VYLEESI Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Palatin Technologies
Λέξεις κλειδιά
80064-141
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1. Indications and Usage
VYLEESI 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 ...
2. Dosage and Administration
2.1 Recommended Dosage 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 ...
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 <em>[see Warnings and Precautions (5.1)]</em>.
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 ...
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 <em>[see Warnings and Precautions (5.1) and Clinical ...
6.1. 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 ...
7. Drug Interactions
7.1 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 ...
8.1. Pregnancy
Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers ...
8.2. Lactation
Risk Summary 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 ...
8.3. Females and Males of Reproductive Potential
Contraception Use of VYLEESI during pregnancy is not recommended <em>[see Use in Specific Populations (8.1)]</em>. Advise females of reproductive potential to use effective contraception while taking VYLEESI, ...
8.4. Pediatric Use
The safety and effectiveness of VYLEESI have not been established in pediatric patients.
8.5. Geriatric Use
The safety and effectiveness of VYLEESI have not been established in geriatric patients.
8.6. Renal Impairment
No dosing adjustments are recommended for patients with mild to moderate (eGFR 30-89 mL/min/1.73 m²) renal impairment. Use with caution in patients with severe (eGFR <30 mL/min/1.73 m²) renal impairment, ...
8.7. Hepatic Impairment
No dosing adjustments are recommended for patients with mild to moderate (Child-Pugh A and B; score 5-9) hepatic impairment. VYLEESI has not been evaluated in patients with severe hepatic impairment. Use ...
10. Overdosage
No reports of overdosage with VYLEESI have been reported. Nausea, focal hyperpigmentation and more pronounced blood pressure increases are more likely with higher doses. In the event of overdosage, treatment ...
11. Description
VYLEESI (bremelanotide injection) contains bremelanotide, a melanocortin receptor agonist for subcutaneous administration via an autoinjector. Bremelanotide acetate is a synthetic, cyclic heptapeptide ...
12.1. Mechanism of Action
Bremelanotide is a melanocortin receptor (MCR) agonist that nonselectively activates several receptor subtypes with the following order of potency: MC1R, MC4R, MC3R, MC5R, MC2R. At therapeutic dose levels, ...
12.2. Pharmacodynamics
Transient Increases in Blood Pressure In an open-label ambulatory blood pressure monitoring study of 127 premenopausal women receiving VYLEESI once daily, there was a mean increase of 1.9 mmHg (95% CI: ...
12.3. Pharmacokinetics
Following subcutaneous administration of VYLEESI, the mean plasma C<sub>max</sub> and AUC of bremelanotide are 72.8 ng/mL and 276 hr*ng/mL, respectively. Mean plasma concentrations of bremelanotide increase ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis There were no significant increases in tumor incidence in two-year carcinogenicity studies with intranasal administration (0.5, 2.5, and 5 mg/animal/day) of bremelanotide to male and female ...
14. Clinical Studies
The efficacy of VYLEESI for the treatment of HSDD in premenopausal women was evaluated in two identical, Phase 3, randomized, double-blind, placebo-controlled trials: NCT02333071 and NCT02338960 (Study ...
16.1. How Supplied
VYLEESI (bremelanotide) is supplied as: 1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 80064-141-01) provided in a carton of 4 autoinjectors (NDC 80064-141-04), ...
16.2. Storage and Handling
Store at or below 25°C (77°F). Do not freeze. Protect from light.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Transient Increase in Blood Pressure and Decrease in Heart Rate Advise patients that increases ...