Lumateperone

لوماتپرون

⚠ Unverified

🧠 Nervous SystemAtypical antipsychotic

Market / country: 🇺🇸 USA

Caplyta (US)

🧮 Dose calculator

Schizophrenia · Regimen source: FDA Caplyta · 2.1

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🛡️ Safety & information

Contraindications

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

👥 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) ].”

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