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Powder and solvent for prolonged-release suspension for injection formulation of aripiprazole.
Maintenance treatment of schizophrenia
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with aripiprazole depot injection.
Two starting dose regimens
One injection start: On the day of initiation, administer one injection of 400mg then continue treatment with 10mg to 20mg oral aripiprazole per day for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
Two injection start: On the day of initiation, administer two separate injections of 400mg at separate injection sites with one 20mg oral aripiprazole dose.
Maintenance dose of 400mg administered once a month as a single injection, no sooner than 26 days after the previous injection. Reduction to 300mg once monthly should be considered if adverse reactions occur.
Titration of the dose of aripiprazole is not required.
Additional Dosage Information
If second or third injection dose is missed and the time since last injection is:
Greater than 4 weeks and less than 5 weeks: The injection should be administered as soon as possible and then resume monthly injection schedule.
Greater than 5 weeks: Concomitant oral aripiprazole should be restarted for 14 days with next administered injection or two separate injections given at one time, with a single dose of 20mg oral aripiprazole. Then resume monthly injection schedule.
If fourth or subsequent doses are missed and time since last injection is:
Greater than 4 weeks and less than 6 weeks:The injection should be administered as soon as possible and then resume monthly injection schedule.
Greater than 6 weeks: Concomitant oral aripiprazole should be restarted for 14 days with next administered injection or two separate injections given at one time, with a single dose of 20mg oral aripiprazole. Then resume monthly injection schedule.
Known poor metabolisers of CYP2D6
One injection start: Starting dose of 300mg then continue treatment with prescribed dose of oral aripiprazole per day for 14 consecutive days.
Two injection start: Starting dose of 2 separate injections of 300mg with a single dose of the previously prescribed of oral aripiprazole.
Maintenance dose of 300mg every month, minimum of 26 days between injections.
Known poor metabolisers of CYP2D6 and concomitant use of strong CYP3A4 inhibitor
One injection start: Starting dose of 200mg then continue treatment with prescribed dose of oral aripiprazole per day for 14 consecutive days.
Two injection start: Not recommended
Dose adjustments due to drug interactions
Use with either a strong CYP3A4 inhibitor OR a strong CYP2D6 inhibitor for more than 14 days:
Original dose of 400mg: Reduce to 300mg.
Original dose of 300mg: Reduce to 200mg.
Upon discontinuation of the CYP3A4 or CYP2D6 inhibitor, consider returning to the previous aripiprazole dose. If adverse reactions occur despite dose adjustments consider discontinuing the CYP3A4/CYP2D6 inhibitor.
Use with both a strong CYP3A4 inhibitor AND a strong CYP2D6 inhibitor for more than 14 days:
Original dose of 400mg: Reduce to 200mg.
Original dose of 300mg: Reduce to 160mg.
Upon discontinuation of the CYP3A4 and/or CYP2D6 inhibitor, consider increasing the aripiprazole dose (see dose reductions above for use with a single CYP inhibitor). If adverse reactions occur despite dose adjustments consider discontinuing the CYP3A4/CYP2D6 inhibitor.
Use with a CYP3A4 inducer
Avoid concomitant use with a CYP3A4 inducer for more than 14 days. No dose adjustments are required.
For intramuscular injection only.
The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel.
If initiating with the two injection start, two different muscles should be used. Sites of concomitant injections should be rotated between the two gluteal or deltoid muscles (do not inject concomitantly into the same deltoid or gluteal muscle). For CYP2D6 poor metabolisers, administer into two separate deltoid muscles or one deltoid and one gluteal muscle. Do not inject into two gluteal muscles.
Children under 18 years
Precautions and Warnings
Family history of diabetes mellitus
Patients over 65 years
Predisposition to aspiration or regurgitation
Predisposition to hypotension
Predisposition to venous thromboembolism
Cardiac conduction defects
CYP2D6 poor metaboliser genotype
History of ischaemic heart disease
History of myocardial infarction
History of seizures
Severe hepatic impairment
May decrease glucose tolerance in patients with diabetes mellitus
Not suitable for use in acutely agitated or severely psychotic patients
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
For intramuscular injection only
Close medical supervision during initial dosing
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor patients at risk of pathological gambling
Monitor periodically for signs or symptoms of hyperglycaemia
Refer women considering pregnancy for specialist advice and monitoring
Advise patient of the risk of weight gain
Advise patients/carers to seek medical advice if suicidal intent develops
Consider discontinuation if signs of tardive dyskinesia occur
Discontinue in patients with unexplained high fever
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient not to take St John's wort concurrently
During antipsychotic treatment, improvement in the patients clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period.
Aripiprazole depot injection is not indicated for the treatment of patients with dementia-related psychosis.
The occurrence of suicidal behaviour is inherent in psychotic illness, and so patients at risk of suicide should be closely monitored, especially at initiation or switch or antipsychotic therapy.
Antipsychotic drug use is associated with oesophageal dysmotility and aspiration, and so aripiprazole should be used with caution in patients at risk of aspiration pneumonia such as patients with dysphagia.
Pregnancy and Lactation
Use aripiprazole with caution in pregnancy.
At the time of writing, there are no adequate data on the use of aripiprazole in human pregnancy. It is not known if aripiprazole or its major metabolite cross the placenta, but it is thought likely due to their molecular weight, degree of protein binding and long elimination half lives. The extensive serum protein binding should limit foetal transfer. Congenital abnormalities have been reported; however, the manufacturer states that causal relationship with aripiprazole could not be established.
The animal data (rats and rabbits) from high dose studies suggest a possible risk of developmental toxicity and teratogenicity.
Schaefer (2007) concludes that atypical antipsychotics such as aripiprazole may be used during pregnancy where the treatment of acute psychosis or chronic psychotic illness is necessary. Olanzapine or quetiapine are the drugs of choice, due to the documented experience in pregnancy, but treatment with aripiprazole is not an indication for termination of the pregnancy, and antipsychotic medication should not be changed if patients are stable, as this may worsen the mother's health. However, consider a detailed foetal ultrasonography if used during the first trimester. If dose reduction or interruption in the days immediately preceding delivery is deemed appropriate, this may prevent neonatal adaptation disorders. Pre-pregnancy dosage should be then started immediately after delivery to prevent relapse.
Briggs (2011) concludes that the safest course is to avoid aripiprazole during pregnancy, but recognises the importance of keeping maternal treatment stable. If used, it should be at the lowest effective dose, avoiding the first trimester if possible, and with long term evaluation of the neonate.
New born infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy 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, new born infants 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 ).
Aripiprazole is contraindicated in breastfeeding.
The molecular weight and prolonged elimination half life are consistent with excretion in human milk, but the extensive serum protein binding should limit foetal exposure.
The manufacturer does not recommend breastfeeding during treatment with aripiprazole, due to the lack of published human experience. LactMed agrees that other antipsychotic agents with more experience may be preferred, hence aripiprazole should only be administered if the mother and infant can be monitored. The effects of exposure on the nursing infant are unknown, but potent CNS effects and rare but potentially serious toxicities are possible. If breastfeeding during treatment, the infant should be monitored for somnolence, orthostatic hypotension, seizures, dysphagia, nausea, vomiting and other adverse effects. Briggs concludes that long term evaluation of the infant is warranted.
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
Abnormal liver function tests
Blood glucose disturbances
Changes in libido
Creatine phosphokinase increased
Disturbances of appetite
Increase in blood levels of insulin
Increased blood pressure
Injection site reactions
Interference with temperature regulation
Neuroleptic malignant syndrome
Prolongation of QT interval
Serum bilirubin increased
Torsades de pointes
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 ).
Last Full Review Date: December 2015
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection and suspension for injection in pre filled syringe. Otsuka Pharmaceuticals Europe Ltd. Revised October 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 January 2023.
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
Aripiprazole Last revised: 06 November 2015
Last accessed: 16 December 2015
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