T-02
PT-141 side-effect odds explorer
Renders the label's adverse-reaction table as an interactive comparison (Vyleesi vs placebo), with the nausea time course (first dose vs later doses), the anti-emetic numbers, and the discontinuation rates. Unique per-compound data component: every value is a label number with a claim id.
Every number here is from the label's own tables, pooled from 1,247 women in the placebo-controlled trials. The two columns matter together: 40% nausea sounds different next to placebo's 1.3%, and injection-site reactions (13.2%) sound different next to placebo injections' 8.4%.
Published records (11 of 11)
| Effect | Vyleesi % | Placebo % |
|---|---|---|
| Nausea | 40 | 1.3 |
| Flushing | 20.3 | 0.3 |
| Injection site reactions | 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 |
| Dizziness | 2.2 | 0.5 |
| Nasal congestion | 2.1 | 0.5 |
Every row restates a published record; sources resolve on the sourced monograph. Species is part of the data: this table never scales an animal dose into a human figure.
Frequently asked questions
Why is there no reconstitution calculator for PT-141?
Because the approved product needs none and the unapproved ones deserve none: Vyleesi is a sealed fixed-dose autoinjector, and vials sold as PT-141 are unverified products FDA has not approved. A mixing table would add false precision to an unverifiable input. That is an editorial decision and it is permanent.
Can the label-limits checker tell me a dose is safe?
No. It checks three arithmetic rules from the label (lead time, spacing, monthly cap). Safety lives in the parts it cannot see: your blood pressure, your heart, your other medications, your prescriber's judgment. Passing three comparisons is not clearance.
Where do the side-effect percentages come from?
From the label's own pooled trial tables (1,247 women, placebo-controlled): nausea 40.0% vs 1.3%, flushing 20.3% vs 0.3%, and so on. We render both columns because a rate without its placebo comparator is marketing, not information.
Why does the study-dose table include a retracted study?
Because the gray market still cites it. The row exists to carry the flag: the Journal of Sexual Medicine retracted that trial, so anyone quoting its results is quoting withdrawn science. We report the retraction, not the findings.
What does the 7.5 mg plateau mean for high-dose vials?
Above roughly 7.5 mg subcutaneous, peak blood levels stop rising with dose (the label calls it less than dose-proportional, plateauing at about 4.3 times the approved dose). Doubling a vial dose past that point does not double exposure; it mostly lengthens the nausea, flushing and blood-pressure window.
Is the 8-dose monthly cap arbitrary?
No; the label gives its reasons: few phase 3 patients exceeded 8 doses a month, and more frequent dosing raises focal-hyperpigmentation risk and the fraction of each month spent with elevated blood pressure. Daily dosing for just 8 days produced skin darkening in 38% of women.
Do these tools work for men using PT-141?
The rules they encode are from a label that does not apply to men: Vyleesi is not indicated for men at any dose, no male regimen was ever approved, and the male evidence is small, old and partly integrity-flagged. The tools will do arithmetic for anyone; the label behind them covers only premenopausal women with HSDD.
Why do results show the stop-at-8-weeks rule?
Because the label builds its own exit: discontinue after 8 weeks without symptom improvement. A limits checker that never mentioned the stop rule would imply indefinite use the label does not support.
Tools: educational calculators and references only.