VYLEESI(bremelanotide injection)for subcutaneous(三)
rved.
2.2 Discontinuation of VYLEESI
Discontinue VYLEESI after 8 weeks if the patient does not report an improvement in her symptoms.
3 DOSAGE FORMS AND STRENGTHS
Subcutaneous injection: 1.75 mg/0.3 mL clear solution in a single-dose autoinjector.
4 CONTRAINDICATIONS
VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease[see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Transient Increase in Blood Pressure and Reduction in Heart Rate
VYLEESI transiently increases blood pressure and reduces heart rate after each dose. In clinical studies,VYLEESI induced maximal increases of 6 mmHg in systolic blood pressure (SBP) and 3 mmHg in diastolicblood pressure (DBP) that peaked between 2 to 4 hours post dose. There was a corresponding reduction in heart
rate up to 5 beats per minute. Blood pressure and heart rate returned to baseline usually within 12 hours postdose.
No additive effects were seen for blood pressure or heart rate following repeat daily dosing 24-hours apartfor up to 16 days [see Clinical Pharmacology (12.2)].
Before initiating VYLEESI, and periodically during treatment, consider the patient’s cardiovascular risk andensure blood pressure is well-controlled. VYLEESI is not recommended for patients at high risk forcardiovascular disease and is contraindicated in patients with uncontrolled hypertension or knowncardiovascular disease [see Contraindications (4)].
To minimize the risk of more pronounced blood pressure effects, advise patients to not take more than oneVYLEESI dose within 24 hours [see Dosage and Administration (2.1)].
5.2 Focal Hyperpigmentation
In the phase 3 placebo-controlled trials, focal hyperpigmentation, including involvement of the face, gingiva,and breasts, was reported in 1% of patients who received up to 8 doses per month of VYLEESI compared to noplacebo-treated patients. In another clinical study, 38% of patients developed focal hyperpigmentation afterreceiving VYLEESI daily for 8 days; among patients who continued VYLEESI for 8 more consecutive days, anadditional 14% developed new focal pigmentary changes. Patients with dark skin were more likely to developfocal hyperpigmentation. Resolution of the focal hyperpigmentation was not confirmed in all patients afterdiscontinuation of VYLEESI. More than 8 monthly doses of VYLEESI is not recommended. Considerdiscontinuing VYLEESI if hyperpigmentation develops.
5.3 Nausea
In the phase 3 placebo-controlled trials, nausea was the most commonly reported adverse reaction, reported in40% of VYLEESI-treated patients, requiring anti-emetic therapy in 13% of VYLEESI-treated patients andleading to premature discontinuation from the trials for 8% of VYLEESI-treated patients. Nausea improves formost patients with the second dose [see Adverse Reactions (6.1)]. Consider discontinuing VYLEESI forpersistent or severe nausea or initiating anti-emetic therapy for those patients who are bothered by nausea butwish to continue with VYLEESI treatment.
6 ADVERSE REACTIONS
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 (5.1)and Clinical Pharmacology (12.2)]
• Focal hyperpigmentation [see Warnings and Precautions (5.2)]
• Nausea [see Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
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