PT-141 (bremelanotide) — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for PT-141 (bremelanotide) as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | 40.0 | 1.3 | +38.7 | RECONNECT pooled |
| Flushing | 20.3 | 0.3 | +20.0 | RECONNECT pooled |
| Injection-site reaction | 13.2 | 8.0 | +5.2 | RECONNECT pooled |
| Headache | 11.3 | 1.9 | +9.4 | RECONNECT pooled |
| Vomiting | 4.8 | 0.3 | +4.5 | RECONNECT pooled |
| Focal hyperpigmentation | 1.2 | 0.0 | +1.2 | RECONNECT pooled; more frequent with repeated dosing and on the face, gingiva and breasts |
| Transient blood-pressure increase | — | — | — | A mean rise of approximately 6 mmHg systolic peaking at 2–4 hours, with compensatory heart-rate reduction |
| Discontinuation for adverse events | 18.0 | 2.0 | +16.0 | RECONNECT pooled |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Uncontrolled hypertension
- Known cardiovascular disease
- Known hypersensitivity
§4.3Warnings and precautions
- Transient increases in blood pressure with compensatory heart-rate decrease occur after each dose; use is limited to a maximum of one dose in 24 hours and eight doses per month
- Focal hyperpigmentation may not resolve on discontinuation
- Nausea is common and dose-limiting for a substantial minority
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.