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Trintellix vortioxetine 20 mg Tablet, Film Coated, 30-count — NDC 64764-0750-30 package photo

Trintellix vortioxetine 20 mg Tablet, Film Coated, 30-count

by Takeda Pharmaceuticals America, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-30)
NDC 64764-0750-30
🏷️ FDA NDC (as labeled) 64764-750-30 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$17.22 NADAC Per package$516.54 / 30 tablets Pack sizes5 compare ↓
Also priced by: Medicaid pays $16.56/unit · Part D plans $17.31/unit — full pricing hub ↓
Also comes in: 7 tablets 64764-0750-07 30 tablets 64764-0750-09 90 tablets 64764-0750-90 500 tablets 64764-0750-77
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 64764-750-30
Product NDC 64764-750
11-digit billing NDC 64764075030
NCPDP billing unit EA — each (per item)
RxCUI 1439808, 1439810, 1439812, 1790886, 1790890, 1790892
UNII TKS641KOAY
UPC 0364764720308, 0364764750305, 0364764730307
Application # NDA204447
SPL Set ID 1a5b68e2-14d0-419d-9ec6-1ca97145e838
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-10-02
Route ORAL
Dosage form TABLET, FILM COATED
Substance VORTIOXETINE HYDROBROMIDE
GPI-14 58120093100340
GPI class Trintellix
GCN Seq No 071512
GCN 35349
HICL code 040637
Ingredient (HICL) Vortioxetine Hydrobromide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8T
Therapeutic class — specific (HIC3) Ssri, Serotonin Receptor Modulator Antidepressants
AHFS code 28:16.04.24
AHFS class Serotonin Modulators
FDB label name TRINTELLIX 20 MG TABLET
FDB brand name Trintellix
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 64764-750-30 — 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 → 64764-0750-30. 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 Other antidepressants class.

Drug family (ATC) Other antidepressants
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

LabelerTakeda Pharmaceuticals America, Inc.
Application holderTAKEDA PHARMACEUTICALS USA INC
FDA applicationNDA204447 (NDA)
Labeler code64764
First marketedOct 2013
Product typeHuman Prescription Drug
Portfolio154 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 TRINTELLIX 20 MG TABLET Ingredient Vortioxetine Hydrobromide
📖 What it is MedlinePlus · NLM

Vortioxetine is used to treat depression in adults. Vortioxetine is in a class of medications called serotonin modulators. It works mainly by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Trintellix is used to treat major depressive disorder — what most people call clinical depression — in adults. It's a prescription antidepressant that works on the serotonin system...
  • Antidepressants generally take several weeks to show their full effect — it's not an overnight fix. Your body reaches stable blood levels of vortioxetine within about two weeks of...
  • How long does it take for Trintellix to start working?
  • The most common side effect is nausea, which tends to be worst early on and often improves after the first week or two. You might also notice constipation, diarrhea, dry mouth, or...
📖 Read our full Vortioxetine guide →
1
Nutrient depletion considerations

Vortioxetine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Vortioxetine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 / Yellow / Red
ShapeTear
Imprint20;TL
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII UKE75GEA7F
    Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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 $17.218 $516.54 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $16.56 $496.71 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $17.31 $519.32 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2024 May 2026 Aug 2026 $17.232 $13.535
▲ Up 27% 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
Trintellix 20 mgthis 64764-0750-30 Takeda 30 tablets $17.218 — Availability likely —
Trintellix 20 mg 55154-0257-08 Cardinal 2430 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
First FDA approval
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2032
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 Sep 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 30, 2013 RLD RS ⏳ ~6 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 9227946 — method of use (U-1668)
US 9861630 — method of use (U-1668)
US 9861630 — method of use (U-1668)
US 9861630 — method of use (U-1668)
US 9125908 — method of use (U-2309)
US 9125908 — method of use (U-2309)
US 9125909 — method of use (U-2309)
US 9125909 — method of use (U-2309)
US 9125910 — method of use (U-2309)
US 9125910 — method of use (U-2309)
US 7144884 — drug substance (U-1439)
US 7144884 — drug substance (U-1439)
US 9278096 — method of use (U-2436)
US 9278096 — method of use (U-2436)
US 8969355 — method of use (U-1668)
US 8969355 — method of use (U-1668)
US 9227946 — method of use (U-1668)
US 9227946 — method of use (U-1668)
US 9125910 — method of use (U-2309)
US 7144884 — drug substance (U-1439)
US 8969355 — method of use (U-1668)
US 9227946 — method of use (U-1668)
US 9125909 — method of use (U-2309)
US 9125908 — method of use (U-2309)
US 9125908 — method of use (U-2309)
US 9125910 — method of use (U-2309)
US 11458134 — method of use (U-3463)
US 11458134 — method of use (U-3463)
US 11458134 — method of use (U-3463)
US 11458134 — method of use (U-3463)
US 9125909 — method of use (U-2309)
US 9861630 — method of use (U-1668)
US 9278096 — method of use (U-2436)
US 9278096 — method of use (U-2436)
US 7144884 — drug substance (U-1439)
US 8969355 — method of use (U-1668)
US 8722684 — drug substance
US 8722684 — drug substance
US 8722684 — drug substance
US 8722684 — drug substance
US 8722684*PED — drug product
US 8722684*PED — drug product
US 8722684*PED — drug product
US 8722684*PED — drug product
US 7144884*PED — drug product
US 7144884*PED — drug product
US 7144884*PED — drug product
US 7144884*PED — drug product
US 8969355*PED — drug product
US 8969355*PED — drug product
US 8969355*PED — drug product
US 8969355*PED — drug product
US 9227946*PED — drug product
US 9227946*PED — drug product
US 9227946*PED — drug product
US 9227946*PED — drug product
US 9125908*PED — drug product
US 9125909*PED — drug product
US 9125908*PED — drug product
US 9125909*PED — drug product
US 9125908*PED — drug product
US 9125909*PED — drug product
US 9125908*PED — drug product
US 9125909*PED — drug product
US 9125910*PED — drug product
US 9125910*PED — drug product
US 9125910*PED — drug product
US 9125910*PED — drug product
US 9861630*PED — drug product
US 9861630*PED — drug product
US 9861630*PED — drug product
US 9861630*PED — drug product
US 9278096*PED — drug product
US 9278096*PED — drug product
US 9278096*PED — drug product
US 9278096*PED — drug product
US 11458134*PED — drug product
US 11458134*PED — drug product
US 11458134*PED — drug product
US 11458134*PED — drug product
Exclusivity M-232
Exclusivity M-232
Exclusivity M-232
Exclusivity M-232
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
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 (80)
PatentTypeUse codeExpires
US 9227946 ↗ Method of use U-1668 Jun 15, 2027
US 9861630 ↗ Method of use U-1668 Jun 15, 2027
US 9861630 ↗ Method of use U-1668 Jun 15, 2027
US 9861630 ↗ Method of use U-1668 Jun 15, 2027
US 9125908 ↗ Method of use U-2309 Jun 15, 2027
US 9125908 ↗ Method of use U-2309 Jun 15, 2027
US 9125909 ↗ Method of use U-2309 Jun 15, 2027
US 9125909 ↗ Method of use U-2309 Jun 15, 2027
US 9125910 ↗ Method of use U-2309 Jun 15, 2027
US 9125910 ↗ Method of use U-2309 Jun 15, 2027
US 7144884 ↗ Drug substance U-1439 Jun 17, 2026
US 7144884 ↗ Drug substance U-1439 Jun 17, 2026
US 9278096 ↗ Method of use U-2436 Mar 21, 2032
US 9278096 ↗ Method of use U-2436 Mar 21, 2032
US 8969355 ↗ Method of use U-1668 Jun 15, 2027
US 8969355 ↗ Method of use U-1668 Jun 15, 2027
US 9227946 ↗ Method of use U-1668 Jun 15, 2027
US 9227946 ↗ Method of use U-1668 Jun 15, 2027
US 9125910 ↗ Method of use U-2309 Jun 15, 2027
US 7144884 ↗ Drug substance U-1439 Jun 17, 2026
US 8969355 ↗ Method of use U-1668 Jun 15, 2027
US 9227946 ↗ Method of use U-1668 Jun 15, 2027
US 9125909 ↗ Method of use U-2309 Jun 15, 2027
US 9125908 ↗ Method of use U-2309 Jun 15, 2027
US 9125908 ↗ Method of use U-2309 Jun 15, 2027
US 9125910 ↗ Method of use U-2309 Jun 15, 2027
US 11458134 ↗ Method of use U-3463 Jun 15, 2027
US 11458134 ↗ Method of use U-3463 Jun 15, 2027
US 11458134 ↗ Method of use U-3463 Jun 15, 2027
US 11458134 ↗ Method of use U-3463 Jun 15, 2027
US 9125909 ↗ Method of use U-2309 Jun 15, 2027
US 9861630 ↗ Method of use U-1668 Jun 15, 2027
US 9278096 ↗ Method of use U-2436 Mar 21, 2032
US 9278096 ↗ Method of use U-2436 Mar 21, 2032
US 7144884 ↗ Drug substance U-1439 Jun 17, 2026
US 8969355 ↗ Method of use U-1668 Jun 15, 2027
US 8722684 ↗ Drug substance — Jun 30, 2031
US 8722684 ↗ Drug substance — Jun 30, 2031
US 8722684 ↗ Drug substance — Jun 30, 2031
US 8722684 ↗ Drug substance — Jun 30, 2031
US 8722684*PED ↗ Drug product — Dec 30, 2031
US 8722684*PED ↗ Drug product — Dec 30, 2031
US 8722684*PED ↗ Drug product — Dec 30, 2031
US 8722684*PED ↗ Drug product — Dec 30, 2031
US 7144884*PED ↗ Drug product — Dec 17, 2026
US 7144884*PED ↗ Drug product — Dec 17, 2026
US 7144884*PED ↗ Drug product — Dec 17, 2026
US 7144884*PED ↗ Drug product — Dec 17, 2026
US 8969355*PED ↗ Drug product — Dec 15, 2027
US 8969355*PED ↗ Drug product — Dec 15, 2027
US 8969355*PED ↗ Drug product — Dec 15, 2027
US 8969355*PED ↗ Drug product — Dec 15, 2027
US 9227946*PED ↗ Drug product — Dec 15, 2027
US 9227946*PED ↗ Drug product — Dec 15, 2027
US 9227946*PED ↗ Drug product — Dec 15, 2027
US 9227946*PED ↗ Drug product — Dec 15, 2027
US 9125908*PED ↗ Drug product — Dec 15, 2027
US 9125909*PED ↗ Drug product — Dec 15, 2027
US 9125908*PED ↗ Drug product — Dec 15, 2027
US 9125909*PED ↗ Drug product — Dec 15, 2027
US 9125908*PED ↗ Drug product — Dec 15, 2027
US 9125909*PED ↗ Drug product — Dec 15, 2027
US 9125908*PED ↗ Drug product — Dec 15, 2027
US 9125909*PED ↗ Drug product — Dec 15, 2027
US 9125910*PED ↗ Drug product — Dec 15, 2027
US 9125910*PED ↗ Drug product — Dec 15, 2027
US 9125910*PED ↗ Drug product — Dec 15, 2027
US 9125910*PED ↗ Drug product — Dec 15, 2027
US 9861630*PED ↗ Drug product — Dec 15, 2027
US 9861630*PED ↗ Drug product — Dec 15, 2027
US 9861630*PED ↗ Drug product — Dec 15, 2027
US 9861630*PED ↗ Drug product — Dec 15, 2027
US 9278096*PED ↗ Drug product — Sep 21, 2032
US 9278096*PED ↗ Drug product — Sep 21, 2032
US 9278096*PED ↗ Drug product — Sep 21, 2032
US 9278096*PED ↗ Drug product — Sep 21, 2032
US 11458134*PED ↗ Drug product — Dec 15, 2027
US 11458134*PED ↗ Drug product — Dec 15, 2027
US 11458134*PED ↗ Drug product — Dec 15, 2027
US 11458134*PED ↗ Drug product — Dec 15, 2027
FDA exclusivity
CodeWhat it grantsExpires
M-232New indication / labeling change (3-year)Aug 23, 2026
M-232New indication / labeling change (3-year)Aug 23, 2026
M-232New indication / labeling change (3-year)Aug 23, 2026
M-232New indication / labeling change (3-year)Aug 23, 2026
PEDPediatric Exclusivity (+6 months)Feb 23, 2027
PEDPediatric Exclusivity (+6 months)Feb 23, 2027
PEDPediatric Exclusivity (+6 months)Feb 23, 2027
PEDPediatric Exclusivity (+6 months)Feb 23, 2027
Common questions
Is there a generic version of TRINTELLIX 20 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TRINTELLIX 20 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2032 — 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 64764-0750-30, 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
173K
Units reimbursed last 4 qtrs
5.8M
Gross reimbursed last 4 qtrs
$96.14M
Avg / prescription
$555.79
Avg / unit
$16.5570
Latest quarter Q4 2025
39.9KRx
Medicaid pays / ea
$16.5570
gross reimbursed
vs
NADAC / ea
$17.2181
acquisition cost
=
Spread
−$0.6611
-4% 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 ⓘ
47% FFS 53% MCO
Fee-for-service · 81,868 Rx Managed care · 91,103 Rx
State Medicaid map
Alaska: 14,498 units · 1,978 per 100k residents AK Maine: 27,187 units · 1,949 per 100k residents ME Washington: 68,999 units · 883 per 100k residents WA Idaho: 50,181 units · 2,555 per 100k residents ID Montana: 19,765 units · 1,746 per 100k residents MT North Dakota: 16,491 units · 2,106 per 100k residents ND Minnesota: 105,442 units · 1,838 per 100k residents MN Wisconsin: 98,088 units · 1,660 per 100k residents WI Michigan: 517,183 units · 5,153 per 100k residents MI New York: 349,169 units · 1,784 per 100k residents NY Vermont: 13,258 units · 2,049 per 100k residents VT New Hampshire: 20,876 units · 1,489 per 100k residents NH Oregon: 120,083 units · 2,837 per 100k residents OR Nevada: 32,389 units · 1,014 per 100k residents NV Wyoming: 4,013 units · 687 per 100k residents WY South Dakota: 13,487 units · 1,468 per 100k residents SD Iowa: 164,861 units · 5,141 per 100k residents IA Illinois: 80,079 units · 638 per 100k residents IL Indiana: 418,174 units · 6,094 per 100k residents IN Ohio: 450,087 units · 3,819 per 100k residents OH Pennsylvania: 256,609 units · 1,980 per 100k residents PA New Jersey: 50,682 units · 546 per 100k residents NJ Massachusetts: 108,528 units · 1,550 per 100k residents MA California: 581,143 units · 1,491 per 100k residents CA Utah: 53,207 units · 1,557 per 100k residents UT Colorado: 97,537 units · 1,659 per 100k residents CO Nebraska: 47,011 units · 2,377 per 100k residents NE Missouri: 195,499 units · 3,155 per 100k residents MO Kentucky: 294,844 units · 6,514 per 100k residents KY West Virginia: 46,573 units · 2,631 per 100k residents WV Virginia: 146,064 units · 1,676 per 100k residents VA Maryland: 102,559 units · 1,660 per 100k residents MD Connecticut: 131,337 units · 3,631 per 100k residents CT Rhode Island: 25,848 units · 2,361 per 100k residents RI Arizona: 44,754 units · 602 per 100k residents AZ New Mexico: 19,034 units · 900 per 100k residents NM Kansas: 34,195 units · 1,163 per 100k residents KS Arkansas: 18,730 units · 611 per 100k residents AR Tennessee: 106,957 units · 1,501 per 100k residents TN North Carolina: 236,571 units · 2,183 per 100k residents NC South Carolina: 31,160 units · 580 per 100k residents SC Delaware: 26,792 units · 2,599 per 100k residents DE Oklahoma: 73,863 units · 1,822 per 100k residents OK Louisiana: 176,851 units · 3,866 per 100k residents LA Mississippi: 41,944 units · 1,427 per 100k residents MS Alabama: 21,222 units · 415 per 100k residents AL Georgia: 53,503 units · 485 per 100k residents GA D.C.: 3,035 units · 447 per 100k residents DC Hawaii: 30,496 units · 2,125 per 100k residents HI Texas: 101,829 units · 334 per 100k residents TX Florida: 63,628 units · 281 per 100k residents FL
Units reimbursed · per 100k residents
2816,514
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 Kentucky 6,514 /100k
2 Indiana 6,094 /100k
3 Michigan 5,153 /100k
4 Iowa 5,141 /100k
5 Louisiana 3,866 /100k
6 Ohio 3,819 /100k
7 Connecticut 3,631 /100k
8 Missouri 3,155 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets this page64764-0750-30 172,971 Rx · $96,135,045
7 tablets64764-0750-07 No Medicaid data
30 tablets64764-0750-09 No Medicaid data
500 tablets64764-0750-77 No Medicaid data
90 tablets64764-0750-90 No Medicaid data
Drug total (last 4 qtrs): 172,971 Rx · 5,806,315 units · $96,135,045 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Trintellix — 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 Trintellix. 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
$97.55M
Claims incl. refills
150.1K
Beneficiaries
66.8K
Spend / beneficiary
$1,461.00
Spend / claim
$649.83
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 Trintellix (this brand).

Top reported reactions

Nausea2,259
Fatigue1,212
Headache1,066
Anxiety1,039
Vomiting1,020
Suicidal Ideation942
Insomnia925

Age at onset

Neonate9
Infant1
Child5
Adolescent8
Adult1,283
Elderly608

Reporter sex

16,915 reports
Male · 30%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization2,858
Death1,001
Disabling419
Life-threatening350
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,005 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
64764-0750-07 1 BOTTLE in 1 CARTON (64764-750-07) / 7 TABLET, FILM COATED in 1 BOTTLE — — 2013-10-02 Active
64764-0750-09 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-09) — — 2013-10-02 Active
64764-0750-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-30) $17.22 / ea $516.54 2013-10-02 Active
64764-0750-77 500 TABLET, FILM COATED in 1 BOTTLE (64764-750-77) — — 2013-10-02 Active
64764-0750-90 90 TABLET, FILM COATED in 1 BOTTLE (64764-750-90) — — 2013-10-02 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 64764-0750-30?
NDC 64764-0750-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 64764-0750-30 and NDC 64764-0750-07?
Both are Trintellix vortioxetine 20 mg Tablet, Film Coated — the drug itself is identical. NDC 64764-0750-30 is the 30-count package, while NDC 64764-0750-07 is the 7 tablets package.
What NDC number is used to bill for this package of Trintellix vortioxetine 20 mg Tablet, Film Coated?
Bill NDC 64764-0750-30 — the 11-digit billing format is 64764075030. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 117 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . TRINTELLIX is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] .

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

TRINTELLIX is not approved for use in pediatric patients ( 8.4 ).

🎯 Indications and Usage 35 words ▾

1 INDICATIONS AND USAGE TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended starting dose is 10 mg administered orally once daily without regard to meals ( 2.1 ). The dose should then be increased to 20 mg/day, as tolerated ( 2.1 ). Consider 5 mg/day for patients who do not tolerate higher doses ( 2.1 ).

TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible ( 2.3 ). The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers ( 2.5 ).

2.1Recommended Dosage The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses [see Clinical Studies (14) ] .

2.2Screen for Bipolar Disorder Prior to Starting TRINTELLIX Prior to initiating treatment with TRINTELLIX or another antidepressant, screen patients for personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4) ] .

2.3Discontinuing Treatment Although TRINTELLIX can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of TRINTELLIX 15 mg/day or 20 mg/day. It is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of TRINTELLIX 15 mg/day or 20 mg/day [see Warnings and Precautions (5.5) and Adverse Reactions (6) ] .

2.4Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days must elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with TRINTELLIX to avoid the risk of Serotonin Syndrome [see Warnings and Precautions (5.2) ] . Conversely, at least 21 days must elapse after stopping TRINTELLIX before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4) ] .

2.5Use of TRINTELLIX in Known CYP2D6 Poor Metabolizers or in Patients Taking Strong CYP2D6 Inhibitors The maximum recommended dose of TRINTELLIX is 10 mg/day in known CYP2D6 poor metabolizers. Reduce the dose of TRINTELLIX by one-half when patients are receiving a CYP2D6 strong inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) concomitantly. The dose should be increased to the original level when the CYP2D6 inhibitor is discontinued [see Drug Interactions (7.1) , Use in Specific Populations (8.6) ] .

2.6Use of TRINTELLIX in Patients Taking Strong CYP Inducers Consider increasing the dose of TRINTELLIX when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for greater than 14 days. The maximum recommended dose should not exceed three times the original dose. The dose of TRINTELLIX should be reduced to the original level within 14 days, when the inducer is discontinued [see Drug Interactions (7.1) ] .

💊 Dosage Forms and Strengths 83 words ▾

3 DOSAGE FORMS AND STRENGTHS TRINTELLIX is available as: 5 mg: pink, almond shaped biconvex film coated tablet, debossed with "5" on one side and "TL" on the other side 10 mg: yellow, almond shaped biconvex film coated tablet, debossed with "10" on one side and "TL" on the other side 20 mg: red, almond shaped biconvex film coated tablet, debossed with "20" on one side and "TL" on the other side Tablets: 5 mg, 10 mg, and 20 mg ( 3 ).

⛔ Contraindications 204 words ▾

4 CONTRAINDICATIONS Hypersensitivity to vortioxetine or any component of the formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX [see Adverse Reactions (6.2) ] . The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of serotonin syndrome.

The use of TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) ] . Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation ( 4 ).

Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome : Increased risk when coadministered with other serotonergic agents, but also when taken alone. If it occurs, discontinue TRINTELLIX and serotonergic agents and initiate supportive measures ( 5.2 ). Increased Risk of Bleeding : Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, or other drugs that affect coagulation may increase risk ( 5.3 ).

Activation of Mania/Hypomania : Screen patients for bipolar disorder ( 5.4 ). Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.6 ). Hyponatremia : Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) ( 5.7 ).

Sexual Dysfunction: TRINTELLIX may cause symptoms of sexual dysfunction ( 5.8 ).

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1 . Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric TRINTELLIX is not approved for use in pediatric patients. and Adult Patients Age Range Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in adolescents and young adults extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that the use of antidepressants can delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for all approved populations for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing TRINTELLIX, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts and behaviors.

5.2Serotonin Syndrome Serotonergic antidepressants, including TRINTELLIX, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4) , Drug Interactions (7.1) ] .

Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic i…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4) ] Clinical Worsening and Suicide Risk [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Increased Risk of Bleeding [see Warnings and Precautions (5.3) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.4) ] Discontinuation Syndrome [see Warnings and Precautions (5.5) ] Angle Closure Glaucoma [see Warnings and Precautions (5.6) ] Hyponatremia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies 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. Patient Exposure TRINTELLIX was evaluated for safety in 5,852 patients (18 years to 88 years of age) diagnosed with MDD who participated in pre- and postmarketing clinical studies; 2,616 of those patients were exposed to TRINTELLIX in 6 to 8 week, placebo-controlled studies at doses ranging from 5 mg to 20 mg once daily; 204 patients were exposed to TRINTELLIX in a 24 to 64 week placebo-controlled maintenance study at doses of 5 mg to 10 mg once daily; and 429 patients were exposed to TRINTELLIX in a 32 week placebo-controlled maintenance study in the U.S. at doses of 5 mg, 10 mg, and 20 mg, once daily.

Patients from the 6 to 8 week studies continued into 12-month open-label studies. A total of 2,586 patients were exposed to at least one dose of TRINTELLIX in open-label studies, 1,727 were exposed to TRINTELLIX for 6 months and 885 were exposed for at least 1 year. Adverse Reactions Reported as Reasons for Discontinuation of Treatment In pooled 6 to 8 week placebo-controlled studies the incidence of patients who received TRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day, and 20 mg/day and discontinued treatment because of an adverse reaction was 5%, 6%, 8%, and 8%, respectively, compared to 4% of placebo-treated patients.

Nausea was the most common adverse reaction reported as a reason for discontinuation. Common Adverse Reactions in Placebo-Controlled MDD Studies The most commonly observed adverse reactions in MDD patients treated with TRINTELLIX in 6 to 8 week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were nausea, constipation and vomiting. Table 2 shows the incidence of common adverse reactions that occurred in ≥2% of MDD patients treated with any TRINTELLIX dose and at least 2% more frequently than in placebo-treated patients in the 6 to 8 week placebo-controlled studies.

Table 2: Adverse Reactions Occurring in ≥2% of Patients Treated with Any TRINTELLIX Dose and at Least 2% Greater Than the Incidence in Placebo-Treated Patients System Organ Class Preferred Term TRINTELLIX 5 mg/day TRINTELLIX 10 mg/day TRINTELLIX 15 mg/day TRINTELLIX 20 mg/day Placebo N=1013 % N=699 % N=449 % N=455 % N=1621 % Gastrointestinal disorders Nausea 21 26 32 32 9 Diarrhea 7 7 10 7 6 Dry mouth 7 7 6 8 6 Constipation 3 5 6 6 3 Vomiting 3 5 6 6 1 Flatulence 1 3 2 1 1 Nervous system disorders Dizziness 6 6 8 9 6 Psychiatric disorders Abnormal dreams <1 <1 2 3 1 Skin and subcutaneous tissue disorders Pruritus includes pruritus generalized 1 2 3 3 1 Nausea Nausea was the most common adverse reaction and its frequency was dose-related (Table 2) .

It was usually considered mild or moderate in intensity and the median duration was two weeks. Nausea was more common in females than males. Nausea most commonly occurred in the first week of TRI…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered ( 2.5 , 7.1 ). Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose ( 2.6 , 7.1 ).

7.1Drugs Having Clinically Important Interactions with TRINTELLIX Table 4: Clinically Important Drug Interactions with TRINTELLIX Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of TRINTELLIX is contraindicated: With an MAOI intended to treat psychiatric disorders or within 21 days of stopping treatment with TRINTELLIX. Within 14 days of stopping an MAOI intended to treat psychiatric disorders.

In a patient who is being treated with linezolid or intravenous methylene blue. [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of TRINTELLIX with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems.

If serotonin syndrome occurs, consider discontinuation of TRINTELLIX and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ] . Examples Other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Strong Inhibitors of CYP2D6 Clinical Impact Concomitant use of TRINTELLIX with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine.

Intervention Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor is coadministered [see Dosage and Administration (2.5) ] . Examples bupropion, fluoxetine, paroxetine, quinidine Strong CYP Inducers Clinical Impact Concomitant use of TRINTELLIX with a strong CYP inducer decreases plasma concentrations of vortioxetine. Intervention Consider increasing the TRINTELLIX dose when a strong CYP inducer is coadministered.

The maximum dose is not recommended to exceed three times the original dose [see Dosage and Administration (2.6) ]. Examples rifampin, carbamazepine, phenytoin Drugs that Interfere with Hemostasis (antiplatelets agents and anticoagulants) Clinical Impact Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet agents and anticoagulants.

For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions (5.3) , Drug Interactions (7.2) ] . Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in plasma .

Intervention Monitor for adverse reactions and reduce dosage of TRINTELLIX or other protein bound drugs as warranted [see Drug Interactions (7.2) ] . Examples Warfarin

7.2Effect of TRINTELLIX on Other Drugs Other CNS Active Agents No clinically relevant effect was observed on steady-state lithium exposure following coadministration with multiple daily doses of TRINTELLIX. Multiple doses of TRINTELLIX did not affect the pharmacokinetics or pharmacodynamics (composite cognitive score) of diazepam [see Clinical Pharmacology (12.3) ] . A clinical study has shown that TRINTELLIX (single dose of 20 or 40 mg) did not increase the impairment of mental and motor skills caused by alcohol (single dos…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn ( 8.1 ).

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs or SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations ] .

There are limited human data on TRINTELLIX use during pregnancy to inform any drug-associated risks. However, there are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including TRINTELLIX, during the third trimester of pregnancy [see Clinical Considerations ] . Vortioxetine administered to pregnant rats and rabbits during the period of organogenesis at doses ≥15 times and 10 times the maximum recommended human dose (MRHD), respectively, resulted in decreased fetal body weight and delayed ossification.

No malformations were seen at doses up to 77 times and 58 times the MRHD, respectively. Vortioxetine administered to pregnant rats during gestation and lactation at oral doses ≥20 times the MRHD resulted in a decrease in the number of live-born pups and an increase in early postnatal pup mortality. Decreased pup weight at birth to weaning occurred at 58 times the MRHD and delayed physical development occurred at ≥20 times the MRHD.

These effects were not seen at 5 times the MRHD [see Data ] . Advise a pregnant woman of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/Neonatal Adverse Reactions Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

Monitor neonates who were exposed to TRINTELLIX in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [see Data ] . Maternal Adverse Reactions Use of TRINTELLIX in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3) ]. Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding.

These findings are based on postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypo…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs or SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations ] .

There are limited human data on TRINTELLIX use during pregnancy to inform any drug-associated risks. However, there are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including TRINTELLIX, during the third trimester of pregnancy [see Clinical Considerations ] . Vortioxetine administered to pregnant rats and rabbits during the period of organogenesis at doses ≥15 times and 10 times the maximum recommended human dose (MRHD), respectively, resulted in decreased fetal body weight and delayed ossification.

No malformations were seen at doses up to 77 times and 58 times the MRHD, respectively. Vortioxetine administered to pregnant rats during gestation and lactation at oral doses ≥20 times the MRHD resulted in a decrease in the number of live-born pups and an increase in early postnatal pup mortality. Decreased pup weight at birth to weaning occurred at 58 times the MRHD and delayed physical development occurred at ≥20 times the MRHD.

These effects were not seen at 5 times the MRHD [see Data ] . Advise a pregnant woman of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/Neonatal Adverse Reactions Exposure to serotonergic antidepressants, including TRINTELLIX, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

Monitor neonates who were exposed to TRINTELLIX in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [see Data ] . Maternal Adverse Reactions Use of TRINTELLIX in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3) ]. Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding.

These findings are based on postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.

These features are consistent with either a direct to…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of TRINTELLIX have not been established in pediatric patients. The safety and efficacy of TRINTELLIX were evaluated in two randomized, double-blind, placebo- and active-controlled 8-week studies in pediatric patients with MDD, one in patients 7 to 11 years of age (N=540 randomized) and one in patients 12 to 17 years of age (N=616 randomized). The primary efficacy endpoint for both studies was the change from baseline to week 8 in the Children's Depression Rating Scale-Revised (CDRS-R) total score.

The CDRS-R assesses the severity of depression and change in depressive symptoms in children and adolescents with depression. TRINTELLIX was not superior to placebo in either study. Patients from the controlled 8-week studies were eligible to enroll in a 6-month open-label extension study (N=662 treated).

Across the three studies, the most commonly observed adverse reactions to TRINTELLIX in pediatric patients 7 to 17 years of age were generally similar to those observed in adults [see Adverse Reactions (6) ] . Antidepressants, such as TRINTELLIX, increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning and Warnings and Precautions (5.1) ] . Juvenile Animal Toxicity Data Administration of vortioxetine to juvenile rats (oral doses of 10, 20, and 40 mg/kg/day twice daily from Postnatal Day 21 to 91) resulted in a neurobehavioral effect at the highest dose of 40 mg/kg twice daily (increased peak auditory startle amplitude) during the treatment period.

The effect was not seen at the end of the recovery period. When animals were mated after the 4-week recovery period, viability was decreased in the offspring of mated pairs treated with 40 mg/kg twice daily. The no-observed adverse effect dose was 20 mg/kg twice daily based on both the neurobehavioral and reproductive effects.

This dose was associated with plasma vortioxetine exposure (AUC) approximately 2 times that in pediatric patients.

🧓 Geriatric Use 142 words ▾

8.5Geriatric Use No dose adjustment is recommended on the basis of age (Figure 1) . Results from a single-dose pharmacokinetic study in elderly (>65 years old) vs young (24 to 45 years old) subjects demonstrated that the pharmacokinetics were generally similar between the two age groups. Of the 2,616 subjects in clinical studies of TRINTELLIX, 11% (286) were 65 and over, which included subjects from a placebo-controlled study specifically in elderly patients [see Clinical Studies (14) ] .

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions (5.7) ] .

🆘 Overdosage 156 words ▾

10 OVERDOSAGE There is limited clinical trial experience regarding human overdosage with TRINTELLIX. In premarketing clinical studies, cases of overdose were limited to patients who accidentally or intentionally consumed up to a maximum dose of 40 mg of TRINTELLIX. The maximum single dose tested was 75 mg in men.

Ingestion of TRINTELLIX in the dose range of 40 to 75 mg was associated with increased rates of nausea, dizziness, diarrhea, abdominal discomfort, generalized pruritus, somnolence, and flushing. There have been postmarketing reports of overdoses of TRINTELLIX. The most frequently reported symptoms with overdoses up to 80 mg (four times the maximum recommended daily dose) were nausea and vomiting.

With overdoses greater than 80 mg, a case of serotonin syndrome in combination with another serotonergic drug, and a case of seizure, have been reported. No specific antidotes for TRINTELLIX are known. 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 The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.

12.2Pharmacodynamics Vortioxetine binds with high affinity to the human serotonin transporter (Ki=1.6 nM), but not to the norepinephrine (Ki=113 nM) or dopamine (Ki>1000 nM) transporters. Vortioxetine potently and selectively inhibits reuptake of serotonin (IC50=5.4 nM). Vortioxetine binds to 5-HT3 (Ki=3.7 nM), 5-HT1A (Ki=15 nM), 5-HT7 (Ki=19 nM), 5-HT1D (Ki=54 nM), and 5-HT1B (Ki=33 nM), receptors and is a 5-HT3, 5-HT1D, and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, and 5-HT1A receptor agonist.

In humans, the mean 5-HT transporter occupancy, based on the results from two clinical PET studies using 5-HTT ligands ([ 11 C]-MADAM or [ 11 C]-DASB), was approximately 50% at 5 mg/day, 65% at 10 mg/day and approximately 80% at 20 mg/day in the regions of interest. Effect on Cardiac Repolarization The effect of vortioxetine 10 mg and 40 mg administered once daily on QTc interval was evaluated in a randomized, double-blind, placebo-, and active-controlled (moxifloxacin 400 mg), four-treatment-arm parallel study in 340 male subjects.

In the study the upper bound of the one-sided 95% confidence interval for the QTc was below 10 ms, the threshold for regulatory concern. The oral dose of 40 mg is sufficient to assess the effect of metabolic inhibition. Effect on Driving Performance In a clinical study in healthy subjects, TRINTELLIX did not impair driving performance, or have adverse psychomotor or cognitive effects following single and multiple doses of 10 mg/day.

12.3Pharmacokinetics Vortioxetine pharmacological activity is due to the parent drug. The pharmacokinetics of vortioxetine (2.5 mg to 60 mg) are linear and dose-proportional when vortioxetine is administered once daily. The mean terminal half-life is approximately 66 hours, and steady-state plasma concentrations are typically achieved within two weeks of dosing.

Absorption The maximal plasma vortioxetine concentration (C max ) after dosing is reached within 7 to 11 hours postdose (T max ). Steady-state mean C max values were 9, 18, and 33 ng/mL following doses of 5, 10, and 20 mg/day. Absolute bioavailability is 75%.

Effect of Food No effect of food on the pharmacokinetics was observed. Distribution The apparent volume of distribution of vortioxetine is approximately 2600 L, indicating extensive extravascular distribution. The plasma protein binding of vortioxetine in humans is 98%, independent of plasma concentrations.

No apparent difference in the plasma protein binding between healthy subjects and subjects with hepatic (mild, moderate or severe) or renal (mild, moderate, severe, ESRD) impairment is observed. Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation. CYP2D6 is the primary enzyme catalyzing the metabolism of vortioxetine to its major, pharmacologically inactive, carboxylic acid metabolite, and poor metabolizers of CYP2D6 have approximately twice the vortioxetine plasma concentration of extensive metabolizers [see Dosage and Administration (2.5) ] .

Excretion Following a single oral dose of [ 14 C]-labeled vortioxetine, approximately 59% and 26% of the administered radioactivity was recovered in the urine and feces, respectively as metabolites. Negligible amounts of unchanged vortioxetine were excreted in the urine up to 48 hours. The presence of hepatic (mild, moderate or severe) or renal impairment (mild, m…

🧬 Mechanism of Action 66 words ▾

12.1Mechanism of Action The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.

📦 How Supplied / Storage and Handling 100 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TRINTELLIX tablets are available as follows: Features Strengths 5 mg 10 mg 20 mg Color pink yellow red Debossment "5" on one side of tablet "10" on one side of tablet "20" on one side of tablet "TL" on other side of tablet "TL" on other side of tablet "TL" on other side of tablet Presentations and NDC Codes Bottles of 30 64764-720-30 64764-730-30 64764-750-30 Bottles of 90 64764-720-90 64764-730-90 64764-750-90 Bottles of 500 64764-720-77 64764-730-77 64764-750-77 Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

📦 Storage and Handling 18 words ▾

Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

📋 Description 140 words ▾

11 DESCRIPTION TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C 18 H 22 N 2 S, HBr with a molecular weight of 379.36 g/mol.

The structural formula is: Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) . Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions (5.1) ] . Concomitant Medication Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter medications because of a potential for interactions.

Instruct patients not to take TRINTELLIX with an MAOI or within 14 days of stopping an MAOI and to allow 21 days after stopping TRINTELLIX before starting an MAOI [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.2) , Drug Interactions (7.1) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of TRINTELLIX and triptans, tricyclic antidepressants, opioids, lithium, tryptophan supplements, busipirone, and 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 Warnings and Precautions (5.2) , Drug Interactions (7.1 , 7.2) ] .

Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Increased Risk of Bleeding Inform patients about the concomitant use of TRINTELLIX with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation because combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care provider if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.3) ] .

Activation of Mania/Hypomania Advise patients and their caregivers to look for signs of activation of mania/hypomania [see Warnings and Precautions (5.4) ] . Discontinuation of Treatment Advise patients not to abruptly stop taking TRINTELLIX without first talking to their healthcare provider. Patients should be aware that discontinuation effects may occur when stopping TRINTELLIX and they should monitor for discontinuation symptoms [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ].

Angle Closure Glaucoma Patients should be advised that taking TRINTELLIX can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma.

Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.6) ] . Hyponatremia Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking TRINTELLIX [see Warnings and Precautions (5.7) ] . Sexual Dysfunction Advise patients that use of TRINTELLIX may cause symptoms of sexual dysfunction in both male and female patients.

Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.8) ]. Nausea Advise patients that nausea is one of the most common adverse reactions, and is dose related. Nausea commonly occurs within the first week of treatment, then decreases in frequency but can persist in some patients [see Adverse Reactions (6.1) ] .

Allergic Reactions Advise patients to notify their healthcare provider…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 2/2025 MEDICATION GUIDE TRINTELLIX ® (trin'-TELL-ix) (vortioxetine) Tablets What is the most important information I should know about TRINTELLIX?

TRINTELLIX can cause serious side effects, including: Increased risk of suicidal thoughts and actions. TRINTELLIX and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children.

Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, of if you develop suicidal thoughts or actions.

This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide thoughts about suicide or dying feeling agitated, restless, angry or irritable other unusual changes in behavior or mood acting on dangerous impulses new or worse depression trouble sleeping acting aggressive or violent new or worse anxiety or panic attacks an increase in activity or talking more than what is normal for you What is TRINTELLIX?

TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD). TRINTELLIX has not been shown to be safe and effective for use in children. Do not take TRINTELLIX if you: are allergic to vortioxetine or any of the ingredients in TRINTELLIX.

See the end of this Medication Guide for a complete list of ingredients in TRINTELLIX are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX. Before taking TRINTELLIX, tell your healthcare provider about all your medical conditions, including if you: have or had bleeding problems have, or have a family history of, bipolar disorder, mania, or hypomania have high pressure in the eye (glaucoma) have low sodium levels in your blood are pregnant or plan to become pregnant.

TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester of pregnancy may cause your baby to have withdrawal symptoms after birth or may cause your baby to be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take TRINTELLIX during pregnancy.

Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with TRINTELLIX. There is a pregnancy registry for females who are exposed to TRINTELLIX during pregnancy. The purpose of the registry is to collect information about the health of females exposed to TRINTELLIX and their baby.

If you become pregnant during treatment with TRINTELLIX, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnan…

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