Bremelanotide Injection
Bremelanotide is an injectable medication used to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
🧬 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 →
📖 Bremelanotide Injection: Patient Information Guide
A plain-language walkthrough of Bremelanotide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Bremelanotide injection (Vyleesi) is approved for one specific use in a defined patient population.
- Vyleesi is indicated for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) — meaning low sexual desire that developed after a period of normal desire, occurs in all situations regardless of partner or setting, and causes significant distress or relationship difficulty
- The low sexual desire must not be caused by a co-existing medical or psychiatric condition, relationship problems, or the effects of another medication or substance
- Vyleesi is not approved for HSDD in postmenopausal women or in men
- Vyleesi is not intended to enhance sexual performance in people without HSDD
⚙️How it works▾
Bremelanotide activates a family of receptors in the body called melanocortin receptors (MCRs). At therapeutic doses, it primarily binds to MC4R receptors, which are found in many parts of the central nervous system (brain and spinal cord). The exact way this improves sexual desire in women with HSDD isn't fully known. It also binds to MC1R receptors on melanocytes (skin pigment cells), which can trigger increased melanin (pigment) production — explaining why skin darkening is a known side effect.
💊How it's taken▾
Vyleesi is self-administered as a subcutaneous (under-the-skin) injection into the abdomen or thigh, using a prefilled autoinjector pen. It is taken as needed — at least 45 minutes before anticipated sexual activity. No more than one dose should be taken within any 24-hour period. Using more than 8 doses per month is not recommended, as more frequent use raises the risk of blood pressure effects and skin darkening.
- Inject into the abdomen or thigh (site does not affect how well it works)
- Take at least 45 minutes before sexual activity
- No more than one dose per 24 hours
- No more than 8 doses per month
- If no improvement is seen after 8 weeks, your prescriber may recommend stopping treatment
🤒Side effects — in detail▾
The most common side effects with Vyleesi include:
- Nausea — the most frequent, affecting about 40% of patients; often improves with the second dose
- Flushing — warmth or redness, usually temporary
- Injection site reactions — redness, bruising, or discomfort where injected
- Headache
- Vomiting
- Temporary blood pressure increase and heart rate decrease — peaks within a few hours and usually resolves within 12 hours
More serious reactions to watch for include significant or prolonged blood pressure changes, persistent or severe nausea, and new patches of darkened skin (especially on the face, gums, or breasts). Contact your doctor if any of these occur.
⚠️Warnings & precautions▾
- Blood pressure and heart rate: Every dose temporarily raises blood pressure and lowers heart rate. This usually resolves within 12 hours. Vyleesi must not be used by people with uncontrolled high blood pressure or known cardiovascular disease, and is not recommended for those at high cardiovascular risk.
- Skin darkening (focal hyperpigmentation): Patches of darkened skin — including on the face, gums, and breasts — can develop, especially with daily use or in people with darker skin tones. Darkening did not fully go away in all patients after stopping. Using more than 8 doses per month increases this risk.
- Nausea: Nausea affected 40% of patients and caused 8% to stop treatment early. Anti-nausea medication may help. If nausea is severe or persistent, talk to your doctor about whether to continue.
🔀What it interacts with▾
Vyleesi can affect how your body absorbs other medications taken by mouth, so timing and drug choice matters:
- Oral medications in general: Vyleesi slows stomach emptying, which can reduce or delay absorption of pills taken around the same time
- Antibiotics and time-sensitive medications: Avoid taking Vyleesi at the same time as oral drugs that need to reach a specific level in the blood to be effective
- Pain relievers with quick-onset needs (e.g., indomethacin): Vyleesi may delay their effect — consider stopping Vyleesi if this becomes a problem
- Oral naltrexone (for alcohol or opioid addiction): Vyleesi significantly lowers naltrexone blood levels, which could cause treatment failure — do not use these together
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Uncontrolled high blood pressure or cardiovascular disease: Vyleesi is contraindicated — do not use it
- High cardiovascular risk: Vyleesi is not recommended — discuss your heart health history with your doctor before starting
- Pregnancy: Use effective contraception while taking Vyleesi; stop and call your doctor if you think you may be pregnant — animal studies suggest potential fetal harm
- Breastfeeding: It is unknown whether bremelanotide passes into breast milk; discuss risks and benefits with your doctor
- Children and teenagers: Safety and effectiveness have not been established in pediatric patients
- Older adults: Safety and effectiveness have not been established in geriatric patients
- Severe kidney impairment: Use with caution; no dose adjustment is needed for mild to moderate kidney impairment
- Other medications: Tell your doctor about all drugs you take — especially anything that must be absorbed quickly or reach precise blood levels
🚑If you take too much▾
No overdose cases with Vyleesi have been reported. Taking too much is more likely to cause nausea, more pronounced blood pressure increases, and skin darkening. If an overdose is suspected, treatment focuses on managing symptoms with supportive care as needed.
📡Pharmacodynamics — effects in the body▾
After each dose of Vyleesi, blood pressure rises temporarily — peaking within 2 to 4 hours and returning to baseline within about 12 hours. Heart rate decreases slightly at the same time. These cardiovascular effects are transient and do not appear to build up with repeated daily dosing spaced 24 hours apart. Vyleesi also activates skin pigment receptors, which can lead to focal skin darkening with repeated use.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, Vyleesi is absorbed quickly — peak blood levels are reached in about 1 hour — with nearly complete (about 100%) absorption regardless of whether it's injected into the abdomen or thigh. Bremelanotide has a short half-life of approximately 2.7 hours, meaning the body clears it relatively quickly. It is broken down primarily through a process called hydrolysis (chemical breakdown in the body), and most of it leaves the body through the urine. In people with severe kidney impairment, the drug stays in the body longer, so caution is advised in that group.
📦How to store it▾
Store at or below 25°C (77°F). Do not freeze. Protect from light.
📄 Written from Bremelanotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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 exactly is HSDD and how do I know if Vyleesi is right for me? ▾
How and when do I use the injection? ▾
What side effects should I expect, and when should I call my doctor? ▾
Can I use Vyleesi with my other medications? ▾
Is it safe to use if I'm trying to get pregnant or think I might be? ▾
What if I don't notice any improvement after a few weeks? ▾
Is Bremelanotide Injection available over the counter? ▾
When was Bremelanotide Injection first available? ▾
Who makes Bremelanotide Injection? ▾
💬 Answers drafted from Bremelanotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Bremelanotide Injection 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.
Injection
How this form is used
- Vyleesi is used to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women who experience low sexual desire causing marked distress or relationship difficulty
- Vyleesi is not approved for postmenopausal women, men, or to enhance sexual performance
- Vyleesi is injected subcutaneously (under the skin) into the abdomen or thigh using a prefilled autoinjector pen
- Vyleesi should be given at least 45 minutes before anticipated sexual activity
- Do not use more than one Vyleesi dose within 24 hours; more than 8 doses per month is not recommended
- Before injecting Vyleesi, inspect the solution — discard it if it appears cloudy, discolored, or contains visible particles
📊 Bremelanotide Injection across the U.S. market
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 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 | AMAG Pharmaceuticals, Inc. | NDA | Find on DailyMed ↗ |
| 1.75 mg/0.3 mL | Subcutaneous | Cosette Pharmaceuticals, Inc. | NDA | View NDC → |
| 1.75 mg/0.3 mL | — | Novo Nordisk Production Belgium SA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1.75 mg/0.3 mL | Subcutaneous | Palatin Technologies × 3 listings | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Bremelanotide Injection NDCs →
📈 What people report — real-world data (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.
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.
🏛️ The road to your pharmacy
How Bremelanotide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 2176312 1 dose form · 1 strength
-
Dose form (SCDF) Auto-Injector RxCUI 2176315In current FDA listingsClinical drug / strength (SCD) 0.3 ML bremelanotide 5.83 MG/MLRxCUI 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.
📦 Supply & shortage status
Whether Bremelanotide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Bremelanotide Injection belongs to the Melanocortin Receptor Agonist class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cosette Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.