Lumateperone
لوماتپرون
🧠 Nervous SystemAtypical antipsychotic
Market / country: 🇺🇸 USA
Caplyta (US)
🧮 Dose calculator
Schizophrenia · Regimen source: FDA Caplyta · 2.1
- • Moderate/severe hepatic impairment or moderate CYP3A4 inhibitors: 21 mg; strong CYP3A4 inhibitors: 10.5 mg. FDA Caplyta · 2.3FDA Caplyta · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ History of hypersensitivity to lumateperone. FDA Caplyta · 4
Warnings
- • Boxed warning: increased mortality in elderly patients with dementia-related psychosis; suicidal thoughts in children and young adults (antidepressant). FDA Caplyta · Boxed Warning
- • NMS; tardive dyskinesia; metabolic changes; leukopenia; orthostatic hypotension; seizures. FDA Caplyta · 5
Formulations
- 42 mg capsule — capsule 🇺🇸 USA FDA Caplyta · 3
- 21 mg capsule — capsule 🇺🇸 USA FDA Caplyta · 3
- 10.5 mg capsule — capsule 🇺🇸 USA FDA Caplyta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Caplyta · 8.1
“Risk Summary Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ).”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Caplyta · 8.2
“Risk Summary Lumateperone and its metabolites are present in human breast milk in low amounts.”
- 👶 ChildrenDangerous / avoid
Boxed warning in the label about children. FDA Caplyta · Boxed Warning
“Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies.”
- 👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Caplyta · Boxed Warning
“Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Caplyta · 8.3
“Infertility Based on findings from animal studies, lumateperone may impair male and female fertility [see Nonclinical Toxicology (13.1) ].”
🔗 Reference links
- FDA (approval record)NDA209500
- DailyMed (FDA label)FDA Caplyta
- MedlinePlus (NIH)Lumateperone
- WHO ATC/DDDN05AD10
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Caplyta · 3FDA Caplyta · 2.1FDA Caplyta · 2.3FDA Caplyta · 2.2FDA Caplyta · 4FDA Caplyta · Boxed WarningFDA Caplyta · 5FDA Caplyta · SPL approval / marketing categoryFDA Caplyta · 8.1FDA Caplyta · 8.2FDA Caplyta · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified