Bremelanotide for Low Sex Drive in Women: Drug Warnings

Generic drug: bremelanotide

Brand name: Vyleesi

What is Vyleesi (bremelanotide), and how does it work?

Vyleesi (bremelanotide) injection 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.

What are the side effects of Vyleesi?

Vyleesi may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• temporary increase in blood pressure,
• decrease in heart rate, and
• severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vyleesi include:

• nausea,
• vomiting,
• flushing,
• redness, irritation, or pain at the injection site,
• darkening of the skin (face, gums, and breast),
• headache, and
• dizziness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vyleesi. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is pelvic inflammatory disease (PID)?
See Answer

What is the dosage for Vyleesi?

• 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.
• 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.
• 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.
• 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.

Discontinuation Of Vyleesi

• Discontinue Vyleesi after 8 weeks if the patient does not
  report an improvement in her symptoms.

What drugs interact with Vyleesi?

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).

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.

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Is Vyleesi safe to use while pregnant or breastfeeding?

• 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.
• 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 be considered along with the mother’s clinical need for
  Vyleesi and any potential adverse effects on the breastfed child from
  Vyleesi or from the underlying maternal condition.