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XOLREMDI mavorixafor 100 mg Capsule, Gelatin Coated, 60-count — NDC 83296-0100-60 package photo

XOLREMDI mavorixafor 100 mg Capsule, Gelatin Coated, 60-count

by X4 Pharmaceuticals, Inc. · 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60)
NDC 83296-0100-60
🏷️ FDA NDC (as labeled) 83296-100-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $398.45/unit — full pricing hub ↓
Also comes in: 90 capsules 83296-0100-90 120 capsules 83296-0100-12
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) 83296-100-60
Product NDC 83296-100
11-digit billing NDC 83296010060
NCPDP billing unit EA — each (per item)
RxCUI 2684026, 2684032
UNII 0G9LGB5O2W
Application # NDA218709
SPL Set ID 7f3a5ee3-ca73-4876-85a0-ed1e108a2237
Established class (EPC) CXC Chemokine Receptor 4 Antagonist
Mechanism of action CXC Chemokine Receptor 4 Antagonists; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-21
Route ORAL
Dosage form CAPSULE, GELATIN COATED
Substance MAVORIXAFOR
GPI-14 82502046000120
GCN Seq No 086022
GCN 55646
HICL code 049557
Ingredient (HICL) Mavorixafor
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1G
Therapeutic class — specific (HIC3) Cxcr4 Chemokine Receptor Antagonist
AHFS code 20:16.00.00
AHFS class Hematopoietic Agents
FDB label name XOLREMDI 100 MG CAPSULE
FDB brand name Xolremdi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 83296-100-60 — 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 → 83296-0100-60. 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 CXC Chemokine Receptor 4 Antagonist class.

Pharmacologic class CXC Chemokine Receptor 4 Antagonist
Drug family (ATC) Other immunostimulants
How it works Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, CXC Chemokine Receptor 4 Antagonists
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

LabelerX4 Pharmaceuticals, Inc.
Application holderX4 PHARMACEUTICALS INC
FDA applicationNDA218709 (NDA)
Labeler code83296
First marketedMay 2024
Product typeHuman Prescription Drug
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 XOLREMDI 100 MG CAPSULE Ingredient Mavorixafor

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 white
ShapeCapsule
Imprint100;mg;MX4
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 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.

6 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 $398.45 $23,906.71 / 60 capsules
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
Xolremdi 100 mgthis 83296-0100-60 X4 60 capsules — — 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

🏛️
2024
First FDA approval
Apr 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2038
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 Dec 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 26, 2024 RLD RS ⏳ ~12.2 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 11219621 — method of use (U-3932)
US 10610527 — method of use (U-3932)
US 11045461 — drug product
US 10953003 — drug product
US 12115156 — drug product
US 10548889 — drug product
Exclusivity NCE
Exclusivity ODE-480
2024 2026 2028 2030 2032 2034 2036 2038
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 (6)
PatentTypeUse codeExpires
US 11219621 ↗ Method of use U-3932 Dec 22, 2036
US 10610527 ↗ Method of use U-3932 Dec 22, 2036
US 11045461 ↗ Drug product — Dec 11, 2038
US 10953003 ↗ Drug product — Dec 14, 2036
US 12115156 ↗ Drug product — Dec 11, 2038
US 10548889 ↗ Drug product — Dec 11, 2038
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Apr 26, 2029
ODE-480Orphan Drug Exclusivity (7-year)Apr 26, 2031
Common questions
Is there a generic version of XOLREMDI 100 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for XOLREMDI 100 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2038 — 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.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Xolremdi — 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 Xolremdi. 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.
Total Part D spend
$635.8K
Claims incl. refills
15
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$42,388.49
💵 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 XOLREMDI (this brand).

Top reported reactions

Product Administration Error3
Nausea2
Product Storage Error2
Alopecia1
Anaemia1
Antidepressant Discontinuation Syndrome1
Arthralgia1

Reporter sex

8 reports
Male · 13%
Female · 88%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83296-0100-12 120 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-12) 2024-05-21 Active
83296-0100-60 You're viewing this 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60) 2024-05-21 Active
83296-0100-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-90) 2024-11-01 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 83296-0100-60?
NDC 83296-0100-60 is a 60-count package — 60 capsule, gelatin coated in 1 bottle.
What is the difference between NDC 83296-0100-60 and NDC 83296-0100-90?
Both are XOLREMDI mavorixafor 100 mg Capsule, Gelatin Coated — the drug itself is identical. NDC 83296-0100-60 is the 60-count package, while NDC 83296-0100-90 is the 90 capsules package.
What NDC number is used to bill for this package of XOLREMDI mavorixafor 100 mg Capsule, Gelatin Coated?
Bill NDC 83296-0100-60 — the 11-digit billing format is 83296010060. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83296-100-60, 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: 83296-0100-60, written without dashes as 83296010060. 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 83296-0100-60, the first segment (83296) is the labeler code FDA assigned to X4 Pharmaceuticals, Inc.; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 X4 Pharmaceuticals, 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 2 other package presentations of this same product, including 90 capsules (83296-0100-90), 120 capsules (83296-0100-12). 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?
X4 Pharmaceuticals, 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 71 words ▾

1 INDICATIONS AND USAGE XOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lympocytes. XOLREMDI is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. ( 1 )

⏱️ Dosage and Administration 181 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: Weight more than 50 kg: 400 mg orally once daily. ( 2 ) Weight less than or equal to 50 kg: 300 mg orally once daily. ( 2 ) Administer XOLREMDI on an empty stomach after an overnight fast, and at least 30 minutes before food. ( 2 )

2.1Recommended Dosage The recommended dosage of XOLREMDI is: Weight more than 50 kg: 400 mg orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food. Weight less than or equal to 50 kg: 300 mg orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food. Swallow the capsules whole.

Do not open, break, or chew capsules. If a dose of XOLREMDI is missed, the next dose should be taken as scheduled. Do not take more than 1 XOLREMDI dose each day.

2.2Dosage Modifications for Strong CYP3A4 inhibitors Reduce daily dosage of XOLREMDI to 200 mg when used concomitantly with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ] .

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 100 mg mavorixafor. ( 3 ) Capsules: 100 mg, opaque hard gelatin capsules with white body and light blue cap. The white capsule body is imprinted with "100 mg" in black ink, and the light blue capsule cap is imprinted with "MX4" in black ink.

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS Use of XOLREMDI is contraindicated with drugs that are highly dependent on CYP2D6 for clearance [see Drug Interactions (7.2) ] . Use with drugs highly dependent on CYP2D6 for clearance. ( 4 , 7.2 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-fetal toxicity: Expected to cause fetal harm. Advise women of reproductive potential to use effective contraception. ( 5.1 , 8.1 , 8.3 ) QTc Interval Prolongation: : Correct any modifiable risk factors, assess QTc at baseline and monitor QTc during treatment as clinically indicated. XOLREMDI dose reduction or discontinuation may be required due to drug-drug interactions. ( 5.2 )

5.1Embryo-Fetal Toxicity Based on its mechanism of action, XOLREMDI is expected to cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.2) ] . Animal models link reductions in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development and to abnormal placental development. Verify the pregnancy status of female patients of reproductive potential prior to starting XOLREMDI.

Advise females of reproductive potential to use an effective method of contraception during treatment with XOLREMDI and for 3 weeks after the final dose [see Use in Specific Populations (8.1 , 8.3) ] .

5.2QTc Interval Prolongation XOLREMDI causes concentration-dependent QTc interval prolongation. QTc interval prolongation may occur when XOLREMDI is taken with concomitant medications that increase XOLREMDI exposure and/or drug products with a known potential to prolong QTc. Correct any modifiable risk factors for QTc prolongation (e.g., hypokalemia), assess QTc at baseline and monitor QTc during treatment as clinically indicated in patients with risk factors for QTc prolongation such as those receiving concomitant medications that increase XOLREMDI exposure and drug products with a known potential to prolong QTc.

A dose reduction in XOLREMDI or discontinuation of XOLREMDI may be required [see Drug Interactions (7.1 , 7.3) and Clinical Pharmacology (12.2) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QTc Interval Prolongation [see Warnings and Precautions (5.2) ] The most common adverse reactions (›10% and at a frequency higher than placebo) were: thrombocytopenia, pityriasis, rash, rhinitis, epistaxis, vomiting, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact X4 Pharmaceuticals, Inc. at 1-866-MED-X4MI (1-866-633-9464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XOLREMDI was evaluated in Study 1, a randomized placebo-controlled trial of 31 adult and pediatric patients 12 years and older with WHIM syndrome [see Clinical Studies (14) ] . Patients received XOLREMDI 400 mg or 200 mg, based on age and body weight (N=14) or placebo (N=17).

One patient received the 200 mg dose, and 13 patients received the 400 mg dose. Note that the 200 mg XOLREMDI daily dose is only recommended for use in patients receiving strong CYP3A4 inhibitors [see Dosage and Administration (2.1 , 2.2) ] . For all other patients, the recommended dosage is either 400 mg daily (if weighing more than 50 kg) or 300 mg daily (if weighing up to 50 kg), unless dose reductions are needed due to concomitant use with moderate CYP3A4 inhibitors or P-gp inhibitors [see Drug Interactions (7.1) ] .

The data below are based on the 52-week, placebo-controlled portion of the study. Twelve patients received XOLREMDI for at least 6 months, and 10 patients received XOLREMDI for at least 1 year. Table 1 summarizes the most common adverse reactions (>10%) in Study 1, which were thrombocytopenia, pityriasis, rash, rhinitis, epistaxis, vomiting, and dizziness.

Table 1: Adverse Reactions in ≥10% Patients with WHIM Syndrome Receiving XOLREMDI and More Frequently Reported than Placebo During Study 1 Number (N) and Percent (%) of Patients Adverse Reaction XOLREMDI (N=14) Placebo (N=17) Thrombocytopenia 3 (21%) 0 Pityriasis 2 (14%) 0 Rash 2 (14%) 0 Rhinitis 2 (14%) 0 Epistaxis 2 (14%) 1 (6%) Vomiting 2 (14%) 1 (6%) Dizziness 2 (14%) 1 (6%) Serious adverse reactions of thrombocytopenia occurred in 3 of the 14 patients who received XOLREMDI, 2 of which occurred in the setting of infection or febrile neutropenia.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Reduce XOLREMDI daily dosage. ( 2.2 , 7.1 ) P-gp inhibitors or moderate CYP3A4 inhibitors: Monitor more frequently for XOLREMDI adverse reactions and reduce XOLREMDI daily dosage if necessary. ( 7.1 ) Strong CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) CYP3A4 or P-gp substrates: Monitor more frequently for substrate adverse reactions unless otherwise recommended. ( 7.2 )

7.1Effect of Other Drugs on XOLREMDI Strong or Moderate CYP3A4 Inhibitors Reduce XOLREMDI daily dosage to 200 mg when used concomitantly with a strong CYP3A4 inhibitor [see Dosage and Administration (2.2) ] . Monitor more frequently for XOLREMDI adverse reactions that may be associated with an increase in mavorixafor exposure when used concomitantly with moderate CYP3A4 inhibitor and reduce the XOLREMDI daily dosage by steps of 100 mg, if necessary, but not to a dose less than 200 mg. Mavorixafor is a CYP3A4 substrate.

Concomitant use with a strong CYP3A4 inhibitor increases mavorixafor maximal concentrations (C max ) and area under the concentration-time curve (AUC) [see Clinical Pharmacology (12.3) ] , which may increase the risk of XOLREMDI adverse reactions. Strong CYP3A4 Inducers Avoid concomitant use with a strong CYP3A4 inducer. Mavorixafor is a CYP3A4 substrate.

Concomitant use with a strong CYP3A4 inducer is predicted to decrease mavorixafor C max and AUC based upon a mechanistic understanding of its elimination [see Clinical Pharmacology (12.3) ] , which may reduce XOLREMDI's effectiveness. P-gp Inhibitors Monitor more frequently for XOLREMDI adverse reactions that may be associated with an increase in mavorixafor exposure when used concomitantly with P-gp inhibitors and reduce the XOLREMDI daily dosage by steps of 100 mg, if necessary, but not to a dose less than 200 mg.

Mavorixafor is a P-gp substrate. Concomitant use with a P-gp inhibitors increases mavorixafor C max and AUC [see Clinical Pharmacology (12.3) ] , which may increase the risk of XOLREMDI adverse reactions.

7.2Effect of XOLREMDI on Other Drugs CYP2D6 Substrates The use of XOLREMDI with drugs that are another drug highly dependent on CYP2D6 for clearance is contraindicated [see Contraindications (4) ] . Mavorixafor is a CYP2D6 inhibitor. Mavorixafor increases exposure of CYP2D6 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.

CYP3A4 Substrates Monitor for CYP3A4 substrate related adverse reactions more frequently, unless otherwise recommended in the substrate's Prescribing Information, when XOLREMDI is used concomitantly with CYP3A4 substrates where minimal substrate concentration changes may lead to serious adverse reactions. Mavorixafor is an inhibitor of CYP3A4. Mavorixafor may increase the C max and AUC of CYP3A4 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions from the CYP3A4 substrate.

P-gp Substrates Monitor for P-gp substrate related adverse reactions more frequently, unless otherwise recommended in the substrate's Prescribing Information, when XOLREMDI is used concomitantly with P-gp substrates where minimal substrate concentration changes may lead to serious adverse reactions. Digoxin: Measure serum digoxin concentrations before initiating concomitant use with XOLREMDI, and continue monitoring serum digoxin concentrations as recommended in the Prescribing Information for digoxin [see Clinical Pharmacology (12.3) ] .

Mavorixafor is an inhibitor of P-gp. Mavorixafor may increase the C max and AUC of P-gp substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions from the P-gp substrate. Metformin: Monitor for glycemic control and adjust the dose of metformin as necessary.

Mavorixafor may decrease the mean C max and AUC of metformin, which may reduce metformin's effectiveness. The mechanism of this interaction is unknown.

7.3 Drugs that Prolong the QTc Interval Obta…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise females that breastfeeding is not recommended. ( 8.2 ) Renal Impairment: Not recommended for use in patients with severe renal impairment or end stage renal disease. ( 8.6 ) Hepatic Impairment: Not recommended for use in patients with moderate to severe hepatic impairment. ( 8.7 )

8.1Pregnancy Risk Summary Based on its mechanism of action, XOLREMDI is expected to cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on XOLREMDI use in pregnant women informing the risk of embryo-fetal developmental toxicities. Animal models link reductions in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development (see Data ) .

No definitive animal studies have been conducted to evaluate the effect of mavorixafor on reproduction and fetal development. Advise pregnant women of the potential risk to the fetus and to use effective contraception [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . The estimated background risk of major birth defects and miscarriages 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 Animal reproduction studies have not been conducted with mavorixafor to evaluate effects on reproduction and embryo-fetal development.

CXCR4/SDF-1 signaling plays an important role in mammalian embryo-fetal and placental development. In mice, CXCR4-/- knockout is embryo lethal and causes multiple developmental toxicities, most notably in the hematopoietic, cardiovascular and nervous systems. CXCR4/SDF-1 levels have a key role in stimulating trophoblast proliferation and differentiation necessary for appropriate placental growth and function in humans [see Warnings and Precautions (5.1) ].

8.2Lactation Risk Summary There are no data on the presence of mavorixafor in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise females that breastfeeding is not recommended during treatment with XOLREMDI and for 3 weeks after the final dose.

8.3Females and Males of Reproductive Potential XOLREMDI is expected to cause fetal harm when administered to pregnant women [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating XOLREMDI [see Use in Specific Populations (8.1) ] . Contraception Advise females of reproductive potential to use an effective form of contraception during treatment with XOLREMDI and for 3 weeks after the final dose [see Use in Specific Populations (8.1) ].

8.4Pediatric Use The safety and effectiveness of XOLREMDI in WHIM syndrome for increasing the number of circulating mature neutrophils and lymphocytes have been established in pediatric patients aged 12 years and older. Use of XOLREMDI for this indication is supported by evidence from an adequate and well-controlled study in adults and pediatric patients aged 12 years and older [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of XOLREMDI have not been established in pediatric patients younger than 12 years of age.

8.5Geriatric Use In clinical studies of XOLREMDI in patients with WHIM syndrome, 2 (5%) patients were aged 65 years and older, and no patients were aged 75 years and older. Clinical studies did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

8.6Renal Impairment XOLREMDI is not recommended in patients with severe renal impairment (creatinine clearance [CLcr] 15 to…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action, XOLREMDI is expected to cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on XOLREMDI use in pregnant women informing the risk of embryo-fetal developmental toxicities. Animal models link reductions in CXCR4/SDF-1 signaling to adverse outcomes in mammalian embryo-fetal development (see Data ) .

No definitive animal studies have been conducted to evaluate the effect of mavorixafor on reproduction and fetal development. Advise pregnant women of the potential risk to the fetus and to use effective contraception [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . The estimated background risk of major birth defects and miscarriages 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 Animal reproduction studies have not been conducted with mavorixafor to evaluate effects on reproduction and embryo-fetal development.

CXCR4/SDF-1 signaling plays an important role in mammalian embryo-fetal and placental development. In mice, CXCR4-/- knockout is embryo lethal and causes multiple developmental toxicities, most notably in the hematopoietic, cardiovascular and nervous systems. CXCR4/SDF-1 levels have a key role in stimulating trophoblast proliferation and differentiation necessary for appropriate placental growth and function in humans [see Warnings and Precautions (5.1) ].

🧒 Pediatric Use 88 words ▾

8.4Pediatric Use The safety and effectiveness of XOLREMDI in WHIM syndrome for increasing the number of circulating mature neutrophils and lymphocytes have been established in pediatric patients aged 12 years and older. Use of XOLREMDI for this indication is supported by evidence from an adequate and well-controlled study in adults and pediatric patients aged 12 years and older [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of XOLREMDI have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use In clinical studies of XOLREMDI in patients with WHIM syndrome, 2 (5%) patients were aged 65 years and older, and no patients were aged 75 years and older. Clinical studies did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mavorixafor is an orally bioavailable CXCR4 antagonist that blocks the binding of the CXCR4 ligand, stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12). SDF-1/CXCR4 plays a role in trafficking and homing of leukocytes to and from the bone marrow compartment. Gain of function mutations in the CXCR4 receptor gene that occur in patients with WHIM syndrome lead to increased responsiveness to CXCL12 and retention of leukocytes in the bone marrow.

Mavorixafor inhibits the response to CXCL12 in both wild‑type and for mutated CXCR4 variants associated with WHIM syndrome. Treatment with mavorixafor results in increased mobilization of leukocytes and lymphocytes from the bone marrow into peripheral circulation.

12.2Pharmacodynamics Absolute Neutrophil Count (ANC) and Absolute Lymphocyte Count (ALC) ANC and ALC peaked at 4 hours after XOLREMDI dosing and returned towards baseline within 24 h after dosing. Over mavorixafor doses of 50 mg (0.125 times the maximum recommended dosage) to 400 mg once daily, higher mavorixafor exposure at steady state was associated with longer mean time (hours) above ANC threshold (TAT ANC ) of 500 cells/µL and longer mean time (hours) above ALC threshold (TAT ALC ) of 1,000 cells/µL over a 24-hour period.

Cardiac Electrophysiology In a thorough QT (TQT) study, the maximum mean increase in the QTc interval was 15.6 ms (upper bound of the 90% confidence interval = 19.8 ms) after administration of XOLREMDI 800 mg (2 times the maximum recommended dose) in healthy volunteers [ see Warnings and Precautions (5.2) ]. In concentration-QT analysis, increase in QTc interval was concentration-dependent.

12.3Pharmacokinetics Mavorixafor pharmacokinetic parameters are presented as geometric mean (CV%) in adults with WHIM syndrome unless otherwise specified. Mavorixafor steady state C max is 3304 (58.6%) ng/mL and the AUC from 0 to 24 hours (AUC 0-24h ) is 13970 (58.4%) ng*h/mL following 400 mg once daily. Mavorixafor demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in C max and AUC 0-24 over a dose range of 50 mg (0.125 times the recommended dosage) to 400 mg.

Mavorixafor steady state is reached after approximately 9 to 12 days at the highest approved recommended dosage in healthy subjects. Absorption Mavorixafor median (range) time to C max (T max ) is 2.8 hours (1.9 to 4 hours) at the highest approved recommended dosage. Effect of Food High Fat Meal: Mavorixafor C max decreased by 66% and AUC decreased by 55% following single-dose administration of XOLREMDI 400 mg with a high‑fat meal (1000 calories, 50% fat) to healthy subjects.

Low Fat Meal: Mavorixafor C max decreased by 55% and AUC decreased by 51% following single-dose administration of XOLREMDI 400 mg with a low-fat meal (500 calories, 25% fat) to healthy subjects. In addition, a 14% higher mavorixafor C max and 18% lower AUC was observed following single-dose administration of XOLREMDI 400 mg with a low-fat meal to healthy subjects after an overnight fast compared to fasting for an additional 4 hours after the XOLREMDI dose. Distribution Mavorixafor volume of distribution is 768 L.

Mavorixafor is >93% bound to human plasma proteins in vitro . Elimination Mavorixafor's terminal half-life is 82 h (34%) with an apparent clearance of 62 L/h (40%) following single-dose administration of XOLREMDI 400 mg in health subjects. Mavorixafor exhibits at least partial nonlinear apparent clearance; however, this is not clinically significant at the approved recommended dosage.

Metabolism CYP3A4 and, to a lesser extent, CYP2D6 are primarily responsible for mavorixafor metabolism. Excretion After a single oral dose of radiolabeled mavorixafor, 74.2% of the administered dose was recovered out of which 61.0% of administered radioactivity was recovered in feces and 13.2% (3% unchanged) was recovered in the urine over the 240-hour collection period in healthy subjects. Specific Po…

🧬 Mechanism of Action 109 words ▾

12.1Mechanism of Action Mavorixafor is an orally bioavailable CXCR4 antagonist that blocks the binding of the CXCR4 ligand, stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12). SDF-1/CXCR4 plays a role in trafficking and homing of leukocytes to and from the bone marrow compartment. Gain of function mutations in the CXCR4 receptor gene that occur in patients with WHIM syndrome lead to increased responsiveness to CXCL12 and retention of leukocytes in the bone marrow.

Mavorixafor inhibits the response to CXCL12 in both wild‑type and for mutated CXCR4 variants associated with WHIM syndrome. Treatment with mavorixafor results in increased mobilization of leukocytes and lymphocytes from the bone marrow into peripheral circulation.

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING XOLREMDI is supplied as an opaque white, hard gelatin capsule with a light blue cap, containing 100 mg of the active ingredient mavorixafor. The white capsule body is axially imprinted with "100 mg" in black ink, and the light blue capsule cap is axially imprinted with "MX4" in black ink. XOLREMDI is supplied in child-resistant bottles as follows: 60 count– NDC 83296-100-60 90 count - NDC 83296-100-90 120 count– NDC 83296-100-12 Store XOLREMDI refrigerated at 2°C to 8°C (36°F to 46°F).

Keep bottle tightly closed. Store in and dispense from original container to protect from moisture.

📦 Storage and Handling 25 words ▾

Store XOLREMDI refrigerated at 2°C to 8°C (36°F to 46°F). Keep bottle tightly closed. Store in and dispense from original container to protect from moisture.

📋 Description ~1 min read ▾

11 DESCRIPTION Mavorixafor is an orally bioavailable CXC Chemokine Receptor 4 (CXCR4) antagonist [see Clinical Pharmacology (12.1) ] . The chemical name of the active ingredient, mavorixafor, is N 1 -(1 H -benzimidazol-2-ylmethyl)- N 1 -[(8 S )-5,6,7,8-tetrahydroquinolin-8-yl]butane-1,4-diamine. It has a molecular formula of C 21 H 27 N 5 and a molecular weight of 349.48 g/mol.

Mavorixafor is of the S configuration and its structural formula is provided in Figure 1. Figure 1: Structural Formula Mavorixafor is optically active and is a white to pale yellow to light brown solid. Mavorixafor is hygroscopic above relative humidities of 70%.

Mavorixafor is freely soluble in methanol, 95% ethanol and n-octanol, soluble in toluene, sparingly soluble in DMSO and acetonitrile, and very slightly soluble in HPLC grade water according to the USP solubility criteria. Mavorixafor is soluble in pH 1.2 to 5.5 aqueous buffers and in pH 6.0 aqueous buffer, sparingly soluble in pH 6.8 aqueous buffer and slightly soluble in pH 7.5 aqueous buffer, according to the USP solubility criteria. XOLREMDI is a hard gelatin capsule for oral administration.

Each capsule contains 100 mg of mavorixafor with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. The hard gelatin capsule contains FD&C Blue #2, gelatin, and titanium dioxide. The Black Ink contains ammonium hydroxide 28%, ferrosoferric oxide/black iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze in ethanol.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Advise patients to take XOLREMDI on an empty stomach after an overnight fast, 30 minutes before food. Advise patients to swallow the capsules whole and not to open, break, or chew capsules [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) ] . Embryo-Fetal Toxicity XOLREMDI is expected to cause fetal harm.

Advise females of reproductive potential to use an effective form of contraception during treatment with XOLREMDI and for 3 weeks after the final dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use In Specific Populations (8.1) ] . Lactation Advise females that breastfeeding is not recommended during treatment with XOLREMDI and for 3 weeks after the final dose [see Use in Specific Populations (8.2) ] .

Drug Interactions Advise patients to avoid taking dietary supplements that include goldenseal, as it is a strong CYP3A4 inhibitor and may increase risk of adverse reactions to XOLREMDI. Advise patients to avoid taking dietary supplements that include St. John's Wort, as it is an inducer of CYP3A4 and may reduce the efficacy of XOLREMDI [see Drug Interactions (7.2) ] .

Food Interactions Advise patients to avoid eating or drinking products with grapefruit, as grapefruit is a strong CYP3A4 inhibitor and may increase the risk of adverse reactions to XOLREMDI [see Drug Interactions (7.1) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83295-8000-01 · Strand 83299-0029-01 · Consilii →
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.