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DYANAVEL XR amphetamine 5 mg Tablet, Extended Release, 30-count — NDC 24478-0106-01 package photo

DYANAVEL XR amphetamine 5 mg Tablet, Extended Release, 30-count

by NextWave Pharmaceuticals, Inc · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01)
NDC 24478-0106-01
🏷️ FDA NDC (as labeled) 24478-106-01 billing pads the product segment with a zero
Rx only Brand On market CII
🗂️ 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) 24478-106-01
Product NDC 24478-106
11-digit billing NDC 24478010601
NCPDP billing unit EA — each (per item)
RxCUI 1720586, 1720592, 2585460, 2585461, 2585462, 2585465, 2585468, 2585471,
UNII CK833KGX7E
UPC 0324478102029, 0324478108014, 0324478110017, 0324478109011
Application # NDA210526
SPL Set ID ae304b29-0b40-40ec-ad0d-76b742d4a9b9
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-04
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance AMPHETAMINE
GPI-14 61100010000410
GCN Seq No 082799
GCN 51439
HICL code 043652
Ingredient (HICL) Amphetamine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5B
Therapeutic class — specific (HIC3) Adrenergics, Aromatic, Non-Catecholamine
AHFS code 28:20.04.00
AHFS class Amphetamines
FDB label name DYANAVEL XR 5 MG TABLET
FDB brand name Dyanavel Xr
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 24478-106-01 — 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 → 24478-0106-01. 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 Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant
Drug family (ATC) Centrally acting sympathomimetics
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

LabelerNextWave Pharmaceuticals, Inc
Application holderTRIS PHARMA INC
FDA applicationNDA210526 (NDA)
Labeler code24478
First marketedNov 2021
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio13 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 DYANAVEL XR 5 MG TABLET Ingredient Amphetamine
📗 Our plain-language guide HelloPharmacist
  • It depends on the specific product. Most amphetamine products — including Adzenys XR-ODT, Dyanavel XR, and the extended-release orally disintegrating tablets — are approved to trea...
  • What conditions is amphetamine actually approved to treat?
  • You can take most amphetamine products with or without food — it won't meaningfully change how much you absorb. That said, eating (especially a high-fat meal) can delay when it kic...
  • Is it okay to take this with food, or does it have to be on an empty stomach?
📖 Read our full Amphetamine 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 brown / white
ShapeOval
Imprint20
Size19 mm
ScoringNot scored
FlavorBubble Gum
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII E89I1637KE
    Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 32K497ZK2U
    Polyvinyl acetate is a synthetic plastic polymer derived from vinyl acetate. It acts as a binder and film-forming agent in medicines, helping to hold ingredients together and create protective coatings on tablets or capsules.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $7.853 $235.60 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $7.86 $235.85 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2023 Jan 2026 Jun 2026 Sep 2026 $7.855 $7.162
▲ Up 10% over the last 8 months.
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
Dyanavel Xr 5 mgthis 24478-0106-01 NextWave 30 tablets $7.853 — Availability likely —
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

🏛️
2021
First FDA approval
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2040
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 Feb 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 4, 2021 RLD RS ⏳ ~13.4 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 11590081 — method of use (U-3538)
US 11590081 — method of use (U-3538)
US 11590081 — method of use (U-3538)
US 11590081 — method of use (U-3538)
US 12458592 — method of use (U-3538)
US 12458592 — method of use (U-3538)
US 12458592 — method of use (U-3538)
US 12458592 — method of use (U-3538)
US 9675704 — drug product
US 8337890 — drug product
US 8747902 — drug product
US 9675704 — drug product
US 8337890 — drug product
US 8337890 — drug product
US 8747902 — drug product
US 9675704 — drug product
US 8747902 — drug product
US 8337890 — drug product
US 9675704 — drug product
US 8747902 — drug product
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (20)
PatentTypeUse codeExpires
US 11590081 ↗ Method of use U-3538 Sep 24, 2038
US 11590081 ↗ Method of use U-3538 Sep 24, 2038
US 11590081 ↗ Method of use U-3538 Sep 24, 2038
US 11590081 ↗ Method of use U-3538 Sep 24, 2038
US 12458592 ↗ Method of use U-3538 Feb 11, 2040
US 12458592 ↗ Method of use U-3538 Feb 11, 2040
US 12458592 ↗ Method of use U-3538 Feb 11, 2040
US 12458592 ↗ Method of use U-3538 Feb 11, 2040
US 9675704 ↗ Drug product — Mar 15, 2027
US 8337890 ↗ Drug product — Mar 15, 2027
US 8747902 ↗ Drug product — Mar 15, 2027
US 9675704 ↗ Drug product — Mar 15, 2027
US 8337890 ↗ Drug product — Mar 15, 2027
US 8337890 ↗ Drug product — Mar 15, 2027
US 8747902 ↗ Drug product — Mar 15, 2027
US 9675704 ↗ Drug product — Mar 15, 2027
US 8747902 ↗ Drug product — Mar 15, 2027
US 8337890 ↗ Drug product — Mar 15, 2027
US 9675704 ↗ Drug product — Mar 15, 2027
US 8747902 ↗ Drug product — Mar 15, 2027
Common questions
Is there a generic version of DYANAVEL XR 5 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DYANAVEL XR 5 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2040 — 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 24478-0106-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.6K
Units reimbursed last 4 qtrs
196.5K
Gross reimbursed last 4 qtrs
$1.55M
Avg / prescription
$232.96
Avg / unit
$7.8616
Latest quarter Q4 2025
1.8KRx
Medicaid pays / ea
$7.8616
gross reimbursed
vs
NADAC / ea
$7.8534
acquisition cost
=
Spread
+$0.0082
+0% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
27% FFS 73% MCO
Fee-for-service · 1,772 Rx Managed care · 4,860 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 3,365 units · 171 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 4,270 units · 42.5 per 100k residents MI New York: 525 units · 2.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,254 units · 70.3 per 100k residents IA Illinois: no data reported IL Indiana: 33,954 units · 495 per 100k residents IN Ohio: 49,313 units · 418 per 100k residents OH Pennsylvania: 2,147 units · 16.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 17,637 units · 45.3 per 100k residents CA Utah: 2,951 units · 86.4 per 100k residents UT Colorado: 745 units · 12.7 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 7,858 units · 174 per 100k residents KY West Virginia: no data reported WV Virginia: 1,850 units · 21.2 per 100k residents VA Maryland: 8,583 units · 139 per 100k residents MD Connecticut: 3,684 units · 102 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 870 units · 29.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 4,117 units · 57.8 per 100k residents TN North Carolina: 14,908 units · 138 per 100k residents NC South Carolina: 450 units · 8.4 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 11,278 units · 247 per 100k residents LA Mississippi: 4,974 units · 169 per 100k residents MS Alabama: 4,828 units · 94.5 per 100k residents AL Georgia: 1,240 units · 11.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 11,149 units · 36.6 per 100k residents TX Florida: 3,575 units · 15.8 per 100k residents FL
Units reimbursed · per 100k residents
2.7495
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 495 /100k
2 Ohio 418 /100k
3 Louisiana 247 /100k
4 Kentucky 174 /100k
5 Idaho 171 /100k
6 Mississippi 169 /100k
7 Maryland 139 /100k
8 North Carolina 138 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Dyanavel XR — 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 Dyanavel XR. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$206.4K
Claims incl. refills
458
Beneficiaries
213
Spend / beneficiary
$969.18
Spend / claim
$450.73
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DYANAVEL XR (this brand).

Top reported reactions

Toxicity To Various Agents1,575
Drug Abuse1,272
Completed Suicide649
Overdose399
Death351
Cardiac Arrest282
Cardio-respiratory Arrest265

Age at onset

Neonate21
Infant4
Child29
Adolescent48
Adult757
Elderly55

Reporter sex

6,281 reports
Male · 53%
Female · 46%
Unknown · 0%

Serious outcomes

Death2,939
Hospitalization1,449
Life-threatening324
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 784 271
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
24478-0106-01 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (24478-106-01) 2022-08-01 Active

📄 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning.

DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.

Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

🎯 Indications and Usage 165 words ▾

1 INDICATIONS AND USAGE DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14) ]. Limitations of Use The use of DYANAVEL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ]. DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older ( 1 ) Limitations of Use The use of DYANAVEL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.5 , 8.4 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended starting dosage is 2.5 mg or 5 mg once daily in the morning ( 2.2 ) Dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum daily dose of 20 mg ( 2.2 ) May be taken with or without food ( 2.3 ) Extended-release oral suspension: Shake bottle before administering ( 2.3 ) Extended-release tablets: May be chewed or swallowed whole ( 2.3 ) DYANAVEL XR oral suspension can be substituted with DYANAVEL XR tablets on a milligram per milligram basis ( 2.4 ) Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles ( 2.4 )

2.1Pretreatment Screening Prior to treating patients with DYANAVEL XR, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating DYANAVEL XR [see Warnings and Precautions (5.8) ].

2.2Recommended Dosage The recommended starting dosage is 2.5 mg or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days based on clinical response. The maximum recommended dosage is 20 mg once daily.

2.3Administration Information Administer DYANAVEL XR orally once daily in the morning with or without food. DYANAVEL XR Extended-Release Oral Suspension Instruct patients to read the “Instructions for Use” for complete administration instructions. Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.

Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration. Use with the oral dosing dispenser provided by the pharmacist. DYANAVEL XR Extended-Release Tablets May be chewed or swallowed whole [see Clinical Pharmacology (12.3) ].

The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.

2.4Switching from Other Amphetamine Products DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis [ see Clinical Pharmacology (12.3) ] . If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles [ see Description (11) , Clinical Pharmacology (12.3) ] .

2.5Dosage Modifications due to Drug Interactions Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust DYANAVEL XR dosage accordingly [ see Drug Interactions (7.1) ] .

💊 Dosage Forms and Strengths 143 words ▾

3 DOSAGE FORMS AND STRENGTHS DYANAVEL XR (amphetamine) extended-release oral suspension: Extended-release oral suspension contains 2.5 mg amphetamine base equivalents per mL. DYANAVEL XR (amphetamine) extended-release tablets: 5 mg: Off-white, speckled, caplet shaped tablet with ‘5’ debossed on one side and functionally scored on the other side 10 mg: Off-white, speckled, diamond shaped tablet with ‘10’ debossed on one side and plain on the other side 15 mg: Off-white, speckled, triangle shaped tablet with ‘15’ debossed on one side and plain on the other side 20 mg: Off-white, speckled, oval shaped tablet with ‘20’ debossed on one side and plain on the other side All strengths are expressed in terms of amphetamine base equivalents.

Extended-release oral suspension: containing 2.5 mg amphetamine base equivalents per mL ( 3 ) Extended-release tablets: 5 mg (functionally scored), 10 mg, 15 mg, 20 mg ( 3 )

⛔ Contraindications 120 words ▾

4 CONTRAINDICATIONS DYANAVEL XR is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [ see Adverse Reactions (6) ] . Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [ see Warnings and Precautions (5.7) , Drug Interactions (7.1) ].

Known hypersensitivity to amphetamine products or other ingredients in DYANAVEL XR ( 4 ) Use of monoamine oxidase inhibitor (MAOI) or within 14 days of the last MAOI dose ( 4 , 7.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating DYANAVEL XR, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients.

Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted ( 5.5 ) Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during DYANAVEL XR treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations.

If it occurs, discontinue DYANAVEL XR and initiate supportive treatment ( 5.7 ). Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.

Discontinue treatment if clinically appropriate. ( 5.8 )

5.1Abuse, Misuse, and Addiction DYANAVEL XR has a high potential for abuse and misuse. The use of DYANAVEL XR exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. DYANAVEL XR can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ].

Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug.

Advise patients to store DYANAVEL XR in a safe place, preferably locked, and instruct patients to not give DYANAVEL XR to anyone else. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2Risks for Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages. Avoid DYANAVEL XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

5.3Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all DYANAVEL XR-treated patients for potential tachycardia and hypertension.

5.4Psychiatric Adverse Reactions Exacerbation of Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar di…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3 ) ] Hypersensitivity to amphetamine, or other components of DYANAVEL XR [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [ see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, tachycardia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 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 clinical practice. Adverse Reactions in Studies with Other Amphetamine Products in Pediatric Patients and Adults with ADHD Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea. Eye Disorders: Vision blurred, mydriasis. Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Anorexia and weight loss may occur as undesirable effects. Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido. Skin: Alopecia. Adverse Reactions in Studies with DYANAVEL XR in Pediatric Patients with ADHD There is limited experience with DYANAVEL XR in controlled trials.

Based on this limited experience, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted with DYANAVEL XR extended-release oral suspension in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis, allergic rhinitis, and upper abdominal pain. Table 1.

Common Adverse Reactions Occurring in ≥2% of Patients on DYANAVEL XR Extended-Release Oral Suspension and Greater than Placebo During the Double Blind Phase. Preferred Term DYANAVEL XR (N=52) Placebo (N=48) Respiratory, thoracic and mediastinal disorders Epistaxis 3.8% 0% Rhinitis allergic 3.8% 0% Gastrointestinal disorders Abdominal pain upper 3.8% 2.1%

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

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. Adjust DYANAVEL XR dosage accordingly ( 2.5 , 7.1 )

7.1Drugs Having Clinically Important Interactions with Amphetamines Table 2. Drugs having clinically important interactions with amphetamines. MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis.

Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer DYANAVEL XR concomitantly or within 14 days following administration of MAOI [ see Contraindications (4) and Warnings and Precautions (5.7) ] . Serotonergic Drugs Clinical Impact The concomitant use of DYANAVEL XR and serotonergic drugs increases the risk of serotonin syndrome.

Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DYANAVEL XR initiation or dosage increase. If serotonin syndrome occurs, discontinue DYANAVEL XR and the concomitant serotonergic drug(s) [ see Warnings and Precautions ( 5.7 ) ] . CYP2D6 Inhibitors Clinical Impact The concomitant use of DYANAVEL XR and CYP2D6 inhibitors may increase the exposure of DYANAVEL XR compared to the use of the drug alone and increase the risk of serotonin syndrome.

Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during DYANAVEL XR initiation and after a dosage increase. If serotonin syndrome occurs, discontinue DYANAVEL XR and the CYP2D6 inhibitor [ see Warnings and Precautions (5.7) , Overdosage (10) ] . Alkalinizing Agents (Urinary and Gastrointestinal) Clinical Impact Increase blood levels and potentiate the action of amphetamine.

Intervention Co-administration of DYANAVEL XR and gastrointestinal or urinary alkalinizing agents should be avoided. Acidifying Agents (Urinary and Gastrointestinal) Clinical Impact Lower blood levels and efficacy of amphetamines. Intervention Increase dose based on clinical response.

Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d- amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.

7.2Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

🔄 Drug / Laboratory Test Interactions 28 words ▾

7.2Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm ( 8.1 ) Lactation: Breastfeeding not recommended ( 8.2 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. Risk Summary There are limited published data on the use of amphetamines in pregnant women.

These data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines. No effects on morphological development were observed in embryo-fetal development studies with oral administration of amphetamine to rats and rabbits during organogenesis at doses that are approximately 3 and 16 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day (as base equivalents) on a mg/m 2 basis, given to adults.

However, long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine [see Data ]. 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. Clinical Considerations Fetal/Neonatal adverse reactions Amphetamines, such as DYANAVEL XR, may cause vasoconstriction, including vasoconstriction of placental blood vessels, and may increase the risk for intrauterine growth restriction.

In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal, such as feeding difficulties, irritability, agitation, and excessive drowsiness.

Data Animal Data Amphetamine ( d - to l - enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 3 and 16 times, respectively, the MRHD of 20 mg/day (as base equivalents) on a mg/m 2 basis, given to adults. Fetal malformations and death have been reported in mice following parenteral administration of d -amphetamine doses of 50 mg/kg/day (approximately 12 times the MRHD) given to adults on a mg/m 2 basis or greater to pregnant animals.

Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine ( d - or d , l -), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

8.2Lactation Risk Summary Based on limited case reports in published literature, amphetamine ( d - or d , l -) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no reports of adverse effects on the breastfed infant and no effects on milk production. However, long term neurodevelopmental effects on infants from stimulant exposure are unknown.

Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with DYANAVEL XR.

8.4 Pediatric Use The safety and effectiveness of DYANAVEL XR have not b…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. Risk Summary There are limited published data on the use of amphetamines in pregnant women.

These data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines. No effects on morphological development were observed in embryo-fetal development studies with oral administration of amphetamine to rats and rabbits during organogenesis at doses that are approximately 3 and 16 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day (as base equivalents) on a mg/m 2 basis, given to adults.

However, long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine [see Data ]. 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. Clinical Considerations Fetal/Neonatal adverse reactions Amphetamines, such as DYANAVEL XR, may cause vasoconstriction, including vasoconstriction of placental blood vessels, and may increase the risk for intrauterine growth restriction.

In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal, such as feeding difficulties, irritability, agitation, and excessive drowsiness.

Data Animal Data Amphetamine ( d - to l - enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 3 and 16 times, respectively, the MRHD of 20 mg/day (as base equivalents) on a mg/m 2 basis, given to adults. Fetal malformations and death have been reported in mice following parenteral administration of d -amphetamine doses of 50 mg/kg/day (approximately 12 times the MRHD) given to adults on a mg/m 2 basis or greater to pregnant animals.

Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine ( d - or d , l -), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

🧒 Pediatric Use 144 words ▾

8.4Pediatric Use The safety and effectiveness of DYANAVEL XR have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years [ see Adverse Reactions (6.1) , Clinical Pharmacology (12) , and Clinical Studies (14) ]. Long-Term Growth Suppression Growth should be monitored during treatment with stimulants, including DYANAVEL XR, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [ see Warnings and Precautions (5.5) ] .

🧓 Geriatric Use 13 words ▾

8.5Geriatric Use DYANAVEL XR has not been studied in the geriatric population.

🆘 Overdosage 111 words ▾

10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.

CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.

Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of DYANAVEL XR should be considered when treating patients with overdose. D-amphetamine is not dialyzable.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.

12.2Pharmacodynamics Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extra neuronal space.

12.3Pharmacokinetics Absorption Extended-Release Oral Suspension Following a single 18.8 mg dose of DYANAVEL XR extended-release oral suspension in 29 healthy adult subjects under fasting conditions in a crossover study, the median (range) time to peak plasma concentrations (T max ) for both d- and l- isomers of amphetamine were 4 (2 to 7) hours after dosing. Peak concentrations (C max ) of d- and l- amphetamine were 102% and 106%, respectively, of the C max of immediate-release (IR) mixed amphetamine salts (MAS) tablets.

The relative bioavailability of DYANAVEL XR compared with an equal dose of IR MAS tablets is 106% for d - and 111% for l -amphetamine. Following a single 18.8 mg dose of DYANAVEL XR extended-release oral suspension in 28 healthy adult subjects in a crossover study under fasting conditions, the median (range) time to peak plasma concentrations (T max ) were about 4 (2 to 7) hours and 5 (3 to 7) hours for d - and l -amphetamine, respectively. Peak concentration (C max ) was 93% and 94%, respectively, of the C max of extended release (ER) MAS capsules.

The relative bioavailability of DYANAVEL XR compared with an equal dose of ER MAS capsules is 94% for both d - and l -amphetamine. Figure 1. Mean d - and l -Amphetamine Plasma Concentration-Time Profile Following Administration of a Single Dose (18.8 mg amphetamine base) of DYANAVEL XR Extended-Release Oral Suspension and MAS ER Under Fasting Conditions Extended-Release Tablet Following a single 20 mg dose of DYANAVEL XR extended-release tablets (swallowed whole) to 36 healthy adults under fasted conditions in a crossover study, the median (range) time to peak plasma concentration (T max ) for both d - and l -amphetamine, were 5.0 (2 to 9) hours after dosing.

Peak concentrations (C max ) for both d - and l -amphetamine, were 101% of the C max of DYANAVEL XR oral suspension. The relative bioavailability of DYANAVEL XR tablets compared with an equal dose of DYANAVEL XR oral suspension, for d - and l -amphetamine, were 105% and 106%, respectively. Dyanavel XR extended-release tablets chewed or swallowed whole under fasted conditions did not significantly affect exposure and T max.

Figure 2. Mean Plasma d - and l- Amphetamine Concentration-Time Profiles for DYANAVEL XR Extended-Release Tablet and DYANAVEL XR Extended-Release Oral Suspension Effect of Food Extended-Release Oral Suspension Ingestion of 18.8 mg of DYANAVEL XR extended-release oral suspension with a high-fat meal increased the average C max of both isomers of DYANAVEL XR by about 2%, decreased the AUC of d- and l- amphetamine by 5.7% and 7.4%, respectively. A delay of T max by approximately 1 hour was observed for both isomers.

Extended-Release Tablet Ingestion of 20 mg DYANAVEL XR extended-release tablets with a high-fat meal decreased the average C max of both isomers of amphetamine by about 3%, decreased AUC of d - and l -amphetamine by about 4.0% and 7.3%, respectively. Median T max was not delayed for either isomer. Elimination The mean plasma terminal elimination half-lives of d - and l- amphetamine were 12.4 hours and 15.1 hours, respectively, following a single 18.8 mg dose of DYANAVEL XR extended-release oral suspension.

The mean plasma terminal elimination half-lives of d- and l- amphetamine were 13.5 hours and 17.3 hours, respectively, following a single 20 mg dose of DYANAVEL XR extended-release tablets. Metabolism Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4‑hydroxyamphetamine, or on the side chain A or B carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. N…

🧬 Mechanism of Action 23 words ▾

12.1Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DYANAVEL XR (amphetamine) extended-release oral suspension: The concentration is 2.5 mg/mL amphetamine base equivalents and is supplied as light beige to tan viscous suspension with bubblegum flavor in bottles of 60 mL (NDC 24478-102-02) and 464 mL (NDC 24478-102-01). The product is provided in a carton. 60 mL carton contains two oral dispensers and two bottle adapters.

464 mL carton contains four oral dispensers and four bottle adapters. DYANAVEL XR (amphetamine) extended-release tablets: Supplied in bottles (that contain a desiccant) with child-resistant closure as 5 mg, 10 mg, 15 mg, and 20 mg strengths. 5 mg DYANAVEL XR extended-release tablet is functionally scored and is available as an off-white, speckled, caplet shaped tablet with 5 debossed on one side and scored on the other side, supplied in bottles of 30 (NDC 24478-106-01).

10 mg DYANAVEL XR extended-release tablet is available as an off-white, speckled, diamond shaped tablet with 10 debossed on one side and plain on the other side, supplied in bottles of 30 (NDC 24478-108-01). 15 mg DYANAVEL XR extended-release tablet is available as an off-white, speckled, triangle shaped tablet with 15 debossed on one side and plain on the other side, supplied in bottles of 30 (NDC 24478-109-01). 20 mg DYANAVEL XR extended-release tablet is available as an off-white, speckled, oval shaped tablet with 20 debossed on one side and plain on the other side, supplied in bottles of 30 (NDC 24478-110-01).

Storage and Handling Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15º to 30ºC (59º to 86ºF) [ see USP Controlled Room Temperature ] . DYANAVEL XR extended-release oral suspension : The pharmacist should insert the bottle adapter firmly into the neck of the bottle and provide the oral dosing dispenser to the patient when dispensing this product.

📋 Description ~2 min read ▾

11 DESCRIPTION DYANAVEL XR (amphetamine) extended-release oral suspension and DYANAVEL XR (amphetamine) extended-release tablets contain amphetamine, a CNS stimulant, in a 3.2:1 ratio of d - to l - amphetamine. There are three active ingredients: amphetamine (complexed with sodium polystyrene sulfonate), dextroamphetamine sulfate and amphetamine aspartate. The dosage strengths are expressed in terms of amphetamine base.

DYANAVEL XR contains both immediate-release and extended-release components. Structural Formula: C 9 H 13 N MW 135.21 Active Ingredients: DYANAVEL XR extended-release oral suspension 2.5 mg/mL: Each 1 mL contains 2 mg of amphetamine (in a 3.2 to 1 ratio of d- to l- amphetamine complexed with sodium polystyrene sulfonate), and 0.5 mg amphetamine (present as 0.5 mg of amphetamine aspartate and 0.3 mg of dextroamphetamine sulfate). DYANAVEL XR extended-release tablets: Each 5 mg strength tablet contains 4 mg of amphetamine (in a 3.2 to 1 ratio of d- to l- amphetamine complexed with sodium polystyrene sulfonate), and 1 mg of amphetamine (present as 1 mg of amphetamine aspartate and 0.7 mg of dextroamphetamine sulfate).

Each 10 mg strength tablet contains 8 mg of amphetamine (in a 3.2 to 1 ratio of d- to l- amphetamine complexed with sodium polystyrene sulfonate), and 2 mg of amphetamine (present as 2 mg amphetamine aspartate and 1.4 mg dextroamphetamine sulfate). Each 15 mg strength tablet contains 12 mg of amphetamine (in a 3.2 to 1 ratio of d- to l- amphetamine complexed with sodium polystyrene sulfonate), and 3 mg of amphetamine (present as 3 mg amphetamine aspartate and 2 mg dextroamphetamine sulfate). Each 20 mg strength tablet contains 16 mg of amphetamine (in a 3.2 to 1 ratio of d- to l- amphetamine complexed with sodium polystyrene sulfonate), and 4 mg of amphetamine (present as 4 mg amphetamine aspartate and 2.7 mg dextroamphetamine sulfate).

DYANAVEL XR extended-release oral suspension and DYANAVEL XR extended-release tablets are intended for oral administration. Inactive Ingredients: DYANAVEL XR extended-release oral suspension: anhydrous citric acid, bubblegum flavor, glycerin, methylparaben, modified starch, polysorbate 80, povidone, polyvinyl acetate, propylparaben, sodium lauryl sulfate, sodium polystyrene sulfonate, sucralose, triacetin and xanthan gum. DYANAVEL XR extended-release tablets: bubblegum flavor, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl acetate, povidone, silicon dioxide, sodium polystyrene sulfonate, sucralose, talc, triacetin and xanthan gum.

DXR chem draw structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of DYANAVEL XR, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ]. Advise patients to store DYANAVEL XR in a safe place, preferably locked, and instruct patients to not give DYANAVEL XR to anyone else.

Dosage and Administration Instructions Provide the following instructions on administration to the patient [see Dosage and Administration (2.3) ] : DYANAVEL XR extended-release oral suspension Use with the oral dosing dispenser provided by the pharmacist. Ensure that the bottle adapter has been firmly inserted into the bottle by the pharmacist. Do not remove the bottle adapter once it has been inserted into the bottle.

Shake the bottle before each dose. DYANAVEL XR extended-release tablets Tablets may be chewed or swallowed whole. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with DYANAVEL XR use.

Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [ see Warnings and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Instruct patients and their caregivers that DYANAVEL XR can cause elevations of their blood pressure and pulse rate [ see Warnings and Precautions (5.3) ] . Psychiatric Adverse Reactions Advise patients and their caregivers that DYANAVEL XR, at recommended doses, may cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [ see Warnings and Precautions (5.4) ] .

Long-Term Suppression of Growth in Pediatric Patients Advise patients and their caregivers that DYANAVEL XR may cause slowing of growth and weight loss [ see Warnings and Precautions (5.5) ] . Circulation Problems in Fingers and Toes [ Peripheral vasculopathy, including Raynaud’s phenomenon ] Instruct patients and their caregivers beginning treatment with DYANAVEL XR about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Instruct patients and their caregivers to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients and their caregivers to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking DYANAVEL XR. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [ see Warnings and Precautions (5.6) ].

Serotonin Syndrome Caution patients and their caregivers about the risk of serotonin syndrome with concomitant use of DYANAVEL XR and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [ see Contraindications (4) , Warnings and Precautions (5.7) and Drug Interactions (7.1) ].

Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with DYANAVEL XR. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE DYANAVEL ® XR (dī-an-uh-vel) (amphetamine) extended-release oral suspension, CII DYANAVEL ® XR (dī-an-uh-vel) (amphetamine) extended-release tablets, CII What is the most important information I should know about DYANAVEL XR ? ­­­­DYANAVEL XR may cause serious side effects, including: Abuse, misuse, and addiction. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DYANAVEL XR, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death.

The risk of overdose and death is increased with higher doses of DYANAVEL XR or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting, treatment with DYANAVEL XR and will monitor you or your child during treatment. DYANAVEL XR may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.

Do not give DYANAVEL XR to anyone else. See “ What is DYANAVEL XR? ” for more information. Keep DYANAVEL XR in a safe place and properly dispose of any unused medicine.

See “ How should I store DYANAVEL XR? ” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease.

Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with DYANAVEL XR. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DYANAVEL XR. Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.

Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with DYANAVEL XR, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is DYANAVEL XR? DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

DYANAVEL XR is not recommended for use in children under 6 years of age with ADHD. DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep DYANAVEL XR in a safe place to protect it from theft.

Never give your DYANAVEL XR to anyone else, because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law. Do not take DYANAVEL XR if you or your child are: allergic to amphetamine products or any of the ingredients in DYANAVEL XR.

See the end of this Medication Guide for a complete list of ingredients in DYANAVEL XR. taking, or have taken within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and the intravenous medicin…

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