PT-141 200mg/0.1mL

Route: Subcutaneous (SC) injection.

• Draw the prescribed volume (as directed by your prescriber) from the vial using an insulin syringe.
• Administer subcutaneously into the abdomen (below the navel) or anterior thigh. Pinch the skin, insert the needle at a 45–90° angle, and inject slowly.
• Rotate injection sites with each dose to prevent local tissue reactions.
• Administer at least 45 minutes prior to anticipated sexual activity.
• Do not inject into muscle (intramuscular) or vein.
• Dispose of needles and syringes in an approved sharps container immediately after use.

All dosing is prescriber-determined. The FDA-approved dose of bremelanotide subcutaneous (Vyleesi) is 1.75 mg (1.75 mL of a 1 mg/mL solution) administered 45 minutes before activity. At a concentration of 200 mg/0.1 mL (= 2,000 mcg/0.1 mL), typical dose volumes will be very small (e.g., 0.0875 mL for a 1.75 mg equivalent dose). Prescribers should provide precise volume instructions to avoid dosing errors. Key guidance:

• Do not administer more than once per 24-hour period.
• Do not administer more than 8 times per month.
• Adjust dose volume only under prescriber direction.
• Do not share vials, syringes, or needles between patients.

• Bremelanotide (PT-141): Cyclic peptide agonist at melanocortin-3 (MC3R) and melanocortin-4 (MC4R) receptors in the hypothalamus and limbic system. MC4R activation increases dopaminergic neurotransmission in the medial preoptic area and ventromedial hypothalamus, enhancing the motivational and anticipatory components of sexual arousal without direct effect on genital vascular tone. The mechanism is therefore distinct from, and complementary to, PDE5 inhibitors.

Indication context: Compounded injectable PT-141 is used for HSDD (particularly in premenopausal women), FSAD, and male erectile dysfunction or libido impairment not adequately managed by PDE5 inhibitors. The high-concentration vial format allows prescribers to offer patient-specific subcutaneous dosing at fraction-of-Vyleesi-volume amounts.

Monitoring:

• Pre-treatment blood pressure assessment; monitor BP response at first use.
• Skin inspection at injection sites for local reactions at each follow-up.
• Pigmentation changes (facial, gingival) with cumulative use.
• FSFI or IIEF scores to objectively assess treatment response.
• If no response after 8 weeks of appropriate use, reassess diagnosis and treatment plan.

Contraindications:

• Uncontrolled hypertension or cardiovascular/cerebrovascular disease.
• Concurrent naltrexone use (reduces bremelanotide systemic absorption).
• Known hypersensitivity to bremelanotide or excipients.

Warnings & Precautions:

• Concentrated solution—dose calculation and volume measurement must be performed accurately; dosing errors with high-concentration solutions can result in over- or under-dosing.
• Transient BP elevation and HR decrease (~3 mmHg SBP/DBP rise, ~5% HR decrease) lasting up to 4 hours.
• Hyperpigmentation: focal, reversible pigmentation changes on the face, gums, or breasts with repeated use, especially with darker skin; reassess at each follow-up.
• Local injection site reactions: redness, swelling, itching—rotate sites.

Drug Interactions:

• Naltrexone: markedly reduces bremelanotide Cmax and AUC; do not co-administer.
• Drugs slowing gastric emptying (relevant for oral PT-141 forms, not injection).

Common Side Effects: Nausea (most common), flushing, headache, injection site reactions (erythema, pruritus, swelling), transient hyperpigmentation.

Store the vial refrigerated (2–8°C / 36–46°F). Protect from light. Do not freeze. Once the vial is punctured, note the date and use within the beyond-use period assigned by Genesis Compounding. Allow the solution to come to room temperature before injecting. Discard any remaining solution at the end of the beyond-use period. Keep out of reach of children.

Why is this solution so concentrated?

The 200 mg/0.1 mL concentration allows the prescriber to customize doses by adjusting injection volume with an insulin syringe. It reduces the total volume of each injection, which may improve comfort for frequent users and allows precise patient-specific titration.

How do I calculate my dose volume?

Your prescriber and Genesis Compounding will provide precise volume instructions based on your prescribed dose. Never estimate or guess injection volumes for high-concentration peptide solutions. Always confirm the exact volume with your prescriber before drawing from the vial.

What if I experience nausea after injecting?

Nausea is the most frequently reported side effect of bremelanotide. Injecting with a light snack beforehand may reduce nausea. Contact your prescriber if nausea is severe or persistent—dose adjustment may be appropriate.

How long before sexual activity should I inject this?

Administer at least 45 minutes before anticipated sexual activity. Do not inject more than once in a 24-hour period.

Is this the same as Vyleesi?

Vyleesi is the FDA-approved bremelanotide subcutaneous injection (1.75 mg/1.75 mL, single-use autoinjector for premenopausal women with HSDD). This compounded high-concentration preparation is a patient-specific 503A product from Genesis Compounding that is not FDA-approved as a compounded product.