Vyleesi

Last updated on RxList: 6/1/2021
Vyleesi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vyleesi?

Vyleesi (bremelanotide injection) is a melanocortin receptor agonist 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.

What Are Side Effects of Vyleesi?

Common side effects of Vyleesi include:

  • nausea,
  • flushing,
  • injection site reactions
    • redness,
    • bruising,
    • itching,
    • bleeding, and
    • numbness,
  • headache, and
  • vomiting

Dosage for Vyleesi

The dose of Vyleesi is 1.75 mg injected subcutaneously via the autoinjector to the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity.

What Drugs, Substances, or Supplements Interact with Vyleesi?

Vyleesi may interact with naltrexone and other drugs taken orally at the same time. Tell your doctor all medications and supplements you use.

Vyleesi During Pregnancy or Breastfeeding

Vyleesi is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception while using Vyleesi. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vyleesi during pregnancy. It is unknown if Vyleesi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vyleesi (bremelanotide injection), for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Vyleesi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe or ongoing nausea;
  • slow heartbeats; or
  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

Your blood pressure and heart rate should return to normal within 12 hours after an injection. Tell your doctor if these side effects last longer that 12 hours.

Bremelanotide may darken the color of your gums or your skin (especially on the face or breasts). People with darker skin color may be more likely to develop this side effect. These skin changes may be permanent, even after you stop using bremelanotide. Talk with your doctor about your own risk.

Common side effects may include:

  • nausea, vomiting;
  • flushing (sudden warmth, redness, or tingly feeling);
  • cough, stuffy nose;
  • headache, tiredness, dizziness; or
  • pain, bruising, redness, itching, bleeding, numbness, or tingling where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vyleesi (Bremelanotide Injection)

SLIDESHOW

Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
Vyleesi Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail elsewhere in labeling:

  • Transient increases in blood pressure and reductions in heart rate [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]
  • Focal hyperpigmentation [see WARNINGS AND PRECAUTIONS]
  • Nausea [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The efficacy and safety of VYLEESI was studied in two identical, 24-week, randomized, double-blind, placebo-controlled trials in 1247 premenopausal women with acquired, generalized HSDD. The age range was 19-56 years old with a mean age of 39 years old; 86% were White and 12% were Black. Both trials also included a 52-week open-label, uncontrolled extension phase during which 684 patients received VYLEESI [see Clinical Studies]. Most patients used VYLEESI two to three times per month and no more than once a week.

Serious adverse reactions were reported in 1.1% of VYLEESI-treated patients and 0.5% of placebo-treated patients.

Adverse Reactions Leading To Study Discontinuation

The discontinuation rate due to adverse reactions was 18% among patients treated with VYLEESI and 2% among patients treated with placebo. The most common adverse reactions leading to study drug discontinuation in the VYLEESI group were nausea (8%), headache (2%), vomiting (1%), flushing (1%), injection site reactions (1%), flu-like symptoms (<1%) and increased blood pressure (<1%).

Common Adverse Reactions

Table 1 provides the incidence of common adverse reactions (those reported in at least 2% of patients in the VYLEESI treatment group and at an incidence that was greater than in the placebo group). The most common adverse reactions included nausea, flushing, injection site reactions and headache. The majority of events were reported to be mild (31%) to moderate (40%) in intensity and transient.

Table 1: Adverse Reactions Occurring in ≥ 2% of Patients in Randomized, Double Blind Controlled Trials with VYLEESI in Premenopausal Women with HSDD

VYLEESI
(n = 627) %

Placebo
(n= 620) %
Nausea 40.0 1.3
Flushing 20.3 0.3
Injection site reactionsa 13.2 8.4
Headache 11.3 1.9
Vomiting 4.8 0.2
Cough 3.3 1.3
Fatigue 3.2 0.5
Hot flush 2.7 0.2
Paraesthesia 2.6 0.0
Dizziness 2.2 0.5
Nasal congestion 2.1 0.5
aIncludes injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia and hypoesthesia

Nausea

In the pooled phase 3 placebo-controlled trials, nausea was the most common adverse reaction, reported in 40% of VYLEESI-treated patients compared to 1% of placebo-treated patients. The median onset of nausea was within one-hour post-dose and lasted about two hours in duration. The incidence of nausea was highest after the first VYLEESI dose (reported in 21% of patients) then declined to about 3% after subsequent doses. Thirteen percent of VYLEESI-treated patients received an anti-emetic medication. Overall, 8% of VYLEESI-treated patients and no placebo-treated patients prematurely discontinued the trials due to nausea. [see WARNINGS AND PRECAUTIONS]

Headache

In the pooled phase 3 placebo-controlled trials, headache occurred at a higher incidence in VYLEESItreated patients (11%) than placebo-treated patients (2%). One patient experienced a headache event that was serious (intractable pain leading to hospitalization) and 1% of patients who received VYLEESI discontinued the study due to headache.

Flushing

In the pooled phase 3 placebo-controlled trials, flushing occurred more frequently in VYLEESI-treated patients (20%) than placebo-treated patients (<1%). None of the flushing events were serious and few were severe (<1%), and 1% of patients who received VYLEESI discontinued the study due to flushing.

Less Common Adverse Reactions

Less common adverse reactions occurring in <2% of VYLEESI-treated patients and at an incidence greater than in the placebo group were upper abdominal pain, diarrhea, myalgia, arthralgia, pain, restless leg syndrome, rhinorrhea, increased creatine phosphokinase, blood pressure increased, pain in extremity and focal skin hyperpigmentation.

Acute Hepatitis

In the open-label, uncontrolled extension phase of one study, a single case of acute hepatitis was reported in a patient who had received 10 doses of VYLEESI over one year. She presented with serum transaminases exceeding 40 times the upper limit of normal (ULN), total bilirubin 6 times the ULN, and alkaline phosphatase less than 2 times ULN. Liver tests returned to normal 4 months after study drug discontinuation. Because another etiology was not identified, the role of VYLEESI could not definitively be excluded. There was no imbalance between treatment groups in serum transaminase outliers or other signals for hepatotoxicity in the clinical development program.

DRUG INTERACTIONS

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 [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Vyleesi (Bremelanotide Injection)

© Vyleesi Patient Information is supplied by Cerner Multum, Inc. and Vyleesi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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