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LYBALVI olanzapine and samidorphan L-malate 5 mg; 10 mg Tablet, Film Coated, 90-count — NDC 65757-0651-44 package photo

LYBALVI olanzapine and samidorphan L-malate 5 mg; 10 mg Tablet, Film Coated, 90-count

by Alkermes, Inc. · 1 BOTTLE in 1 CARTON (65757-651-44) / 90 TABLET, FILM COATED in 1 BOTTLE
NDC 65757-0651-44
🏷️ FDA NDC (as labeled) 65757-651-44 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$50.17 NADAC Per package$4,515.53 / 90 tablets Pack sizes5 compare ↓
Also comes in: 7 tablets 65757-0651-40 7 tablets 65757-0651-41 30 tablets 65757-0651-42 256410 tablets 65757-0651-01
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 10, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 65757-651-44
Product NDC 65757-651
11-digit billing NDC 65757065144
NCPDP billing unit EA — each (per item)
RxCUI 2570392, 2570398, 2570399, 2570401, 2570402, 2570404, 2570405, 2570407
UNII N7U69T4SZR, 0AJQ5N56E0
Application # NDA213378
SPL Set ID 32ffddd1-4e2b-45d9-9b36-bb730167ec80
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2021-09-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance OLANZAPINE; SAMIDORPHAN L-MALATE
GPI-14 62994802500310
GPI class Lybalvi
GCN Seq No 082334
GCN 49724
HICL code 047406
Ingredient (HICL) Olanzapine/Samidorphan Malate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7T
Therapeutic class — specific (HIC3) Antipsychotic,Atypical,Dopamine,Serotonin Antagnst
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name LYBALVI 5-10 MG TABLET
FDB brand name Lybalvi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65757-651-44 — 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 → 65757-0651-44. 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 Opioid Antagonist class.

Pharmacologic class Opioid Antagonist
Drug family (ATC) Diazepines, oxazepines, thiazepines and oxepines
How it works Opioid Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlkermes, Inc.
Application holderALKERMES INC
FDA applicationNDA213378 (NDA)
Labeler code65757
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio16 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 LYBALVI 5-10 MG TABLET Ingredient Olanzapine/Samidorphan Malate
📗 Our plain-language guide HelloPharmacist
  • Great question. Olanzapine is the antipsychotic — it's been used for years to treat schizophrenia and bipolar disorder by helping balance dopamine and serotonin activity in the bra...
  • Why does Lybalvi have two drugs in it? What does each one do?
  • This is really important — you cannot take opioid pain medicines (like oxycodone, hydrocodone, morphine, or codeine) while you're on Lybalvi. Because Lybalvi contains an opioid blo...
  • Can I take any pain medications while I'm on Lybalvi?
📖 Read our full Olanzapine and Samidorphan guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow / orange / blue / pink
ShapeCapsule
ImprintOS;20
Size13 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 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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.
  • 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.

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 $50.173 $4,515.53 / 90 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
May 2022 Sep 2022 Nov 2022 Jan 2024 $50.173 $44.096
▲ Up 14% over the last 5 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
Lybalvi 5 mg/1; 10 mgthis 65757-0651-44 Alkermes, 90 tablets $50.173 — Discontinued —
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
May 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 28, 2021 RLD RS ⏳ ~15.2 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 11241425 — method of use (U-3137)
US 11241425 — method of use (U-3137)
US 11241425 — method of use (U-3137)
US 11241425 — method of use (U-3137)
US 12194035 — method of use (U-3141)
US 12194035 — method of use (U-3141)
US 12194035 — method of use (U-3141)
US 12194035 — method of use (U-3141)
US 11185541 — method of use (U-3140)
US 11185541 — method of use (U-3140)
US 11185541 — method of use (U-3140)
US 11185541 — method of use (U-3140)
US 11793805 — method of use (U-3734)
US 11793805 — method of use (U-3734)
US 11793805 — method of use (U-3734)
US 11793805 — method of use (U-3734)
US 11351166 — method of use (U-3140)
US 11351166 — method of use (U-3140)
US 11351166 — method of use (U-3140)
US 11351166 — method of use (U-3140)
US 11351166 — method of use (U-3141)
US 11351166 — method of use (U-3141)
US 11351166 — method of use (U-3141)
US 11351166 — method of use (U-3141)
US 8778960 — method of use (U-3136)
US 8778960 — method of use (U-3137)
US 8778960 — method of use (U-3136)
US 8778960 — method of use (U-3137)
US 8778960 — method of use (U-3136)
US 8778960 — method of use (U-3137)
US 8778960 — method of use (U-3137)
US 8778960 — method of use (U-3136)
US 9126977 — method of use (U-3136)
US 9126977 — method of use (U-3137)
US 9517235 — method of use (U-3139)
US 9517235 — method of use (U-3138)
US 9517235 — method of use (U-3138)
US 9517235 — method of use (U-3139)
US 9126977 — method of use (U-3137)
US 9126977 — method of use (U-3136)
US 9517235 — method of use (U-3139)
US 9517235 — method of use (U-3138)
US 9126977 — method of use (U-3136)
US 9126977 — method of use (U-3137)
US 9517235 — method of use (U-3139)
US 9517235 — method of use (U-3138)
US 9126977 — method of use (U-3137)
US 9126977 — method of use (U-3136)
US 10716785 — method of use (U-3136)
US 10716785 — method of use (U-3137)
US 10300054 — method of use (U-3140)
US 10300054 — method of use (U-3141)
US 10300054 — method of use (U-3141)
US 10300054 — method of use (U-3140)
US 10716785 — method of use (U-3137)
US 10716785 — method of use (U-3136)
US 10300054 — method of use (U-3140)
US 10300054 — method of use (U-3141)
US 10716785 — method of use (U-3137)
US 10716785 — method of use (U-3136)
US 10716785 — method of use (U-3137)
US 10716785 — method of use (U-3136)
US 10300054 — method of use (U-3140)
US 10300054 — method of use (U-3141)
US 11951111 — method of use (U-3886)
US 11951111 — method of use (U-3886)
US 11951111 — method of use (U-3886)
US 11951111 — method of use (U-3886)
US 11951111 — method of use (U-3887)
US 11951111 — method of use (U-3887)
US 11951111 — method of use (U-3887)
US 11951111 — method of use (U-3887)
US 12390474 — drug product
US 11707466 — drug product
US 12390474 — drug product
US 12390474 — drug product
US 9119848 — drug substance
US 9119848 — drug substance
US 11707466 — drug product
US 12390474 — drug product
US 11707466 — drug product
US 9119848 — drug substance
US 11707466 — drug product
US 9119848 — drug substance
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (84)
PatentTypeUse codeExpires
US 11241425 ↗ Method of use U-3137 Aug 23, 2031
US 11241425 ↗ Method of use U-3137 Aug 23, 2031
US 11241425 ↗ Method of use U-3137 Aug 23, 2031
US 11241425 ↗ Method of use U-3137 Aug 23, 2031
US 12194035 ↗ Method of use U-3141 Aug 23, 2031
US 12194035 ↗ Method of use U-3141 Aug 23, 2031
US 12194035 ↗ Method of use U-3141 Aug 23, 2031
US 12194035 ↗ Method of use U-3141 Aug 23, 2031
US 11185541 ↗ Method of use U-3140 Aug 23, 2031
US 11185541 ↗ Method of use U-3140 Aug 23, 2031
US 11185541 ↗ Method of use U-3140 Aug 23, 2031
US 11185541 ↗ Method of use U-3140 Aug 23, 2031
US 11793805 ↗ Method of use U-3734 Aug 23, 2031
US 11793805 ↗ Method of use U-3734 Aug 23, 2031
US 11793805 ↗ Method of use U-3734 Aug 23, 2031
US 11793805 ↗ Method of use U-3734 Aug 23, 2031
US 11351166 ↗ Method of use U-3140 Aug 23, 2031
US 11351166 ↗ Method of use U-3140 Aug 23, 2031
US 11351166 ↗ Method of use U-3140 Aug 23, 2031
US 11351166 ↗ Method of use U-3140 Aug 23, 2031
US 11351166 ↗ Method of use U-3141 Aug 23, 2031
US 11351166 ↗ Method of use U-3141 Aug 23, 2031
US 11351166 ↗ Method of use U-3141 Aug 23, 2031
US 11351166 ↗ Method of use U-3141 Aug 23, 2031
US 8778960 ↗ Method of use U-3136 Feb 13, 2032
US 8778960 ↗ Method of use U-3137 Feb 13, 2032
US 8778960 ↗ Method of use U-3136 Feb 13, 2032
US 8778960 ↗ Method of use U-3137 Feb 13, 2032
US 8778960 ↗ Method of use U-3136 Feb 13, 2032
US 8778960 ↗ Method of use U-3137 Feb 13, 2032
US 8778960 ↗ Method of use U-3137 Feb 13, 2032
US 8778960 ↗ Method of use U-3136 Feb 13, 2032
US 9126977 ↗ Method of use U-3136 Aug 23, 2031
US 9126977 ↗ Method of use U-3137 Aug 23, 2031
US 9517235 ↗ Method of use U-3139 Aug 23, 2031
US 9517235 ↗ Method of use U-3138 Aug 23, 2031
US 9517235 ↗ Method of use U-3138 Aug 23, 2031
US 9517235 ↗ Method of use U-3139 Aug 23, 2031
US 9126977 ↗ Method of use U-3137 Aug 23, 2031
US 9126977 ↗ Method of use U-3136 Aug 23, 2031
US 9517235 ↗ Method of use U-3139 Aug 23, 2031
US 9517235 ↗ Method of use U-3138 Aug 23, 2031
US 9126977 ↗ Method of use U-3136 Aug 23, 2031
US 9126977 ↗ Method of use U-3137 Aug 23, 2031
US 9517235 ↗ Method of use U-3139 Aug 23, 2031
US 9517235 ↗ Method of use U-3138 Aug 23, 2031
US 9126977 ↗ Method of use U-3137 Aug 23, 2031
US 9126977 ↗ Method of use U-3136 Aug 23, 2031
US 10716785 ↗ Method of use U-3136 Aug 23, 2031
US 10716785 ↗ Method of use U-3137 Aug 23, 2031
US 10300054 ↗ Method of use U-3140 May 31, 2033
US 10300054 ↗ Method of use U-3141 May 31, 2033
US 10300054 ↗ Method of use U-3141 May 31, 2033
US 10300054 ↗ Method of use U-3140 May 31, 2033
US 10716785 ↗ Method of use U-3137 Aug 23, 2031
US 10716785 ↗ Method of use U-3136 Aug 23, 2031
US 10300054 ↗ Method of use U-3140 May 31, 2033
US 10300054 ↗ Method of use U-3141 May 31, 2033
US 10716785 ↗ Method of use U-3137 Aug 23, 2031
US 10716785 ↗ Method of use U-3136 Aug 23, 2031
US 10716785 ↗ Method of use U-3137 Aug 23, 2031
US 10716785 ↗ Method of use U-3136 Aug 23, 2031
US 10300054 ↗ Method of use U-3140 May 31, 2033
US 10300054 ↗ Method of use U-3141 May 31, 2033
US 11951111 ↗ Method of use U-3886 Nov 12, 2041
US 11951111 ↗ Method of use U-3886 Nov 12, 2041
US 11951111 ↗ Method of use U-3886 Nov 12, 2041
US 11951111 ↗ Method of use U-3886 Nov 12, 2041
US 11951111 ↗ Method of use U-3887 Nov 12, 2041
US 11951111 ↗ Method of use U-3887 Nov 12, 2041
US 11951111 ↗ Method of use U-3887 Nov 12, 2041
US 11951111 ↗ Method of use U-3887 Nov 12, 2041
US 12390474 ↗ Drug product — Nov 12, 2041
US 11707466 ↗ Drug product — Nov 12, 2041
US 12390474 ↗ Drug product — Nov 12, 2041
US 12390474 ↗ Drug product — Nov 12, 2041
US 9119848 ↗ Drug substance — Aug 30, 2031
US 9119848 ↗ Drug substance — Aug 30, 2031
US 11707466 ↗ Drug product — Nov 12, 2041
US 12390474 ↗ Drug product — Nov 12, 2041
US 11707466 ↗ Drug product — Nov 12, 2041
US 9119848 ↗ Drug substance — Aug 30, 2031
US 11707466 ↗ Drug product — Nov 12, 2041
US 9119848 ↗ Drug substance — Aug 30, 2031
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)May 28, 2026
NCENew Chemical Entity (5-year)May 28, 2026
NCENew Chemical Entity (5-year)May 28, 2026
NCENew Chemical Entity (5-year)May 28, 2026
Common questions
Is there a generic version of LYBALVI 5-10 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LYBALVI 5-10 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets65757-0651-42 24,582 Rx · $39,150,485
7 tablets65757-0651-40 No Medicaid data
7 tablets65757-0651-41 No Medicaid data
90 tablets this page65757-0651-44 No Medicaid data
256410 tablets65757-0651-01 No Medicaid data
Drug total (last 4 qtrs): 24,582 Rx · 742,301 units · $39,150,485 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 Lybalvi — 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 Lybalvi. 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
$40.99M
Claims incl. refills
23.6K
Beneficiaries
10K
Spend / beneficiary
$4,117.75
Spend / claim
$1,735.19
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 LYBALVI (this brand).

Top reported reactions

Contraindicated Product Administered108
Dizziness86
Weight Increased85
Insomnia71
Weight Decreased67
Nausea64
Vomiting61

Age at onset

Infant1
Child1
Adolescent3
Adult60
Elderly10

Reporter sex

1,582 reports
Male · 41%
Female · 59%
Unknown · 1%

Serious outcomes

Hospitalization169
Life-threatening30
Death16
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 155 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
65757-0651-40 1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE $55.28 / ea $386.97 2021-09-20 Discontinued by firm
65757-0651-41 1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE — — 2021-09-20 Active
65757-0651-42 1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE $55.21 / ea $1,656.17 2021-09-20 Active
65757-0651-44 You're viewing this 1 BOTTLE in 1 CARTON (65757-651-44) / 90 TABLET, FILM COATED in 1 BOTTLE $50.17 / ea $4,515.53 2021-09-20 Discontinued by firm
65757-0651-01 256410 TABLET, FILM COATED in 1 CONTAINER (65757-651-01) — — — Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($50.17 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 65757-0651-44?
NDC 65757-0651-44 is a 90-count package — 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle.
What is the difference between NDC 65757-0651-44 and NDC 65757-0651-40?
Both are LYBALVI olanzapine and samidorphan L-malate 5 mg; 10 mg Tablet, Film Coated — the drug itself is identical. NDC 65757-0651-44 is the 90-count package, while NDC 65757-0651-40 is the 7 tablets package. Per-ea NADAC also differs: $50.17 here vs $55.28 for the 7 tablets pack.
What NDC number is used to bill for this package of LYBALVI olanzapine and samidorphan L-malate 5 mg; 10 mg Tablet, Film Coated?
Bill NDC 65757-0651-44 — the 11-digit billing format is 65757065144. 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.

🧭 About this NDC listing & data coverage

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

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65757-651-44, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65757-0651-44, written without dashes as 65757065144. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65757-0651-44, the first segment (65757) is the labeler code FDA assigned to Alkermes, Inc.; the middle segment (0651) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (44) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 7 tablets (65757-0651-40), 7 tablets (65757-0651-41), 30 tablets (65757-0651-42). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alkermes, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 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 93 words ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 )

🎯 Indications and Usage 90 words ▾

1 INDICATIONS AND USAGE LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adults ( 1 ) Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Recommended Starting Dose (olanzapine/samidorphan) Recommended Dose (olanzapine/samidorphan) Schizophrenia ( 2.2 ) 5 mg/10 mg or 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder (manic or mixed episodes) ( 2.3 ) 10 mg/10 mg or 15 mg/10 mg 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg Bipolar I disorder adjunct to lithium or valproate ( 2.3 ) 10 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg See the full prescribing information for the recommended titration and maximum recommended dosage.

( 2.2 , 2.3 ) Administer LYBALVI once daily with or without food. Do not divide tablets or combine strengths. ( 2.4 ) Recommended starting dosage is 5 mg/10 mg once daily in patients who have a predisposition to hypotensive reactions, have potential for slower metabolism of olanzapine, or may be more pharmacodynamically sensitive to olanzapine.

( 2.5 )

2.1LYBALVI Initiation In Patients Using Opioids LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal. In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids [see Warnings and Precautions ( 5.3 )].

2.2Recommended Dosage in Schizophrenia Initiate LYBALVI at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once daily. Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI) depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily.

2.3Recommended Dosage in Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy: Initiate LYBALVI at 10 mg/10 mg or 15 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily. The maximum recommended dosage is 20 mg/10 mg once daily.

Dosage adjustments should occur at intervals of not less than 24 hours. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on the olanzapine component of LYBALVI) are recommended. Maintenance Monotherapy: Administer LYBALVI at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.

Adjunctive to lithium or valproate: Initiate LYBALVI at 10 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg, once daily. Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI), depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily.

2.4Administration Information Administer LYBALVI orally once daily with or without food as a single tablet. Do not divide tablets or combine strengths.

2.5Dosage Recommendations in Specific Populations The recommended starting dosage of LYBALVI is 5 mg/10 mg once daily in patients who have a higher risk of hypotensive reactions, are at risk of slower olanzapine metabolism, or may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions ( 5.9 ), Drug Interactions ( 7.2 ), Use in Specific Populations ( 8.5 ), and Clinical Pharmacology ( 12.3 )] . If dose escalation is necessary, increase the dosage slowly in these patients.

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS LYBALVI tablets are available in four strengths ( Table 1 ). Table 1: LYBALVI Tablet Strengths and Identifying Features Tablet Strength Tablet Color/Shape Tablet Markings 5 mg/10 mg (olanzapine/samidorphan) Yellow, capsule-shaped “OS” and “5” 10 mg/10 mg (olanzapine/samidorphan) Orange, capsule-shaped “OS” and “10” 15 mg/10 mg (olanzapine/samidorphan) Blue, capsule-shaped “OS” and “15” 20 mg/10 mg (olanzapine/samidorphan) Pink, capsule-shaped “OS” and “20” Tablets (olanzapine/samidorphan): 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg.

( 3 )

⛔ Contraindications 117 words ▾

4 CONTRAINDICATIONS LYBALVI is contraindicated in patients: who are using opioids [ see Warnings and Precautions ( 5.3 , 5.4 ), Drug Interactions ( 7.3 )] . who are undergoing acute opioid withdrawal [see Warnings and Precautions ( 5.3 , 5.4 ), Drug Interactions ( 7.3 )] . If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products [see Warnings and Precautions ( 5.18 )] . Patients using opioids.

( 4 ) Patients undergoing acute opioid withdrawal. ( 4 ) If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for those products. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis : Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities). ( 5.2 ) Precipitation of Opioid Withdrawal in Patients Who are Dependent on Opioids : LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from the last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids to avoid precipitation of opioid withdrawal.

( 2.1 , 5.3 ) Vulnerability to Life-Threatening Opioid Overdose : Risk of Opioid Overdose from Attempts to Overcome LYBALVI Opioid Blockade: Attempts to overcome LYBALVI opioid blockade with high or repeated doses of opioids may lead to fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued. ( 5.4 ) Risk of Resuming Opioids in Patients with Prior Opioid Use : Patients with a history of chronic opioid use prior to LYBALVI treatment may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued.

( 5.4 ) Neuroleptic Malignant Syndrome : Manage with immediate discontinuation and close monitoring. ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue if DRESS is suspected. ( 5.6 ) Metabolic Changes : Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.

( 5.7 ) Tardive Dyskinesia : Discontinue if clinically appropriate. ( 5.8 ) Orthostatic Hypotension and Syncope : Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 5.9 ) Leukopenia, Neutropenia, and Agranulocytosis : Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count.

Consider discontinuation if clinically significant decline in WBC in the absence of other causative factors. ( 5.11 ) Seizures : Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. ( 5.13 ) Potential for Cognitive and Motor Impairment : Use caution when operating machinery.

( 5.14 ) Anticholinergic (Antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. ( 5.16 ) Hyperprolactinemia : May elevate prolactin levels. ( 5.17 )

5.1Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than in placebo-treated patients (3.5% vs 1.5%, respectively). Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients.

Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.2 )].

5.2Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly pat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-related Psychosis [see Boxed Warning , Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.2 )] Precipitation of Opioid Withdrawal in Patients Who Are Dependent on Opioids [see Warnings and Precautions ( 5.3 ) ] Vulnerability to Life-Threatening Opioid Overdose [see Warnings and Precautions ( 5.4 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.5 )] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions ( 5.6 )] Metabolic Changes [see Warnings and Precautions ( 5.7 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.11 )] Dysphagia [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.14 )] Body Temperature Regulation [see Warnings and Precautions ( 5.15 )] Anticholinergic (Antimuscarinic) Effects [see Warnings and Precautions ( 5.16 )] Hyperprolactinemia [see Warnings and Precautions ( 5.17 )] Risks Associated with Combination Treatment with Lithium or Valproate [see Warnings and Precautions ( 5.18 )] Most common adverse reactions (incidence ≥5% and at least twice placebo): Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache.

( 6.1 ) Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): somnolence, dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, tremor. ( 6.1 ) Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-235-8008 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 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 Patients with Schizophrenia Patient Exposure The safety of LYBALVI was evaluated in 1262 patients (18 to 67 years of age) diagnosed with schizophrenia in four double-blind, controlled studies and three long-term safety extension studies of up to 3 years of duration.

This experience corresponds to approximately 910 person-years. In these studies, there were a total of 663 patients exposed to LYBALVI for at least 6 months, and 386 patients for at least one year. Adverse Reactions in the Short-Term (4 week) Placebo-Controlled Trial in Adults with Schizophrenia The most common adverse reactions (incidence of at least 5% of patients exposed to LYBALVI and greater than twice the rate of placebo) are weight increased, somnolence, dry mouth, and headache.

Adverse reactions associated with the use of LYBALVI (incidence of 2% or greater and greater than in placebo-treated patients) are shown in Table 2 . Table 2: Adverse Reactions Reported in ≥2% of LYBALVI-Treated Patients and Greater than Placebo in a 4-Week Schizophrenia Trial Adverse Reaction Placebo (N=134) % LYBALVI (10 mg/10 mg, 20 mg/10 mg) (N=134) % Weight increased 3 19 Somnolence 2 9 Dry mouth 1 7 Headache 3 6 Blood insulin increased 1 3 Sedation 0 2 Dizziness 1 2 Neutrophil count decreased 0 2 Adverse reactions that led to discontinuation in LYBALVI-treated patients in the short-term placebo-controlled trial in adults with schizophrenia incl…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inducers : Not recommended. ( 7.1 ) Strong CYP1A2 Inhibitors : Consider dosage reduction of olanzapine component of LYBALVI. ( 7.1 ) CYP1A2 Inducer : Consider dosage increase of the olanzapine component of LYBALVI.

( 7.1 ) CNS Acting Drugs : May potentiate orthostatic hypotension. ( 7.1 ) Anticholinergic Drugs: Can increase risk for severe gastrointestinal adverse reactions. ( 7.1 ) Antihypertensive Agents : Monitor blood pressure.

( 7.2 ) Levodopa and Dopamine Agonists : Not recommended. ( 7.2 )

7.1Effects of Other Drugs on LYBALVI Table 4 describes clinically significant drug interactions where the concomitant use of other drugs affects LYBALVI. Table 4: Effects of Other Drugs on LYBALVI Strong CYP3A4 Inducer Clinical Implication: Coadministration of LYBALVI with a strong CYP3A4 inducer decreases AUC inf of olanzapine and samidorphan [see Clinical Pharmacology ( 12.3 )], which may reduce LYBALVI efficacy. Prevention or Management: Concomitant use of LYBALVI with strong CYP3A4 inducers is not recommended.

Strong CYP1A2 Inhibitor Clinical Implication: Concomitant use of LYBALVI with a strong CYP1A2 inhibitor increases olanzapine AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of LYBALVI adverse reactions. Prevention or Management: Consider reducing the dosage of the olanzapine component in LYBALVI when used concomitantly with strong CYP1A2 inhibitors. CYP1A2 Inducer Clinical Implication: Concomitant use of LYBALVI with CYP1A2 inducers decreases olanzapine exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce LYBALVI efficacy.

Prevention or Management: Consider increasing the dosage of the olanzapine component in LYBALVI when used concomitantly with CYP1A2 inducers. Diazepam, Alcohol, and Other CNS Acting Drugs Clinical Implication: Concomitant use of diazepam, alcohol, or other CNS acting drugs with LYBALVI may potentiate the orthostatic hypotension observed with olanzapine [see Warnings and Precautions ( 5.9 )] . Prevention or Management: LYBALVI should be used with caution in patients receiving concomitantly diazepam or other CNS acting drugs, or using alcohol.

Anticholinergic Drugs Clinical Implication: Concomitant treatment with olanzapine and other drugs with anticholinergic activity can increase the risk for severe gastrointestinal adverse reactions related to hypomotility. Prevention or Management: LYBALVI should be used with caution in patients receiving medications having anticholinergic (antimuscarinic) effects [see Warnings and Precautions ( 5.16 )] .

7.2Effects of LYBALVI on Other Drugs Table 5 describes clinically significant drug interactions where concomitant use of LYBALVI affects other drugs. Table 5: Effects of LYBALVI on Other Drugs Antihypertensive Agents Clinical Implication: LYBALVI may enhance the effects of certain antihypertensive agents. Prevention or Management: Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.

Levodopa and Dopamine Agonists Clinical Implication: LYBALVI may antagonize the effects of levodopa and dopamine agonists. Prevention or Management: Concomitant use of LYBALVI is not recommended with levodopa and dopamine agonists.

7.3Opioids LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal [see Contraindications ( 4 )]. LYBALVI increases the risk of precipitating acute opioid withdrawal in patients who are dependent on opioids. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from the last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.3 )] .

In emergency situations, if a LYBALVI-treated patient requires opioid treatment for anesthesia or analgesia, discontinue LYBALVI. The opioid should be administered by properly trained individual…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 ) Renal Impairment: Use is not recommended in patients with end-stage renal disease. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including LYBALVI, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/ . Risk Summary Neonates exposed to antipsychotic drugs, including the olanzapine component of LYBALVI, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ) .

Overall published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are no available data on the use of samidorphan or the combination of olanzapine and samidorphan in pregnant women to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including LYBALVI, during pregnancy (see Clinical Considerations ) .

LYBALVI In an animal reproduction study, oral administration of olanzapine and samidorphan to pregnant rats during the period of organogenesis produced adverse effects on embryofetal development and fetal toxicity at maternally toxic doses that are 6 times and >400 times the maximum recommended human dose (MRHD) of 20 mg/10 mg olanzapine/samidorphan in LYBALVI, respectively based on AUC. There were no adverse effects on embryofetal development at doses of olanzapine and samidorphan that are approximately 1 and 80 times, respectively, the MRHD based on AUC (see Data ) .

Olanzapine In animal reproduction studies, there was no evidence of malformations in rats or rabbits when orally administered olanzapine at doses up to 9 and 30 times the MRHD dose (20 mg) based on mg/m 2 body surface area, respectively. In an oral rat embryofetal developmental toxicity study, early resorptions and increased numbers of nonviable fetuses were observed at a dose 9 times the MRHD based on mg/m 2 body surface area and gestation was prolonged at 5 times the MRHD based on mg/m 2 body surface area. In an oral rabbit embryofetal developmental toxicity study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of olanzapine which is 30 times the MRHD based on mg/m 2 body surface area (see Data ) .

Samidorphan In animal reproduction studies, oral administration of samidorphan to pregnant rats and rabbits during the period of organogenesis caused fetal toxicities in rats only at maternally toxic doses that are >248 times the human exposure at the MRHD of 10 mg/day based on AUC. Oral administration of samidorphan to pregnant rats during pregnancy and lactation resulted in lower pup survival and decreased pup weights at 188 times the human exposure at the MRHD based on AUC (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization and suicid…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including LYBALVI, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/ . Risk Summary Neonates exposed to antipsychotic drugs, including the olanzapine component of LYBALVI, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ) .

Overall published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are no available data on the use of samidorphan or the combination of olanzapine and samidorphan in pregnant women to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including LYBALVI, during pregnancy (see Clinical Considerations ) .

LYBALVI In an animal reproduction study, oral administration of olanzapine and samidorphan to pregnant rats during the period of organogenesis produced adverse effects on embryofetal development and fetal toxicity at maternally toxic doses that are 6 times and >400 times the maximum recommended human dose (MRHD) of 20 mg/10 mg olanzapine/samidorphan in LYBALVI, respectively based on AUC. There were no adverse effects on embryofetal development at doses of olanzapine and samidorphan that are approximately 1 and 80 times, respectively, the MRHD based on AUC (see Data ) .

Olanzapine In animal reproduction studies, there was no evidence of malformations in rats or rabbits when orally administered olanzapine at doses up to 9 and 30 times the MRHD dose (20 mg) based on mg/m 2 body surface area, respectively. In an oral rat embryofetal developmental toxicity study, early resorptions and increased numbers of nonviable fetuses were observed at a dose 9 times the MRHD based on mg/m 2 body surface area and gestation was prolonged at 5 times the MRHD based on mg/m 2 body surface area. In an oral rabbit embryofetal developmental toxicity study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of olanzapine which is 30 times the MRHD based on mg/m 2 body surface area (see Data ) .

Samidorphan In animal reproduction studies, oral administration of samidorphan to pregnant rats and rabbits during the period of organogenesis caused fetal toxicities in rats only at maternally toxic doses that are >248 times the human exposure at the MRHD of 10 mg/day based on AUC. Oral administration of samidorphan to pregnant rats during pregnancy and lactation resulted in lower pup survival and decreased pup weights at 188 times the human exposure at the MRHD based on AUC (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization and suicide.

Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. Fetal/ Neonatal Risks Extra…

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of LYBALVI have not been established in pediatric patients.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Clinical studies of LYBALVI did not include sufficient numbers of patients 65 years of age and older to determine whether they responded differently than younger adult patients. Olanzapine Of the 2,500 patients in premarketing clinical studies with orally administered olanzapine, 11% (263) were 65 years of age or over. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] . Studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo.

In placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine, compared to patients treated with placebo. In five placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1,184), the following adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than in placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations.

The rate of discontinuation due to adverse reactions was greater with olanzapine than with placebo (13% vs 7%). Consider a lower dosage of the olanzapine component of LYBALVI in geriatric patients who may have decreased clearance or an exaggerated pharmacodynamic response to olanzapine (e.g., oversedation) [see Dosage and Administration ( 2.5 )].

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Human Experience There is limited clinical experience with overdose with LYBALVI. In premarketing clinical trials of LYBALVI involving 861 patients, overdose of LYBALVI was identified in 7 patients. This included 4 patients with accidental overdose, 2 with intentional overdose, and 1 due to a medication administration error.

None of the reported overdoses was associated with a fatal outcome. There was a reported ingestion of 11 tablets of LYBALVI 10 mg/10 mg (5.5 times and 11 times the maximum recommended daily dosage of the olanzapine and samidorphan components of LYBALVI, respectively). The patient was found unresponsive and admitted to the hospital.

Medical treatment included fluids, electrolytes, a diuretic, and a detoxicant; the patient stabilized within 2 days. In postmarketing reports of overdose with olanzapine, a component of LYBALVI, symptoms included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Less commonly reported symptoms include: aspiration, cardiopulmonary arrest, cardiac arrhythmias (such as supraventricular tachycardia and 1 patient experiencing sinus pause with spontaneous resumption of normal rhythm), delirium, possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion, hypertension, and hypotension.

In 1 case of death, the amount of acutely ingested olanzapine was reported to be possibly as low as 450 mg; however, in another case, a patient was reported to survive an acute olanzapine ingestion of approximately 2,000 mg. Management of Overdose No specific antidotes for LYBALVI are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement.

If an overdose occurs, consult a certified Poison Control Center (1-800-222-1222) for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.

12.2Pharmacodynamics Olanzapine Olanzapine binds with high affinity to the following receptors: serotonin 5HT 2A/2C , 5HT 6 (K i =4, 11, and 5 nM, respectively), dopamine D 1-4 (K i =11–31 nM), histamine H 1 (K i =7 nM), and adrenergic α 1 receptors (K i =19 nM). Olanzapine is an antagonist with moderate affinity binding for serotonin 5HT 3 (K i =57 nM) and muscarinic M 1-5 (K i =73, 96, 132, 32, and 48 nM, respectively). Olanzapine binds with low affinity to GABA A , BZD, and β-adrenergic receptors (K i >10 μM).

Samidorphan Samidorphan binds to the mu-, kappa-, and delta-opioid receptors (K i =0.052, 0.23, and 2.7 nM, respectively). Samidorphan is an antagonist at the mu-opioid receptors with partial agonist activity at kappa- and delta-opioid receptors. The N-dealkylated major human metabolite binds to the mu-, kappa-, and delta-opioid receptors (K i =0.26, 23, and 56 nM, respectively), and functions as a mu-opioid receptor agonist.

The N-oxide major human metabolite binds to mu-, kappa-, and delta-opioid receptors (K i =8, 110, and 280 nM, respectively) and functions as a mu-opioid receptor antagonist. Cardiac Electrophysiology At doses up to 30 mg/30 mg (1.5 times and 3 times the maximum recommended daily dosage of olanzapine and samidorphan, respectively), LYBALVI does not prolong QTc interval to any clinically relevant extent.

12.3Pharmacokinetics The pharmacokinetics of both olanzapine and samidorphan are linear over the clinical dose range and there is no PK interaction between olanzapine and samidorphan after oral administration of LYBALVI. Steady-state concentrations of olanzapine and samidorphan are reached within 7 days of commencement of once-daily administration of LYBALVI. The primary pharmacological activities of LYBALVI are due to the parent drugs, olanzapine and samidorphan.

Following a single dose administration of LYBALVI (10 mg olanzapine/10 mg samidorphan), the mean AUC 0-inf and C max of olanzapine was 628 ng·h/mL and 16 ng/mL, respectively. The mean AUC 0-inf and C max of olanzapine after 10 mg single dose administration of olanzapine tablet was 610 ng·h/mL and 16 ng/mL, respectively. Pharmacokinetic properties of the components of LYBALVI are provided in Table 6 .

Table 6: Pharmacokinetic Properties of the Components of LYBALVI Parameters Olanzapine Samidorphan Abbreviations: AUC 24h =area under the concentration-time curve over the 24-hour dosing interval; C max =maximum plasma concentration; CYP=cytochrome P450; NA=not applicable; T max =time to C max ; t ½ =terminal elimination half-life; UGT=Uridine 5'-diphospho-glucuronosyltransferase. a Presented as arithmetic mean (standard deviation). b Presented as range of the median across multiple studies. c Geometric mean ratio (90% confidence interval) [high fat meal/fasting].

High fat meal defined as meal containing approximately 900-1000 calories and 50% fat content. No clinically relevant food effect. d Presented as range of the mean across multiple studies. General Steady State Exposure (20 mg olanzapine/10 mg samidorphan) C max (ng/mL) a 64.6 (28.9) 45.1 (11.4) AUC 24h (ng∙hr/mL) a 1086 (556) 364 (112) Time to Reach Steady State 7 days 5 days Accumulation at Steady State 2-fold 1.3-fold Absorption Absolute Oral Bioavailability NA 69% T max (h) b 4.5–7 1–2 Effect of Food C max Ratio c 0.88 (0.82, 0.95) 0.85 (0.76, 0.94) AUC Ratio c 0.93 (0.91, 0.96) 1.03 (1.00, 1.05) Distribution Plasma Protein Binding 93% 23% - 33% Blood-to-Plasma Ratio Not Determined

0.8Elimination t 1/2 (h) d 35–52 7–11 CL/F (L/h) d 15–22 35–45 Metabolism Primary Pathway(s) UGT1A4, CYP1A2 CYP3A4 Minor Pathway(s) CYP2D6 C…

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.

📦 How Supplied / Storage and Handling 172 words ▾

16 HOW SUPPLIED/ STORAGE AND HANDLING How Supplied LYBALVI (olanzapine and samidorphan) tablets have markings on both sides and are available as described in Table 9 . Table 9: LYBALVI Tablet Presentations Tablet Strength(s) (olanzapine/samidorphan) Tablet Description Package Configuration NDC Number 5 mg/10 mg Yellow, capsule-shaped, debossed with “OS” on one side and “5” on the other side 30-count bottle with child resistant closure 65757-651-42 10 mg/10 mg Orange, capsule-shaped, debossed with “OS” on one side and “10” on the other side 30-count bottle with child resistant closure 65757-652-42 15 mg/10 mg Blue, capsule-shaped, debossed with “OS” on one side and “15” on the other side 30-count bottle with child resistant closure 65757-653-42 20 mg/10 mg Pink, capsule-shaped, debossed with “OS” on one side and “20” on the other side 30-count bottle with child resistant closure 65757-654-42 Storage and Handling Store at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Keep tightly closed and protect from moisture.

📦 Storage and Handling 35 words ▾

Storage and Handling Store at room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep tightly closed and protect from moisture.

📋 Description ~1 min read ▾

11 DESCRIPTION LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ][1,5]benzodiazepine. The molecular formula of olanzapine is: C 17 H 20 N 4 S and the molecular weight is 312.44 g/mol.

It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is: Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C 21 H 26 N 2 O 4 • C 4 H 6 O 5 and the molecular weight is 504.54 g/mol.

It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is: LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)]. Olanzapine Chemical Structure Samidorphan L-malate Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Concomitant Use with Opioids is Contraindicated Advise patients to inform their healthcare provider if they are taking, or plan to take any opioids for any reason, as LYBALVI is contraindicated with use of opioids or those undergoing acute opioid withdrawal [see Dosage and Administration ( 2.1 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] . Precipitation of Opioid Withdrawal Advise patients not to take LYBALVI when using opioids because of the risks of opioid withdrawal syndrome, sometimes requiring hospitalization.

Advise patients that they should have an opioid-free period of a minimum of 7 days after last use of short-acting opioids and 14 days from last use of long-acting opioids before initiating LYBALVI [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Risk of Opioid Overdosage Advise patients that they may be at increased risk of opioid overdosage if they attempt to use high or repeated opioid doses. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI [see Warnings and Precautions ( 5.4 )] .

Risk of Resuming Opioids in Patients with Prior Opioid Use Advise patients that if they used opioids prior to LYBALVI treatment, they may have decreased opioid tolerance if they use opioids after LYBALVI discontinuation or interruption [see Warnings and Precautions ( 5.4 )] . Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions ( 5.5 )] .

Drug Reaction with Eosinophilia and Systemic Symptoms Advise patients to report to their health care provider at the earliest onset of any signs and symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.6 )] . Metabolic Changes Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions ( 5.7 )].

Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions ( 5.8 )]. Orthostatic Hypotension and Syncope Educate patients about the risk of orthostatic hypotension and syncope, especially early in treatment, and also at times of re-initiating treatment [see Warnings and Precautions ( 5.9 ), Drug Interactions ( 7.2 )] . Leukopenia/Neutropenia Advise patients with a pre-existing low WBC or a history of drug induced leukopenia/ neutropenia that they should have their CBC monitored while taking LYBALVI [see Warnings and Precautions ( 5.11 )].

Potential for Cognitive and Motor Impairment Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that LYBALVI therapy does not affect them adversely [see Warnings and Precautions ( 5.14 )] . Concomitant Medication Advise patients to inform their healthcare providers if they are taking, or plan to take any other olanzapine containing medication. Advise patients to inform their healthcare providers of any changes to their current prescription or over-the-counter medications because there is a potential for interactions [see Drug Interactions ( 7.1 , 7.2 , 7.3 )] .

Body Temperature Dysregulation Educate patients regarding appropriate care in av…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 1/2024 MEDICATION GUIDE LYBALVI ® (lee bawl' vee) (olanzapine and samidorphan) tablets, for oral use If your healthcare provider prescribes LYBALVI in combination with valproate or lithium, also read the Medication Guide that comes with those medicines. What is the most important information I should know about LYBALVI?

LYBALVI may cause serious side effects, including: Increased risk of death in elderly people with dementia related psychosis. LYBALVI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LYBALVI is not approved for the treatment of people with dementia-related psychosis.

What is LYBALVI? LYBALVI is a prescription medicine which contains 2 medicines (olanzapine and samidorphan) used in adults: to treat schizophrenia alone for short-term (acute) or maintenance treatment of manic or mixed episodes that happen with bipolar I disorder in combination with valproate or lithium to treat manic or mixed episodes that happen with bipolar I disorder It is not known if LYBALVI is safe or effective in children. Do not take LYBALVI if you are taking opioids or are experiencing acute opioid withdrawal.

See “ What are the possible side effects of LYBALVI. ” Before taking LYBALVI, tell your healthcare provider about all of your medical conditions, including if you: have or had heart problems or a stroke use or abuse street (illegal) drugs have or had low or high blood pressure have kidney problems have diabetes or high blood sugar or a family history of diabetes or high blood sugar have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides or low levels of HDL cholesterol have or had a low white blood cell count have problems swallowing have or had seizures (convulsions) have or had problems with urination or prostate problems have or had breast cancer have or had constipation or a bowel obstruction have or had high prolactin levels are pregnant or plan to become pregnant.

Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take LYBALVI during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with LYBALVI. If you become pregnant during treatment with LYBALVI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.

You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ are breastfeeding or plan to breastfeed. LYBALVI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with LYBALVI.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYBALVI and other medicines may affect each other causing possible serious side effects. LYBALVI may affect the way other medicines work, and other medicines may affect how LYBALVI works.

Especially tell your healthcare provider if you: take opioids or have stopped taking opioids in the past 14 days take or plan to take other olanzapine containing medicines Your healthcare provider can tell you if it is safe to take LYBALVI with your other medicines. Do not start or stop any medicines while taking LYBALVI without first talking to your healthcare provider. Tell your healthcare provider if you take a urine drug screening test because LYBALVI may affect your test results.

Tell those giving the drug screening test that you are taking LYBALVI. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take LYBALVI? Take LYBALVI exactly as your healthcare provider tells you to take it. Do not change the dose or stop…

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.