PALSONIFY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PALSONIFY (PALSONIFY).
Selective serotonin reuptake inhibitor (SSRI) that enhances serotonergic neurotransmission by blocking the reuptake of serotonin at the presynaptic neuron, thereby increasing extracellular serotonin levels in the brain.
| Metabolism | Primarily hepatic via CYP2D6 and CYP2C19 isoenzymes; major metabolite is norfluoxetine, which is equally potent and has a longer half-life. |
| Excretion | Renal: 65% unchanged; biliary/fecal: 30% as metabolites; 5% other |
| Half-life | Terminal half-life 12 hours (range 10–14 h) in healthy adults; prolonged to 24–30 h in severe renal impairment (CrCl <30 mL/min) |
| Protein binding | 92% bound to albumin and α1-acid glycoprotein |
| Volume of Distribution | 0.8 L/kg (total body water), indicating extensive tissue distribution |
| Bioavailability | Oral: 75% (range 60–85%) due to first-pass metabolism; IV: 100% |
| Onset of Action | Oral: 30–45 min; IV: 2–5 min |
| Duration of Action | 6–8 hours for oral; 4–6 hours for IV; extended in hepatic impairment due to reduced clearance |
70 mg/m2 IV every 3 weeks. Infusion over 60 minutes.
| Dosage form | TABLET |
| Renal impairment | GFR 30-89 mL/min: No adjustment. GFR 15-29 mL/min: Reduce dose to 50 mg/m2. GFR <15 mL/min or dialysis: Not recommended. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce to 50 mg/m2. Child-Pugh C: Not recommended. |
| Pediatric use | 1-18 years: 70 mg/m2 IV every 3 weeks. Maximum dose 140 mg. |
| Geriatric use | No specific adjustment. Monitor renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PALSONIFY (PALSONIFY).
| Breastfeeding | PALSONIFY is excreted into human breast milk with a milk-to-plasma (M/P) ratio of 0.8. The estimated infant daily dose is 0.5% of the maternal weight-adjusted dose. Due to potential adverse effects on infant growth and development, breastfeeding is contraindicated during therapy and for at least 5 half-lives (approximately 2 weeks) after the last dose. |
| Teratogenic Risk | PALSONIFY is classified as Pregnancy Category X based on human and animal studies demonstrating teratogenicity. First trimester exposure is associated with craniofacial defects, neural tube malformations, and cardiac anomalies. Second and third trimester exposure risks include fetal growth restriction, oligohydramnios, and premature closure of the ductus arteriosus. Use is contraindicated throughout pregnancy. |
■ FDA Black Box Warning
Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. Monitor closely for clinical worsening, suicidality, or unusual changes in behavior.
| Serious Effects |
Concurrent use with MAOIs or within 14 days of MAOI discontinuation; history of hypersensitivity to the drug; concurrent use with pimozide or thioridazine.
| Precautions | Serotonin syndrome, risk of bleeding (especially with NSAIDs/aspirin), activation of mania/hypomania, QT prolongation, hyponatremia, and discontinuation syndrome upon abrupt withdrawal. |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, and liver enzymes monthly. Fetal ultrasound every 4 weeks for growth assessment and amniotic fluid volume. Perform fetal echocardiography if exposure occurs in first trimester. Obtain baseline and periodic complete blood counts due to risk of neutropenia. |
| Fertility Effects | PALSONIFY reduces fertility in both males and females. In females, it may disrupt menstrual cycles and inhibit ovulation. In males, it impairs spermatogenesis with reduction in sperm count and motility. Fertility effects may be reversible after discontinuation, but recovery time is variable. |