Names and pronunciation
(bre′me-lan′oh-tide) Vyleesi
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Drug reference
(bre′me-lan′oh-tide) Vyleesi
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Func. class.: Sexual dysfunction agent
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Chem. class.: Melanocortin receptor agonists
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ACTION: Nonselectively activates sev- eral receptor subtypes. The mechanism is unknown. It may activate selected brain pathways involved in normal sexual responses
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USES: Premenopausal women with acquired, generalized hypoactive sexual desire disorder
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CONTRAINDICATIONS: Hyper- sensitivity, men, postmenopausal women, cardiac disease Precautions: Pregnancy, breastfeeding, contraception requirement, geriatric, hepatic disease, hypertension, renal dys- function, skin hyperpigmentation
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SIDE EFFECTS CNS: Flushing, headache INTEG: Injection site reactions GI: Nausea, hepatitis GU: Hot flashes CV: Hypertension
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INTERACTIONS Decreased: effect of naltrexone; do not use together
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DOSAGE AND ROUTES • Adult premenopausal women: SUB- CUT 1.75 mg as needed, at least 45 min prior to anticipated sexual activity; max: 1 dose/24 hr
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Available forms: Autoinjector solution for injection 1.75 mg/0.3 mL
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Administer: SUBCUT route • Visually inspect parenteral products for particulate matter and discoloration before use. Do not use injections that are unusu- ally cloudy, discolored, or contain particu- late; injection is clear and colorless • Inject SUBCUT into the abdomen or thigh. Do not administer within 2 inches around the umbilicus or where the skin is tender, bruised, red, hard, thick, or scaly • The dose is administered at least 45 min before anticipated sexual activity • Not to be used more than 1 dose/24 hr. No more than 8 doses/mo • Discard the used autoinjector in a sharps container after use
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Assess: • Sexual arousal: identify characteristics of lack of sexual arousal, length of time, other treatments administered in the past • Hypertension/cardiac disease: moni- tor B/P before starting treatment and periodically ensure B/P is well controlled • Nausea/vomiting: is a common side effect, may require an antiemetic; prod- uct may need to be discontinued for persistent or severe nausea or antiemetic therapy initiated for those patients who are bothered by nausea • Skin hyperpigmentation: may be more common in those with darker skin and with daily dosing, more common on face, gingiva, and breast; may be permanent • Severe hepatic/renal disease (Child- Pugh C; score 10-15) or severe renal impairment (eGFR <30 mL/min/1.73 m2): may have an increase in severity of adverse reactions • Pregnancy/breastfeeding: contraception requirements are advised; females of childbearing potential should be coun- seled regarding appropriate methods of contraception while on therapy; discon- tinue if pregnancy is suspected; pregnant women are encouraged to call the Bremelanotide Pregnancy Exposure Reg- istry at (877) 411-2510; avoid breastfeeding—no data are available regarding safety
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Evaluate: • Therapeutic response • Sexual arousal
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Sexual arousal: report if product has resolved lack of sexual arousal • Hypertension/cardiac disease: teach patient that B/P will be evaluated periodically • Nausea/vomiting: teach patient to report nausea and vomiting, may require an antiemetic • Skin hyperpigmentation: teach patient to report skin hyperpigmentation; prod- uct may need to be discontinued Train the patient on the use of the autoin- jector, to read the manufacturer-provided instructions for use • Pregnancy/breastfeeding: counsel patients on need for contraception; females of childbearing potential should be counseled regarding appropriate methods of contraception while on ther- apy; advise patient to discontinue if preg- nancy is suspected; pregnant women are encouraged to call the Bremelanotide Pregnancy Exposure Registry at (877) 411-2510; avoid breastfeeding HIGH ALERT
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PHARMACOKINETICS 21% binds to human serum protein, half-life 1.9-4 hr; metabolism involves multiple hydrolyses of the amide bond of the cyclic peptide; excreted 64.8% urine, 22.8% feces
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• Adult premenopausal women: SUB- CUT 1.75 mg as needed, at least 45 min prior to anticipated sexual activity; max: 1 dose/24 hr
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