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RHAPSIDO remibrutinib 25 mg Tablet, 60-count — NDC 00078-1483-92 package photo

RHAPSIDO remibrutinib 25 mg Tablet, 60-count

by Novartis Pharmaceuticals Corporation · 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE
NDC 00078-1483-92
🏷️ FDA NDC (as labeled) 0078-1483-92 billing pads the labeler segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $71.93/unit — full pricing hub ↓
Also comes in: 30 tablets 00078-1483-93 60 tablets 00078-1483-20
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) 0078-1483-92
Product NDC 0078-1483
11-digit billing NDC 00078148392
RxCUI 2724392, 2724398
UNII I7MVZ8HDNU
Application # NDA218436
SPL Set ID e5e89bff-6ced-4165-acc5-fb13136b3a3d
Established class (EPC) Kinase Inhibitor
Mechanism of action Bruton's Tyrosine Kinase Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-30
Route ORAL
Dosage form TABLET
Substance REMIBRUTINIB
GPI-14 99393765000320
GCN Seq No 088306
GCN 58417
HICL code 050918
Ingredient (HICL) Remibrutinib
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z24
Therapeutic class — specific (HIC3) Spleen/Bruton's Tyrosine Kinase Inhibitors
AHFS code 84:06.28.00
AHFS class Immunomodulatory Agents (84:06)
FDB label name RHAPSIDO 25 MG TABLET
FDB brand name Rhapsido
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0078-1483-92 — a 4-4-2 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 labeler segment → 00078-1483-92. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Selective immunosuppressants
How it works P-Glycoprotein Inhibitors, Bruton's Tyrosine Kinase 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

LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA218436 (NDA)
Labeler code00078
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio209 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 RHAPSIDO 25 MG TABLET Ingredient Remibrutinib
📖 What it is MedlinePlus · NLM

Remibrutinib is used to treat chronic spontaneous urticaria (CSU; a skin disease where hives appear and stay for longer than 6 weeks without a known trigger). Remibrutinib is in a class of medications called kinase inhibitors. It works by stopping the release of substances in the body that cause hives.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeRound
ImprintLV;IMPRINT
Size7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $71.93 $4,315.91 / 60 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
Rhapsido 25 mgthis 00078-1483-92 Novartis 60 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

🏛️
2025
First FDA approval
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2043
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 Jan 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 30, 2025 RLD RS ⏳ ~16.3 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 10457647 — method of use (U-4280)
US 12419889 — method of use (U-4281)
US 9512084 — drug substance
Exclusivity NCE
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (3)
PatentTypeUse codeExpires
US 10457647 ↗ Method of use U-4280 Nov 13, 2034
US 12419889 ↗ Method of use U-4281 Jan 19, 2043
US 9512084 ↗ Drug substance — Nov 13, 2034
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Sep 30, 2030
Common questions
Is there a generic version of RHAPSIDO 25 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for RHAPSIDO 25 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2043 — 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.

💊 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.
60 tablets00078-1483-20 12 Rx · $54,407
30 tablets this page00078-1483-92 No Medicaid data
30 tablets00078-1483-93 No Medicaid data
Drug total (last 4 qtrs): 12 Rx · 720 units · $54,407 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 Rhapsido — 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 Rhapsido. 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
$6.59M
Claims incl. refills
1.3K
Beneficiaries
733
Spend / beneficiary
$8,988.61
Spend / claim
$5,002.77
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 Remibrutinib — the ingredient across all brands.

Top reported reactions

Petechiae145
Urticaria128
Contusion92
Pruritus77
Headache67
Condition Aggravated44
Nausea43

Reporter sex

972 reports
Male · 20%
Female · 80%
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 731 9
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
00078-1483-20 60 TABLET in 1 BOTTLE (0078-1483-20) $72.46 / ea $4,347.73 2025-09-30 Active
00078-1483-92 You're viewing this 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE — — 2025-09-30 Active
00078-1483-93 30 TABLET in 1 BOTTLE (0078-1483-93) — — 2026-03-23 Active

Pack size FAQ

What quantity is in NDC 00078-1483-92?
NDC 00078-1483-92 is a 60-count package — 2 bottle in 1 carton / 30 tablet in 1 bottle.
What is the difference between NDC 00078-1483-92 and NDC 00078-1483-93?
Both are RHAPSIDO remibrutinib 25 mg Tablet — the drug itself is identical. NDC 00078-1483-92 is the 60-count package, while NDC 00078-1483-93 is the 30 tablets package.
What NDC number is used to bill for this package of RHAPSIDO remibrutinib 25 mg Tablet?
Bill NDC 00078-1483-92 — the 11-digit billing format is 00078148392. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 0078-1483-92, 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: 00078-1483-92, written without dashes as 00078148392. 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 00078-1483-92, the first segment (00078) is the labeler code FDA assigned to Novartis Pharmaceuticals Corporation; the middle segment (1483) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (92) 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 Novartis Pharmaceuticals Corporation. 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 2 other package presentations of this same product, including 30 tablets (00078-1483-93), 60 tablets (00078-1483-20). 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?
Novartis Pharmaceuticals Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 79 words ▾

1 INDICATIONS AND USAGE RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.

( 1 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1 )

⏱️ Dosage and Administration 158 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage is 25 mg orally twice daily with or without food. ( 2.1 ) Swallow tablets whole. Do not split, crush, or chew RHAPSIDO. ( 2.1 ) Interrupt RHAPSIDO for 3 to 7 days pre- and post-surgery. ( 2.2 )

2.1Recommended Dosage The recommended dosage is 25 mg taken orally twice daily with or without food. Swallow RHAPSIDO tablet whole with water. Do not split, crush, or chew RHAPSIDO. Missed Dose(s) If a dose or doses of RHAPSIDO is missed, skip the missed dose, and take the next dose at its regularly scheduled time. Do not take an extra dose(s) of RHAPSIDO to make up for a missed dose(s).

2.2Temporary Interruption of RHAPSIDO for Surgery Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding [see Warnings and Precautions (5.1), Adverse Reactions (6.1) and Drug Interactions (7.2)] .

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, light yellow, round, curved, unscored, film-coated tablet, debossed with “LV” on one side and Novartis logo on the other side. The tablet diameter is 7 mm. Tablets: 25 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 196 words ▾

5 WARNINGS AND PRECAUTIONS Risk of Bleeding: Monitor for signs and symptoms of bleeding. Interrupt treatment with RHAPSIDO if bleeding is observed or pre- and post-surgery. Concomitant use of antithrombotic agents with RHAPSIDO may further increase risk of bleeding. ( 5.1 ) Live Attenuated Vaccines: Avoid live or live-attenuated vaccines in patients receiving RHAPSIDO. ( 5.2 )

5.1Risk of Bleeding In placebo-controlled studies in patients with CSU, mucocutaneous-related bleeding occurred in 9% of patients who received RHAPSIDO [see Adverse Reactions (6.1)] . Interrupt treatment with RHAPSIDO if bleeding is observed and resume if the benefit is expected to outweigh the risk. Interrupt treatment with RHAPSIDO for 3 to 7 days pre- and post-surgery or invasive procedures [see Dosage and Administration (2.2)] .

Use of antithrombotic agents concomitantly with RHAPSIDO may further increase the risk of bleeding [see Drug Interactions (7.2)] . Consider the benefits and risks of antithrombotic agents when used concomitantly with RHAPSIDO. Monitor for signs and symptoms of bleeding.

5.2Live Attenuated Vaccines No data are available on the effects of live or live-attenuated vaccines in patients receiving RHAPSIDO. The use of live and live-attenuated vaccines should be avoided in patients receiving RHAPSIDO.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 drug reaction (ADR) 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 RHAPSIDO was based on a pooled safety population from two identical clinical trials of 52 weeks duration, REMIX-1 and REMIX-2 [see Clinical Studies (14)] . The pooled safety population consisted of 912 adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and who received RHAPSIDO 25 mg orally twice daily (N=606) or placebo (N=306) for 24 weeks during the double-blind, controlled treatment period of the trial.

Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than the placebo group from the pooled safety population (REMIX-1 and REMIX-2) during the 24-week blinded, placebo-controlled treatment period are shown in Table 1. Table 1 Adverse Reactions with RHAPSIDO with Incidence ≥3% and More Common than Placebo in Adult Patients with CSU (REMIX-1 and REMIX-2) a includes acute sinusitis, chronic sinusitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, rhinitis, rhinitis allergic, and upper respiratory tract infection b includes conjunctival bleeding, contusion, ecchymosis, epistaxis, gingival bleeding, hematoma, hematuria, hemorrhagic ovarian cyst, intermenstrual bleeding, petechiae, purpura, and urinary occult blood c includes headache and migraine d includes abdominal discomfort, abdominal distention, abdominal pain and abdominal pain upper Adverse Reaction RHAPSIDO (N = 606) n (%) Placebo (N = 306) n (%) Nasopharyngitis a 67 (11%) 27 (9%) Bleeding b 55 (9%) 6 (2%) Headache c 41 (7%) 19 (6%) Nausea 18 (3%) 5 (2%) Abdominal Pain d 18 (3%) 6 (2%) Specific Adverse Reactions Bleeding In the pooled safety population (REMIX-1 and REMIX-2), bleeding occurred in 9% of patients treated with RHAPSIDO compared to 2% in the placebo group during the 24-week controlled treatment period [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Drug Interactions (7.2)] .

Petechiae (4%) and contusion (2%) were the most commonly reported reactions in patients treated with RHAPSIDO. No severe bleeding reactions occurred. No association between bleeding reactions and low platelet counts was observed.

In patients treated with RHAPSIDO, 0.5% experienced bleeding reactions that led to RHAPSIDO discontinuation, while none of these reactions occurred in the placebo group. Similar safety findings were observed through Week 52 [see Clinical Studies (14)] .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Strong or Moderate CYP3A4 Inhibitors: Avoid concomitant use with RHAPSIDO. ( 7.1 ) Strong or Moderate CYP3A4 Inducers: Avoid concomitant use with RHAPSIDO. ( 7.1 ) P-gp Substrates: Exposure increases where minimal concentration changes may lead to serious adverse reactions: Monitor more frequently for adverse reactions when used concomitantly with RHAPSIDO.

( 7.2 ) Antithrombotic Agents: Consider the risks and benefits of concomitant use of antithrombotic agents with RHAPSIDO. ( 7.2 )

7.1Effect of Other Drugs on RHAPSIDO Strong or Moderate CYP3A4 Inhibitors Avoid use of RHAPSIDO with strong or moderate CYP3A4 inhibitors. Remibrutinib is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inhibitor increases remibrutinib exposure [see Clinical Pharmacology (12.3)] , which may increase the risk of RHAPSIDO adverse reactions.

Strong or Moderate CYP3A4 Inducers Avoid use of RHAPSIDO with strong or moderate CYP3A4 inducers. Remibrutinib is a CYP3A4 substrate. Concomitant use with a strong or moderate CYP3A4 inducer decreases remibrutinib exposure [see Clinical Pharmacology (12.3)] , which may decrease the efficacy of RHAPSIDO.

7.2Effect of RHAPSIDO on Other Drugs P-gp Substrates Monitor more frequently for adverse reactions when using RHAPSIDO with P-glycoprotein (P-gp) substrates where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin). Remibrutinib is a P-gp inhibitor. Remibrutinib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to P-gp substrates [see Clinical Pharmacology (12.3)] .

Antithrombotic Agents Consider the risks and benefits of concomitant administration of antithrombotic agents with RHAPSIDO [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Adverse Reactions (6.1)] . No data are available on concomitant use of RHAPSIDO with anticoagulants. The concomitant use of RHAPSIDO and anticoagulants was not allowed in clinical studies.

Use of the antiplatelet agents, acetyl salicylic acid at doses up to 100 mg daily or clopidogrel up to 75 mg daily, was allowed in the RHAPSIDO clinical studies.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Mild, Moderate, or Severe Hepatic Impairment: Avoid use of RHAPSIDO. ( 8.6 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy. Pregnant women exposed to RHAPSIDO and healthcare providers are encouraged to contact Novartis Pharmaceuticals Corporation at 1-888-669-6682. Risk Summary Available data on the use of RHAPSIDO during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of remibrutinib to pregnant rabbits during organogenesis at exposures 141-times the human exposure at the maximum recommended human dose (MRHD) of 25 mg twice daily based on area under the curve (AUC) resulted in adverse developmental outcomes including external malformations. No adverse developmental effects were observed with oral administration of remibrutinib to pregnant rats during organogenesis at exposures up to 126-times the human exposure at the MRHD (see Data) .

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

Data Animal Data In an embryo-fetal development (EFD) study in pregnant rabbits, remibrutinib was administered orally at doses of 100, 300, and 450 mg/kg/day during the period of organogenesis. Increased fetal external malformations (e.g. open/opaque eyes, small jaws, hyperflexion of forelimbs) and maternal toxicity (transiently reduced food consumption and adverse clinical signs) occurred at 300 mg/kg/day (141-times the MRHD based on AUC). The fetal findings were considered unlikely to be secondary to the maternal toxicity.

The dose of 450 mg/kg/day was not tolerated by the pregnant rabbits. In an EFD study in pregnant rats, remibrutinib was administered orally at doses of 100, 300, and 1000 mg/kg/day during the period of organogenesis. Remibrutinib did not cause adverse effects to the fetus at exposures up to 126 times that at the MRHD based on AUC.

In a pre- and postnatal development (PPND) study, remibrutinib was administered orally to pregnant rats at doses of 100, 300, and 1000 mg/kg/day from gestation day 6 to lactation day (LD) 21. Remibrutinib induced adverse effects at 1000 mg/kg/day (approximately 194 times the MRHD based on body surface area [BSA]), affected maternal animals (moribundity and clinical signs of toxicity, slightly longer gestation lengths) and offspring up to LD1 (slightly higher mean number of stillborn, dead, or missing pups, and smaller mean litter size).

No adverse effects at doses up to 1000 mg/kg/day were noted in the surviving offspring developing into adulthood. No effects were observed at 300 mg/kg/day (approximately 58 times the MRHD based on BSA).

8.2Lactation Risk Summary No data are available regarding the presence of remibrutinib in either human or animal milk, its effects on the breastfed child, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RHAPSIDO and any potential adverse effects on the breastfed child from RHAPSIDO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of RHAPSIDO have not been established in pediatric patients.

8.5Geriatric Use Of the total number of patients treated with RHAPSIDO in clinical studies for CSU, 53 (8.7%) were 65 to 85 years of age, with no patients over 85 years of age [see Clinical Studies (14)] . There were no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.

8.6 Hepatic Impai…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy. Pregnant women exposed to RHAPSIDO and healthcare providers are encouraged to contact Novartis Pharmaceuticals Corporation at 1-888-669-6682. Risk Summary Available data on the use of RHAPSIDO during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of remibrutinib to pregnant rabbits during organogenesis at exposures 141-times the human exposure at the maximum recommended human dose (MRHD) of 25 mg twice daily based on area under the curve (AUC) resulted in adverse developmental outcomes including external malformations. No adverse developmental effects were observed with oral administration of remibrutinib to pregnant rats during organogenesis at exposures up to 126-times the human exposure at the MRHD (see Data) .

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

Data Animal Data In an embryo-fetal development (EFD) study in pregnant rabbits, remibrutinib was administered orally at doses of 100, 300, and 450 mg/kg/day during the period of organogenesis. Increased fetal external malformations (e.g. open/opaque eyes, small jaws, hyperflexion of forelimbs) and maternal toxicity (transiently reduced food consumption and adverse clinical signs) occurred at 300 mg/kg/day (141-times the MRHD based on AUC). The fetal findings were considered unlikely to be secondary to the maternal toxicity.

The dose of 450 mg/kg/day was not tolerated by the pregnant rabbits. In an EFD study in pregnant rats, remibrutinib was administered orally at doses of 100, 300, and 1000 mg/kg/day during the period of organogenesis. Remibrutinib did not cause adverse effects to the fetus at exposures up to 126 times that at the MRHD based on AUC.

In a pre- and postnatal development (PPND) study, remibrutinib was administered orally to pregnant rats at doses of 100, 300, and 1000 mg/kg/day from gestation day 6 to lactation day (LD) 21. Remibrutinib induced adverse effects at 1000 mg/kg/day (approximately 194 times the MRHD based on body surface area [BSA]), affected maternal animals (moribundity and clinical signs of toxicity, slightly longer gestation lengths) and offspring up to LD1 (slightly higher mean number of stillborn, dead, or missing pups, and smaller mean litter size).

No adverse effects at doses up to 1000 mg/kg/day were noted in the surviving offspring developing into adulthood. No effects were observed at 300 mg/kg/day (approximately 58 times the MRHD based on BSA).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of RHAPSIDO have not been established in pediatric patients.

🧓 Geriatric Use 56 words ▾

8.5Geriatric Use Of the total number of patients treated with RHAPSIDO in clinical studies for CSU, 53 (8.7%) were 65 to 85 years of age, with no patients over 85 years of age [see Clinical Studies (14)] . There were no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.

🆘 Overdosage 17 words ▾

10 OVERDOSAGE Consider contacting the poison help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes. BTK is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR).

Remibrutinib also inhibits the BTK-related kinases tec protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX). Remibrutinib inhibits mast cell and basophil degranulation, including release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG directed against the FcεR1 or IgE.

12.2Pharmacodynamics Exposure-Response Within the range from 0.2 to 4 times the daily recommended dose, a flat dose-response relationship was observed for the weekly urticaria activity score (UAS7) at Week 4. Cardiac Electrophysiology At concentrations approximately 9 times the mean steady state peak plasma concentrations provided by the recommended dose, clinically significant QTc prolongation was not observed. Effects on Blood Pressure The effect of remibrutinib treatment on blood pressure was assessed in CSU patients using a 24-hour blood pressure measurement by ambulatory blood pressure monitoring (ABPM) at steady state (Week 4) compared to baseline in a multi-center, open-label study (A2305).

The study enrolled 144 patients with CSU inadequately controlled by H1 antihistamines, who were administered remibrutinib 25 mg twice daily. Remibrutinib 25 mg twice daily was not associated with clinically significant changes in blood pressure.

12.3Pharmacokinetics Following administration of remibrutinib 25 mg twice daily, the mean (standard deviation) C max is 57 (27) ng/mL and AUC last is 193 (136) ng*h/mL at steady state. Remibrutinib C max and AUC increase in a dose-proportional manner between 0.4 to 4 times the recommended dosage. Following administration of multiple doses of 25 mg twice daily, C max increases 1.6-fold and AUC 0-4 increases 2.7-fold.

No clinically significant differences in remibrutinib pharmacokinetics were observed between healthy subjects and patients with CSU. Absorption Remibrutinib median (min, max) time to maximum plasma concentration (T max ) is 1 hour (0, 4 hours) at steady state. Effect of food No clinically significant differences in remibrutinib pharmacokinetics were observed following administration of a high-fat meal (1000 calories, 50% fat).

Distribution Remibrutinib blood-to-plasma ratio is 0.813 in vitro. Plasma protein binding is 95.4% and is not concentration-dependent in vitro. The estimated remibrutinib steady state apparent (oral) volume of distribution is 1238 L.

Elimination Remibrutinib estimated elimination half-life is 1 to 2 hours with an apparent (oral) clearance of 160 L/hr. Metabolism Remibrutinib is primarily metabolized by CYP3A4. Excretion Following IV administration of 14 C remibrutinib to healthy subjects, 70% of the total radioactivity was recovered in feces (0% as unchanged remibrutinib), and 30% was recovered in urine (2.9% as unchanged remibrutinib).

Specific Populations No clinically significant differences in the pharmacokinetics of remibrutinib were observed based on age (range: 18 to 80 years), sex (63.5% females and 36.5% males), race/ethnicity (59.3% Non-Asian [White, Black, and Others], 8.8% Mainland Chinese, 12.2% Japanese, and 19.7% other Asian), body weight (range: 39 to 162 kg), and mild (eGFR 60-89 mL/min/1.73 m 2 , estimated by Cockcroft-Gault), moderate (eGFR 30-59 mL/min/1.73 m 2 ) or severe (eGFR 15-29 mL/min/1.73 m 2 ) renal impairment. Patients with Hepatic Impairment The pharmacokinetics of remibrutinib were evaluated in subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), and severe (Child-Pugh Class C) hepatic impairment following administration of 25 mg twice daily.

Relative to patients with normal hepatic functi…

🧬 Mechanism of Action 99 words ▾

12.1Mechanism of Action Remibrutinib is an oral, small molecule kinase inhibitor that inhibits Bruton’s tyrosine kinase (BTK). BTK is an intracellular protein expressed in mast cells, basophils, B cells, macrophages, and thrombocytes. BTK is involved in intracellular signaling via Fc epsilon receptor-1 (FcεR1), Fc gamma receptors (FcγR), and the B cell antigen receptor (BCR).

Remibrutinib also inhibits the BTK-related kinases tec protein tyrosine kinase (TEC) and BMX non-receptor tyrosine kinase (BMX). Remibrutinib inhibits mast cell and basophil degranulation, including release of histamine and other proinflammatory mediators, mediated by pathogenic IgE or IgG directed against the FcεR1 or IgE.

📦 How Supplied / Storage and Handling 107 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RHAPSIDO tablets are supplied as described in Table 4: Table 4 RHAPSIDO Tablets and Package Configuration Strength Tablet Description Package Configuration NDC 25 mg light yellow, round, curved, unscored, film-coated tablet, debossed with “LV” on one side and Novartis logo on the other side. Tablet diameter is 7 mm. 40 mL HDPE bottle containing 60 tablets with 2 gm silica gel and a child-resistant closure 0078-1483-20 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense and store in the original container in order to protect from moisture.

📋 Description 123 words ▾

11 DESCRIPTION RHAPSIDO (remibrutinib) is a kinase inhibitor. Its empirical formula (remibrutinib) is C 27 H 27 F 2 N 5 O 3 . The chemical name for remibrutinib is N-(3-{6-Amino-5-[2-(N-methylprop-2-enamido)ethoxy]pyrimidin-4-yl}-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide.

Its molecular weight is approximately 507.54 g/mol. The chemical structure of remibrutinib is: Remibrutinib is white to pale yellow powder, and it is practically insoluble in water. RHAPSIDO is supplied as film-coated tablets for oral administration, with each film-coated tablet containing 25 mg of remibrutinib.

The tablet core inactive ingredients are copovidone, croscarmellose sodium, mannitol, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet coating inactive ingredients are polyethylene glycol 4000, polyvinyl alcohol, red iron oxide (E172), talc, titanium dioxide (E171), and yellow iron oxide (E172). chemical structure of remibrutinib

💬 Information for Patients 211 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information). Administration Instructions: Inform patients to take RHAPSIDO with or without food. Advise patients not to split, crush, or chew the tablet and to swallow the tablet whole with water [see Dosage and Administration (2.1)] .

Risk of Bleeding: Inform patients that bleeding can occur with the use of RHAPSIDO, and to report any signs and symptoms to their healthcare practitioner. Inform patients that RHAPSIDO should be interrupted for 3 to 7 days for any surgical procedures. Instruct patients to inform their healthcare practitioner if they use RHAPSIDO with antithrombotic agents due to the potential increased risk of bleeding [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)] .

Live Attenuated Vaccines: Instruct patients to inform the healthcare practitioner that they are taking RHAPSIDO prior to any potential vaccinations. Advise patients that the vaccines containing live virus (live and live-attenuated) should not be given during treatment with RHAPSIDO [see Warnings and Precautions (5.2)] . Pregnancy: Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy [see Use in Specific Populations (8.1)] .

Distributed by: Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, New Jersey 07936 © Novartis T2025-55

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