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Bremelanotide Injection

Bremelanotide Injection (Vyleesi) is a self-injected prescription medicine for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), a condition of low sexual desire that causes marked distress.

Brand name Vyleesi
Drug class Melanocortin Receptor Agonist
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Bremelanotide Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Vyleesi (bremelanotide) is an as-needed, self-injected medicine for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD, low sexual desire that causes real distress). It acts on melanocortin receptors in the brain in a way that is not fully understood, and since arriving around 2019 it has remained a specialized, less familiar option. Nausea is the side effect most people notice, though it often eases after the second dose, and flushing and headache are common too. Blood pressure rises briefly after every dose, so it is not for anyone with uncontrolled high blood pressure or known heart or blood vessel disease, and dark skin patches can appear that may not fade.

Clinical pearls

  • Inject at least 45 minutes before sex, and never use more than one dose in 24 hours or eight a month.
  • Avoid it if you take oral naltrexone for alcohol or opioid addiction, since Vyleesi can sharply lower naltrexone levels.
  • It slows stomach emptying, so oral antibiotics or a fast-acting pain reliever like indomethacin may not work as expected.
  • Use effective birth control while on it, and stop it if your desire has not improved after 8 weeks.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedNov 13, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Bremelanotide Injection, written from its FDA label.

What Bremelanotide Injection is used for

▾

Bremelanotide Injection is used for one condition:

  • Vyleesi (subcutaneous injection) treats acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
  • Acquired means it developed in someone who previously had no desire problems.
  • Generalized means it happens regardless of the type of stimulation, situation or partner.
  • It is not for HSDD caused by another medical or psychiatric condition, relationship problems, or a medication or drug.
  • It is not indicated for postmenopausal women, men, or to enhance sexual performance.

How Bremelanotide Injection works

▾

Bremelanotide is a melanocortin receptor agonist. It switches on several receptors, and MC1R and MC4R matter most at usual doses. MC4R is found in many parts of the brain. The way it improves HSDD in women is not known.

MC1R is found on pigment cells, which is why skin darkening can occur.

Bremelanotide Injection dosage

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Vyleesi is injected under the skin of the abdomen or thigh with a prefilled autoinjector pen. You use it as needed, at least 45 minutes before expected sexual activity.

  • Do not use more than one dose in 24 hours.
  • More than 8 doses a month is not recommended.
  • Check the solution first. Discard it if cloudy, discolored or containing particles.
  • Treatment should stop after 8 weeks if you notice no improvement.

Dosing details from the FDA-approved label

From the Bremelanotide Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (VYLEESI; indication not named in the dosing text)
    • 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity
    • Maximum: Do not administer more than one dose within 24 hours; administering more than 8 doses per month is not recommended
    • Discontinue after 8 weeks if the patient does not report an improvement in her symptoms
Read the label’s full dosing text

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

Read the full Dosage and Administration section on DailyMed →

Bremelanotide Injection side effects

▾

The most common side effects are:

Common side effects

  • Nausea (the most common, about 40% of patients in trials)
  • Flushing
  • Injection site reactions
  • Headache
  • Vomiting

When to get medical help

  • Call your doctor if nausea is severe or doesn't go away. Treatment may be stopped, or an anti-nausea medicine may be added.
  • Tell your doctor if you notice dark patches or spots on your skin, face, gums or breasts (focal hyperpigmentation). They may not fade after stopping.
  • Get medical help for symptoms of high blood pressure or heart problems, since blood pressure rises after each dose.
  • Tell your doctor right away if you think you may be pregnant.

Nausea is the main reason people stop, and it often improves after the second dose. Skin darkening and blood pressure increases need attention from your doctor.

Bremelanotide Injection warnings and precautions

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  • Blood pressure: Blood pressure rises and heart rate drops after each dose, usually resolving within 12 hours. Your doctor should assess cardiovascular risk and blood pressure control before and during treatment.
  • Skin darkening: Focal hyperpigmentation can affect the face, gums and breasts. It is more likely in people with darker skin and with frequent dosing, and may not be reversible. Your doctor may stop treatment if it appears.
  • Nausea: It can be bothersome. Your doctor may stop Vyleesi or add anti-nausea medicine.

Bremelanotide Injection interactions

▾

Vyleesi can slow stomach emptying and affect other medicines.

  • Oral naltrexone for alcohol or opioid addiction: Vyleesi may greatly lower its levels, risking treatment failure. Avoid combining.
  • Oral medicines that need threshold levels to work (such as antibiotics): absorption may drop, so avoid Vyleesi with them.
  • Oral medicines needed to act quickly (such as indomethacin): the effect may be delayed.
  • Alcohol: flushing and headache were more common together in a study, but alcohol did not change bremelanotide levels.

Interactions listed in the FDA-approved label

From the Bremelanotide Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Concomitantly administered oral medications: VYLEESI may slow gastric emptying and thus has the potential to reduce the rate and extent of absorption of concomitantly administered oral medications. Avoid use of VYLEESI when taking concomitant oral drugs that are dependent on threshold concentrations for efficacy (e.g., antibiotics). 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).
  • Orally administered naltrexone-containing products intended to treat alcohol and opioid addiction: VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone, with severe consequence of naltrexone treatment failure. Avoid using VYLEESI with an orally administered naltrexone-containing product intended to treat alcohol and opioid addiction.
Read the label’s full interactions text

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 ) 7.1 Effect 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). 7.2 Naltrexone 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 ) ].

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Bremelanotide Injection against a supplement or herb →

Before taking Bremelanotide Injection

▾
  • Do not use with uncontrolled high blood pressure or known cardiovascular disease.
  • Not recommended if you are at high risk for cardiovascular disease.
  • Use effective contraception. Stop and call your doctor if pregnancy is suspected.
  • Breastfeeding: no information on effects on milk or the infant, so discuss with your doctor.
  • Not established as safe or effective in children or older adults.
  • No dose changes for mild to moderate kidney impairment. Use caution with severe impairment.

Bremelanotide Injection overdose

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No overdoses have been reported. Higher doses are more likely to cause nausea, skin darkening and larger blood pressure increases. If too much is used, treatment focuses on the symptoms with supportive care.

What Bremelanotide Injection does in the body

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After each dose, blood pressure rises briefly and heart rate dips slightly. In one study, average daytime blood pressure rose by about 2 mmHg after 8 days of daily dosing. Values were back to pre-dose levels 12 to 24 hours later. A higher intranasal dose did not meaningfully affect heart rhythm (QTc interval).

How your body processes Bremelanotide Injection

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After injection under the skin, nearly all of the drug is absorbed, peaking in about 1 hour. Injecting in the abdomen or thigh gives similar exposure. The half-life is about 2.7 hours. The body breaks it down like a small protein (peptide), and it leaves mostly in urine, with some in feces. Exposure is higher in kidney impairment.

How to store Bremelanotide Injection

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

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Bremelanotide Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Bremelanotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What is Vyleesi for?

▾
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, relationship issues or a medication. It is not for postmenopausal women, men, or to boost sexual performance.

How do I use it?

▾
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 dose in 24 hours or more than 8 in a month. Check the solution first and discard it if it looks cloudy, discolored or has particles.

What side effects should I expect?

▾
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 happen. Tell your doctor if nausea is severe or persistent, since there are ways to help.

Is it safe if I have high blood pressure?

▾
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 should check your blood pressure and heart risk before and during treatment.

Can I take it with my other medicines?

▾
Tell me about everything you take. Avoid it with oral naltrexone for alcohol or opioid addiction, since it can lower naltrexone levels a lot. It can also slow how oral medicines are absorbed, which matters for antibiotics and fast-acting pain relievers.

What if I get pregnant?

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Use effective birth control while on Vyleesi. Animal studies showed possible harm to the fetus. If you think you might be pregnant, stop and call your doctor.

Is Bremelanotide Injection available over the counter?

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No. Bremelanotide Injection is a prescription medicine: every Bremelanotide Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Bremelanotide Injection first available?

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The earliest FDA record we hold for Bremelanotide Injection is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Bremelanotide Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Bremelanotide Injection on HelloPharmacist

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Detailed data & references for Bremelanotide Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Bremelanotide Injection forms and strengths (how it comes)

Bremelanotide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Bremelanotide Injection inactive ingredients by manufacturer.

Injection

By injection · Under the skin
Brands Vyleesi
How this form is used
What it may be used for
  • Vyleesi is used for premenopausal women with acquired, generalized HSDD.
  • Vyleesi is not indicated for postmenopausal women, men, or to enhance sexual performance.
Important instructions
  • Vyleesi is self-injected under the skin of the abdomen or thigh using a prefilled autoinjector pen.
  • Vyleesi is used as needed, at least 45 minutes before anticipated sexual activity.
  • Do not use Vyleesi more than once in 24 hours or more than 8 times a month.
  • Do not use Vyleesi if the solution is cloudy, discolored, or has visible particles.
Available strengths 1 strength
1.75 mg/0.3 mL
2 FDA-listed product records ⓘ

Bremelanotide Injection on the U.S. market: products, makers and brands

How Bremelanotide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 1 Bremelanotide Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2019. Brand names on the directory include Vyleesi; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

Compare Bremelanotide Injection products

A representative set of FDA-listed product records for Bremelanotide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
1.75 mg/0.3 mL Subcutaneous Cosette Pharmaceuticals, Inc. NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Bremelanotide Injection NDCs →

Bremelanotide Injection side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bremelanotide Injection — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Bremelanotide Injection are nausea, headache, vomiting; about 3% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

1,004
Reports mentioning it
3%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
432
Headache
148
Vomiting
115
Flushing
72
Illness
72
Adverse Drug Reaction
53
Dizziness
43
Feeling Abnormal
40
Fatigue
39
Cough
34
Age groups
Adult · 535Elderly · 37

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bremelanotide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Bremelanotide Injection FDA approval history

How Bremelanotide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Bremelanotide Injection was first approved by the FDA in 2019 (Brand: VYLEESI (AUTOINJECTOR) · Cosette). It remains available in U.S. pharmacies today.

2019
Brand approved
Brand: VYLEESI (AUTOINJECTOR) · Cosette
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Bremelanotide Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Bremelanotide recalls since July 2021.

✅No Bremelanotide recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Bremelanotide Injection RxCUI 2176312 1 dose form · 1 strength
  1. Dose form (SCDF) Auto-Injector RxCUI 2176315 In current FDA listings
    Clinical drug / strength (SCD) 0.3 ML bremelanotide 5.83 MG/ML RxCUI 2176316

Look up RxCUI 2176312 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Bremelanotide Injection brand names

Bremelanotide Injection is sold under one brand name in the FDA directory — Vyleesi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Vyleesi

Who makes Bremelanotide Injection: manufacturers and labelers

One company lists Bremelanotide Injection products with the FDA. By number of product records, the largest are Cosette Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Cosette Pharmaceuticals, Inc. 1

Bremelanotide Injection drug class (RxNorm)

Bremelanotide Injection belongs to the Melanocortin Receptor Agonist class.

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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Bremelanotide Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 13, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bremelanotide Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Bremelanotide Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Cosette Pharmaceuticals, Inc.
Linked label effective
Nov 13, 2025
Composite sections available
22
Linked SPL Set ID
f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Linked SPL Document ID
437e6c45-dfb9-35ec-e063-6394a90a7874
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cosette Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →