Home › NDC Lookup › Ingredients › Bremelanotide › 00713-0897-04
Vyleesi bremelanotide 1.75 mg/.3mL Injection, 4 syringes — NDC 00713-0897-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vyleesi bremelanotide 1.75 mg/.3mL Injection, 4 syringes — NDC 0713-0897-04 (Billing 00713-0897-04)

by Cosette Pharmaceuticals, Inc. · 4 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE

This is a package of 4 syringes of Vyleesi bremelanotide 1.75 mg/.3mL Injection from Cosette Pharmaceuticals, Inc., marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 00713-0897-04
🏷️ FDA NDC (as labeled) 0713-0897-04 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0713-0897-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0713 labeler · 0897 product · 04 package
Package marketed since
Nov 12, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0713089704 4
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0713-0897-04
Product NDC 0713-0897
11-digit billing NDC 00713089704
NCPDP billing unit ML — per mL (volume)
RxCUI 2176316, 2176321
UNII PV2WI7495P
Application # NDA210557
SPL Set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Established class (EPC) Melanocortin Receptor Agonist
Mechanism of action Melanocortin Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-12
Route SUBCUTANEOUS
Dosage form INJECTION
Substance BREMELANOTIDE ACETATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 080019
GCN 46679
HICL code 045878
Ingredient (HICL) Bremelanotide Acetate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8V
Therapeutic class — specific (HIC3) Hypoactive Sexual Desire Disorder (Hsdd) Tx Agents
AHFS code 28:92.00.00
AHFS class Central Nervous System Agents, Misc.
FDB label name VYLEESI 1.75 MG/0.3 ML AUTOINJ
FDB brand name Vyleesi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080019
  • GCN: 46679
  • HICL (First Databank): 045878
  • AHFS class code: 28:92.00.00
  • RxCUI (RxNorm): 2176316
Why two NDCs? The FDA registers this code as 0713-0897-04 — a 4-4-2 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 labeler segment → 00713-0897-04. 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 Melanocortin Receptor Agonist class.

Pharmacologic class Melanocortin Receptor Agonist
Drug family (ATC) Other gynecologicals
How it works Melanocortin Receptor Agonists
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.

Clinical

Label name VYLEESI 1.75 MG/0.3 ML AUTOINJ Ingredient Bremelanotide Acetate
📖 What it is MedlinePlus · NLM

Bremelanotide injection is used to treat women with hypoactive sexual desire disorder (HSDD; a low sexual desire that causes distress or interpersonal difficulty) who have not experienced menopause (change of life; the end of monthly menstrual periods); who have not had problems with low sexual desire in the past; and whose low sexual desire is not due to a medical or mental health problem, a relationship problem, or medication or other drug use. Bremelanotide injection should not be used for the treatment of HSDD in women who have gone through menopause, in men, or to improve sexual performan...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. That means low desire that bothers you and isn't explained by another condition, re...
  • You inject it under the skin of your abdomen or thigh with the prefilled pen, at least 45 minutes before expected sexual activity. Use it only as needed. Don't take more than one d...
  • Nausea is the big one, affecting about 4 in 10 people in trials, though it often improves after the second dose. Flushing, headache, vomiting and injection site reactions can also...
  • If your blood pressure is uncontrolled or you have known cardiovascular disease, you should not use it. Vyleesi raises blood pressure for several hours after each dose. Your doctor...
📖 Read our full Bremelanotide Injection 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.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00713-0897-04 You're viewing this Main listing 4 SYRINGE in 1 CARTON / .3 mL in 1 SYRINGE 2025-11-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vyleesi 1.75 mg/.3mLthis 00713-0897-04 Cosette 4 syringes — — FDA listed —
Vyleesi 1.75 mg/.3mL 80064-0141-02 Palatin 2 syringes — — 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

🏛️
2019
First FDA approval
Jun 2019
📍
2026
Currently FDA-listed
7 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 Apr 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 21, 2019 RLD RS ⏳ ~14.6 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 9352013 — method of use (U-2568)
US 11590209 — method of use (U-3539)
US 9700592 — method of use (U-2568)
US 10286034 — method of use (U-2568)
2019 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 (4)
PatentTypeUse codeExpires
US 9352013 ↗ Method of use U-2568 Nov 5, 2033
US 11590209 ↗ Method of use U-3539 Apr 29, 2041
US 9700592 ↗ Method of use U-2568 Nov 5, 2033
US 10286034 ↗ Method of use U-2568 Nov 5, 2033
Common questions
Is there a generic version of VYLEESI 1.75 MG/0.3 ML AUTOINJ?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VYLEESI 1.75 MG/0.3 ML AUTOINJ. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 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.

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.

🧪 Avoiding an ingredient? See Bremelanotide Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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.

Manufacturer & labeler

LabelerCosette Pharmaceuticals, Inc.
Application holderCOSETTE PHARMACEUTICALS INC
FDA applicationNDA210557 (NDA)
Labeler code00713
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio99 products on file

More NDCs from Cosette Pharmaceuticals, Inc. labeler code 00713

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 203 words ▾

1 INDICATIONS AND USAGE VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.

Limitations of Use VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance. VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance ( 1 ).

Limitations of Use ( 1 ): Not indicated for treatment of HSDD in postmenopausal women or in men. Not indicated to enhance sexual performance.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. ( 2.1 ) Do not administer more than one dose within 24 hours. ( 2.1 ) More than 8 doses per month is not recommended. ( 2.1 )

2.1Recommended Dosage The recommended dosage of VYLEESI is 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. The duration of efficacy after each dose is unknown and the optimal window for VYLEESI administration has not been fully characterized. Patients may decide the optimal time for VYLEESI administration based on how they experience the duration of effect on desire and any adverse reactions such as nausea [see Warnings and Precautions ( 5.3 )].

Patients should not administer more than one dose within 24 hours. The efficacy of consecutive doses within 24 hours has not been established and administering doses close together may increase the risk of additive effects on blood pressure [see Warnings and Precautions ( 5.1 )]. Administering more than 8 doses per month is not recommended.

Few patients in the phase 3 program received more than 8 doses per month. Also, more frequent dosing increases the risk for focal hyperpigmentation and the length of time per month when blood pressure is increased [see Warnings and Precautions ( 5.1 , 5.2 )]. VYLEESI is self-administered via a prefilled autoinjector pen.

Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is cloudy, discolored, or visible particles are observed.

2.2Discontinuation of VYLEESI Discontinue VYLEESI after 8 weeks if the patient does not report an improvement in her symptoms.

💊 Dosage Forms and Strengths 25 words ▾

3 DOSAGE FORMS AND STRENGTHS Subcutaneous injection: 1.75 mg/0.3 mL clear solution in a single-dose autoinjector. Subcutaneous injection: 1.75 mg/0.3 mL solution. ( 3 )

⛔ Contraindications 31 words ▾

4 CONTRAINDICATIONS VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease [see Warnings and Precautions ( 5.1 )]. Uncontrolled hypertension or known cardiovascular disease. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Transient increase in blood pressure and decrease in heart rate: Occurs after each dose and usually resolves within 12 hours. Consider the patient's cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. VYLEESI is not recommended in patients at high risk for cardiovascular disease.

( 5.1 ) Focal hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Higher risk in patients with darker skin and with daily dosing. Resolution was not confirmed in some patients.

Consider discontinuing VYLEESI if hyperpigmentation develops. ( 5.2 ) Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Improved for most patients with the second dose.

Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea. ( 5.3 )

5.1Transient Increase in Blood Pressure and Reduction in Heart Rate VYLEESI transiently increases blood pressure and reduces heart rate after each dose. In clinical studies, VYLEESI induced maximal increases of 6 mmHg in systolic blood pressure (SBP) and 3 mmHg in diastolic blood pressure (DBP) that peaked between 2 to 4 hours post dose. There was a corresponding reduction in heart rate up to 5 beats per minute.

Blood pressure and heart rate returned to baseline usually within 12 hours post-dose. No additive effects were seen for blood pressure or heart rate following repeat daily dosing 24-hours apart for up to 16 days [see Clinical Pharmacology ( 12.2 )]. Before initiating VYLEESI, and periodically during treatment, consider the patient's cardiovascular risk and ensure blood pressure is well-controlled.

VYLEESI is not recommended for patients at high risk for cardiovascular disease and is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease [ see Contraindications ( 4 )]. To minimize the risk of more pronounced blood pressure effects, advise patients to not take more than one VYLEESI dose within 24 hours [see Dosage and Administration ( 2.1 )].

5.2Focal Hyperpigmentation In the phase 3 placebo-controlled trials, focal hyperpigmentation, including involvement of the face, gingiva, and breasts, was reported in 1% of patients who received up to 8 doses per month of VYLEESI compared to no placebo-treated patients. In another clinical study, 38% of patients developed focal hyperpigmentation after receiving VYLEESI daily for 8 days; among patients who continued VYLEESI for 8 more consecutive days, an additional 14% developed new focal pigmentary changes. Patients with dark skin were more likely to develop focal hyperpigmentation.

Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI. More than 8 monthly doses of VYLEESI is not recommended. Consider discontinuing VYLEESI if hyperpigmentation develops.

5.3Nausea In the phase 3 placebo-controlled trials, nausea was the most commonly reported adverse reaction, reported in 40% of VYLEESI-treated patients, requiring anti-emetic therapy in 13% of VYLEESI-treated patients and leading to premature discontinuation from the trials for 8% of VYLEESI-treated patients. Nausea improves for most patients with the second dose [see Adverse Reactions ( 6.1 )] . Consider discontinuing VYLEESI for persistent or severe nausea or initiating anti-emetic therapy for those patients who are bothered by nausea but wish to continue with VYLEESI treatment.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail elsewhere in labeling: Transient increases in blood pressure and reductions in heart rate [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.2 ) ] Focal hyperpigmentation [see Warnings and Precautions ( 5.2 )] Nausea [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The efficacy and safety of VYLEESI was studied in two identical, 24-week, randomized, double-blind, placebo-controlled trials in 1247 premenopausal women with acquired, generalized HSDD. The age range was 19-56 years old with a mean age of 39 years old; 86% were White and 12% were Black.

Both trials also included a 52-week open-label, uncontrolled extension phase during which 684 patients received VYLEESI [see Clinical Studies ( 14 )]. Most patients used VYLEESI two to three times per month and no more than once a week. Serious adverse reactions were reported in 1.1% of VYLEESI-treated patients and 0.5% of placebo-treated patients.

Adverse Reactions Leading to Study Discontinuation The discontinuation rate due to adverse reactions was 18% among patients treated with VYLEESI and 2% among patients treated with placebo. The most common adverse reactions leading to study drug discontinuation in the VYLEESI group were nausea (8%), headache (2%), vomiting (1%), flushing (1%), injection site reactions (1%), flu-like symptoms (<1%) and increased blood pressure (<1%). Common Adverse Reactions Table 1 provides the incidence of common adverse reactions (those reported in at least 2% of patients in the VYLEESI treatment group and at an incidence that was greater than in the placebo group).

The most common adverse reactions included nausea, flushing, injection site reactions and headache. The majority of events were reported to be mild (31%) to moderate (40%) in intensity and transient. Table 1: Adverse Reactions Occurring in ≥ 2% of Patients in Randomized, Double-Blind Controlled Trials with VYLEESI in Premenopausal Women with HSDD a Includes injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia and hypoesthesia VYLEESI (n = 627) % Placebo (n= 620) % Nausea 40.0

1.3Flushing 20.3

0.3Injection site reactions a 13.2

8.4Headache 11.3

1.9Vomiting 4.8

0.2Cough 3.3

1.3Fatigue 3.2

0.5Hot flush 2.7

0.2Paraesthesia 2.6

0.0Dizziness 2.2

0.5Nasal congestion 2.1

0.5Nausea In the pooled phase 3 placebo-controlled trials, nausea was the most common adverse reaction, reported in 40% of VYLEESI-treated patients compared to 1% of placebo-treated patients. The median onset of nausea was within one-hour post-dose and lasted about two hours in duration. The incidence of nausea was highest after the first VYLEESI dose (reported in 21% of patients) then declined to about 3% after subsequent doses.

Thirteen percent of VYLEESI-treated patients received an anti-emetic medication. Overall, 8% of VYLEESI-treated patients and no placebo-treated patients prematurely discontinued the trials due to nausea. [see Warnings and Precautions ( 5.3 )] In a phase 4, single-dose, placebo-controlled clinical study, pre-treatment with oral ondansetron (a 5-HT 3 receptor antagonist) did not reduce the incidence of nausea associated with VYLEESI treatment. In this study, 228 healthy women were randomized (1:1) to receive 8 mg ondansetron or placebo orally 30 minutes prior to a single administr… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 182 words ▾

7 DRUG INTERACTIONS VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. ( 7.1 ) VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction. ( 7.2 )

7.1Effect of VYLEESI on Other Drugs VYLEESI may slow gastric emptying and thus has the potential to reduce the rate and extent of absorption of concomitantly administered oral medications. Instruct patients to avoid the use of VYLEESI when taking concomitant oral drugs that are dependent on threshold concentrations for efficacy (e.g., antibiotics). In addition, patients should consider discontinuing VYLEESI if there is a delayed drug effect of concomitant oral medications when a quick onset of drug effect is desired (e.g. drugs for pain relief such as indomethacin).

7.2Naltrexone As VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone, patients should avoid using VYLEESI with an orally administered naltrexone-containing product that is intended to treat alcohol and opioid addiction due to the severe consequence of naltrexone treatment failure [see Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Advise patients to discontinue VYLEESI if pregnancy is suspected. ( 8.1 ) Females of Reproductive Potential: Advise patients to use effective contraception while taking VYLEESI. ( 8.3 )

8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at (800) 922-1038. Risk Summary The few pregnancies in women exposed to VYLEESI in clinical trials are insufficient for determining whether there is a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Based on findings in animal studies, the use of VYLEESI in pregnant women may be associated with the potential for fetal harm. In animal reproduction and development studies, daily subcutaneous administration of bremelanotide to pregnant dogs during the period of organogenesis at exposures greater than or equal to 16 times the maximum recommended dose (based on area under the concentration-time curve or AUC) produced fetal harm. In mice subcutaneously dosed with bremelanotide during pregnancy and lactation, developmental effects were observed in the offspring at greater than or equal to 125-times the maximum recommended dose (based on AUC) [see Data ].

However, the lowest bremelanotide dose associated with fetal harm has not been identified for either species. For this reason, women should use effective contraception while taking VYLEESI and discontinue VYLEESI if pregnancy is suspected. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data There were 7 pregnancies reported in the clinical trials of more than 1057 patients treated with VYLEESI for up to 12 months. Among these 7 pregnancies, no major congenital anomalies were reported. There was one spontaneous abortion (miscarriage), five full-term live births, and one outcome was unknown due to loss to follow-up.

Animal Data An embryofetal development study was conducted in the dog and a pre- and postnatal development study was conducted in the mouse to inform developmental risk. These two species are not routinely used for reproductive toxicity assessment but were the only two species that could be successfully dosed by the subcutaneous route during gestation. Bremelanotide was administered subcutaneously to pregnant dogs (8/dose) at 2, 8, or 20 mg/kg from gestation day (GD) 18-35, corresponding to the period from implantation to late embryogenesis in the dog.

Embryofetal toxicity, as measured by post-implantation loss, was elevated approximately 3 to 8-fold compared to controls across all treated groups but was not dose-dependent. A developmental no-observed-effect level (NOEL) was not set. At the low dose of 2 mg/kg/day in the dog, exposure was approximately 16 times the human exposure based on AUC.

In a pre- and postnatal development study, female mice (30/dose) were dosed subcutaneously at 0, 30, 75, and 150 mg/kg/day from GD 6 through lactation day (LD) 28, and two generations of offspring were assessed (F1 and F2). There were no effects on reproductive parameters in parental (F0) or F1 generation animals at doses up to 150 mg/kg/day (approximately 760 times the human AUC). However, developmental delays were observed in the F1 generation mice at ≥ 30 mg/kg/day (approximately 125 times the human AUC).

For that reason, a developmental NOEL was not set. There were no significant effects on the growth and development of F2 generation pups.

8.2Lactation Risk Summary There is no information on the presence of bremelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at (800) 922-1038. Risk Summary The few pregnancies in women exposed to VYLEESI in clinical trials are insufficient for determining whether there is a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Based on findings in animal studies, the use of VYLEESI in pregnant women may be associated with the potential for fetal harm. In animal reproduction and development studies, daily subcutaneous administration of bremelanotide to pregnant dogs during the period of organogenesis at exposures greater than or equal to 16 times the maximum recommended dose (based on area under the concentration-time curve or AUC) produced fetal harm. In mice subcutaneously dosed with bremelanotide during pregnancy and lactation, developmental effects were observed in the offspring at greater than or equal to 125-times the maximum recommended dose (based on AUC) [see Data ].

However, the lowest bremelanotide dose associated with fetal harm has not been identified for either species. For this reason, women should use effective contraception while taking VYLEESI and discontinue VYLEESI if pregnancy is suspected. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data There were 7 pregnancies reported in the clinical trials of more than 1057 patients treated with VYLEESI for up to 12 months. Among these 7 pregnancies, no major congenital anomalies were reported. There was one spontaneous abortion (miscarriage), five full-term live births, and one outcome was unknown due to loss to follow-up.

Animal Data An embryofetal development study was conducted in the dog and a pre- and postnatal development study was conducted in the mouse to inform developmental risk. These two species are not routinely used for reproductive toxicity assessment but were the only two species that could be successfully dosed by the subcutaneous route during gestation. Bremelanotide was administered subcutaneously to pregnant dogs (8/dose) at 2, 8, or 20 mg/kg from gestation day (GD) 18-35, corresponding to the period from implantation to late embryogenesis in the dog.

Embryofetal toxicity, as measured by post-implantation loss, was elevated approximately 3 to 8-fold compared to controls across all treated groups but was not dose-dependent. A developmental no-observed-effect level (NOEL) was not set. At the low dose of 2 mg/kg/day in the dog, exposure was approximately 16 times the human exposure based on AUC.

In a pre- and postnatal development study, female mice (30/dose) were dosed subcutaneously at 0, 30, 75, and 150 mg/kg/day from GD 6 through lactation day (LD) 28, and two generations of offspring were assessed (F1 and F2). There were no effects on reproductive parameters in parental (F0) or F1 generation animals at doses up to 150 mg/kg/day (approximately 760 times the human AUC). However, developmental delays were observed in the F1 generation mice at ≥ 30 mg/kg/day (approximately 125 times the human AUC).

For that reason, a developmental NOEL was not set. There were no significant effects on the growth and development of F2 generation pups.

🧒 Pediatric Use 16 words ▾

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

🧓 Geriatric Use 16 words ▾

8.5Geriatric Use The safety and effectiveness of VYLEESI have not been established in geriatric patients.

🆘 Overdosage 41 words ▾

10 OVERDOSAGE No reports of overdosage with VYLEESI have been reported. Nausea, focal hyperpigmentation and more pronounced blood pressure increases are more likely with higher doses. In the event of overdosage, treatment should address the symptoms with supportive measures, as needed.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bremelanotide is a melanocortin receptor (MCR) agonist that nonselectively activates several receptor subtypes with the following order of potency: MC1R, MC4R, MC3R, MC5R, MC2R. At therapeutic dose levels, binding to MC1R and MC4R is most relevant. Neurons expressing MC4R are present in many areas of the central nervous system (CNS).

The mechanism by which VYLEESI improves HSDD in women is unknown. The MC1R is expressed on melanocytes; binding at this receptor leads to melanin expression and increased pigmentation.

12.2Pharmacodynamics Transient Increases in Blood Pressure In an open-label ambulatory blood pressure monitoring study of 127 premenopausal women receiving VYLEESI once daily, there was a mean increase of 1.9 mmHg (95% CI: 1.0 to 2.7) in daytime systolic blood pressure (SBP) and a mean increase of 1.7 mmHg (95% CI: 0.9 to 2.4) in daytime diastolic blood pressure (DBP) after 8 days of dosing. The increase in SBP and DBP was transient with a mean peak effect in SBP of 2.8 mmHg between 4 to 8 hours post-dose and 2.7 mmHg for DBP at 0 to 4 hours post-dose.

The increase in BP after 8 days of dosing was accompanied by a simultaneous and transient mean decrease in heart rate of 0.5 beats per minute (95% CI: -1.6 to -0.7). The SBP and DBP values 12 to 24-hours post-dose were similar to the pre-dose values [see Warnings and Precautions ( 5.1 )]. Alcohol Interaction A placebo-controlled, randomized, double-blind, three-period, three-way crossover study was conducted to assess the safety of a single intranasal 20 mg dose of bremelanotide co-administered with alcohol in 12 healthy male and 12 healthy female subjects.

Intranasal bremelanotide or placebo spray was administered 10 minutes after consumption of placebo drink or 0.6 g/kg ethanol (equivalent of three 12 ounce cans of beer containing 5% alcohol content, three 5 ounce glasses of wine containing 12% alcohol content, or three 1.5 ounce shots of 80-proof spirit in a 70 kg person). The 20 mg intranasal dose achieves a 2.5-fold higher mean C max than that of VYLEESI. Alcohol consumption had no effect on the pharmacokinetic profile of bremelanotide.

The incidence of flushing was higher with bremelanotide plus ethanol compared to ethanol alone, but similar to the incidence with bremelanotide alone. The incidence of headache was higher with bremelanotide plus ethanol compared to bremelanotide alone, but similar to the incidence with ethanol alone. The incidence of other adverse reactions was similar across the treatment groups.

The incidence of abnormal orthostatic blood pressure reductions was comparable between the bremelanotide plus ethanol group and the ethanol alone group. No participants discontinued due to adverse reactions. Cardiac Electrophysiology A 20 mg intranasal dose of bremelanotide does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Following subcutaneous administration of VYLEESI, the mean plasma C max and AUC of bremelanotide are 72.8 ng/mL and 276 hr*ng/mL, respectively. Mean plasma concentrations of bremelanotide increase in a less than dose proportional manner in the dose range of 0.3 to 10 mg, with mean C max levels reaching a plateau at the 7.5 mg subcutaneous dose level (approximately 4.3 times the maximum recommended dose). Absorption Bremelanotide median T max is approximately 1.0 hour (range: 0.5 - 1.0 hours) in plasma.

The absolute bioavailability of bremelanotide following subcutaneous administration of VYLEESI was about 100%. The site of subcutaneous administration (abdomen and thigh) had no significant effect on the systemic exposure to bremelanotide. Distribution Twenty-one percent of bremelanotide binds to human serum protein.

The mean (SD) volume of distribution after a single subcutaneous administration of VYLEESI is 25.0 ±

5.8L. Elimination Following a single subcutaneous administration of VYLEESI, mean terminal half-life of bremelanotide is approximate… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Bremelanotide is a melanocortin receptor (MCR) agonist that nonselectively activates several receptor subtypes with the following order of potency: MC1R, MC4R, MC3R, MC5R, MC2R. At therapeutic dose levels, binding to MC1R and MC4R is most relevant. Neurons expressing MC4R are present in many areas of the central nervous system (CNS).

The mechanism by which VYLEESI improves HSDD in women is unknown. The MC1R is expressed on melanocytes; binding at this receptor leads to melanin expression and increased pigmentation.

📦 How Supplied / Storage and Handling 55 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING VYLEESI (bremelanotide) is supplied as: 1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 0713-0897-06) provided in a carton of 4 autoinjectors (NDC 0713-0897-04), carton of 2 autoinjectors (NDC 0713-0897-02). Storage Store at or below 25°C (77°F). Do not freeze. Protect from light.

📋 Description 145 words ▾

11 DESCRIPTION VYLEESI (bremelanotide injection) contains bremelanotide, a melanocortin receptor agonist for subcutaneous administration via an autoinjector. Bremelanotide acetate is a synthetic, cyclic heptapeptide with a free acid at the carboxyl terminus and an acetylated amino group at the amino terminus of the peptide with the following structure: Ac-Nle-cyclo-(Asp-His-D-Phe-Arg-Trp-Lys-OH) ● xCH 3 COOH The molecular formula of bremelanotide acetate is C 50 H 68 N 14 O 10 ● xCH 3 COOH (1≤ x ≤ 2) and the molecular weight is 1025.2 (free base).

VYLEESI (bremelanotide injection) is supplied as a sterile, clear solution in a pre-filled syringe contained in a single-dose autoinjector for subcutaneous administration. Each pre-filled syringe contains 1.75 mg of bremelanotide (equivalent to 1.89 mg bremelanotide acetate) in 0.3 mL solution. Inactive ingredients consist of 2.5% glycerin, sterile water for injection, and hydrochloric acid or sodium hydroxide added to adjust the pH.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Transient Increase in Blood Pressure and Decrease in Heart Rate Advise patients that increases in blood pressure and decreases in heart rate may occur after taking each VYLEESI dose, and that these changes usually resolve within 12 hours post-dose [see Warnings and Precautions ( 5.1 )]. Advise patients not to take VYLEESI within 24 hours of a prior dose and that more than 8 doses per month is not recommended.

Advise patients that taking VYLEESI more frequently or too close together may lead to more pronounced increases in blood pressure [see Dosage and Administration ( 2.1 )]. Focal Hyperpigmentation Advise patients that focal hyperpigmentation, including on the face, gingiva and breasts, may occur when VYLEESI is used intermittently, particularly in patients with darker skin. The incidence may increase with daily VYLEESI use.

Advise patients that the pigmentary changes may not resolve completely after stopping VYLEESI, and to contact their healthcare provider if they have any concerns about changes to their skin [see Warnings and Precautions ( 5.2 )] . Nausea Advise patients that nausea may occur, most commonly with the first injection of VYLEESI, but could occur intermittently with continued use. Advise patients that nausea most commonly lasts for two hours after taking a dose but could last longer in some patients, and that anti-emetic medications may be necessary.

Advise patients to contact their healthcare provider for persistent or severe nausea [see Warnings and Precautions( 5.3 )]. Females of Reproductive Potential Advise patients to use effective contraception while taking VYLEESI and to discontinue VYLEESI if pregnancy is suspected. Advise pregnant patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy [see Use in Specific Populations ( 8.1 , 8.3 )].

Marketed By: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 VYLEESI is a registered trademark of Cosette Pharmaceuticals, Inc. © 2024 Cosette Pharmaceuticals, Inc. All rights reserved.

8-0897CP1 Rev. 03/2024

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following subcutaneous administration of VYLEESI, the mean plasma C max and AUC of bremelanotide are 72.8 ng/mL and 276 hr*ng/mL, respectively. Mean plasma concentrations of bremelanotide increase in a less than dose proportional manner in the dose range of 0.3 to 10 mg, with mean C max levels reaching a plateau at the 7.5 mg subcutaneous dose level (approximately 4.3 times the maximum recommended dose). Absorption Bremelanotide median T max is approximately 1.0 hour (range: 0.5 - 1.0 hours) in plasma.

The absolute bioavailability of bremelanotide following subcutaneous administration of VYLEESI was about 100%. The site of subcutaneous administration (abdomen and thigh) had no significant effect on the systemic exposure to bremelanotide. Distribution Twenty-one percent of bremelanotide binds to human serum protein.

The mean (SD) volume of distribution after a single subcutaneous administration of VYLEESI is 25.0 ±

5.8L. Elimination Following a single subcutaneous administration of VYLEESI, mean terminal half-life of bremelanotide is approximately 2.7 hours (range: 1.9– 4.0 hours) and the mean (± SD) clearance (CL/F) is 6.5 ±1.0 L/hr. Metabolism As a peptide with 7 amino acids, the primary metabolic pathway of bremelanotide involves multiple hydrolyses of the amide bond of the cyclic peptide.

Excretion Following administration of a radiolabeled dose, 64.8% of the total radioactivity was recovered in urine and 22.8% in feces. Specific Populations Patients with Renal Impairment Following a single subcutaneous dose of VYLEESI, bremelanotide exposure (AUC) increased 1.2-fold in patients with mild (eGFR, 60 to 89 mL/min/1.73 m 2 ) renal impairment, 1.5-fold in patients with moderate (eGFR, 30 to 59 mL/min/1.73 m 2 ) renal impairment, and 2-fold in patients with severe (eGFR, <30 mL/min/1.73 m 2 ) renal impairment [see Use in Specific Populations ( 8.6 )] .

Patients with Hepatic Impairment Following a single subcutaneous dose of VYLEESI, bremelanotide exposure (AUC 0-inf ) increased 1.2-fold in patients with mild (Child-Pugh A; score of 5-6) hepatic impairment and 1.7-fold in patients with moderate (Child-Pugh B; score of 7-9) hepatic impairment [see Use in Specific Populations( 8.7 )]. The effect of severe hepatic impairment on the pharmacokinetics of bremelanotide was not studied. Drug Interaction Studies Potential for VYLEESI to Influence the Pharmacokinetics of Other Drugs VYLEESI may reduce the rate and extent of absorption of concomitantly administered oral medications, likely due to slowing gastric motility.

In clinical pharmacology studies, VYLEESI did not affect the absorption of the tested orally administered concomitant medications to any clinically relevant degree, except for naltrexone and indomethacin [see Drug Interactions ( 7 )]. The effects of bremelanotide on the pharmacokinetics of other drugs are summarized below as change relative to the other drug administered alone (test/reference) ( Figure 1 ). Figure 1: Effects of Bremelanotide 1.75 mg SC on the Pharmacokinetic Exposures of Orally Administered Medications Note: AUC = area under the plasma concentration-time curve; BMT = bremelanotide; CI = confidence interval; C max = maximum plasma concentration; SC = subcutaneous.

Figure 1

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Transient Increases in Blood Pressure In an open-label ambulatory blood pressure monitoring study of 127 premenopausal women receiving VYLEESI once daily, there was a mean increase of 1.9 mmHg (95% CI: 1.0 to 2.7) in daytime systolic blood pressure (SBP) and a mean increase of 1.7 mmHg (95% CI: 0.9 to 2.4) in daytime diastolic blood pressure (DBP) after 8 days of dosing. The increase in SBP and DBP was transient with a mean peak effect in SBP of 2.8 mmHg between 4 to 8 hours post-dose and 2.7 mmHg for DBP at 0 to 4 hours post-dose.

The increase in BP after 8 days of dosing was accompanied by a simultaneous and transient mean decrease in heart rate of 0.5 beats per minute (95% CI: -1.6 to -0.7). The SBP and DBP values 12 to 24-hours post-dose were similar to the pre-dose values [see Warnings and Precautions ( 5.1 )]. Alcohol Interaction A placebo-controlled, randomized, double-blind, three-period, three-way crossover study was conducted to assess the safety of a single intranasal 20 mg dose of bremelanotide co-administered with alcohol in 12 healthy male and 12 healthy female subjects.

Intranasal bremelanotide or placebo spray was administered 10 minutes after consumption of placebo drink or 0.6 g/kg ethanol (equivalent of three 12 ounce cans of beer containing 5% alcohol content, three 5 ounce glasses of wine containing 12% alcohol content, or three 1.5 ounce shots of 80-proof spirit in a 70 kg person). The 20 mg intranasal dose achieves a 2.5-fold higher mean C max than that of VYLEESI. Alcohol consumption had no effect on the pharmacokinetic profile of bremelanotide.

The incidence of flushing was higher with bremelanotide plus ethanol compared to ethanol alone, but similar to the incidence with bremelanotide alone. The incidence of headache was higher with bremelanotide plus ethanol compared to bremelanotide alone, but similar to the incidence with ethanol alone. The incidence of other adverse reactions was similar across the treatment groups.

The incidence of abnormal orthostatic blood pressure reductions was comparable between the bremelanotide plus ethanol group and the ethanol alone group. No participants discontinued due to adverse reactions. Cardiac Electrophysiology A 20 mg intranasal dose of bremelanotide does not prolong the QTc interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of VYLEESI for the treatment of HSDD in premenopausal women was evaluated in two identical, Phase 3, randomized, double-blind, placebo-controlled trials: NCT02333071 and NCT02338960 (Study 1 and Study 2). Both trials included premenopausal women with acquired, generalized HSDD of at least 6 months' duration. All patients in heterosexual relationships were required to use an effective form of contraception.

A majority of patients (74% in Study 1 and 67% in Study 2) reported HSDD with concomitant decreased arousal. The trials consisted of two phases: a Core Study Phase (24-week placebo-controlled, double-blind treatment period) and an uncontrolled, 52-week Open-label Extension Study Phase. Study participants were randomized to subcutaneous injections of VYLEESI 1.75 mg (n= 635) or placebo (n= 632), self-administered by an autoinjector on an as-needed basis.

Patients were instructed to administer the drug approximately 45 minutes prior to anticipated sexual activity. Patients were not to administer more than one dose within a 24-hour period and no more than twelve doses per month. Trial participants were mostly Caucasian (86%) or Black (12%).

The mean age of study participants was 39 years old (range 19 to 56 years old); the mean duration in a monogamous relationship was 12 years, and the mean duration of HSDD was approximately 4 years. Across the two trials, the median number of VYLEESI injections was 10 in the 24-week double-blind treatment period and 12 during the uncontrolled open-label extension. Most patients used VYLEESI two to three times per month and no more than once a week.

Study 1 and Study 2 had the following co-primary efficacy endpoints: Change from baseline to end of study (EOS) in the Desire domain from the Female Sexual Function Index (FSFI) (Questions 1 and 2). Question 1 asks patients “Over the past 4 weeks, how often did you feel sexual desire or interest?” , with responses ranging from 1 (almost never or never) to 5 (almost always or always). Question 2 asks patients “Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest?” , with responses ranging from 1 (very low or none at all) to 5 (very high).

The FSFI Desire domain score was calculated by adding the patient's responses to these two questions then multiplying that sum by 0.6. The FSFI Desire Domain score ranged from 1.2 to 6. An increase in the FSFI Desire domain score over time denotes improvement in sexual desire.

Change from baseline to EOS in the score for feeling bothered by low sexual desire as measured by the Female Sexual Distress Scale – Desire/Arousal/Orgasm Question 13 (FSDS-DAO Q13). This question asks patients, “How often did you feel: Bothered by low sexual desire?” Patients assessed their sexual distress over a 30-day recall period and responded on a scale of 0 (never) to 4 (always). A decrease in the FSDS-DAO Q13 score over time denotes improvement in the level of distress associated with low sexual desire.

EOS is defined as the patient's last study visit during the double-blind treatment period. For patients who completed the double-blind treatment period, the EOS visit occurred at Week 24. Efficacy results for these co-primary endpoints from Study 1 and Study 2 are summarized in Table 2 and Table 3 .

In both studies, VYLEESI showed a statistically significant increase in the FSFI Desire Domain score and a statistically significant decrease in the FSDS-DAO Q13 score from baseline to the EOS visit compared to placebo. The magnitude of the treatment differences was similar in both studies. Table 2: Efficacy Results for the FSFI-Desire Domain Score in Premenopausal HSDD Patients in Study 1 and Study 2 (MITT* Population) 1 FSFI Desire score range: 1.2 to 6.0, with higher scores indicating greater desire.

2 p-value from unadjusted Wilcoxon rank-sum test. *MITT: modified intent to treat defined as all patients who were randomized, used at least one dose of double-blind stud… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 155 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis There were no significant increases in tumor incidence in two-year carcinogenicity studies with intranasal administration (0.5, 2.5, and 5 mg/animal/day) of bremelanotide to male and female rats, and subcutaneous administration (3, 9, and 15 mg/kg/day) to male and female mice. Multiples of exposure were calculated based on average C max at the high dose over the course of the study and were 1.1-fold and 111-fold the human C max for rats and mice, respectively.

Mutagenesis Bremelanotide was not genotoxic or mutagenic in a battery of tests, including the in vitro bacterial reverse mutation assay, the in vitro chromosomal aberration test in Chinese Hamster Ovary cells, and the in vivo mouse micronucleus assay. Impairment of Fertility There were no effects on fertility in male (75 mg/kg/day, approximately 375 times the human AUC) or female (150 mg/kg/day, approximately 760 times the human AUC) mice following subcutaneous administration.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 152 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis There were no significant increases in tumor incidence in two-year carcinogenicity studies with intranasal administration (0.5, 2.5, and 5 mg/animal/day) of bremelanotide to male and female rats, and subcutaneous administration (3, 9, and 15 mg/kg/day) to male and female mice. Multiples of exposure were calculated based on average C max at the high dose over the course of the study and were 1.1-fold and 111-fold the human C max for rats and mice, respectively.

Mutagenesis Bremelanotide was not genotoxic or mutagenic in a battery of tests, including the in vitro bacterial reverse mutation assay, the in vitro chromosomal aberration test in Chinese Hamster Ovary cells, and the in vivo mouse micronucleus assay. Impairment of Fertility There were no effects on fertility in male (75 mg/kg/day, approximately 375 times the human AUC) or female (150 mg/kg/day, approximately 760 times the human AUC) mice following subcutaneous administration.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 03/2024 PATIENT INFORMATION VYLEESI ® (vahy-lee-see) (bremelanotide injection) for subcutaneous use What is VYLEESI? VYLEESI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: a medical or mental health problem problems in the relationship medicine or other drug use VYLEESI is not for the treatment of HSDD in women who have gone through menopause or in men. VYLEESI is not for use to improve sexual performance.

VYLEESI is not for use in children. Do not use VYLEESI if you have: high blood pressure that is not controlled (uncontrolled hypertension) known heart (cardiovascular) disease Before using VYLEESI, tell your healthcare provider about all of your medical conditions, including if you : have high blood pressure. have heart problems. have kidney problems. have liver problems. are pregnant or plan to become pregnant. It is not known if VYLEESI will harm your unborn baby.

Pregnancy Registry : There will be a pregnancy registry for women who use VYLEESI during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry or call the VYLEESI Pregnancy Exposure Registry at 800-922-1038.

Women who can become pregnant should use effective birth control during treatment with VYLEESI. Talk to your healthcare provider about birth control choices that may be right for you during this time. Stop using VYLEESI and tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with VYLEESI. are breastfeeding or plan to breastfeed.

It is not known if VYLEESI passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you use VYLEESI. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VYLEESI may affect the way other medicines work, and other medicines may affect the way VYLEESI works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use VYLEESI? See the detailed “ Instructions for Use ” that comes with VYLEESI for information on how to prepare and inject a dose of VYLEESI . Talk to your healthcare provider or pharmacist if you have any questions.

Use VYLEESI exactly as prescribed by your healthcare provider. VYLEESI comes in an autoinjector that you or your caregiver may use at home to give injections. VYLEESI is given as an injection under the skin (subcutaneous injection), in your thighs or stomach area (abdomen).

Inject VYLEESI at least 45 minutes before you think that you will begin sexual activity. Do not inject more than 1 dose of VYLEESI within 24 hours of your last dose. Do not inject more than 8 doses of VYLEESI within a month.

Tell your healthcare provider if your symptoms of HSDD have not improved after you have used VYLEESI for 8 weeks. What are the possible side effects of VYLEESI? VYLEESI can cause serious side effects, including: Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject VYLEESI.

These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use VYLEESI more often than prescribed by your healthcare provider. See “How should I use VYLEESI?” Darkening of the s… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use Read this Instructions for Use before you use VYLEESI and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Do not inject VYLEESI unless you have been trained by your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions. Important Information Do not use more than 1 dose of VYLEESI in 24 hours.

Do not use more than 8 doses of VYLEESI within a month. Use 1 autoinjector for your dose of VYLEESI. Throw away (dispose of) the autoinjector after giving your injection.

See Step 6: Throw away (dispose of) the VYLEESI autoinjector. Inject VYLEESI into the skin of the stomach area (abdomen) or thigh only. Do not pull off the clear cap from the VYLEESI autoinjector until you are ready to inject VYLEESI.

Storage Store at or below 77°F (25°C). Do not freeze. Protect from light.

Keep VYLEESI and all medicines out of the reach of children. Instructions for Use Read this Instructions for Use before you use VYLEESI and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Do not inject VYLEESI unless you have been trained by your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions.

Supplies Needed for Your Injection: 1 alcohol wipe (not included in carton) 1 VYLEESI autoinjector 1 cotton ball or gauze (not included in carton) 1 adhesive bandage (not included in carton) 1 sharps disposal container for VYLEESI autoinjector disposal. See Step 6: Throw away (dispose of) the VYLEESI autoinjector. Read and follow Step 1 to Step 6 to use the VYLEESI autoinjector.

Check the label on the autoinjector for the expiration date (EXP). Do not use the autoinjector if the expiration date has passed. Check the view window.

You should see the gray tip in half of the view window and the medicine in half of the view window. If the view window is purple, the autoinjector will not work. Use a new autoinjector if the view window is purple.

Look at the medicine in the view window. It should be clear and free of particles. Do not use if the medicine is cloudy, discolored, or contains particles.

The autoinjector must be used right away after it is activated. Pull the clear cap from the autoinjector (See Figure A) to activate. Do not try to recap the autoinjector.

The autoinjector should be used or thrown away right after the cap is removed . See Step 6: Throw away (dispose of) the VYLEESI autoinjector. Important :During the injection you will hear two clicks .

Place the purple tip flat against the center of the clean skin at your injection site. Make sure you can see the view window (See Figure B). Check that the clear cap fits tightly on the purple tip of the autoinjector.

If the cap does not fit tightly or is damaged, do not use the autoinjector. Call Cosette Pharmaceuticals,Inc. at 1-800-922-1038. Wash your hands with soap and water.

Choose an injection site on your stomach area (abdomen) or the front of your thigh. Avoid the area on your abdomen that is 2 inches around your belly button (navel). Do not inject into skin that is irritated, sore, bruised, red, hard, or scarred.

Do not inject through your clothes. Choose a different site each time you give yourself an injection. Press down and hold the autoinjector firmly against your skin (See Figure C).

You will hear the 1 st click right away , which tells you that your injection has started. In about 2 seconds , you will hear a 2 nd click . Continue to press and hold the autoinjector firmly against your skin for about 5 seconds after the 2 nd click to be sure your injection is complete (See Figure D).

Clean the injection site with an alcohol wipe. Let the injection site air dry. Do not fan or blow on the clean area.

Do not touch the injection site again before g… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 50 words ▾

Principal Display Panel – 4 Syringe Carton Label NDC 0713- 0897 -04 Rx ONLY vyleesi ® (bremelanotide injection) 1.75 mg/0.3 mL | for subcutaneous use only Principal Display Panel – 4 Syringe Carton Label

Principal Display Panel – Syringe Label vyleesi ® (bremelanotide injection) Principal Display Panel – Syringe Label

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

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 Vyleesi (this brand).

Top reported reactions

Nausea432
Headache148
Vomiting115
Flushing72
Illness72
Adverse Drug Reaction53
Dizziness43

Age at onset

Adult535
Elderly37

Reporter sex

1,004 reports
Male · 5%
Female · 95%

Serious outcomes

Hospitalization6
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 341 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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cosette Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosette Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00713-0886-18 · Cosette 00713-0935-30 · Cosette →
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.