Drugs List

Therapeutic Indications

Uses

Schizophrenia

Contraindications

Children under 13 years

Precautions and Warnings

Family history of long QT syndrome
Patients over 65 years
Predisposition to diabetes mellitus
Predisposition to orthostatic hypotension
Predisposition to venous thromboembolism
Suicidal ideation
Breastfeeding
Cardiovascular disorder
Dementia
Diabetes mellitus
Electrolyte imbalance
Hepatic impairment - Child-Pugh score greater than 7
History of seizures
Parkinson's disease
Pregnancy
Reduced seizure threshold
Renal impairment - creatinine clearance below 50ml/minute

Consider preventative measures in patients at risk of thromboembolism
Patients at risk of suicide should be closely supervised
Reduce dose in patients with moderate hepatic impairment
Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patient initially- response may take 2 or more weeks
Monitor patient's weight
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with existing or tendency towards diabetes mellitus
Monitor serum electrolytes
Monitor serum prolactin during long-term use
When used with SSRIs, risk of Serotonin syndrome
Advise patient to report signs of elevated prolactin levels
Consider discontinuation if signs of tardive dyskinesia occur
Consider dose reduction or discontinuation if serotonin syndrome suspected
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level

Caution should be exercised when treating patients aged 65 and above with higher doses of lurasidone as experience is limited.

Use of antipsychotics in patients with dementia is associated with an increased risk of cerebrovascular adverse reactions. Use caution in patients with dementia who have risk factors for stroke.

Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks. If used in ESRD, clinical monitoring is advised.

Pregnancy and Lactation

Pregnancy

Use lurasidone with caution in pregnancy.

There is limited data regarding the use of lurasidone in pregnancy. The potential risk for humans is unknown.

Animal studies are insufficient with respect to effects on pregnancy, embryo foetal development, parturition and postnatal development.

The manufacturer recommends only using lurasidone when clearly necessary.

Neonates exposed to antipsychotics (including lurasidone) during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use lurasidone with caution in breastfeeding.

Lurasidone was excreted in milk of rats during lactation. It is not known whether lurasidone or its metabolites are excreted in human milk. Breastfeeding in women receiving lurasidone should be considered only if the potential benefit of treatment justifies the potential risk to the child.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggression
Agitation
Akathisia
Alanine aminotransferase increased
Amenorrhoea
Anaemia
Angina
Angioedema
Anxiety
Apathy
Back pain
Blurred vision
Bradycardia
Breast enlargement
Breast pain
Catatonia
Changes in libido
Confusion
Convulsions
Creatine phosphokinase increased
Decreased appetite
Depressed mood
Depression
Diarrhoea
Dissociation
Dizziness
Dry mouth
Dysarthria
Dysgeusia
Dyskinesia
Dysmenorrhoea
Dyspepsia
Dysphagia
Dystonia
Dysuria
Elevated blood glucose (transient)
Eosinophilia
Erectile dysfunction
Fatigue
First degree AV block
Flatulence
Gait abnormality
Galactorrhoea
Gastritis
Hallucinations
Hot flushes
Hyperacusis
Hyperhidrosis
Hyperinsulinemia
Hyperkinesia
Hypersalivation
Hypersensitivity reactions
Hypertension
Hyponatraemia
Hypotension
Hypothyroidism
Increased appetite
Increased blood pressure
Increased prolactin
Increased serum androgens
Insomnia
Lethargy
Leukopenia
Migraine
Myalgia
Nasopharyngitis
Nausea
Neck pain
Neuroleptic malignant syndrome
Neutropenia
Nightmares
Orthostatic hypotension
Palpitations
Panic attack
Parkinsonism
Pruritus
Psychotic disorder
Rash
Renal failure
Restless legs
Restlessness
Rhabdomyolysis
Rhinitis
Schizophrenia
Serum creatinine increased
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Stiffness
Stomach discomfort
Sudden cardiac death
Suicidal tendencies
Tachycardia
Tardive dyskinesia
Upper abdominal pain
Upper respiratory tract infection
Vertigo
Vomiting
Weight gain

Presentation

Oral formulations containing lurasidone.

Drugs List

Therapeutic Indications

Uses

Schizophrenia

Dosage

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Children under 13 years

Precautions and Warnings

Family history of long QT syndrome
Patients over 65 years
Predisposition to diabetes mellitus
Predisposition to orthostatic hypotension
Predisposition to venous thromboembolism
Suicidal ideation
Breastfeeding
Cardiovascular disorder
Dementia
Diabetes mellitus
Electrolyte imbalance
Hepatic impairment - Child-Pugh score greater than 7
History of seizures
Parkinson's disease
Pregnancy
Reduced seizure threshold
Renal impairment - creatinine clearance below 50ml/minute

Consider preventative measures in patients at risk of thromboembolism
Patients at risk of suicide should be closely supervised
Reduce dose in patients with moderate hepatic impairment
Reduce dose in patients with moderate renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patient initially- response may take 2 or more weeks
Monitor patient's weight
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with existing or tendency towards diabetes mellitus
Monitor serum electrolytes
Monitor serum prolactin during long-term use
When used with SSRIs, risk of Serotonin syndrome
Advise patient to report signs of elevated prolactin levels
Consider discontinuation if signs of tardive dyskinesia occur
Consider dose reduction or discontinuation if serotonin syndrome suspected
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient grapefruit products may increase plasma level

Caution should be exercised when treating patients aged 65 and above with higher doses of lurasidone as experience is limited.

Use of antipsychotics in patients with dementia is associated with an increased risk of cerebrovascular adverse reactions. Use caution in patients with dementia who have risk factors for stroke.

Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks. If used in ESRD, clinical monitoring is advised.

Pregnancy and Lactation

Pregnancy

Use lurasidone with caution in pregnancy.

There is limited data regarding the use of lurasidone in pregnancy. The potential risk for humans is unknown.

Animal studies are insufficient with respect to effects on pregnancy, embryo foetal development, parturition and postnatal development.

The manufacturer recommends only using lurasidone when clearly necessary.

Neonates exposed to antipsychotics (including lurasidone) during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use lurasidone with caution in breastfeeding.

Lurasidone was excreted in milk of rats during lactation. It is not known whether lurasidone or its metabolites are excreted in human milk. Breastfeeding in women receiving lurasidone should be considered only if the potential benefit of treatment justifies the potential risk to the child.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggression
Agitation
Akathisia
Alanine aminotransferase increased
Amenorrhoea
Anaemia
Angina
Angioedema
Anxiety
Apathy
Back pain
Blurred vision
Bradycardia
Breast enlargement
Breast pain
Catatonia
Changes in libido
Confusion
Convulsions
Creatine phosphokinase increased
Decreased appetite
Depressed mood
Depression
Diarrhoea
Dissociation
Dizziness
Dry mouth
Dysarthria
Dysgeusia
Dyskinesia
Dysmenorrhoea
Dyspepsia
Dysphagia
Dystonia
Dysuria
Elevated blood glucose (transient)
Eosinophilia
Erectile dysfunction
Fatigue
First degree AV block
Flatulence
Gait abnormality
Galactorrhoea
Gastritis
Hallucinations
Hot flushes
Hyperacusis
Hyperhidrosis
Hyperinsulinemia
Hyperkinesia
Hypersalivation
Hypersensitivity reactions
Hypertension
Hyponatraemia
Hypotension
Hypothyroidism
Increased appetite
Increased blood pressure
Increased prolactin
Increased serum androgens
Insomnia
Lethargy
Leukopenia
Migraine
Myalgia
Nasopharyngitis
Nausea
Neck pain
Neuroleptic malignant syndrome
Neutropenia
Nightmares
Orthostatic hypotension
Palpitations
Panic attack
Parkinsonism
Pruritus
Psychotic disorder
Rash
Renal failure
Restless legs
Restlessness
Rhabdomyolysis
Rhinitis
Schizophrenia
Serum creatinine increased
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Stiffness
Stomach discomfort
Sudden cardiac death
Suicidal tendencies
Tachycardia
Tardive dyskinesia
Upper abdominal pain
Upper respiratory tract infection
Vertigo
Vomiting
Weight gain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2018

Reference Sources

Summary of Product Characteristics: Latuda 18.5mg film coated tablets. Takeda Pharma. Revised July 2020.
Summary of Product Characteristics: Latuda 37mg film coated tablets. Takeda Pharma. Revised July 2020.
Summary of Product Characteristics: Latuda 74mg film coated tablets. Takeda Pharma. Revised July 2020.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Lurasidone Last revised: 01 March 2018
Last accessed: 08 August 2018