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XPHOZAH 20 mg Tenapanor 20 mg Tablet, Film Coated, 14-count — NDC 73154-0120-14 package photo

XPHOZAH 20 mg Tenapanor 20 mg Tablet, Film Coated, 14-count

by Ardelyx, Inc. · 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-14)
NDC 73154-0120-14
🏷️ FDA NDC (as labeled) 73154-120-14 billing pads the product segment with a zero
This package
Contains14-count Pack sizes3 compare ↓
Also comes in: 14 tablets 73154-0120-99 60 tablets 73154-0120-60
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) 73154-120-14
Product NDC 73154-120
11-digit billing NDC 73154012014
RxCUI 2669440, 2669446, 2669448, 2669450, 2669452, 2669454
UNII 50605O2ZNS
Application # NDA213931
SPL Set ID c57e279c-0f1b-4238-81b7-4e0dc0cc60c5
Established class (EPC) Sodium-Hydrogen Exchanger 3 Inhibitor
Mechanism of action Organic Anion Transporting Polypeptide 2B1 Inhibitors; Sodium-Hydrogen Exchanger 3 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance TENAPANOR HYDROCHLORIDE
GPI-14 30903260600325
GCN Seq No 085414
GCN 54891
HICL code 046009
Ingredient (HICL) Tenapanor Hcl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1A
Therapeutic class — specific (HIC3) Electrolyte Depleters
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name XPHOZAH 20 MG TABLET
FDB brand name Xphozah
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 73154-120-14 — 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 → 73154-0120-14. 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 Sodium-Hydrogen Exchanger 3 Inhibitor class.

Pharmacologic class Sodium-Hydrogen Exchanger 3 Inhibitor
Drug family (ATC) Other drugs for constipation
How it works Organic Anion Transporting Polypeptide 2B1 Inhibitors, Sodium-Hydrogen Exchanger 3 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

LabelerArdelyx, Inc.
Application holderARDELYX INC
FDA applicationNDA213931 (NDA)
Labeler code73154
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio4 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 XPHOZAH 20 MG TABLET Ingredient Tenapanor Hcl
📖 What it is MedlinePlus · NLM

Tenapanor is used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) in adults. Tenapanor is in a class of medications called sodium/hydrogen exchanger (NHE3) inhibitors. It works by increasing the movement of food and waste through the stomach and intestines.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on which brand you have. Ibsrela is prescribed for irritable bowel syndrome with constipation — that means belly pain and not being able to go regularly. XPHOZAH is a co...
  • Yes, timing genuinely matters here. Studies showed that taking tenapanor 5 to 10 minutes before a meal — rather than during or after — produces the best effect. For Ibsrela, take i...
  • Why do I need to take it right before eating — does timing really matter?
  • Diarrhea is by far the most common side effect — it happened in about 1 in 6 people taking Ibsrela in clinical trials. You may also notice bloating, gas, or some dizziness. Mild di...
📖 Read our full Tenapanor guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow / Brown
ShapeOval
ImprintA;T30
Size12 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 tablets 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
XPHOZAH 20 mgthis 73154-0120-14 Ardelyx, 14 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

🏛️
2023
First FDA approval
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2042
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 Nov 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 17, 2023 RLD RS ⏳ ~16.2 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 10940146 — method of use (U-381)
US 10940146 — method of use (U-3736)
US 10940146 — method of use (U-3736)
US 10940146 — method of use (U-3736)
US 10940146 — method of use (U-381)
US 10940146 — method of use (U-381)
US 10272079 — method of use (U-381)
US 10272079 — method of use (U-3736)
US 10272079 — method of use (U-3736)
US 10272079 — method of use (U-3736)
US 10272079 — method of use (U-381)
US 10272079 — method of use (U-381)
US 8969377 — drug substance
US 12539299 — drug product
US 12016856 — drug substance
US 8541448 — drug substance
US 12539299 — drug product
US 8541448 — drug substance
US 8969377 — drug substance
US 12539299 — drug product
US 8969377 — drug substance
US 12016856 — drug substance
US 12016856 — drug substance
US 8541448 — drug substance
Exclusivity NP
Exclusivity NP
Exclusivity NP
2023 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 (24)
PatentTypeUse codeExpires
US 10940146 ↗ Method of use U-381 Apr 10, 2034
US 10940146 ↗ Method of use U-3736 Apr 10, 2034
US 10940146 ↗ Method of use U-3736 Apr 10, 2034
US 10940146 ↗ Method of use U-3736 Apr 10, 2034
US 10940146 ↗ Method of use U-381 Apr 10, 2034
US 10940146 ↗ Method of use U-381 Apr 10, 2034
US 10272079 ↗ Method of use U-381 Apr 10, 2034
US 10272079 ↗ Method of use U-3736 Apr 10, 2034
US 10272079 ↗ Method of use U-3736 Apr 10, 2034
US 10272079 ↗ Method of use U-3736 Apr 10, 2034
US 10272079 ↗ Method of use U-381 Apr 10, 2034
US 10272079 ↗ Method of use U-381 Apr 10, 2034
US 8969377 ↗ Drug substance — Dec 30, 2029
US 12539299 ↗ Drug product — Nov 26, 2042
US 12016856 ↗ Drug substance — Dec 30, 2029
US 8541448 ↗ Drug substance — Aug 1, 2033
US 12539299 ↗ Drug product — Nov 26, 2042
US 8541448 ↗ Drug substance — Aug 1, 2033
US 8969377 ↗ Drug substance — Dec 30, 2029
US 12539299 ↗ Drug product — Nov 26, 2042
US 8969377 ↗ Drug substance — Dec 30, 2029
US 12016856 ↗ Drug substance — Dec 30, 2029
US 12016856 ↗ Drug substance — Dec 30, 2029
US 8541448 ↗ Drug substance — Aug 1, 2033
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductOct 17, 2026
NPNew ProductOct 17, 2026
NPNew ProductOct 17, 2026
Common questions
Is there a generic version of XPHOZAH 20 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for XPHOZAH 20 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2042 — 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 tablets73154-0120-60 1,648 Rx · $5,328,806
14 tablets this page73154-0120-14 No Medicaid data
14 tablets73154-0120-99 No Medicaid data
Drug total (last 4 qtrs): 1,648 Rx · 98,584 units · $5,328,806 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 XPHOZAH 20 mg (this brand).

Top reported reactions

Nausea3
Asthenia2
Cough2
Diarrhoea2
Drug Ineffective For Unapproved Indication2
Gastrointestinal Disorder2
Pre-existing Condition Improved2

Reporter sex

20 reports

Serious outcomes

Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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
73154-0120-14 You're viewing this 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-14) 2023-10-17 Active
73154-0120-60 60 TABLET, FILM COATED in 1 BOTTLE (73154-120-60) 2023-10-17 Active
73154-0120-99 14 TABLET, FILM COATED in 1 BOTTLE (73154-120-99) 2023-10-17 Active

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 73154-0120-14?
NDC 73154-0120-14 is a 14-count package — 14 tablet, film coated in 1 bottle.
What is the difference between NDC 73154-0120-14 and NDC 73154-0120-99?
Both are XPHOZAH 20 mg Tenapanor 20 mg Tablet, Film Coated — the drug itself is identical. NDC 73154-0120-14 is the 14-count package, while NDC 73154-0120-99 is the 14 tablets package.
What NDC number is used to bill for this package of XPHOZAH 20 mg Tenapanor 20 mg Tablet, Film Coated?
Bill NDC 73154-0120-14 — the 11-digit billing format is 73154012014. 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) — 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 73154-120-14, 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: 73154-0120-14, written without dashes as 73154012014. 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 73154-0120-14, the first segment (73154) is the labeler code FDA assigned to Ardelyx, Inc.; the middle segment (0120) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 Ardelyx, 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 14 tablets (73154-0120-99), 60 tablets (73154-0120-60). 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?
Ardelyx, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 94 words ▾

1 INDICATIONS AND USAGE XPHOZAH is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a sodium hydrogen exchanger 3 (NHE3) inhibitor indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy ( 1 ).

⏱️ Dosage and Administration 182 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: 30 mg orally twice daily before the morning and evening meals ( 2.1 ). Manage serum phosphorus levels and tolerability with dosage adjustments ( 2.1 ). Take just prior to the first and last meals of the day ( 2.2 ). Instruct patients not to take right before a hemodialysis session, and instead take right before the next meal following dialysis ( 2.2 ).

2.1Recommended Dosage The recommended dosage is 30 mg orally twice daily before the morning and evening meals. Monitor serum phosphorus and adjust the dosage as needed to manage gastrointestinal tolerability.

2.2Administration Instructions Instruct patients to take XPHOZAH just prior to the first and last meals of the day [see Clinical Pharmacology (12.2) ] . Instruct patients not to take XPHOZAH right before a hemodialysis session, and instead take right before the next meal following dialysis, as patients may experience diarrhea after taking XPHOZAH [see Warnings and Precautions (5.1) ] . Instruct patients who miss a dose to skip the missed dose and take the next dose at the regular time.

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS XPHOZAH tablets available as: 10 mg tenapanor supplied as a yellow, oval, biconvex film-coated tablet debossed with " " on one side and "T10" on the other side. 20 mg tenapanor supplied as a brown, oval, biconvex film-coated tablet debossed with " " on one side and "T20" on the other side. 30 mg tenapanor supplied as a red, oval, biconvex film-coated tablet debossed with " " on one side and "T30" on the other side.

Tablets: 10 mg, 20 mg, 30 mg ( 3 ). Image Image Image

⛔ Contraindications 66 words ▾

4 CONTRAINDICATIONS XPHOZAH is contraindicated in patients under 6 years of age because of the risk of diarrhea and serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.5) ]. XPHOZAH is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Pediatric patients under 6 years of age ( 4 ). Patients with known or suspected mechanical gastrointestinal obstruction ( 4 ).

⚠️ Warnings and Cautions 82 words ▾

5 WARNINGS AND PRECAUTIONS Patients may experience severe diarrhea ( 5.1 ).

5.1Diarrhea Diarrhea was the most common adverse reaction in XPHOZAH-treated patients with CKD on dialysis [see Dosage and Administration (2) , Contraindications (4) and Adverse Reactions (6.1) ]. In clinical trials, diarrhea was reported in up to 53% of patients, reported as severe in 5%, and associated with dehydration and hyponatremia in less than 1% of patients. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reaction in the combined clinical trials was diarrhea, reported by 43-53% of patients ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ardelyx at 1-844-974-6924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect data from 754 adults with CKD on dialysis taking XPHOZAH in clinical trials as monotherapy and in combination with phosphate binders. Among the 754 patients, 258 patients were exposed to tenapanor for at least 26 weeks and 75 were exposed to tenapanor for at least one year. [see Clinical Studies (14) ] .

Most Common Adverse Reaction Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH.

Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials [see Warnings and Precautions (5.1) ] .

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of XPHOZAH. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions: pruritis, rash, and urticaria

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). Monitor for signs related to loss of efficacy and adjust the dosage of the concomitantly administered drug as needed ( 7.1 ). Sodium Polystyrene Sulfonate (SPS): Separate administration by at least three hours ( 7.2 ).

7.1OATP2B1 Substrates Tenapanor is an inhibitor of intestinal uptake transporter, OATP2B1 [see Clinical Pharmacology (12.3) ] . Drugs which are substrates of OATP2B1 may have reduced exposures when concomitantly taken with XPHOZAH. Monitor for signs related to loss of efficacy and adjust the dose of concomitantly administered drug as needed.

Enalapril is a substrate of OATP2B1. When enalapril was coadministered with XPHOZAH (30 mg twice daily for five days), the peak exposure (C max ) of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic exposures (AUC) decreased by 50 to 65% compared to when enalapril was administered alone [see Clinical Pharmacology (12.3) ] . However, the decrease in enalaprilat's exposure with XPHOZAH may be offset by the inherently higher exposures observed in patients with CKD on dialysis due to its reduced renal clearance.

Therefore, a lower starting dose of enalapril, which is otherwise recommended in patients with CKD on dialysis is not required when enalapril is coadministered with XPHOZAH.

7.2Sodium Polystyrene Sulfonate Separate administration of XPHOZAH and sodium polystyrene sulfonate (SPS) by at least 3 hours. SPS binds to many commonly prescribed oral medicines.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Tenapanor is essentially non-absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology (12.3) ]. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on XPHOZAH exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.2 times the maximum recommended human dose and in rabbits at doses up to 15 times the maximum recommended human dose (based on body surface area) [see Nonclinical Toxicology (13.1) ] . The estimated background risk of major birth defects and miscarriage for women with CKD on dialysis with hyperphosphatemia is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States 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. Animal Data In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day. Tenapanor doses of 10 and 30 mg/kg/day were not tolerated by the pregnant rats and was associated with mortality and moribundity with body weight loss.

The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology. No adverse fetal effects were observed in rats at 1 mg/kg/day (approximately 0.2 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 15 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developmental study in mice, tenapanor at doses up to 200 mg/kg/day (approximately 16.5 times the maximum recommended human dose, based on body surface area) had no effect on pre- and post-natal development.

8.2Lactation Risk Summary Tenapanor and its major metabolite, M1, were not detected in the breast milk of lactating women ( see Data ). In adults, concentrations of tenapanor were below the limit of quantitation in plasma following multiple doses of tenapanor [see Clinical Pharmacology (12.3) ]. Maternal use of XPHOZAH is not expected to result in exposure to tenapanor or its major metabolite in breastfed infants.

There is no information on the effects of tenapanor or M1 on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XPHOZAH and any potential adverse effects on the breastfed infant from XPHOZAH or from the underlying maternal condition. Data A clinical lactation study was conducted in seven healthy adult women who were 22 to 37 years of age.

Following oral administration of tenapanor 50 mg twice daily for 3 days, the concentrations of tenapanor and its major metabolite were below the limit of quantitation (<1 ng/mL and <1 ng/mL) in all breast milk samples collected over 24 hours post dosing.

8.4Pediatric Use Risk Summary XPHOZAH is contraindicated in patients less than 6 years of age. In nonclinical studies, deaths occurred in young juvenile rats (less than 1-week old rats; approximate human age-equivalent of less than 2 years of age) and in older juvenile rats (approximate human age-equivalent of 2 years of age) following oral administration of tenapanor, as described below in Juvenile Animal Toxicity Data. The safety and effectiveness of XPHOZAH in pediatric patients have not been established.

Juvenile Animal Toxicity Data In a 21-day oral dose range finding toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal da…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Tenapanor is essentially non-absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology (12.3) ]. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on XPHOZAH exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In reproduction studies with tenapanor in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.2 times the maximum recommended human dose and in rabbits at doses up to 15 times the maximum recommended human dose (based on body surface area) [see Nonclinical Toxicology (13.1) ] . The estimated background risk of major birth defects and miscarriage for women with CKD on dialysis with hyperphosphatemia is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States 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. Animal Data In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day. Tenapanor doses of 10 and 30 mg/kg/day were not tolerated by the pregnant rats and was associated with mortality and moribundity with body weight loss.

The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology. No adverse fetal effects were observed in rats at 1 mg/kg/day (approximately 0.2 times the maximum recommended human dose) and in rabbits at doses up to 45 mg/kg/day (approximately 15 times the maximum recommended human dose, based on body surface area). In a pre- and post-natal developmental study in mice, tenapanor at doses up to 200 mg/kg/day (approximately 16.5 times the maximum recommended human dose, based on body surface area) had no effect on pre- and post-natal development.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Risk Summary XPHOZAH is contraindicated in patients less than 6 years of age. In nonclinical studies, deaths occurred in young juvenile rats (less than 1-week old rats; approximate human age-equivalent of less than 2 years of age) and in older juvenile rats (approximate human age-equivalent of 2 years of age) following oral administration of tenapanor, as described below in Juvenile Animal Toxicity Data. The safety and effectiveness of XPHOZAH in pediatric patients have not been established.

Juvenile Animal Toxicity Data In a 21-day oral dose range finding toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal day (PND) 5) at doses of 5 and 10 mg/kg/day. Tenapanor was not tolerated in male and female pups and the study was terminated on PND 16 due to mortalities and decreased body weight (24% to 29% reduction in females at the respective dose groups and 33% reduction in males in the 10 mg/kg/day group, compared to control). In a second dose range finding study, tenapanor doses of 0.1, 0.5, 2.5, or 5 mg/kg/day were administered to neonatal rats from PND 5 through PND 24.

Treatment-related mortalities were observed at 0.5, 2.5, and 5 mg/kg/day doses. These premature deaths were observed as early as PND 8, with majority of deaths occurring between PND 15 and 25. In the 5 mg/kg/day group, mean body weights were 47% lower for males on PND 23 and 35% lower for females on PND 22 when compared to the controls.

Slightly lower mean tibial lengths (5% to 11%) were noted in males and females in the 0.5, 2.5, and 5 mg/kg/day dose groups on PND 25 and correlated with the decrements in body weight noted in these groups. Lower spleen, thymus, and/or ovarian weights were noted at the 0.5, 2.5, and 5 mg/kg/day doses. Tenapanor-related gastrointestinal distension and microscopic bone findings of increased osteoclasts, eroded bone, and/or decreased bone in sternum and/or femorotibial joint were noted in males and females in the 0.5, 2.5, and 5 mg/kg/day dose groups.

In juvenile rats administered tenapanor at 0.03, 0.1, or 0.3 mg/kg/day on PND 5 through PND 61, treatment-related mortalities were observed at 0.3 mg/kg/day. Lower mean body weight gains were noted in the 0.3 mg/kg/day group males and females compared to the control group primarily during PND 12–24 but continuing sporadically during the remainder of the dosing period; corresponding lower mean food consumption was noted in this group during PND 21–33. As a result, mean body weights were up to 15.8% and 16.8% lower in males and females, respectively, compared to the control group; the greatest difference was on PND 24 for males and PND 21 for females.

Mean body weight in the 0.3 mg/kg/day group males was only 3.9% lower than the control group on PND 61. There were no tenapanor-related effects on mean body weights, body weight gains, or food consumption in the 0.03 and 0.1 mg/kg/day group males and females. A dosage level of 0.1 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for juvenile toxicity of tenapanor [see Contraindications (4) , Warnings and Precautions (5.1) ].

In a 21-day oral dose range finding study in older (weaned) juvenile rats administered tenapanor at 0.1, 1, or 5 mg/kg/day on PND 21 through PND 41 (approximate human age-equivalent of 2 to 12 years of age), treatment-related mortalities or moribundities were observed during the first two days of the study in the 1 mg/kg/day males and the 5 mg/kg/day males and females. Watery feces, decreased food consumption, and lower mean body weight were also observed in the 1 and 5 mg/kg/day groups. In weaned juvenile rats administered tenapanor at 0.1, 0.3, and 0.7 (males) or 1 (females) mg/kg/day on PND 21 through PND 80, no mortalities were observed.

Significant decreases in mean body weights were observed in the 0.3 and 0.7 mg/kg/day males throughout the dosing period (up to 20.3% lower than control) and in the 1 mg/kg/day females between PND 23 to…

🧓 Geriatric Use 78 words ▾

8.5Geriatric Use Of 1010 adult patients with CKD on dialysis randomized and treated in two randomized, double-blind, placebo-controlled randomized withdrawal clinical trials for XPHOZAH (TEN-02-201 and TEN-02-301) as well as a third randomized, double-blind, placebo-controlled trial (TEN-02-202) for XPHOZAH in combination with phosphate binders, 282 (28%) were 65 years of age and older. Clinical studies of XPHOZAH did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently than younger patients.

🆘 Overdosage 52 words ▾

10 OVERDOSAGE No data are available regarding overdosage of XPHOZAH in patients. Based on nonclinical data, overdose of XPHOZAH may result in gastrointestinal adverse effects such as diarrhea, as a result of exaggerated pharmacology with a risk for dehydration if diarrhea is severe or prolonged [see Warnings and Precautions (5.1) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tenapanor is a locally acting inhibitor that targets the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the epithelium of the small intestine and colon. Inhibition of NHE3 by tenapanor results in reduced sodium absorption and decreased phosphate absorption by reducing phosphate permeability through the paracellular pathway.

12.2Pharmacodynamics Cardiac Electrophysiology At 3 times the mean maximum exposure of the major pharmacologically inactive metabolite of tenapanor (M1) at the recommended dosage, there were no clinically relevant effects on the QTc. Food Effect Administration of XPHOZAH 5 to 10 minutes before a meal increased the 24-hour stool phosphorus excretion compared to taking XPHOZAH in the fed or fasting condition [see Dosage and Administration (2.2) ] . In clinical trials, XPHOZAH was administered just prior to the first meal and just prior to dinner.

Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of XPHOZAH was studied in 20 subjects with normal or moderate hepatic impairment function (Child-Pugh B) after a single 100-mg dose. Compared to subjects with normal hepatic function, the geometric mean C max of the pharmacologically inactive metabolite M1, was approximately 27% to 35% lower in subjects with moderate hepatic impairment. Tenapanor exhibited minimal systemic bioavailability in subjects with both normal hepatic function and moderate hepatic impairment, with plasma concentrations below the limit of quantitation (less than 0.5 ng/mL) in the majority of samples.

12.3Pharmacokinetics Absorption Tenapanor is minimally absorbed following repeated twice daily oral administration. Plasma concentrations of tenapanor were below the limit of quantitation (less than 0.5 ng/mL) in the majority of samples from subjects following single and repeated oral administration of tenapanor 30 mg twice daily. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (C max ), and half-life (t 1/2 ) could not be determined.

Distribution Plasma protein binding of tenapanor and its major metabolite, M1, is approximately 99% and 97%, respectively , in vitro. Elimination Metabolism Tenapanor is metabolized primarily by CYP3A4/5 and low levels of its major metabolite, M1, are detected in plasma. The C max of M1 is approximately 3 ng/mL after a single dose of XPHOZAH 30 mg and 14 ng/mL at steady state following repeated dosing of XPHOZAH 30 mg twice daily in healthy subjects.

Based on a cross-study comparison, the steady state plasma concentration of M1 in CKD patients on dialysis (eGFR less than 15 mL/min/1.73 m 2 ) was not notably different from those of healthy subjects given similar doses of XPHOZAH. Excretion Following administration of a single 15 mg radiolabeled 14 C- XPHOZAH dose to healthy subjects, approximately 70% of the radioactivity was excreted in feces through 120 hours post-dose (79% through 240 hours post-dose), mostly as the parent drug accounting for 65% of dose within 144 hours post-dose.

Approximately 9% of the administered dose was recovered in urine, primarily as metabolites. M1 is excreted in urine unchanged accounting for 1.5% of dose within 144 hours post-dose. Drug Interaction Studies CYP Metabolism Mediated Drug Interactions Tenapanor and M1 did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 in vitro .

Tenapanor and M1 did not induce CYP1A2 and CYP2B6 in vitro. No significant inhibition or induction of CYP3A4 enzyme using midazolam as a substrate was observed when XPHOZAH 50 mg was administered twice a day for 13 days in healthy subjects. No significant effect on PepT1 activity using cefadroxil as a substrate was observed when tenapanor 50 mg was administered twice a day for 12 days in healthy subjects.

No significant effect on P-gp and CYP2C9 activity using digoxin and warfarin as a substrate was observed when tenapanor 30 mg wa…

🧬 Mechanism of Action 55 words ▾

12.1Mechanism of Action Tenapanor is a locally acting inhibitor that targets the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the epithelium of the small intestine and colon. Inhibition of NHE3 by tenapanor results in reduced sodium absorption and decreased phosphate absorption by reducing phosphate permeability through the paracellular pathway.

📦 How Supplied / Storage and Handling 117 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING XPHOZAH is supplied as 10-, 20-, or 30-mg oval, biconvex, film-coated tablets supplied in white, opaque, high-density polyethylene bottles containing 60 or 14 tablets with a silica gel canister (as the desiccant) and screw-top polypropylene child-resistant cap lined with an induction-activated aluminum foil liner: Strength Color Deboss NDC Bottle/14 Bottle/60 10 mg Yellow /T10 73154-110-14 73154-110-60 20 mg Brown /T20 73154-120-14 73154-120-60 30 mg Red /T30 73154-130-14 73154-130-60 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] .

Keep bottle tightly closed to protect from moisture. Store and dispense in original bottle with the desiccant. Image Image Image

📦 Storage and Handling 44 words ▾

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] . Keep bottle tightly closed to protect from moisture. Store and dispense in original bottle with the desiccant. Image Image Image

📋 Description 180 words ▾

11 DESCRIPTION XPHOZAH (tenapanor) tablets contain tenapanor hydrochloride as an active ingredient. Tenapanor hydrochloride is a sodium/hydrogen exchanger 3 (NHE3) inhibitor for oral use. The chemical name for tenapanor hydrochloride is 12,15-Dioxa-2,7,9-triazaheptadecanamide, 17-[[[3-[(4S)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulphonyl]amino]-N-[2-[2-[2-[[[3-[(4S)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulphonyl]amino]ethoxy]ethoxy]ethyl]-8-oxo-, hydrochloride (1:2).

Tenapanor hydrochloride has the molecular formula of C 50 H 68 Cl 6 N 8 O 10 S 2 , the molecular weight of 1218 Daltons, and the chemical structure below: Tenapanor hydrochloride is a white to off-white to light brown hygroscopic amorphous solid. It is practically insoluble in water. XPHOZAH tablets contain the equivalent of 10, 20, or 30 mg of tenapanor (provided as 10.6, 21.3, and 31.9 mg of tenapanor hydrochloride, respectively).

Inactive ingredients in the tablet are colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, and the coating agent OPADRY ® , which consists of hypromellose, titanium dioxide and triacetin, as well as iron oxide yellow as colorant [10 mg and 20 mg tablets], iron oxide red as colorant [20 mg and 30 mg tablets] and iron oxide black as colorant [30 mg tablet]. Chemical Structure

💬 Information for Patients 157 words ▾

17 PATIENT COUNSELING INFORMATION Advise Patients: Diarrhea Instruct patients to contact their healthcare provider if they experience severe diarrhea [see Warnings and Precautions (5.1) ]. Instruct patients not to use stool softeners or laxatives with XPHOZAH. Administration and Handling Instructions Instruct Patients: To take XPHOZAH just prior to the first and last meals of the day [see Dosage and Administration (2.2) ] .

Patients should be counseled not to take XPHOZAH right before a hemodialysis session, and to take XPHOZAH right before the next meal , as some patients may experience diarrhea after taking XPHOZAH. If a dose is missed, take the dose just before the next meal. Do not take 2 doses at the same time [see Dosage and Administration (2.2) ] .

To keep XPHOZAH in a dry place. Protect from moisture. Keep in the original bottle.

Do not remove desiccant from the bottle. Keep bottles tightly closed [see How Supplied/Storage and Handling (16) ].

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