Category B—No adequate or well-controlled studies of the drug's use have been conducted during pregnancy. Animal studies have shown no evidence of teratogenicity, but exposure to antipsychotic medications during the third trimester has been associated with extrapyramidal and withdrawal symptoms in neonates
No lactation studies of lurasidone have been performed in humans, and it is not clear whether the drug is excreted in human milk.
All atypicals may increase mortality in elderly patients by 1.7 times greater than placebo.
Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day
Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment