm [see Clinical Studies (14.3 ].

There are limited safety data in patients 5 to <12 years at high risk of developing influenza complications. Post-Exposure Prophylaxis of Influenza In a placebo-controlled clinical trial, Trial T0834, conducted in adults, and pediatric subjects ≥ 5 years of age, a total of 360 subjects received XOFLUZA, of which 291 (81%) were adults ≥ 18 years; 12…

🔄 Drug Interactions 156 words ▾

7 DRUG INTERACTIONS Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). ( 2.1 , 7.1 ) Live attenuated influenza vaccines may be affected by antivirals. ( 7.2 )

7.1Effect of Other Drugs on XOFLUZA Baloxavir may form a chelate with polyvalent cations such as calcium, aluminum, or magnesium. Coadministration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir [see Clinical Pharmacology (12.3) ], which may reduce XOFLUZA efficacy. Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

7.2Vaccines The concurrent use of XOFLUZA with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and XOFLUZA have not been evaluated.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy (see Clinical Considerations ). In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits with oral administration of baloxavir marboxil at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age. Data Animal Data Baloxavir marboxil was administered orally to pregnant rats (20, 200, or 1,000 mg/kg/day from gestation day 6 to 17) and rabbits (30, 100, or 1,000 mg/kg/day from gestation day 7 to 19).

No adverse embryo-fetal effects were observed in rats up to the highest dose of baloxavir marboxil (1,000 mg/kg/day), resulting in systemic baloxavir exposure (AUC) of approximately 5 times the exposure at the MRHD. In rabbits, fetal skeletal variations occurred at a maternally toxic dose (1,000 mg/kg/day) resulting in 2 abortions out of 19 pregnancies. No adverse maternal or embryo-fetal effects were observed in rabbits at the middle dose (100 mg/kg/day) resulting in systemic baloxavir exposure (AUC) approximately 7 times the exposure at the MRHD.

In the prenatal and postnatal development study in rats, baloxavir marboxil was administered orally at 20, 200, or 1,000 mg/kg/day from gestation day 6 to postpartum/lactation day 20. No significant effects were observed in the offspring at maternal systemic baloxavir exposure (AUC) approximately 5 times the exposure at the MRHD.

8.2Lactation Risk Summary There are no data on the presence of baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production. Baloxavir and its related metabolites were present in the milk of lactating rats (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XOFLUZA and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Data In a lactation study, baloxavir and its related metabolites were excreted in the milk of lactating rats administered baloxavir marboxil (1 mg/kg) on postpartum/lactation day 11, with peak milk concentration approximately 5 times that of maternal plasma concentrations occurring 2 hours post-dose. No effects of baloxavir marboxil on growth and postnatal development were observed in nursing pups at the highest oral dose tested in rats. Maternal systemic exposure was approximately 5 times the baloxavir exposure in humans at the MRHD.

8.4Pediatric Use Treatment of Acute Uncomplicated Influenza in Adolescent Subjects (≥ 12 Years of Age) The safety and effectiveness of XOFLUZA for the treatment of acute uncomplicated influenza in adolescent subjects 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in otherwise healthy subjects Trial T0831 and one trial in subjects at high risk of developing influenza-related complications Trial T0832 [see Clinical Studies (14.1) ]. A total of 117 otherwise healt…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy (see Clinical Considerations ). In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits with oral administration of baloxavir marboxil at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD) (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age. Data Animal Data Baloxavir marboxil was administered orally to pregnant rats (20, 200, or 1,000 mg/kg/day from gestation day 6 to 17) and rabbits (30, 100, or 1,000 mg/kg/day from gestation day 7 to 19).

No adverse embryo-fetal effects were observed in rats up to the highest dose of baloxavir marboxil (1,000 mg/kg/day), resulting in systemic baloxavir exposure (AUC) of approximately 5 times the exposure at the MRHD. In rabbits, fetal skeletal variations occurred at a maternally toxic dose (1,000 mg/kg/day) resulting in 2 abortions out of 19 pregnancies. No adverse maternal or embryo-fetal effects were observed in rabbits at the middle dose (100 mg/kg/day) resulting in systemic baloxavir exposure (AUC) approximately 7 times the exposure at the MRHD.

In the prenatal and postnatal development study in rats, baloxavir marboxil was administered orally at 20, 200, or 1,000 mg/kg/day from gestation day 6 to postpartum/lactation day 20. No significant effects were observed in the offspring at maternal systemic baloxavir exposure (AUC) approximately 5 times the exposure at the MRHD.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Treatment of Acute Uncomplicated Influenza in Adolescent Subjects (≥ 12 Years of Age) The safety and effectiveness of XOFLUZA for the treatment of acute uncomplicated influenza in adolescent subjects 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in otherwise healthy subjects Trial T0831 and one trial in subjects at high risk of developing influenza-related complications Trial T0832 [see Clinical Studies (14.1) ]. A total of 117 otherwise healthy adolescents 12 to17 years of age were randomized and received either XOFLUZA (N=76) or placebo (N=41) in Trial T0831; 38 adolescents 12 to 17 years of age at high risk for influenza complications were randomized and received either XOFLUZA (N=21) or placebo (N=17) in Trial T0832.

The median time to alleviation of symptoms in influenza-infected adolescent subjects aged 12 to 17 years in Trial T0831 was comparable to that observed in adults. In Trial T0832, the median time to improvement of symptoms in the limited number of influenza-infected adolescent subjects aged 12 to 17 years was similar in the XOFLUZA and placebo arms [see Clinical Studies (14.1) ]. Adverse events reported in adolescents in both trials were similar to those reported in adults [see Adverse Reactions (6.1) ].

Treatment of Acute Uncomplicated Influenza in Pediatric Subjects (5 to < 12 Years of Age) The safety and effectiveness of XOFLUZA in pediatric subjects 5 to less than 12 years of age is supported by one randomized, double-blind, controlled trial Trial CP40563 with a primary endpoint of safety. In this trial, 118 pediatric subjects were randomized and treated in a 2:1 ratio and received either XOFLUZA (N=79) or oseltamivir (N=39). Efficacy was extrapolated from adults and adolescents based on comparable PK exposures in adults, adolescents and pediatric subjects 5 to less than 12 years of age.

The median time to alleviation of signs and symptoms in influenza-infected subjects was comparable in the XOFLUZA and oseltamivir arms. Adverse events reported with XOFLUZA in pediatric subjects were similar to those observed in adults and adolescents except for vomiting and diarrhea, which were both more commonly reported in pediatric subjects [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.1) ]. Post-Exposure Prophylaxis of Influenza in Pediatric and Adolescent Subjects (5 to < 18 Years of Age) The safety and effectiveness of XOFLUZA for post-exposure prophylaxis in pediatric and adolescent subjects 5 to less than 18 years of age is supported by one randomized, double-blind, controlled trial conducted in Japan Trial T0834 [see Clinical Studies (14.3) ].

Subjects in this trial were randomized in a 1:1 ratio to receive XOFLUZA or placebo. A total of 69 subjects from 5 to <18 years of age in Trial T0834 received XOFLUZA. The incidence of RT-PCR-confirmed symptomatic influenza in pediatric subjects 5 to <18 years of age was similar to that observed in adult subjects [see Clinical Pharmacology (12.3) , and Clinical Studies (14.3) ].

Efficacy was extrapolated from adults based on comparable PK exposures in adults, adolescents and pediatric subjects 5 to <18 years of age. Adverse events reported in pediatric and adolescent subjects were similar to those reported in adults in the same trial [see Adverse Reactions (6.1) ]. Pediatric Subjects (< 5 Years of Age) The safety and effectiveness of XOFLUZA for treatment and post-exposure prophylaxis of influenza in pediatric subjects less than 5 years of age, including neonates, have not been established [see Warnings and Precautions (5.2) and Microbiology (12.4) ].

🧓 Geriatric Use 132 words ▾

8.5Geriatric Use The safety and effectiveness of XOFLUZA in subjects 65 years of age and older has been established and is supported by one randomized, double-blind, controlled trial [see Clinical Studies (14.2) ] . In Trial T0832, of 730 XOFLUZA-treated subjects at high risk of influenza-related complications, 209 (29%) subjects were 65 years of age and older. The median time to improvement of influenza symptoms in subjects 65 years of age and older was 70 hours in subjects who received XOFLUZA (N=112) and 88 hours in those who received placebo (N=102).

The safety profile observed for this population was similar to that reported in the overall trial population except for nausea, which was reported in 6% of elderly subjects compared to 1% of subjects from 18 to 64 years of age.

🆘 Overdosage 57 words ▾

10 OVERDOSAGE Treatment of an overdose of XOFLUZA should consist of general supportive measures, including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with XOFLUZA. Baloxavir is unlikely to be significantly removed by dialysis due to high serum protein binding [see Clinical Pharmacology (12.3) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Baloxavir marboxil is an antiviral drug with activity against influenza virus [see Microbiology (12.4) ].

12.2Pharmacodynamics Cardiac Electrophysiology At twice the expected exposure from recommended dosing, XOFLUZA did not prolong the QTc interval. Exposure-Response Relationships In patients 5 years of age and older, when XOFLUZA is dosed by weight as recommended, a flat baloxavir exposure-response (time to alleviation of influenza symptoms) relationship has been observed.

12.3Pharmacokinetics Baloxavir marboxil is a prodrug that is almost completely converted to its active metabolite, baloxavir, following oral administration. Baloxavir pharmacokinetic parameters are presented for healthy adults and adolescents as the mean [% coefficient of variation (%CV)], unless otherwise specified, in Table 5 . Absorption, distribution, metabolism, and elimination data for XOFLUZA is presented in Table 6 .

Table 5 Pharmacokinetic Parameters of Plasma Baloxavir in Adults and Adolescents (≥ 12 Years of Age) Pharmacokinetic Parameters of Plasma Baloxavir in Adults and Adolescents Trial T0831 summary data, mean (%CV) XOFLUZA dose 40 mg XOFLUZA dose 80 mg AUC (ng∙hr/mL) 5520 (46.3%) 6930 (48.6%) C max (ng/mL) 68.9 (44.9%) 82.5 (43.0%) C 24 (ng/mL) 50.9 (45.8%) 62.6 (45.9%) C 72 (ng/mL) 24.2 (45.5%) 30.8 (47.0%) Table 6 Baloxavir Absorption, Distribution, Metabolism, Elimination Data Absorption T max (hr) Median 4 Effect of food (relative to fasting) Meal: approximately 400 to 500 kcal including 150 kcal from fat C max : ↓48%, AUC 0-inf : ↓36% Distribution % bound to human serum proteins in vitro 92.9–93.9 Ratio of blood cell to blood 48.5%–54.4% Volume of distribution (V/F, L) Geometric mean (geometric CV%) 1180 (20.8%) Elimination Clearance (CL/F, L/hr) 10.3 (22.5%) Apparent terminal elimination half-life (hr) 79.1 (22.4%) Metabolism Metabolic pathways Primary: UGT1A3 Secondary: CYP3A4 Excretion % of dose excreted Ratio of radioactivity to radio-labeled baloxavir marboxil dose in mass balance study Urine: 14.7 (total radioactivity); 3.3 (baloxavir) Feces: 80.1 (total radioactivity) No clinically significant differences in the pharmacokinetics of baloxavir were observed based on age, sex, presence of risk factors for complicated influenza, creatinine clearance (CrCl: 50 mL/min and above), or moderate hepatic impairment (Child-Pugh class B).

The effect of severe renal or hepatic impairment on baloxavir pharmacokinetics has not been evaluated. Pediatrics (5 to < 12 Years of Age) Mean (CV%) baloxavir pharmacokinetics in pediatric subjects 5 to < 12 years of age are described in Table 7 . Following the approved recommended dosage, baloxavir exposures are similar in pediatric subjects (5 to < 12 years of age) compared to adult and adolescent subjects.

Table 7 Pharmacokinetic Parameters of Plasma Baloxavir in Pediatrics (5 to < 12 Years of Age) Pharmacokinetic Parameters of Plasma Baloxavir in Pediatrics Trial CP40563 summary data, mean (%CV); patients not receiving the recommended dose (n=3) were excluded XOFLUZA Dose for Subjects Weighing < 20 kg XOFLUZA Dose for Subjects Weighing ≥ 20 kg (n=8) (n=55) 2 mg/kg 40 mg AUC inf (ng.h/mL) 5830 (48.5) 4360 (48.9) C max (ng/mL) 148 (48.7) 81.1 (44.0) T max (h) Median (range) 3.5 (2-5.5) 4.5 (2-23.5) C24 (ng/mL) 77.9 (49.2) 52.4 (43.2) C72 (ng/mL) 19.3 (49.7) 18.0 (50.9) Body Weight Baloxavir exposure decreases as body weight increases.

No clinically significant difference in exposure was observed between body weight groups in adult and pediatric subjects following the approved recommended dosage. Race/Ethnicity Based on a population pharmacokinetic analysis, baloxavir exposure is approximately 35% lower in non-Asians as compared to Asians; this difference is not considered clinically significant when the recommended dose was administered. Drug Interaction Studies Clinical Studies No clinically significant changes in the pharmacokinetics of baloxavir mar…

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Baloxavir marboxil is an antiviral drug with activity against influenza virus [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING XOFLUZA is supplied as tablets (40 mg and 80 mg), granules (30 mg and 40 mg) that are reconstituted into a for oral suspension (packets) and as granules that are reconstituted into a for oral suspension (bottles) [40 mg/20 mL (2 mg/mL)] . The single oral dose to be administered depends on body weight [see Dosage and Administration (2.2) ]. XOFLUZA Tablets How Supplied 40 mg white to light yellow, oblong-shaped, film-coated tablets debossed with "BXM40" on one side available as: 1 × 40 mg tablet per blister card in secondary packaging: NDC 50242-860-01 80 mg white to light yellow, oblong shaped, film-coated tablets debossed with "BXM80" on one side available as: 1 × 80 mg tablet per blister card in secondary packaging: NDC 50242-877-01 Storage: Store tablets in their blister package at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

XOFLUZA for Oral Suspension (Packets) How Supplied: XOFLUZA for oral suspension (packets) are supplied as granules that are white to light yellow in packets. The granules are reconstituted in about 15 to 20 mL of room temperature drinking water to form an oral suspension. Each carton contains 1 packet available as: 1 × 30 mg packet: NDC 50242-599-01 1 × 40 mg packet: NDC 50242-617-01 There is no preservative.

Storage: Store granules (packets) at 20°C to 25°C (68°F to 77°F) and keep in the original package; excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. XOFLUZA for Oral Suspension (Bottles) How Supplied: XOFLUZA for oral suspension, 40 mg/20 mL (2 mg/mL) are supplied as white to light yellow granules in an amber glass bottle with a child-resistant cap. When reconstituted with drinking water or sterile water, the usable volume of the for oral suspension is 20 mL, equivalent to 40 mg of baloxavir marboxil.

XOFLUZA for oral suspension is available as: 40 mg/20 mL (2 mg/mL) for oral suspension: NDC 50242-583-01 There is no preservative. Must administer within 10 hours after reconstitution. Storage: Store granules (bottles) at 20°C to 25°C (68°F to 77°F) and keep in the original bottle; excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] .

Store reconstituted suspension no longer than 10 hours at 20°C to 25°C (68°F to 77°F) when reconstituted with drinking water or sterile water. The suspension must be discarded if not used within 10 hours of preparation or if suspension has been stored above 25°C (77°F).

📦 Storage and Handling 107 words ▾

Storage: Store tablets in their blister package at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Storage: Store granules (bottles) at 20°C to 25°C (68°F to 77°F) and keep in the original bottle; excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Store reconstituted suspension no longer than 10 hours at 20°C to 25°C (68°F to 77°F) when reconstituted with drinking water or sterile water. The suspension must be discarded if not used within 10 hours of preparation or if suspension has been stored above 25°C (77°F).

📋 Description ~1 min read ▾

11 DESCRIPTION Baloxavir marboxil is an influenza virus PA endonuclease inhibitor. The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate.

The empirical formula of baloxavir marboxil is C 27 H 23 F 2 N 3 O 7 S, and the chemical structure is shown below. Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water.

XOFLUZA is supplied as tablets and for oral suspension (in packets and in bottles). XOFLUZA tablets are white to light yellow, film-coated for oral administration . The 40 mg film-coated tablet contains 40 mg of baloxavir marboxil, and the 80 mg film-coated tablet contains 80 mg of baloxavir marboxil.

The inactive ingredients of XOFLUZA tablets are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide. XOFLUZA for oral suspension (packets) is supplied as white to light yellow granules in a packet. Each packet contains either 30 mg or 40 mg of baloxavir marboxil.

The granules must be reconstituted in about 15 to 20 mL of room temperature drinking water. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc. XOFLUZA for oral suspension (bottles) is supplied as white to light yellow granules in an amber glass bottle.

Each bottle contains 40 mg (nominal) of baloxavir marboxil. The granules must be reconstituted with 20 mL of drinking water or sterile water to yield a 2 mg/mL greyish white, white to light yellow opaque suspension with strawberry flavor. The inactive ingredients are: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Dosing Information Instruct patients to begin treatment with XOFLUZA as soon as possible at the first appearance of influenza symptoms, within 48 hours of onset of symptoms. Instruct patients to start taking XOFLUZA for prevention as soon as possible after exposure [see Dosage and Administration (2.2) ] .

XOFLUZA can be taken with or without food, but advise patients not to take with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) [see Dosage and Administration (2.2) and Drug Interactions (7.1) ] . Advise patients to follow the healthcare provider's dosing recommendation for a single, one-time dose of XOFLUZA. XOFLUZA is dosed based on weight and is available as tablets, and for oral suspension (packets and bottles).

XOFLUZA for oral suspension in a packet is not made into a suspension but rather mixed with a small amount of room temperature drinking water to aid administration. Tablets: Provided as a blister card containing either one tablet of 40 mg, or one tablet of 80 mg as a single dose [see Dosage and Administration (2.2) ] . For Oral Suspension: Provided in a packet containing either 30 mg or 40 mg baloxavir marboxil.

Advise patients or caregivers to read and follow the Instructions for Use for details on the preparation and administration (oral or via enteral feeding tube). XOFLUZA for oral suspension (packets) should be taken immediately after mixing and fully dispersing with water because the product does not contain a preservative [see Dosage and Administration (2.2 , 2.3) , and How Supplied/Storage and Handling (16) ] . Provided in a bottle containing 40 mg/20 mL (2 mg/mL) after reconstitution by the healthcare provider.

Advise the patients and/or caregiver to use a measuring device (oral syringe) to measure their prescribed dose. Counsel patients and/or caregivers how to use the measuring device (oral syringe) provided and inform patients that they may need to draw up XOFLUZA for oral suspension (bottles) multiple times using the oral syringe to receive the full dosage. The suspension should be taken as soon as possible but no later than 10 hours after reconstitution by the healthcare provider because the product does not contain a preservative [see Dosage and Administration (2.2 , 2.4) , and How Supplied/Storage and Handling (16) ] .

Hypersensitivity Advise patients and/or caregivers of the risk of severe allergic reactions such as anaphylaxis, angioedema, urticaria, and erythema multiforme. Instruct patients and/or caregivers to seek immediate medical attention if an allergic-like reaction occurs or is suspected [see Contraindications (4) and Warnings and Precautions (5.1) ]. Influenza Vaccines Because of the potential for antivirals to decrease the effectiveness of live attenuated influenza vaccines, advise patients to consult their healthcare provider prior to receiving a live attenuated influenza vaccine after taking XOFLUZA [see Drug Interactions (7.2) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50242-0717-01 · Genentech, 50242-0877-01 · Genentech, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.