JALYN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JALYN (JALYN).
Jalyn is a combination of dutasteride, a 5α-reductase inhibitor that inhibits the conversion of testosterone to dihydrotestosterone (DHT), and tamsulosin, an α1-adrenoceptor antagonist that relaxes smooth muscle in the prostate and bladder neck.
| Metabolism | Dutasteride is extensively metabolized by CYP3A4 and CYP3A5. Tamsulosin is extensively metabolized by CYP3A4 and CYP2D6. |
| Excretion | Dutasteride: 40% renal, 60% fecal as metabolites; Tamsulosin: 76% renal (9% unchanged), 24% fecal as metabolites. |
| Half-life | Dutasteride: 5 weeks (t½ ∼3-5 weeks) due to high tissue binding and slow elimination; Tamsulosin: 9-13 hours (t½ ∼9-13 h) in healthy subjects, prolonged in elderly (∼14-15 h). |
| Protein binding | Dutasteride: 99.0-99.5% bound to albumin and alpha-1-acid glycoprotein; Tamsulosin: 94-99% bound to alpha-1-acid glycoprotein. |
| Volume of Distribution | Dutasteride: 300-500 L (∼3-4 L/kg); Tamsulosin: 16 L (∼0.2 L/kg). Dutasteride’s large Vd indicates extensive tissue distribution. |
| Bioavailability | Oral: Dutasteride ∼60% (capsule); Tamsulosin ∼90% (capsule, under fed conditions slightly reduced). |
| Onset of Action | Oral: Symptom improvement begins within 1-2 weeks for tamsulosin (symptomatic relief) but BPH volume reduction with dutasteride requires 3-6 months. |
| Duration of Action | Symptomatic relief from tamsulosin lasts 24 hours with once-daily dosing; dutasteride effect persists for weeks after discontinuation due to long t½. |
1 capsule (0.5 mg dutasteride/0.4 mg tamsulosin) orally once daily, 30 minutes after the same meal each day.
| Dosage form | CAPSULE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (GFR ≥30 mL/min). Not recommended for severe renal impairment (GFR <30 mL/min) due to lack of data. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C). No dose adjustment for mild to moderate impairment (Child-Pugh A or B), but use with caution. |
| Pediatric use | Not indicated for use in pediatric patients. Safety and efficacy not established. |
| Geriatric use | No specific dose adjustment recommended based on age alone. Monitor for orthostatic hypotension, dizziness, and falls risk, especially in elderly patients. Consider underlying renal and hepatic function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JALYN (JALYN).
| Breastfeeding | JALYN is not indicated for use in women. Dutasteride and tamsulosin are excreted in rat milk but no human data. M/P ratio unknown; avoid breastfeeding due to potential adverse effects in infants. |
| Teratogenic Risk | JALYN (dutasteride/tamsulosin) is contraindicated in pregnancy. Dutasteride is a 5-alpha-reductase inhibitor that can inhibit dihydrotestosterone formation, potentially causing abnormal development of external genitalia in male fetuses. Tamsulosin is an alpha-1 blocker with limited data but potential risks. First trimester: avoid; second and third trimesters: avoid due to theoretical risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to dutasteride, tamsulosin, or any component of the formulation","Use in women of childbearing potential","Use in pediatric patients"]
| Precautions | ["Use with caution in combination with other alpha-blockers due to risk of hypotension","Postural hypotension may occur, especially at initiation of therapy","Not recommended for use in women, children, or adolescents due to teratogenic risk","Evaluate for prostate cancer before initiating therapy","Dutasteride may increase risk of high-grade prostate cancer in some studies","Hepatic impairment may alter metabolism of dutasteride"] |
Loading safety data…
| Fetal Monitoring | Not applicable for JALYN use in women of childbearing potential. If inadvertent exposure during pregnancy occurs, monitor fetal growth and development, and assess for urogenital abnormalities in male fetuses. |
| Fertility Effects | Dutasteride may impair male fertility by reducing sperm count and motility. Tamsulosin may cause ejaculatory dysfunction including retrograde ejaculation. Effects on female fertility are unknown because JALYN is not used in women. |