PHEXXI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PHEXXI (PHEXXI).
PHEXXI is a vaginal gel containing lactic acid, citric acid, and potassium bitartrate that maintains acidic vaginal pH, which inactivates sperm and reduces sperm motility and viability.
| Metabolism | Not systemically absorbed; no metabolism. |
| Excretion | Primarily renal excretion as unchanged drug (70-80%) and metabolites; remainder biliary/fecal. Renal clearance approximates glomerular filtration rate. |
| Half-life | Terminal elimination half-life is approximately 30-60 minutes; clinically, rapid clearance reduces systemic toxicity, requiring repeated administration for sustained effect. |
| Protein binding | Approximately 30-40% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.2-0.3 L/kg, indicating limited extravascular distribution, consistent with a hydrophilic quaternary ammonium compound. |
| Bioavailability | Intramuscular: ~80%; subcutaneous: ~75%; oral: negligible (<5%) due to poor absorption and first-pass metabolism. |
| Onset of Action | Intravenous: within 5 minutes; intramuscular: within 15-30 minutes; subcutaneous: within 15-30 minutes. |
| Duration of Action | Duration of neuromuscular blockade: 20-35 minutes (IV) with recovery to 25% control twitch height. Prolonged in renal impairment. |
Intravaginal gel: 1 applicatorful (5 g of gel containing 1.3% lactic acid, 0.01% citric acid, and 0.3% potassium bitartrate) inserted once daily at bedtime for 7 days, or as directed by physician.
| Dosage form | GEL |
| Renal impairment | No dose adjustment required for renal impairment. Not systemically absorbed. |
| Liver impairment | No dose adjustment required for hepatic impairment. Not systemically absorbed. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment; use same as adult dosing. Limited data in geriatric population. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PHEXXI (PHEXXI).
| Breastfeeding | No systemic absorption; negligible excretion into breast milk. Considered safe during breastfeeding. M/P ratio not applicable. |
| Teratogenic Risk | PHEXXI (lactic acid, citric acid, and potassium bitartrate vaginal gel) is not systemically absorbed; therefore, no fetal exposure occurs. No teratogenic risks are expected. No adverse fetal effects reported in any trimester. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to any ingredient of PHEXXI.","Women with anatomical abnormalities that prevent vaginal gel retention."]
| Precautions | ["Not effective against sexually transmitted infections (STIs) or HIV.","May not be as effective as hormonal contraceptives or IUDs.","Use with caution in women with recurrent urinary tract infections (UTIs)."] |
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| No specific monitoring required beyond routine prenatal care due to lack of systemic absorption. |
| Fertility Effects | No known effects on fertility. Not associated with impairment of reproductive function. |