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Vyleesi Storage, Stability & Shelf Life: Complete Clinical Guide

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At a glance

  • Storage temperature / label says store at or below 25°C (77°F) [1]
  • Freezing / label says do not freeze [1]
  • Light / label says protect from light [1]
  • Form / 1.75 mg in 0.3 mL, single-dose disposable prefilled autoinjector [1]
  • Packaging / cartons of 4 autoinjectors or 2 autoinjectors [1]
  • Expiration / printed on the autoinjector label as EXP [1]
  • Dosing limits / no more than one dose in 24 hours; more than 8 doses a month not recommended [1]

What the Vyleesi label says about storage

The storage and handling section of the label states: store at or below 25°C (77°F), do not freeze, and protect from light [1]. The product is described as a single-dose, disposable prefilled autoinjector that delivers 1.75 mg of bremelanotide in 0.3 mL. It comes in two carton sizes, one holding 4 autoinjectors and one holding 2 [1].

For the expiration date, the Instructions for Use tells the user to check the label on the autoinjector for the date marked EXP [1].

The product the storage statements describe

Vyleesi is bremelanotide 1.75 mg in a prefilled autoinjector, injected subcutaneously into the abdomen or thigh, and it is prescription only [1]. It is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug [1]. The label states it is not indicated for HSDD in postmenopausal women or in men, and not indicated to enhance sexual performance [1].

The label describes use as needed, at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours; it says more than 8 doses per month is not recommended [1]. The duration of effect after a dose is unknown [1]. Vyleesi has no boxed warning, and no REMS appears in the label or in the 2019 approval letter [1][2].

Compounded or research-use PT-141 is not Vyleesi

The storage statements above come from the Vyleesi label and describe the Vyleesi autoinjector. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][3]. Bremelanotide does not appear on FDA's list of bulk drug substances that may present significant safety risks when compounded (content dated 04/22/2026), and it is not one of the six peptides named in HHS's October 2026 draft enforcement-discretion policy [4][5].

Frequently asked questions

How should Vyleesi be stored?
The label says to store it at or below 25°C (77°F), not to freeze it, and to protect it from light [1].
Can Vyleesi be frozen?
The label says do not freeze [1].
Where is the expiration date on a Vyleesi autoinjector?
The Instructions for Use says to check the label on the autoinjector for the expiration date, marked EXP [1].
How does Vyleesi come packaged?
As single-dose, disposable prefilled autoinjectors, each delivering 1.75 mg of bremelanotide in 0.3 mL, in cartons of 4 or 2 autoinjectors [1].
How often does the label allow Vyleesi to be used?
The label recommends no more than one dose in 24 hours, and it does not recommend more than 8 doses per month [1].
Is compounded or research-use PT-141 the same as Vyleesi?
No. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][3].
Does Vyleesi have a boxed warning or a REMS?
No. Vyleesi has no boxed warning, and no REMS appears in the label or in the 2019 approval letter [1][2].

References

  1. U.S. National Library of Medicine, DailyMed. Vyleesi (bremelanotide) injection, 1.75 mg subcutaneous autoinjector prescribing information. Vyleesi (bremelanotide) injection, 1.75 mg subcutaneous autoinjector label
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. Official web page. Official web page
  4. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  5. Official web page. Official web page
Evidence overview for bremelanotide: Vyleesi Storage, Stability & Shelf Life: Complete Clinical Guide