Lurasidone
- Lurasidone
- 367514-87-2
- lurasidona
- (3aR,4S,7R,7aS)-2-((1R,2R)-2-(4-(1,2-Benzothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2H-isoindole-1,3-dione
- Lurasidone [INN]
- Create:2005-08-09
- Modify:2025-01-18
- 13496, SM
- HCl, Lurasidone
- Hydrochloride, Lurasidone
- latuda
- lurasidone
- Lurasidone HCl
- Lurasidone Hydrochloride
- N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide
- SM 13,496
- SM 13496
- SM-13,496
- SM-13496
- SM13,496
- SM13496
- Lurasidone
- 367514-87-2
- lurasidona
- (3aR,4S,7R,7aS)-2-((1R,2R)-2-(4-(1,2-Benzothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2H-isoindole-1,3-dione
- Lurasidone [INN]
- lurasidonum
- UNII-22IC88528T
- CHEBI:70735
- HSDB 8228
- 22IC88528T
- SM13496
- (1S,2R,6S,7R)-4-[[(1R,2R)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione
- (3aR,4S,7R,7aS)-2-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
- (3aR,4S,7R,7aS)-2-(((1R,2R)-2-((4-(1,2-benzothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1H-4,7-methanoisoindole-1,3(2H)-dione
- (3aR,4S,7R,7aS)-2-((1R,2R)-2-(4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2H-isoindole-1,3-dione
- (3aR,4S,7R,7aS)-2-{(1R,2R)-2-(4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione
- (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione
- PS34 - Lurasidone
- Lurasidone (Standard)
- LURASIDONE [MI]
- LURASIDONE [VANDF]
- LURASIDONE [WHO-DD]
- N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide
- SCHEMBL677525
- GTPL7461
- HY-B0032AR
- CHEMBL1237021
- BDBM85222
- SM-13496 FREE BASE
- DTXSID40870340
- EX-A504
- N05AE05
- PQXKDMSYBGKCJA-CVTJIBDQSA-N
- HMS3886A20
- PDSP2_001043
- s5714
- AKOS037643746
- CCG-269635
- DB08815
- EX-3124
- NCGC00386382-03
- AS-35077
- 1ST157185
- CAS_441351-20-8
- L0280
- NS00069589
- AB01566875_01
- EN300-20605510
- Q416992
- J-521660
- BRD-K51143828-003-03-1
- (1R,2S,6R,7S)-4-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0,2,6]decane-3,5-dione
- (1R,2S,6R,7S)-4-{[(1R,2R)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0?,?]decane-3,5-dione
- 4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-, (3aR,4S,7R,7aS)-
H302+H332 (33.3%): Harmful if swallowed or if inhaled [Warning Acute toxicity, oral; acute toxicity, inhalation]
H302 (33.3%): Harmful if swallowed [Warning Acute toxicity, oral]
H317 (66.7%): May cause an allergic skin reaction [Warning Sensitization, Skin]
H332 (33.3%): Harmful if inhaled [Warning Acute toxicity, inhalation]
H336 (33.3%): May cause drowsiness or dizziness [Warning Specific target organ toxicity, single exposure; Narcotic effects]
H351 (66.7%): Suspected of causing cancer [Warning Carcinogenicity]
H361 (33.3%): Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]
H413 (33.3%): May cause long lasting harmful effects to aquatic life [Hazardous to the aquatic environment, long-term hazard]
P203, P261, P264, P270, P271, P272, P273, P280, P301+P317, P302+P352, P304+P340, P317, P318, P319, P321, P330, P333+P317, P362+P364, P403+P233, P405, and P501
(The corresponding statement to each P-code can be found at the GHS Classification page.)
Aggregated GHS information provided per 3 reports by companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.
Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.
Acute Tox. 4 (33.3%)
Skin Sens. 1 (66.7%)
Acute Tox. 4 (33.3%)
STOT SE 3 (33.3%)
Carc. 2 (66.7%)
Repr. 2 (33.3%)
Aquatic Chronic 4 (33.3%)
Liver test abnormalities occur in 1% to 3% of patients on long term therapy with lurasidone, but similar rates have been reported with placebo therapy and with comparator agents. The ALT elevations are usually mild, transient and often resolve even without dose modification or drug discontinuation. There have been no published reports of clinically apparent liver injury with symptoms or jaundice attributed to lurasidone therapy.
Likelihood score: E (unlikely cause of clinically apparent liver injury).
◉ Summary of Use during Lactation
Lurasidone is more than 99% bound to plasma proteins, so it is unlikely that the drug would be excreted into milk in sufficient amounts to affect a breastfed infant. Data from one mother-infant pair appears to support the poor excretion into milk and lack of effect on the breastfed infant. Until more data are available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
◉ Effects in Breastfed Infants
A woman with depressive type schizoaffective disorder was taking lurasidone 40 mg at night and desvenlafaxine 50 mg daily after giving birth. She exclusively breastfed her infant. The infant’s growth and development was good during a follow-up period of 39 days.
Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who were not treated with a second-generation antipsychotic (n = 818). Of the patients who were taking a second-generation antipsychotic drug, 60.4% were on more than one psychotropic. A review of the pediatric medical records, no adverse effects were noted among infants exposed or not exposed to second-generation antipsychotic monotherapy or to polytherapy. The number of women taking lurasidone was not reported.
◉ Effects on Lactation and Breastmilk
Increases in serum prolactin with lurasidone are generally infrequent, small and less than risperidone. A woman with elevated serum prolactin, breast tenderness and galactorrhea while taking risperidone improved when lurasidone was substituted for risperidone and these side effects subsided completely when the lurasidone dose was increased from 20 mg to 40 mg daily. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who had primarily diagnoses of major depressive disorder and anxiety disorders, most often treated with SSRI or SNRI antidepressants, but not with a second-generation antipsychotic (n = 818). Among women on a second-generation antipsychotic, 60.4% were on more than one psychotropic compared with 24.4% among women in the control group. Of the women on a second-generation antipsychotic, 59.3% reported “ever breastfeeding” compared to 88.2% of women in the control group. At 3 months postpartum, 23% of women on a second-generation antipsychotic were exclusively breastfeeding compared to 47% of women in the control group. The number of women taking lurasidone was not reported.
A 14-year-old girl with hallucinatory schizophrenia was treated inadequately with aripiprazole, then paliperidone. As she was transitioned from paliperidone to lurasidone at age 16 years, her serum prolactin increased to 4240 mIU/L (normal range 60-400 mIU/L). As the lurasidone dose was titrated to a maximum of 111 mg daily, prolactin levels continued to increase and the patient experienced breast fullness and galactorrhea. Six of 7 serum prolactin measurements were in the range of 4240 to 6140 mIU/L. Once lurasidone was discontinued, her serum prolactin normalized.
In an Italian study of treatment of schizophrenic patients with lurasidone, 2.4% of patients developed hyperprolactinemia and galactorrhea.
◈ What is lurasidone?
Lurasidone is an antipsychotic medication that has been used to treat schizophrenia and bipolar depression. It is sold under the brand name Latuda®.Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
◈ I take lurasidone. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if lurasidone can make it harder to get pregnant.
◈ Does taking lurasidone increase the chance for miscarriage?
Miscarriage can occur in any pregnancy. Studies have not been done to see if lurasidone can increase the chance for miscarriage.
◈ Does taking lurasidone increase the chance of birth defects?*
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Information on the use of lurasidone in pregnancy is limited. Animal studies in rats and rabbits have not shown an increased chance of birth defects. In a case report of a person taking lurasidone throughout pregnancy, the baby was born healthy and without birth defects. A study looking at 134 people who used lurasidone in pregnancy found no specific patterns of birth defects.
◈ Does taking lurasidone in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if lurasidone use in pregnancy increases the chance for pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).
◈ I need to take lurasidone throughout my entire pregnancy. Will it cause symptoms in my baby after birth?
Product labels written by the U.S. Food and Drug Administration (FDA) note a chance for symptoms in newborns exposed to antipsychotic drugs in the third trimester of pregnancy. Symptoms may include uncontrolled muscle movements, changes in muscle tone, being too sleepy, trouble with breathing, and/or trouble with feeding. Not all babies who are exposed to antipsychotic drugs during pregnancy will have these symptoms. These symptoms can be temporary and can go away on their own. Treatment of symptoms can be started, if needed.These symptoms have not been reported with exposure to lurasidone during pregnancy. The available information on the use of lurasidone in pregnancy is so limited that it is hard to know if these symptoms might happen. Let your healthcare providers know before delivery if you are taking lurasidone. If needed, babies can be monitored for symptoms.
◈ Does taking lurasidone in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if lurasidone use in pregnancy can cause behavior or learning issues for the child.
◈ Breastfeeding while taking lurasidone:
Information on the use of lurasidone while breastfeeding is limited. There is a report of one person who was taking lurasidone while breastfeeding. No negative effects were reported in the nursing child. The benefit of using lurasidone may outweigh possible risks. Your healthcare providers can talk with you about using lurasidone and what treatment is best for you. Be sure to talk to your healthcare provider about all your breastfeeding questions.
◈ If a male takes lurasidone, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done in humans to see if lurasidone could affect fertility or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
- Avoid alcohol. The effects of alcohol could be made worse while taking Lurasidone.
- Avoid grapefruit products. Grapefruit and grapefruit juice may affect the amount of Lurasidone in your blood.
- Take with food. The manufacturer recommends co-administration with at least 350 calories.
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