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Daybue Stix trofinetide 5000 mg For Solution, 60 packets — NDC 63090-0663-60 package photo

Daybue Stix trofinetide 5000 mg For Solution, 60 packets

by Acadia Pharmaceuticals Inc. · 60 PACKET in 1 CARTON (63090-663-60) / 1 FOR SOLUTION in 1 PACKET (63090-663-01)
NDC 63090-0663-60
🏷️ FDA NDC (as labeled) 63090-663-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 63090-663-60
Product NDC 63090-663
11-digit billing NDC 63090066360
NCPDP billing unit EA — each (per item)
UNII Z2ME8F52QL
UPC 0363090660012
Application # NDA219884
SPL Set ID 67e6f2d9-21f6-466f-9def-826c6a4b8257
Mechanism of action Cytochrome P450 3A4 Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-11
Route ORAL
Dosage form FOR SOLUTION
Substance TROFINETIDE
GCN Seq No 088527
GCN 58663
HICL code 048773
Ingredient (HICL) Trofinetide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H1
Therapeutic class — intermediate (HIC2) Drugs Affecting Principally The Brain
HIC3 code H1I
Therapeutic class — specific (HIC3) Glypromate (Gpe) Analogs
AHFS code 28:92.00.00
AHFS class Central Nervous System Agents, Misc.
FDB label name DAYBUE STIX 5,000 MG PACKET
FDB brand name Daybue Stix
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 63090-663-60 — 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 → 63090-0663-60. 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.

🏭 Manufacturer & labeler

LabelerAcadia Pharmaceuticals Inc.
Application holderACADIA PHARMACEUTICALS INC
FDA applicationNDA219884 (NDA)
Labeler code63090
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio6 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 DAYBUE STIX 5,000 MG PACKET Ingredient Trofinetide
📗 Our plain-language guide HelloPharmacist
  • Trofinetide — sold as Daybue and Daybue Stix — is used to treat Rett syndrome in adults and children who are at least 2 years old. Rett syndrome is a rare neurological condition, a...
  • You take it twice a day — once in the morning and once in the evening. The good news is it can be taken with or without food, so you don't need to time it around meals. It comes as...
  • How do I take it, and does it matter if I take it with food?
  • Daybue Stix is a powder you dissolve in water or another water-based drink (like juice, tea, or lemonade) right before giving it. You stir it until it's fully dissolved and then gi...
📖 Read our full Trofinetide 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 Pink
FlavorStrawberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

1 inactive ingredient 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 mLPer 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 $584.43 —
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
Daybue Stix 5000 mgthis 63090-0663-60 Acadia 60 packets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
First FDA approval
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2043
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 11, 2025 RLD RS ⏳ ~16.3 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 12492167 — drug substance (U-3556)
US 12492167 — drug substance (U-3556)
US 12492167 — drug substance (U-3556)
US 11827600 — drug substance (U-3556)
US 11827600 — drug substance (U-3556)
US 11827600 — drug substance (U-3556)
US 9212204 — method of use (U-3556)
US 9212204 — method of use (U-3556)
US 9212204 — method of use (U-3556)
US 11370755 — drug substance
US 11370755 — drug substance
US 11370755 — drug substance
US 12492167*PED — drug product
US 12492167*PED — drug product
US 12492167*PED — drug product
US 11827600*PED — drug product
US 11827600*PED — drug product
US 11827600*PED — drug product
US 11370755*PED — drug product
US 11370755*PED — drug product
US 11370755*PED — drug product
US 9212204*PED — drug product
US 9212204*PED — drug product
US 9212204*PED — drug product
Exclusivity NCE
Exclusivity ODE*
Exclusivity NCE
Exclusivity ODE*
Exclusivity NCE
Exclusivity ODE*
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
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 12492167 ↗ Drug substance U-3556 Jul 12, 2042
US 12492167 ↗ Drug substance U-3556 Jul 12, 2042
US 12492167 ↗ Drug substance U-3556 Jul 12, 2042
US 11827600 ↗ Drug substance U-3556 Jul 12, 2042
US 11827600 ↗ Drug substance U-3556 Jul 12, 2042
US 11827600 ↗ Drug substance U-3556 Jul 12, 2042
US 9212204 ↗ Method of use U-3556 Jan 27, 2032
US 9212204 ↗ Method of use U-3556 Jan 27, 2032
US 9212204 ↗ Method of use U-3556 Jan 27, 2032
US 11370755 ↗ Drug substance — Aug 3, 2040
US 11370755 ↗ Drug substance — Aug 3, 2040
US 11370755 ↗ Drug substance — Aug 3, 2040
US 12492167*PED ↗ Drug product — Jan 12, 2043
US 12492167*PED ↗ Drug product — Jan 12, 2043
US 12492167*PED ↗ Drug product — Jan 12, 2043
US 11827600*PED ↗ Drug product — Jan 12, 2043
US 11827600*PED ↗ Drug product — Jan 12, 2043
US 11827600*PED ↗ Drug product — Jan 12, 2043
US 11370755*PED ↗ Drug product — Feb 3, 2041
US 11370755*PED ↗ Drug product — Feb 3, 2041
US 11370755*PED ↗ Drug product — Feb 3, 2041
US 9212204*PED ↗ Drug product — Jul 27, 2032
US 9212204*PED ↗ Drug product — Jul 27, 2032
US 9212204*PED ↗ Drug product — Jul 27, 2032
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Mar 10, 2028
ODE*Orphan Drug Exclusivity (7-year)Mar 10, 2030
NCENew Chemical Entity (5-year)Mar 10, 2028
ODE*Orphan Drug Exclusivity (7-year)Mar 10, 2030
NCENew Chemical Entity (5-year)Mar 10, 2028
ODE*Orphan Drug Exclusivity (7-year)Mar 10, 2030
PEDPediatric Exclusivity (+6 months)Sep 10, 2028
PEDPediatric Exclusivity (+6 months)Sep 10, 2030
PEDPediatric Exclusivity (+6 months)Sep 10, 2028
PEDPediatric Exclusivity (+6 months)Sep 10, 2030
PEDPediatric Exclusivity (+6 months)Sep 10, 2030
PEDPediatric Exclusivity (+6 months)Sep 10, 2028
Common questions
Is there a generic version of DAYBUE STIX 5,000 MG PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DAYBUE STIX 5,000 MG PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2043 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Daybue Stix — 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 Daybue Stix. 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
$754.6K
Claims incl. refills
12
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$62,882.13
💵 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63090-0663-60 You're viewing this 60 PACKET in 1 CARTON (63090-663-60) / 1 FOR SOLUTION in 1 PACKET (63090-663-01) 2025-12-11 Active

🧭 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 63090-663-60, 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: 63090-0663-60, written without dashes as 63090066360. 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 63090-0663-60, the first segment (63090) is the labeler code FDA assigned to Acadia Pharmaceuticals Inc.; the middle segment (0663) 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 Acadia Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acadia 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 53 words ▾

1 INDICATIONS AND USAGE DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage is twice daily, morning and evening, according to patient weight. DAYBUE or DAYBUE STIX can be given with or without food. ( 2.1 ) Patient Weight Recommended Dosage 9 kg to less than 12 kg 5,000 mg twice daily 12 kg to less than 20 kg 6,000 mg twice daily 20 kg to less than 35 kg 8,000 mg twice daily 35 kg to less than 50 kg 10,000 mg twice daily 50 kg or more 12,000 mg twice daily Can be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.

( 2.1 ) See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. ( 2.3 ) See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.6 , 8.6 )

2.1Recommended Dosage The recommended dosage of DAYBUE or DAYBUE STIX is based on patient weight as shown in Table 1 . Administer DAYBUE or DAYBUE STIX orally or via gastrostomy (G) tube twice daily, in the morning and evening, with or without food. Doses administered via gastrojejunal (GJ) tubes must be administered through the G-port.

Table 1 Recommended Dosage of DAYBUE or DAYBUE STIX in Patients 2 Years of Age and Older Patient Weight Recommended Dosage 9 kg to less than 12 kg 5,000 mg twice daily 12 kg to less than 20 kg 6,000 mg twice daily 20 kg to less than 35 kg 8,000 mg twice daily 35 kg to less than 50 kg 10,000 mg twice daily 50 kg or more 12,000 mg twice daily

2.2DAYBUE Oral Solution Preparation Table 2 includes the volume of DAYBUE oral solution to administer for the corresponding recommended dosage [see Dosage and Administration (2.1 , 2.6) ] . A calibrated measuring device, such as an oral syringe or oral dosing cup, should be obtained from the pharmacy to measure and deliver the prescribed dose accurately. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device.

Table 2 Recommended Volume of DAYBUE Oral Solution for Administration Dosage DAYBUE Oral Solution Volume 2,500 mg twice daily Dosage for patients with moderate renal impairment [see Dosage and Administration (2.6) ] 12.5 mL twice daily 3,000 mg twice daily 15 mL twice daily 4,000 mg twice daily 20 mL twice daily 5,000 mg twice daily 25 mL twice daily 6,000 mg twice daily 30 mL twice daily 8,000 mg twice daily 40 mL twice daily 10,000 mg twice daily 50 mL twice daily 12,000 mg twice daily 60 mL twice daily Discard any unused DAYBUE oral solution after 14 days of first opening the bottle [see How Supplied/Storage and Handling (16.2) ] .

2.3DAYBUE STIX for Oral Solution Preparation Prior to administration, DAYBUE STIX for oral solution powder must be dissolved in a cold to room temperature water or water-based beverage (juice, tea, lemonade, limeade, or liquid hydration). Preparation of DAYBUE STIX Determine the correct dosage as shown in Table 1 or Table 4 (for patients with moderate renal impairment). Select the appropriate packet strength and number of packets required for each dose, as shown in Table 3 .

Determine the appropriate volume of liquid within the recommended volume range as shown in Table 3 , based on individual patient factors (e.g., age, palatability). Measure the volume of liquid determined in Step 3 by using a calibrated measuring device obtained from the pharmacy. Empty the entire contents of the DAYBUE STIX packet(s) into the measured liquid.

Do not attempt to use partial packets to prepare a dose. Stir until the powder is completely dissolved. Administer the prepared oral solution immediately; do not store for future use.

Discard any prepared oral solution that is not immediately administered. Table 3 Preparation Instructions for DAYBUE STIX for Oral Solution Powder Dose DAYBUE STIX Packet(s) Needed to Prepare Each Dose Volume of Liquid Required to Dissolve Entire Dose Liquid types include water or water-based beverage. , Volume should be selected within the recommended range based on individual patient factors. 5,000 m…

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral solution: 200 mg/mL of a pink to red, strawberry flavored solution. For oral solution: 5,000 mg, 6,000 mg, or 8,000 mg of white, off-white to pinkish powder with strawberry flavor, packaged in individual packets. Oral solution: 200 mg/mL ( 3 ) For oral solution: 5,000 mg, 6,000 mg, or 8,000 mg per packet ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider.

Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected. ( 2.4 , 5.1 ) Weight Loss: Weight loss may occur in patients treated with DAYBUE or DAYBUE STIX. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs.

( 2.4 , 5.2 ) Vomiting: Aspiration and aspiration pneumonia have occurred after vomiting in patients treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management. ( 2.5 , 5.3 )

5.1Diarrhea In Study 1 [see Clinical Studies (14) ] and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was of mild or moderate severity in 96% of cases.

In Study 1, antidiarrheal medication was used in 51% of patients treated with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed.

Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected [see Dosage and Administration (2.4) ] .

5.2Weight Loss In Study 1, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs [see Dosage and Administration (2.4) ] .

5.3Vomiting In Study 1, vomiting occurred in 29% of patients treated with DAYBUE and in 12% of patients who received placebo [see Adverse Reactions (6.1) ]. Patients with Rett syndrome are at risk for aspiration and aspiration pneumonia. Aspiration and aspiration pneumonia have been reported following vomiting in patients being treated with DAYBUE.

Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management [see Dosage and Administration (2.5) ] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Diarrhea [see Warnings and Precautions (5.1) ] Weight Loss [see Warnings and Precautions (5.2) ] Vomiting [see Warnings and Precautions (5.3) ] The most common adverse reactions (that occurred in at least 10% of DAYBUE-treated patients and at least 2% greater than in placebo) were diarrhea and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acadia Pharmaceuticals Inc. at 1-844-422-2342 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. In controlled and uncontrolled trials in patients with Rett syndrome, 260 patients ages 2 to 40 years were treated with DAYBUE, including 112 patients treated for more than 6 months, 92 patients treated for more than 1 year, and 44 patients treated for more than 2 years.

The safety of DAYBUE STIX has been established from an adequate, well-controlled study, and open-label studies of DAYBUE [see Clinical Studies (14) ] . Below is a display of the adverse reactions of DAYBUE in these studies. Adult and Pediatric Patients with Rett Syndrome 5 Years of Age and Older The safety of DAYBUE was evaluated in a randomized, double-blind, placebo-controlled, 12-week study of patients with Rett syndrome (Study 1) [see Clinical Studies (14) ] .

In Study 1, 93 patients received DAYBUE and 94 patients received placebo. All patients were female, 92% were White, and the mean age was 11 years (range 5 to 20 years). Adverse Reactions Leading to Discontinuation of Treatment Eighteen patients (19%) receiving DAYBUE had adverse reactions that led to withdrawal from the study.

The most common adverse reaction leading to discontinuation of treatment with DAYBUE was diarrhea (15%). Common Adverse Reactions Adverse reactions that occurred in Study 1 in at least 5% of patients treated with DAYBUE and were at least 2% more frequent than in patients on placebo are presented in Table 5 . Table 5 Adverse Reactions in at Least 5% of Patients Treated with DAYBUE and at Least 2% Greater than Placebo in Study 1 Adverse Reaction DAYBUE (N=93) % Placebo (N=94) % Diarrhea 82 20 Vomiting 29 12 Fever 9 4 Seizure 9 6 Anxiety 8 1 Decreased appetite 8 2 Fatigue 8 2 Nasopharyngitis 5 1 Pediatric Patients with Rett Syndrome 2 to 4 Years of Age In an open-label study in pediatric patients 2 to 4 years of age with Rett syndrome (N=15), a total of 13 patients received DAYBUE for at least 12 weeks and 10 patients received DAYBUE for at least 12 months.

Adverse reactions in pediatric patients 2 to 4 years of age treated with DAYBUE were similar to those reported in adult and pediatric patients 5 years of age and older with Rett syndrome in Study 1.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of DAYBUE. 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. Aspiration and aspiration pneumonia secondary to vomiting [see Warnings and Precautions (5.3) ] .

🔄 Drug Interactions 121 words ▾

7 DRUG INTERACTIONS Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use. ( 7.1 )

7.1Effect of DAYBUE and DAYBUE STIX on Other Drugs CYP3A and/or P-gp Substrates Closely monitor patients when DAYBUE or DAYBUE STIX is administered concomitantly with sensitive CYP3A and/or P-gp substrates where minimal increases in the plasma concentration of these substrates may lead to serious adverse reactions. Trofinetide, a weak inhibitor of CYP3A and an inhibitor of P-gp, increased the plasma concentrations of CYP3A and/or P-gp substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions associated with these substrates.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Severe renal impairment: DAYBUE and DAYBUE STIX are not recommended. ( 8.6 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of DAYBUE or DAYBUE STIX in pregnant women. No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically [see Animal Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the maximum recommended human dose (MRHD) of 12,000 mg twice daily (24,000 mg/day).

Oral administration of trofinetide (0, 75, 150, or 300 mg/kg twice daily; 0, 150, 300, or 600 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in no adverse effects on embryofetal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD. Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development.

At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD.

8.2Lactation Risk Summary There is no information regarding the presence of trofinetide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DAYBUE or DAYBUE STIX and any potential adverse effects on the breastfed infant from the treatment or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of DAYBUE and DAYBUE STIX for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older. The safety and effectiveness of DAYBUE for the treatment of Rett syndrome in pediatric patients 5 years of age and older was established in a randomized, double-blind, placebo-controlled, 12-week study (Study 1), which included 108 pediatric patients age 5 to less than 12 years of age and 47 pediatric patients age 12 to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14) ].

Use of DAYBUE or DAYBUE STIX in patients 2 to 4 years of age is supported by evidence from Study 1 and pharmacokinetic and safety data in 15 pediatric patients 2 to 4 years of age treated with DAYBUE [see Dosage and Administration (2.1) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] . Safety and effectiveness in pediatric patients less than 2 years of age have not been established. Juvenile Animal Data Oral administration of trofinetide (0, 150, 300, or 1000 mg/kg twice daily; 0, 300, 600, or 2000 mg/kg/day) to rats from postnatal day (PND) 13-14 through 28 weeks of age resulted in no adverse effects on growth or neurobehavioral function.

Plasma exposures at the highest dose tested were similar to those in pediatric patients at recommended doses. Oral administration of trofinetide (0, 150, 300, or 1000 mg/kg twice daily; 0, 300, 600, or 2000 mg/kg/day) to juvenile rats for 10 weeks beginning on PND 13-14 resulted in no adverse effects on sexual maturation or reproductive function. Plasma exposures at the highest dose tested were similar to those in pediatric patients at recommended doses.

8.5 Geriatric Use Clinical studies of DAYBUE did…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of DAYBUE or DAYBUE STIX in pregnant women. No adverse developmental effects were observed following oral administration of trofinetide to pregnant animals at doses associated with plasma exposures below those used clinically [see Animal Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

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 Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the maximum recommended human dose (MRHD) of 12,000 mg twice daily (24,000 mg/day).

Oral administration of trofinetide (0, 75, 150, or 300 mg/kg twice daily; 0, 150, 300, or 600 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in no adverse effects on embryofetal development. At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD. Oral administration of trofinetide (0, 150, 450, or 1000 mg/kg twice daily; 0, 300, 900, or 2000 mg/kg/day) to rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development.

At the highest dose tested, plasma exposure (AUC) was less than that in humans at the MRHD.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of DAYBUE and DAYBUE STIX for the treatment of Rett syndrome have been established in pediatric patients aged 2 years and older. The safety and effectiveness of DAYBUE for the treatment of Rett syndrome in pediatric patients 5 years of age and older was established in a randomized, double-blind, placebo-controlled, 12-week study (Study 1), which included 108 pediatric patients age 5 to less than 12 years of age and 47 pediatric patients age 12 to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14) ].

Use of DAYBUE or DAYBUE STIX in patients 2 to 4 years of age is supported by evidence from Study 1 and pharmacokinetic and safety data in 15 pediatric patients 2 to 4 years of age treated with DAYBUE [see Dosage and Administration (2.1) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] . Safety and effectiveness in pediatric patients less than 2 years of age have not been established. Juvenile Animal Data Oral administration of trofinetide (0, 150, 300, or 1000 mg/kg twice daily; 0, 300, 600, or 2000 mg/kg/day) to rats from postnatal day (PND) 13-14 through 28 weeks of age resulted in no adverse effects on growth or neurobehavioral function.

Plasma exposures at the highest dose tested were similar to those in pediatric patients at recommended doses. Oral administration of trofinetide (0, 150, 300, or 1000 mg/kg twice daily; 0, 300, 600, or 2000 mg/kg/day) to juvenile rats for 10 weeks beginning on PND 13-14 resulted in no adverse effects on sexual maturation or reproductive function. Plasma exposures at the highest dose tested were similar to those in pediatric patients at recommended doses.

🧓 Geriatric Use 58 words ▾

8.5Geriatric Use Clinical studies of DAYBUE did not include patients 65 years of age and older to determine whether or not they respond differently from younger patients. This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

12.2Pharmacodynamics Cardiac Electrophysiology At the maximum recommended dose in healthy adult subjects, trofinetide does not prolong the QT interval to any clinically relevant extent .

12.3Pharmacokinetics DAYBUE STIX for oral solution demonstrated comparable bioavailability to DAYBUE oral solution in adult healthy subjects under fasted state. Trofinetide exhibits linear kinetics with no time- or dose-dependent effect on pharmacokinetic parameters. Systemic exposure to trofinetide was dose-proportional across the studied dose range.

Minimal to no accumulation was observed following multiple-dose administration. Absorption The time to maximum drug concentration (T max ) is about 2 to 3 hours after administration. Based on the mass balance study, at least 84% of the administered dose was absorbed following oral administration of 12,000 mg trofinetide.

Effect of Food Coadministration of trofinetide with a high-fat meal had no impact on the total exposure (AUC 0-inf ) of trofinetide and reduced the peak plasma concentration (C max ) by approximately 20% [see Dosage and Administration (2.1) ] . Distribution Following oral administration, the apparent volume of distribution of trofinetide in adult healthy subjects was approximately 80 L. Trofinetide protein binding in human plasma is less than 6%.

Elimination The effective elimination half-life of orally administered trofinetide in healthy subjects is about 1.5 hours. Metabolism Trofinetide is not significantly metabolized by CYP450 enzymes. Hepatic metabolism is not a significant route of trofinetide elimination.

Excretion Trofinetide is primarily excreted unchanged (approximately 80% of the dose) in urine, with minor excretion in feces. Specific Populations Pediatric Patients The drug exposure of trofinetide in pediatric patients ages 2 to 4 years of age is similar to children older than 4 years and adults when following the recommended dosage [see Dosage and Administration (2.1) ] . Patients with Renal Impairment Based on population PK analysis of clinical trials data, patients with mild renal impairment (eGFR 60 to 89 mL/min/1.73 m 2 ) showed no significant impact on the exposure of trofinetide compared to patients with normal renal function.

Based on a renal impairment study in adult subjects, the effect of moderate renal impairment (eGFR 30 to 59 mL/min) increases the exposure (AUC 0-inf ) of trofinetide approximately 80% compared to patients with normal renal function administered the same dose [see Dosage and Administration (2.6) ] . The effect of severe renal impairment on the exposure of trofinetide has not been investigated [see Use in Specific Populations (8.6) ] . Patients with Hepatic Impairment The pharmacokinetics in patients with hepatic impairment have not been studied.

However, hepatic impairment is not expected to impact the exposure of trofinetide because hepatic metabolism is not a significant route of trofinetide elimination. Drug Interaction Studies Clinical Studies CYP3A and/or P-gp Substrates: Coadministration of trofinetide 12,000 mg twice daily with 4 mg of loperamide (a moderately sensitive CYP3A substrate and a P-gp substrate) increased the AUC of loperamide by 1.73-fold and the C max by 1.95-fold [see Drug Interactions (7.1) ] . Administration of trofinetide 2 hours prior to loperamide increased the AUC of loperamide by 1.22-fold and the C max by 1.44-fold.

In Vitro Trofinetide is not a substrate of CYP450 enzymes, uridine diphosphate glucuronosyltransferase (UGT), or major drug transporters. Cytochrome P450 (CYP450) Enzymes: Trofinetide inhibits CYP3A [see Drug Interactions (7.1) ] . Trofinetide inhibits CYP1A2, 2B6, 2C8, 2C19, and 2D6, but is not expected to result in clinically significant drug interactions.

Trofinetide does not inhibit CYP2C9. UDP-Glucuronosyltransferase (UGT): Trofinetide in…

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.

📦 How Supplied / Storage and Handling 165 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied DAYBUE (trofinetide) 200 mg/mL oral solution is a pink to red, strawberry flavored solution supplied in a round high-density polyethylene (HDPE) multi-dose bottle with a child-resistant closure containing 450 mL of oral solution (NDC 63090-660-01). DAYBUE STIX (trofinetide) for oral solution is a white, off-white to pinkish powder with a strawberry flavor supplied in multi-layer aluminum packets as follows: Package Configuration and NDC Number Strength Individual Packet Carton of 60 Packets 5,000 mg 63090-663-01 63090-663-60 6,000 mg 63090-664-01 63090-664-60 8,000 mg 63090-665-01 63090-665-60

16.2Storage and Handling DAYBUE Oral Solution Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the child-resistant cap tightly closed. Discard any unused DAYBUE oral solution after 14 days of first opening the bottle. DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 74 words ▾

16.2Storage and Handling DAYBUE Oral Solution Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the child-resistant cap tightly closed. Discard any unused DAYBUE oral solution after 14 days of first opening the bottle. DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description 168 words ▾

11 DESCRIPTION DAYBUE oral solution and DAYBUE STIX for oral solution contain the active moiety trofinetide. The chemical name of trofinetide is (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid (IUPAC). The molecular formula of trofinetide is C 13 H 21 N 3 O 6 and its molecular weight is 315.33 g/mol.

The chemical structure is shown below. Trofinetide is a white to off-white solid and is freely soluble in water. DAYBUE oral solution is pink to red in color and contains 1 g of trofinetide in each 5 mL of solution (200 mg/mL).

The oral solution also contains FD&C Red No. 40, maltitol, methylparaben sodium, propylparaben sodium, purified water, strawberry flavor, and sucralose as inactive ingredients. DAYBUE STIX for oral solution is a white, off-white to pinkish powder to be dissolved in a cold to room temperature water or water-based beverage before administration and contains 5,000 mg, 6,000 mg, or 8,000 mg of trofinetide in each packet.

The for oral solution powder contains natural strawberry flavor and sucralose as inactive ingredients. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the caregiver or patient to read the FDA-approved patient labeling (Patient Information). Preparation and Administration Advise the caregiver or patient that DAYBUE or DAYBUE STIX may be given orally or via gastrostomy (G) tube; doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. DAYBUE or DAYBUE STIX may be taken with or without food [see Dosage and Administration (2.1) ].

Instruct the caregiver or patient to obtain a calibrated measuring device, such as an oral syringe or oral dosing cup, from the pharmacy. A household measuring cup, teaspoon, or tablespoon is not an adequate measuring device [see Dosage and Administration (2.2 , 2.3) ] . DAYBUE Oral Solution Instruct the caregiver or patient to discard any unused DAYBUE oral solution after 14 days from first opening the bottle.

DAYBUE STIX for Oral Solution Advise the caregiver or patient that DAYBUE STIX for oral solution powder must be dissolved in a cold to room temperature water or water-based beverage (juice, tea, lemonade, limeade, or liquid hydration) prior to administration [see Dosage and Administration (2.3) ] . Instruct the caregiver or patient on how much water or water-based beverage is needed to dissolve the contents of DAYBUE STIX packet(s). Instruct the caregiver or patient to administer the prepared oral solution immediately and not to store for future use.

Any prepared oral solution not administered must be discarded. Instruct patients to not attempt to use partial packets to prepare a dose. Diarrhea Advise the caregiver or patient that DAYBUE or DAYBUE STIX can cause diarrhea.

Instruct the patient to stop taking laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed [see Warnings and Precautions (5.1) ] . Weight Loss Inform the caregiver or patient that DAYBUE or DAYBUE STIX may cause weight loss and to notify their healthcare provider if weight loss occurs [see Warnings and Precautions (5.2) ] .

Vomiting Advise the caregiver or patient that DAYBUE or DAYBUE STIX can cause vomiting and if vomiting occurs after DAYBUE or DAYBUE STIX administration, do not take an additional dose, but continue with the next scheduled dose [see Dosage and Administration (2.5) ] . Instruct patients to notify their healthcare provider if vomiting does not stop despite medical management [see Warnings and Precautions (5.3) ] . Storage DAYBUE Oral Solution Keep bottles of DAYBUE upright and refrigerated before and after opening.

Do not freeze [see How Supplied/Storage and Handling (16.2) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63090-0660-01 · Acadia 63090-0664-60 · Acadia →
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.