Abilify Maintena

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
 
Each vial contains 300 mg aripiprazole. 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
 
Each vial contains 400 mg aripiprazole. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
Each pre-filled syringe contains 300 mg aripiprazole. 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
Each pre-filled syringe contains 400 mg aripiprazole. 
 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for prolonged-release suspension for injection 
 
Powder: white to off-white 
Solvent: clear solution 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised 
with oral aripiprazole. 
 
4.2 Posology and method of administration 
 
Posology 
 
For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to 
initiating treatment with Abilify Maintena. 
 



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The recommended starting and maintenance dose of Abilify Maintena is 400 mg. 
 
Titration of the dose of this medicinal product is not required. It should be administered once monthly 
as a single injection (no sooner than 26 days after the previous injection). 
 
After the first injection, treatment with 10 mg to 20 mg oral aripiprazole per day should be continued 
for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of 
therapy. 
 
If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly 
should be considered. 
 
Missed doses 
 

Missed doses 
If 2nd or 3rd dose is missed and time 
since last injection is: 

Action 

> 4 weeks and < 5 weeks  The injection should be administered as soon as possible 
and then the monthly injection schedule should be resumed. 

> 5 weeks  Concomitant oral aripiprazole should be restarted for 
14 days with next administered injection. 

If 4th or subsequent doses are missed 
(i.e., after attainment of steady state) 
and time since last injection is: 

Action 

> 4 weeks and < 6 weeks The injection should be administered as soon as possible 
and then the monthly injection schedule should be resumed. 

> 6 weeks Concomitant oral aripiprazole should be restarted for 
14 days with next administered injection and then resume 
monthly injection schedule. 

 
Special populations 
 
Elderly 
The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of 
age or older has not been established (see section 4.4). 
 
Renal impairment 
No dosage adjustment is required for patients with renal impairment (see section 5.2). 
 
Hepatic impairment 
No dosage adjustment is required for patients with mild or moderate hepatic impairment. In patients 
with severe hepatic impairment, the data available are insufficient to establish recommendations. In 
these patients dosing should be managed cautiously. Oral formulation should be preferred (see 
section 5.2). 
 
Known CYP2D6 poor metabolisers 
In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should 
be 300 mg. When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 
200 mg (see section 4.5). 
 
Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 
inducers 
Dosage adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or 
strong CYP2D6 inhibitors for more than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is 
withdrawn, the dosage may need to be increased to the previous dose (see section 4.5). In case of 
adverse reactions despite dose adjustments of Abilify Maintena, the necessity of concomitant use of 
CYP2D6 or CYP3A4 inhibitor should be reassessed. 



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Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided for more than 14 days 
because the blood levels of aripiprazole are decreased and may be below the effective levels (see 
section 4.5). 
 
Dose adjustments of Abilify Maintena in patients who are taking concomitant strong CYP2D6 
inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than 14 days 
 
 Adjusted dose 

Patients taking 400 mg of Abilify Maintena 
Strong CYP2D6 or strong CYP3A4 inhibitors 300 mg 
Strong CYP2D6 and strong CYP3A4 inhibitors 200 mg* 
CYP3A4 inducers Avoid use 
Patients taking 300 mg of Abilify Maintena 
Strong CYP2D6 or strong CYP3A4 inhibitors 200 mg* 
Strong CYP2D6 and strong CYP3A4 inhibitors 160 mg* 
CYP3A4 inducers Avoid use 

* 200 mg and 160 mg can be achieved via adjustment of the injection volume only by using Abilify Maintena powder and solvent for 
prolonged-release suspension for injection. 

 
Paediatric population 
The safety and efficacy of Abilify Maintena in children and adolescents aged 0-17 years have not been 
established. No data are available. 
 
Method of administration 
 
Abilify Maintena is only intended for intramuscular use and should not be administered intravenously 
or subcutaneously. It should only be administered by a healthcare professional. 
 
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. 
 
Full instructions for use and handling of Abilify Maintena are provided in the package leaflet 
(information intended for healthcare professionals). 
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
During antipsychotic treatment, improvement in the patient's clinical condition may take several days 
to some weeks. Patients should be closely monitored throughout this period. 
 
Use in patients who are in an acutely agitated or severely psychotic state 
 
Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when 
immediate symptom control is warranted. 
 
Suicidality 
 
The occurrence of suicidal behaviour is inherent in psychotic illnesses, and in some cases has been 
reported early after initiation or switch of antipsychotic treatment, including treatment with 



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aripiprazole (see section 4.8). Close supervision of high risk patients should accompany antipsychotic 
treatment. 
 
Cardiovascular disorders 
 
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of 
myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), 
cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, 
hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including 
accelerated or malignant. Cases of venous thromboembolism (VTE) have been reported with 
antipsychotic medicinal products. Since patients treated with antipsychotics often present with 
acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during 
treatment with aripiprazole and preventive measures undertaken (see section 4.8). 
 
QT prolongation 
 
In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable 
to placebo. Aripiprazole should be used with caution in patients with a family history of QT 
prolongation (see section 4.8). 
 
Tardive dyskinesia 
 
In clinical trials of one year or less duration, there were uncommon reports of treatment emergent 
dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear in a 
patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). These 
symptoms can temporally deteriorate or can even arise after discontinuation of treatment. 
 
Neuroleptic Malignant Syndrome (NMS) 
 
NMS is a potentially fatal symptom complex associated with antipsychotics. In clinical trials, rare 
cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are 
hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular 
pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may 
include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with 
NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, or 
presents with unexplained high fever without additional clinical manifestations of NMS, all 
antipsychotics, including aripiprazole, must be discontinued (see section 4.8). 
 
Seizure 
 
In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. 
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder 
or have conditions associated with seizures (see section 4.8). 
 
Elderly patients with dementia-related psychosis 
 
Increased mortality 
In three placebo-controlled trials of oral aripiprazole in elderly patients with psychosis associated with 
Alzheimer's disease (n = 938; mean age: 82.4 years; range: 56-99 years), patients treated with 
aripiprazole were at an increased risk of death compared to placebo. The rate of death in oral 
aripiprazole-treated patients was 3.5 % compared to 1.7 % in placebo. Although the causes of deaths 
were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) 
or infectious (e.g. pneumonia) in nature (see section 4.8). 
 



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Cerebrovascular adverse reactions 
In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient 
ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 
78-88 years). Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse 
reactions compared with 0.6 % of placebo-treated patients in these trials. This difference was not 
statistically significant. However, in one of these trials, a fixed-dose trial, there was a significant dose- 
response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see 
section 4.8). 
 
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis. 
 
Hyperglycaemia and diabetes mellitus 
 
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or 
death, has been reported in patients treated with aripiprazole. Risk factors that may predispose patients 
to severe complications include obesity and family history of diabetes. Patients treated with 
aripiprazole should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, 
polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for 
diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8). 
 
Hypersensitivity 
 
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see 
section 4.8). 
 
Weight gain 
 
Weight gain is commonly seen in schizophrenic patients due to use of antipsychotics known to cause 
weight gain, co-morbidities, poorly managed life-style and might lead to severe complications. Weight 
gain has been reported post-marketing among patients prescribed oral aripiprazole. When seen, it is 
usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary 
adenoma. In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain 
(see section 4.8). 
 
Dysphagia 
 
Oesophageal dysmotility and aspiration have been associated with the use of aripiprazole. 
Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia. 
 
Pathological gambling and other impulse control disorders 
 
Patients can experience increased urges, particularly for gambling, and the inability to control these 
urges while taking aripiprazole. Other urges, reported, include: increased sexual urges, compulsive 
shopping, binge or compulsive eating, and other impulsive and compulsive behaviours. It is important 
for prescribers to ask patients or their caregivers specifically about the development of new or 
increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other 
urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be 
associated with the underlying disorder; however, in some cases, urges were reported to have stopped 
when the dose was reduced or the medicinal productation was discontinued. Impulse control disorders 
may result in harm to the patient and others if not recognised. A dose reduction or stopping of the 
medicinal product should be considered if a patient develops such urges (see section 4.8). 
 
Falls 
 
Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may 
lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose 
should be considered (e.g., elderly or debilitated patients; see section 4.2). 



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Sodium 
 
Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed with Abilify Maintena. The information below is obtained 
from studies with oral aripiprazole. 
 
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of 
certain antihypertensive medicinal products. 
 
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is 
administered in combination with alcohol or other CNS medicinal products with overlapping adverse 
reactions such as sedation (see section 4.8). 
 
If aripiprazole is administered concomitantly with medicinal products known to cause QT 
prolongation or electrolyte imbalance, caution should be used. 
 
Potential for other medicinal products to affect aripiprazole 
 
Quinidine and other strong CYP2D6 inhibitors 
In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) 
increased aripiprazole AUC by 107 %, while Cmax was unchanged. The AUC and Cmax of dehydro-
aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively. Other strong inhibitors 
of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar 
dose reduction should, therefore, be applied (see section 4.2). 
 
Ketoconazole and other strong CYP3A4 inhibitors 
In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) 
increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively. The AUC and Cmax of dehydro-
aripiprazole increased by 77 % and 43 %, respectively. In CYP2D6 poor metabolisers, concomitant 
use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole 
compared to that in CYP2D6 extensive metabolisers (see section 4.2). When considering concomitant 
administration of ketoconazole or other potent CYP3A4 inhibitors with aripiprazole, potential benefits 
should outweigh the potential risks to the patient. Other strong inhibitors of CYP3A4, such as 
itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose 
reductions should, therefore, be applied (see section 4.2). Upon discontinuation of the CYP2D6 or 
CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the dose prior to the initiation of 
the concomitant therapy. When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. 
escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole 
concentrations may be expected. 
 
Carbamazepine and other CYP3A4 inducers 
Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral 
aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax 
and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when oral 
aripiprazole (30 mg) was administered alone. Similarly, for dehydro-aripiprazole the geometric means 
of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than 
those following treatment with oral aripiprazole alone. Concomitant administration of Abilify 
Maintena and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, 
primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects. The 
concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood 
levels of aripiprazole are decreased and may be below the effective levels. 
 
Serotonin syndrome 



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Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and 
symptoms for this condition can occur especially in cases of concomitant use with other serotonergic 
medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase 
aripiprazole concentrations (see section 4.8). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no adequate and well-controlled trials of aripiprazole in pregnant women. Congenital 
anomalies have been reported; however, causal relationship with aripiprazole could not be established. 
Animal studies could not exclude potential developmental toxicity (see section 5.3). Patients must be 
advised to notify their physician if they become pregnant or intend to become pregnant during 
treatment with aripiprazole. Due to insufficient safety information in humans and concerns raised by 
animal reproductive studies, this medicinal product should not be used in pregnancy unless the 
expected benefit clearly justifies the potential risk to the foetus. 
 
Prescribers need to be aware of the long-acting properties of Abilify Maintena. 
 
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 (see section 4.8). 
 
Breast-feeding 
 
Aripiprazole is excreted in human milk. A decision must be made whether to discontinue breast-
feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breast 
feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
Aripiprazole did not impair fertility based on data from reproductive toxicity studies. 
 
4.7 Effects on ability to drive and use machines 
 
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential 
nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see 
section 4.8). 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of patients in two 
double-blind, long-term trials of Abilify Maintena were weight increased (9.0 %), akathisia (7.9 %), 
insomnia (5.8 %), and injection site pain (5.1 %). 
 
Tabulated list of adverse reactions 
 
The incidences of the ADRs associated with aripiprazole therapy are tabulated below. The table is 
based on adverse reactions reported during clinical trials and/or post-marketing use. 
 
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 
to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) 



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and not known (cannot be estimated from the available data). Within each frequency grouping, 
adverse reactions are presented in order of decreasing seriousness. 
 
The frequency of adverse reactions reported during post-marketing use cannot be determined as they 
are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified 
as "not known". 
 
 Common Uncommon Not known 
Blood and 
lymphatic 
system 
disorders 

 Neutropenia 
Anaemia 
Thrombocytopenia 
Neutrophil count decreased 
White blood cell count 
decreased 

Leukopenia 

Immune 
system 
disorders 

 Hypersensitivity Allergic reaction (e.g. 
anaphylactic reaction, 
angioedema including swollen 
tongue, tongue oedema, face 
oedema, pruritus, or urticaria) 

Endocrine 
disorders 

 Blood prolactin decreased 
Hyperprolactinaemia 

Diabetic hyperosmolar coma 
Diabetic ketoacidosis 

Metabolism 
and nutrition 
disorders 

Weight 
increased 
Diabetes 
mellitus 
Weight 
decreased 

Hyperglycaemia 
Hypercholesterolaemia 
Hyperinsulinaemia 
Hyperlipidaemia 
Hypertriglyceridaemia 
Appetite disorder 

Anorexia 
Hyponatraemia 

Psychiatric 
disorders 

Agitation 
Anxiety 
Restlessness 
Insomnia 

Suicidal ideation 
Psychotic disorder 
Hallucination 
Delusion 
Hypersexuality 
Panic reaction 
Depression 
Affect lability 
Apathy 
Dysphoria 
Sleep disorder 
Bruxism 
Libido decreased 
Mood altered 

Completed suicide 
Suicide attempt 
Pathological gambling 
Impulse-control disorders 
Binge eating 
Compulsive shopping 
Poriomania 
Nervousness 
Aggression 

Nervous 
system 
disorders 

Extrapyramidal 
disorder 
Akathisia 
Tremor 
Dyskinesia 
Sedation 
Somnolence 
Dizziness 
Headache 

Dystonia 
Tardive dyskinesia 
Parkinsonism 
Movement disorder 
Psychomotor hyperactivity 
Restless legs syndrome 
Cogwheel rigidity 
Hypertonia 
Bradykinesia 
Drooling 
Dysgeusia 
Parosmia 

Neuroleptic malignant syndrome 
Grand mal convulsion 
Serotonin syndrome 
Speech disorder 

Eye disorders  Oculogyric crisis 
Vision blurred 
Eye pain 
Diplopia 

 



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 Common Uncommon Not known 
Photophobia 

Cardiac 
disorders 

 Ventricular extrasystoles 
Bradycardia 
Tachycardia 
Electrocardiogram T wave 
amplitude decreased 
Electrocardiogram abnormal 
Electrocardiogram T wave 
inversion 

Sudden unexplained death 
Cardiac arrest 
Torsades de pointes 
Ventricular arrhythmias 
QT prolongation 
 

Vascular 
disorders 

 Hypertension 
Orthostatic hypotension 
Blood pressure increased 
 

Syncope 
Venous thromboembolism 
(including pulmonary embolism 
and deep vein thrombosis) 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Cough 
Hiccups 

Oropharyngeal spasm 
Laryngospasm 
Aspiration pneumonia 

Gastrointesti
nal disorders 

Dry mouth Gastrooesophageal reflux 
disease 
Dyspepsia 
Vomiting 
Diarrhoea 
Nausea 
Abdominal pain upper 
Abdominal discomfort 
Constipation 
Frequent bowel movement 
Salivary hypersecretion 

Pancreatitis 
Dysphagia 

Hepatobiliary 
disorders 

 Liver function test abnormal 
Hepatic enzyme increased 
Alanine aminotransferase 
increased 
Gamma-glutamyl transferase 
increased 
Blood bilirubin increased 
Aspartate aminotransferase 
increased 

Hepatic failure 
Jaundice 
Hepatitis 
Alkaline phosphatase increased 

Skin and 
subcutaneous 
tissue 
disorders 

 Alopecia 
Acne 
Rosacea 
Eczema 
Skin induration 

Rash 
Photosensitivity reaction 
Hyperhidrosis 

Musculoskele
tal and 
connective 
tissue 
disorders 

Musculoskeletal 
stiffness 

Muscle rigidity 
Muscle spasms 
Muscle twitching 
Muscle tightness 
Myalgia 
Pain in extremity 
Arthralgia 
Back pain 
Joint range of motion 
decreased 
Nuchal rigidity 
Trismus 

Rhabdomyolysis 

Renal and 
urinary 

 Nephrolithiasis 
Glycosuria 

Urinary retention 
Urinary incontinence 



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 Common Uncommon Not known 
disorders 
Pregnancy, 
puerperium 
and perinatal 
conditions 

  Drug withdrawal syndrome 
neonatal (see section 4.6) 

Reproductive 
system and 
breast 
disorders 

Erectile 
dysfunction 

Galactorrhoea 
Gynaecomastia 
Breast tenderness 
Vulvovaginal dryness 

Priapism 

General 
disorders and 
administratio
n site 
conditions 
 

Injection site 
pain 
Injection site 
induration 
Fatigue 

Pyrexia 
Asthenia 
Gait disturbance 
Chest discomfort 
Injection site reaction 
Injection site erythema 
Injection site swelling 
Injection site discomfort 
Injection site pruritus 
Thirst 
Sluggishness  

Temperature regulation disorder 
(e.g. hypothermia, pyrexia) 
Chest pain 
Peripheral oedema 

Investigations 
 

Blood creatine 
phosphokinase 
increased 

Blood glucose increased 
Blood glucose decreased 
Glycosylated haemoglobin 
increased 
Waist circumference 
increased 
Blood cholesterol decreased 
Blood triglycerides decreased 

Blood glucose fluctuation 

 
Description of selected adverse reactions 
 
Injection site reactions 
During the double-blind, controlled phases of the two long-term trials, injection site reactions were 
observed; those seen were generally mild to moderate in severity, and resolved over time. Injection 
site pain (incidence 5.1 %), had a median onset on day 2 after the injection and a median duration of 
4 days. 
 
In an open label study comparing bioavailability of Abilify Maintena administered in the deltoid or 
gluteal muscle, injection site related reactions were slightly more frequent in the deltoid muscle. The 
majority were mild and improved on subsequent injections. When compared to studies where Abilify 
Maintena was injected in the gluteal muscle, repeated occurrence of injection site pain was more 
frequent in the deltoid muscle. 
 
Leukopenia 
Neutropenia has been reported in the clinical program with Abilify Maintena and typically started 
around day 16 after first injection, and lasted a median of 18 days. 
 
Extrapyramidal Symptoms (EPS) 
In trials in stable patients with schizophrenia, Abilify Maintena was associated with a higher 
frequency of EPS symptoms (18.4 %) than oral aripiprazole treatment (11.7 %). Akathisia was the 
most frequently observed symptom (8.2 %) and typically started around day 10 after first injection, 
and lasted a median of 56 days. Subjects with akathisia typically received anti-cholinergic medicines 
as treatment, primarily benzatropine mesilate and trihexyphenidyl. Less often substances such as 
propranolol and benzodiazepines (clonazepam and diazepam) were administered to control akathisia. 
Parkinsonism events followed in frequency of 6.9 % for Abilify Maintena, 4.15 % for oral aripiprazole 
10-30 mg tablets and 3.0 % for placebo, respectively. 



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Dystonia 
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in 
susceptible individuals during the first few days of treatment. Dystonic symptoms include spasm of 
the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty 
breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur 
more frequently and with greater severity with high potency and at higher doses of first generation 
antipsychotic medicinal products. An elevated risk of acute dystonia is observed in males and younger 
age groups. 
 
Weight 
During the Double-blind, Active-controlled Phase of the 38-week long-term trial, the incidence of 
weight gain of ≥ 7 % from baseline to last visit was 9.5 % for Abilify Maintena and 11.7 % for the oral 
aripiprazole tablets 10-30 mg. The incidence of weight loss of ≥ 7 % from baseline to last visit was 
10.2 % for Abilify Maintena and 4.5 % for oral aripiprazole tablets 10-30 mg. During the Double-
blind, Placebo-controlled Phase of the 52-week long-term trial, the incidence of weight gain of ≥ 7 % 
from baseline to last visit was 6.4 % for Abilify Maintena and 5.2 % for placebo. The incidence of 
weight loss of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena and 6.7 % for placebo. 
During double-blind treatment, mean change in body weight from baseline to last visit was -0.2 kg for 
Abilify Maintena and -0.4 kg for placebo (p = 0.812). 
 
Prolactin 
In clinical trials for the approved indications and post-marketing, both increase and decrease in serum 
prolactin as compared to baseline was observed with aripiprazole (section 5.1). 
 
Pathological gambling and other impulse control disorders 
Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can 
occur in patients treated with aripiprazole (see section 4.4). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
No cases of overdose associated with adverse reactions were reported in clinical studies with Abilify 
Maintena. Care must be taken to avoid inadvertent injection of this medicinal product into a blood 
vessel. Following any confirmed or suspected accidental overdose/inadvertent intravenous 
administration, close observation of the patient is needed and if any potentially medically serious sign 
or symptom develops, monitoring, which should include continuous electrocardiographic monitoring, 
is required. The medical supervision and monitoring should continue until the patient recovers. 
 
A simulation of dose dumping showed that the predicted median aripiprazole concentration reaches a 
peak of 4,500 ng/ml or approximately 9 times the upper therapeutic range. In case of dose dumping, 
aripiprazole concentrations are predicted to descend rapidly to the upper limit of the therapeutic 
window after approximately 3 days. By the 7th day, the median aripiprazole concentrations further 
decline to concentrations following an IM depot dose with no dose dumping. While overdose is less 
likely with parenteral than oral medicinal products, reference information for oral aripiprazole 
overdose is presented below. 
 
Signs and symptoms 
 
In clinical trials and post-marketing experience, accidental or intentional acute overdose of 
aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


13 

(41 times highest recommended daily aripiprazole dose) with no fatalities. The potentially medically 
important signs and symptoms observed included lethargy, increased blood pressure, somnolence, 
tachycardia, nausea, vomiting and diarrhoea. In addition, reports of accidental overdose with 
aripiprazole alone (up to 195 mg) in children have been received with no fatalities. The potentially 
medically serious signs and symptoms reported included somnolence, transient loss of consciousness 
and extrapyramidal symptoms. 
 
Management of overdose 
 
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, 
oxygenation and ventilation, and management of symptoms. The possibility of multiple medicinal 
product involvement should be considered. Therefore, cardiovascular monitoring should be started 
immediately and should include continuous electrocardiographic monitoring to detect possible 
arrhythmias. Following any confirmed or suspected overdose with aripiprazole, close medical 
supervision and monitoring should continue until the patient recovers. 
 
Haemodialysis 
 
Although there is no information on the effect of haemodialysis in treating an overdose with 
aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is 
highly bound to plasma proteins. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12 
 
Mechanism of action 
 
It has been proposed that aripiprazole’s efficacy in schizophrenia is mediated through a combination 
of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A 
receptors. Aripiprazole exhibited antagonist properties in animal models of dopaminergic 
hyperactivity and agonist properties of dopaminergic hypoactivity. Aripiprazole exhibits high binding 
affinity in vitro for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors and has moderate 
affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic, and histamine H1 receptors. 
Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no 
appreciable affinity for cholinergic muscarinic receptors. Interaction with receptors other than 
dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole. 
 
Aripiprazole oral doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 
2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor 
ligand, to the caudate and putamen detected by positron emission tomography. 
 
Clinical efficacy and safety 
 
Maintenance treatment of schizophrenia in adults 
The efficacy of Abilify Maintena in the maintenance treatment of patients with schizophrenia was 
established in two randomised, double-blind, long-term trials. 
 
The pivotal trial was a 38 week, randomised, double-blind, active-controlled trial designed to establish 
the efficacy, safety, and tolerability of this medicinal product administered as monthly injections 
compared to once daily oral aripiprazole tablets 10-30 mg as maintenance treatment in adult patients 
with schizophrenia. This trial consisted of a screening phase and 3 treatment phases: Conversion 
Phase, Oral Stabilisation Phase, and Double-blind, Active-controlled Phase. 
 



14 

Six-hundred and sixty two patients eligible for the 38-week Double-blind, Active-controlled Phase 
were randomly assigned in a 2:2:1 ratio to double-blind treatment to one of 3 treatment groups: 1) 
Abilify Maintena 2) the stabilisation dose of oral aripiprazole 10-30 mg, or 3) aripiprazole Long-
Acting Injectable 50 mg/25 mg. The aripiprazole Long-Acting Injectable 50 mg/25 mg dose was 
included as a low dose aripiprazole to test assay sensitivity for the non-inferiority design. 
 
The results of analysis of the primary efficacy endpoint, the estimated proportion of patients 
experiencing impending relapse by end of Week 26 of the Double-blind, Active-controlled Phase, 
showed that Abilify Maintena 400 mg/300 mg is non-inferior to aripiprazole oral tablets 10-30 mg. 
The estimated relapse rate by end of Week 26 was 7.12 % for Abilify Maintena, and 7.76 % for oral 
aripiprazole tablets 10-30 mg, a difference of -0.64 %. 
 
The 95 % CI (-5.26, 3.99) for the difference in the estimated proportion of patients experiencing 
impending relapse by end of Week 26 excluded the predefined non-inferiority margin, 11.5 %. 
Therefore, Abilify Maintena is non-inferior to aripiprazole oral tablets 10-30 mg. 
 
The estimated proportion of patients experiencing impending relapse by end of Week 26 for Abilify 
Maintena was 7.12 %, which was statistically significantly lower than in aripiprazole Long-Acting 
Injectable 50 mg/25 mg (21.80 %; p = 0.0006). Thus, superiority of Abilify Maintena over the 
aripiprazole Long-Acting Injectable 50 mg/25 mg was established and the validity of the trial design 
was confirmed. 
 
The Kaplan-Meier curves of the time from randomisation to impending relapse during the 38-week, 
Double-blind, Active-controlled Phase for Abilify Maintena, oral aripiprazole 10-30 mg, and 
aripiprazole Long-Acting Injectable 50 mg/25 mg are shown in Figure 1. 
 
Figure 1 Kaplan-Meier Product Limit Plot for Time to Exacerbation of Psychotic 

Symptoms/Impending Relapse 

 

 

  

IMD 400/ 300 mg 

ARIP 10-30 mg 

IMD 50/25 mg 

ARIP IMD 400/ 300 mg 
ARIP 10-30 mg 
ARIP IMD 50/25 mg 

Pr
op

or
tio

n 
of

 su
bj

ec
ts

 fr
ee

 o
f i

m
pe

nd
in

g 
re

la
ps

e 

Numbers of Subjects at Risk 

Days from Randomization 

Log-Rank Test 
ARIP IMD 400/300 mg vs. ARIP 10-30 mg: p value 0.9920 
ARIP IMD 400/300 mg vs. ARIP IMD 50/25 mg: p value < 0.0001 

1.0 
  
  
0.8 
  
  
0.6 
  
  
0.4 
  
  
0.2 
  
  
0.0 

 
NOTE: ARIP IMD 400/300 mg = Abilify Maintena;ARIP 10-30 mg = oral aripiprazole; ARIP IMD 50/25 mg = Long-acting Injectable 
 
Further, the non-inferiority of Abilify Maintena compared to oral aripiprazole 10-30 mg is supported 
by the results of the analysis of the Positive and Negative Syndrome Scale score (PANSS). 
 



15 

Table 1 PANSS Total Score – Change From Baseline to Week 38-LOCF: 
Randomised Efficacy Samplea, b 

 
PANSS Total Score – Change From Baseline to Week 38-LOCF: 

Randomised Efficacy Samplea, b 
 Abilify Maintena 

 
 400 mg/300 mg 

(n = 263) 

Oral aripiprazole 
 

10-30 mg/day 
(n = 266) 

Aripiprazole Long-Acting 
Injectable 

50 mg/25 mg 
(n = 131) 

Mean baseline (SD) 57.9 (12.94) 56.6 (12.65) 56.1 (12.59) 
Mean change (SD) -1.8 (10.49) 0.7 (11.60) 3.2 (14.45) 
P-value NA 0.0272 0.0002 

a: Negative change in score indicates improvement. 
b: Only patients having both baseline and at least one post baseline were included. P-values were derived from comparison for change from 

baseline within analysis of covariance model with treatment as term and baseline as covariate. 
 
The second trial was a 52-week, randomised, withdrawal, double-blind, trial conducted in US adult 
patients with a current diagnosis of schizophrenia. This trial consisted of a screening phase and 
4 treatment phases: Conversion, Oral Stabilisation, Abilify Maintena Stabilisation, and Double-blind 
Placebo-controlled. Patients fulfilling the oral stabilisation requirement in the Oral Stabilisation Phase 
were assigned to receive, in a single-blind fashion, Abilify Maintena and began an Abilify Maintena 
Stabilisation Phase for a minimum of 12 weeks and a maximum of 36 weeks. Patients eligible for the 
Double-blind, Placebo-controlled Phase were randomly assigned in a 2:1 ratio to double-blind 
treatment with Abilify Maintena or placebo, respectively. 
 
The final efficacy analysis included 403 randomised patients and 80 exacerbations of psychotic 
symptoms/impending relapse events. In the placebo group 39.6 % of the patients had progressed to 
impending relapse, whilst in the Abilify Maintena group impending relapse occurred in 10 % of the 
patients; thus patients in the placebo group had a 5.03-fold greater risk of experiencing impending 
relapse. 
 
Prolactin 
In the Double-blind, Active-controlled Phase of the 38-week trial, from baseline to last visit there was 
a mean decrease in prolactin levels in Abilify Maintena (−0.33 ng/ml) compared with a mean increase 
in oral aripiprazole tablets 10-30 mg (0.79 ng/ml; p < 0.01). The incidence of Abilify Maintena 
patients with prolactin levels > 1 time the upper limit of normal range (ULN) at any assessment was 
5.4 % compared with 3.5 % of the patients on oral aripiprazole tablets 10-30 mg. 
Male patients generally had a higher incidence than female patients in each treatment group. 
 
In the Double-blind Placebo-controlled Phase of the 52-week trial, from baseline to last visit there was 
a mean decrease in prolactin levels in Abilify Maintena (−0.38 ng/ml) compared with a mean increase 
in placebo (1.67 ng/ml). The incidences of Abilify Maintena patients with prolactin levels > 1 time the 
upper limit of normal range (ULN) was 1.9 % compared to 7.1 % for placebo patients. 
 
Acute treatment of schizophrenia in adults 
The efficacy of Abilify Maintena in acutely relapsed adult patients with schizophrenia was established 
in a short-term (12-week), randomised, double-blind, placebo-controlled trial (n = 339). 
The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of 
Abilify Maintena (n = 167) over placebo (n = 172). 
Similar to the PANSS Total Score, both the PANSS positive and negative subscale scores also showed 
an improvement (decrease) from baseline over time. 
 



16 

Table 2 PANSS Total Score – Change From Baseline to week 10: Randomised Efficacy 
Sample 

 
PANSS Total Score – Change From Baseline to Week 10: 

Randomised Efficacy Sample a 
 Abilify Maintena 

400 mg/300 mg 
Placebo 

 

Mean baseline (SD) 102.4 (11.4) 
n = 162 

103.4 (11.1) 
n = 167 

LS Mean change (SE) -26.8 (1.6) 
n = 99 

-11.7 (1.6) 
n = 81 

P-value < 0.0001  
Treatment differenceb (95 % CI) -15.1 (-19.4, -10.8)  

a Data were analysed using a mixed model repeated measures (MMRM) approach. The analysis included only subjects who were 
randomly assigned to treatment, given at least one injection, had baseline and at least one post-baseline efficacy assessment. 

b Difference (Abilify Maintena minus placebo) in least squares mean change from baseline. 
 
Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS 
score change from baseline to week 10. 
 
Personal and social functioning were evaluated using the Personal and Social Performance (PSP) 
scale. The PSP is a validated clinician-rated scale that measures personal and social functioning in four 
domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, 
and disturbing and aggressive behaviours. There was a statistically significant treatment difference in 
favour of Abilify Maintena 400 mg/300 mg compared to placebo at week 10 (+7.1, p < 0.0001, 95 % 
CI: 4.1, 10.1 using an ANCOVA model (LOCF)). 
 
The safety profile was consistent with that known to Abilify Maintena. Nevertheless, there were 
differences from what has been observed with maintenance use in the treatment of schizophrenia. In a 
short-term (12-week), randomised, double-blind, placebo-controlled trial with Abilify Maintena 
400 mg/300 mg treated subjects the symptoms which had at least twice the incidence of placebo were 
increased weight and akathisia. The incidence of weight gain of ≥ 7 % from baseline to last visit 
(week 12) was 21.5 % for Abilify Maintena compared with the placebo group 8.5 %. Akathisia was 
the most frequently observed EPS symptom (Abilify Maintena 11.4 % and placebo group 3.5 %). 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Abilify Maintena in all subsets of the paediatric population in schizophrenia (see section 4.2). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Aripiprazole absorption into the systemic circulation is slow and prolonged following Abilify 
Maintena administration due to low solubility of aripiprazole particles.The average absorption half-life 
of Abilify Maintena is 28 days. Absorption of aripiprazole from the IM depot formulation was 
complete relative to the IM standard (immediate-release) formulation. The dose adjusted Cmax values 
for the depot formulation were approximately 5 % of Cmax from IM standard formulation.Following a 
single dose administration of Abilify Maintena in the deltoid and gluteal muscle, the extent of 
absorption (AUC) was similar for both injection sites, but the rate of absorption (Cmax) was higher 
following administration to the deltoid muscle. Following multiple intramuscular doses, the plasma 
concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median tmax 
of 7 days for the gluteal muscle and 4 days for the deltoid muscle. Steady state concentrations for the 
typical subject were attained by the fourth dose for both sites of administration. Less than dose-
proportional increases in aripiprazole and dehydro-aripiprazole concentrations and AUC parameters 
are observed after monthly Abilify Maintena injections of 300 mg to 400 mg. 
 



17 

Distribution 
 
Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed 
throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive 
extravascular distribution. At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are 
greater than 99 % bound to serum proteins, binding primarily to albumin. 
 
Biotransformation 
 
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: 
dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 
enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is 
catalysed by CYP3A4. Aripiprazole is the predominant medicinal product moiety in systemic 
circulation. After multiple dose administration of Abilify Maintena, dehydro-aripiprazole, the active 
metabolite, represents about 29.1-32.5 % of aripiprazole AUC in plasma. 
 
Elimination 
 
After administration of multiple dose of 400 mg or 300 mg of Abilify Maintena, the mean aripiprazole 
terminal elimination half-life is respectively 46.5 and 29.9 days presumably due to absorption rate-
limited kinetics. Following a single oral dose of [14C]-labelled aripiprazole, approximately 27 % of the 
administered radioactivity was recovered in the urine and approximately 60 % in the faeces. Less than 
1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered 
unchanged in the faeces. 
 
Pharmacokinetics in special patient groups 
 
CYP2D6 poor metabolisers 
Based on population pharmacokinetic evaluation of Abilify Maintena, the total body clearance of 
aripiprazole was 3.71 L/h in extensive metabolisers of CYP2D6 and approximately 1.88 L/h 
(approximately 50 % lower) in poor metabolisers of CYP2D6 (for dose recommendation, see 
section 4.2). 
 
Elderly 
After oral administration of aripiprazole, there are no differences in the pharmacokinetics of 
aripiprazole between healthy elderly and younger adult subjects. Similarly, there was no detectable 
effect of age in a population pharmacokinetic analysis of Abilify Maintena in schizophrenia patients. 
 
Gender 
After oral administration of aripiprazole, there are no differences in the pharmacokinetics of 
aripiprazole between healthy male and female subjects. Similarly, there was no clinically relevant 
effect of gender in a population pharmacokinetic analysis of Abilify Maintena in clinical trials in 
patients with schizophrenia. 
 
Smoking 
Population pharmacokinetic evaluation of oral aripiprazole has revealed no evidence of clinically 
relevant effects from smoking on the pharmacokinetics of aripiprazole. 
 
Race 
Population pharmacokinetic evaluation showed no evidence of race-related differences on the 
pharmacokinetics of aripiprazole. 
 
Renal impairment 
In a single-dose study with oral administration of aripiprazole, the pharmacokinetic characteristics of 
aripiprazole and dehydro-aripiprazole were found to be similar in patients with severe renal disease 
compared to that in young healthy subjects. 
 



18 

Hepatic impairment 
A single-dose study with oral administration of aripiprazole to subjects with varying degrees of liver 
cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on 
the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients 
with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity. 
 
5.3 Preclinical safety data 
 
The toxicological profile for aripiprazole administered to experimental animals by intramuscular 
injection is generally similar to that seen following oral administration at comparable plasma levels. 
With intramuscular injection, however an inflammatory response was seen at the injection site, and 
consisted of granulomatous inflammation, foci (deposited drug), cellular infiltrates, oedema (swelling) 
and, in monkeys, fibrosis. These effects gradually resolved with discontinuation of dosing. 
 
Non-clinical safety data for orally administered aripiprazole reveal no special hazard for humans based 
on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic 
potential, toxicity to reproduction and development. 
 
Oral aripiprazole 
 
For oral aripiprazole, toxicologically significant effects were observed only at doses or exposures that 
were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were 
limited or of no relevance to clinical use. These included: dose-dependent adrenocortical toxicity in 
rats after 104 weeks of oral administration at approximately 3 to 10 times the mean steady-state AUC 
at the maximum recommended human dose and increased adrenocortical carcinomas and combined 
adrenocortical adenomas/carcinomas in female rats at approximately 10 times the mean steady-state 
AUC at the maximum recommended human dose. The highest non-tumorigenic exposure in female 
rats was approximately 7 times the human exposure at the recommended dose. 
 
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of 
hydroxy-metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 
125 mg/kg/day or approximately16 to 81 times the maximum recommended human dose based on 
mg/m2. 
 
However, the concentrations of the sulphate conjugates of hydroxy-aripiprazole in human bile at the 
highest dose proposed, 30 mg per day, were no more than 6 % of the bile concentrations found in the 
monkeys in the 39-week study and are well below (6 %) their limits of in vitro solubility. 
 
In repeated dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable 
to that observed in adult animals, and there was no evidence of neurotoxicity or adverse events on 
development. 
 
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-
genotoxic. Aripiprazole did not impair fertility in reproductive toxicity studies. 
 
Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic 
effects, were observed in rats at doses resulting in sub-therapeutic exposures (based on AUC) and in 
rabbits at doses resulting in exposures approximately 3 and 11 times the mean steady-state AUC at the 
maximum recommended clinical dose. Maternal toxicity occurred at doses similar to those eliciting 
developmental toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 



19 

Powder 
 
Carmellose sodium 
Mannitol 
Sodium dihydrogen phosphate monohydrate 
Sodium hydroxide 
 
Solvent 
 
Water for injections 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
Abilify Maintena powder and solvent for prolonged-release suspension for injection 
The suspension should be injected immediately after reconstitution but can be stored below 25 °C for 
up to 4 hours in the vial. 
 
Abilify Maintena powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
The suspension should be injected immediately after reconstitution but can be stored below 25 °C for 
up to 2 hours in the syringe. 
 
After reconstitution 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
 
Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C. From a 
microbiological point of view, unless the method of opening/ reconstitution precludes the risk of 
microbial contamination, the product should be used immediately. If not used immediately, in-use 
storage times and conditions are the responsibility of user. Do not store the reconstituted suspension in 
the syringe. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. 
 
6.4 Special precautions for storage 
 
Do not freeze. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
Keep the syringe in the outer carton in order to protect from light. 



20 

 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
 
Vial 
Type-I glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium cap. 
 
Solvent 
2 ml Type-1 glass vial stoppered with a laminated rubber stopper and sealed with a flip-off aluminium 
cap. 
 
Single pack 
Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with 
pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 
3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 
25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge. 
 
Multipack 
Bundle pack of 3 single packs. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
Clear glass pre-filled syringe (type-I glass) with grey chlorobutyl stoppers (front-, middle- and end 
stopper), polypropylene front assembly, polypropylene finger grip, plunger rod, and silicone over-cap. 
The front chamber between front stopper and middle stopper contains the powder and the rear 
chamber between middle stopper and end stopper the solvent. 
 
Single pack 
Each single pack containing one pre-filled syringe, and three hypodermic safety needles: one 25 mm 
(1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge. 
 
Multipack 
Bundle pack of 3 single packs. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 



21 

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. If the injection is not performed immediately after reconstitution, the syringe can be 
kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend 
prior to injection if the syringe has been left for more than 15 minutes. 
 
Gluteal muscle administration 
The recommended needle for gluteal administration is a 38 mm (1.5 inch), 22 gauge hypodermic 
safety needle; for obese patients (Body mass index > 28 kg/m2), a 51 mm (2 inch), 21 gauge 
hypodermic safety needle should be used. Gluteal injections should be alternated between the two 
gluteal muscles. 
 
Deltoid muscle administration 
The recommended needle for deltoid administration is a 25 mm (1 inch), 23 gauge hypodermic safety 
needle; for obese patients, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle should be used. 
Deltoid injections should be alternated between the two deltoid muscles. 
 
The powder and solvent vials and the pre-filled syringe are for single-use only. 
 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Full instructions for use and handling of Abilify Maintena are provided in the package leaflet 
(information intended for healthcare professionals). 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
 
EU/1/13/882/001 
EU/1/13/882/003 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
 
EU/1/13/882/002 
EU/1/13/882/004 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
EU/1/13/882/005 
EU/1/13/882/007 



22 

 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
 
EU/1/13/882/006 
EU/1/13/882/008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 November 2013 
Date of latest renewal: 27 August 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



24 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
H. Lundbeck A/S 
Ottiliavej 9 
DK 2500 Valby 
Denmark 
 
Elaiapharm 
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis 
06550 Valbonne 
France 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
 
• At the request of the European Medicines Agency; 
 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton - Single pack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 300 mg aripiprazole. After reconstitution each ml of suspension contains 200 mg 
aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 



28 

 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/001 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



29 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer label (with blue box) - Multipack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 300 mg aripiprazole.After reconstitution each ml of suspension contains 200 mg 
aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Multipack: Three single packages, each containing: 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



31 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 



32 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton (without blue box) – component of multipack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Single package containing: 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 



34 

 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 



35 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



36 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Vial powder 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Abilify Maintena 300 mg powder for prolonged-release injection 
aripiprazole 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
300 mg 
 
 
6. OTHER 
 



37 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton - Single pack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 



38 

 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



39 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



40 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer label (with blue box) - Multipack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Multipack: Three single packages, each containing: 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



41 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 



42 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton (without blue box) – component of multipack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Single package containing: 
 
One vial of powder 
One vial of 2 ml solvent 
Two sterile syringes, one with needle for reconstitution 
Three hypodermic safety needles 
One vial adapter 
 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform. 
If the injection is not performed immediately after reconstitution shake it vigorously for at least 
60 seconds to re-suspend prior to injection. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 



44 

 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Shelf-life after reconstitution: 4 hours below 25 °C 
Do not store the reconstituted suspension in the syringe. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard vial, adapter, syringe, needles, unused suspension and water for injections appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 



45 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



46 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Vial Powder 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Abilify Maintena 400 mg powder for prolonged-release injection 
aripiprazole 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
400 mg 
 
 
6. OTHER 
 



47 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Vial solvent 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Abilify Maintena 
Water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 ml 
 
 
6. OTHER 
 



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton - Single pack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 



49 

EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



50 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer label (with blue box) - Multipack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Multipack: Three single packages, each containing: 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



52 

8. EXPIRY DATE 
 
EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



53 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton (without blue box) – component of multipack 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Single package containing: 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 



55 

 
 
8. EXPIRY DATE 
 
EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 



56 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



57 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Pre-filled syringe - 300 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Abilify Maintena 300 mg injection 
aripiprazole 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
300 mg 
 
 
6. OTHER 
 
 



58 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer carton - Single pack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 



59 

EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



60 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



61 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer label (with blue box) - Multipack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Multipack: Three single packages, each containing: 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



62 

8. EXPIRY DATE 
 
EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



63 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



64 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton (without blue box) – component of multipack 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
 
Solvent 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for prolonged-release suspension for injection 
 
Single package containing: 
 
One pre-filled syringe containing powder in the front chamber and solvent in the rear chamber. 
Three hypodermic safety needles 
 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use only 
 
Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and 
use immediately. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 



65 

 
 
8. EXPIRY DATE 
 
EXP 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection 
if the syringe has been left for more than 15 minutes. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Discard pre-filled syringe and needles appropriately. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/882/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 



66 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



67 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Pre-filled syringe - 400 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Abilify Maintena 400 mg injection 
aripiprazole 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
400 mg 
 
 
6. OTHER 
 



68 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



69 

Package leaflet: Information for the user 
 

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 

aripiprazole 
 
Read all of this leaflet carefully before you receive this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Abilify Maintena is and what it is used for 
2. What you need to know before you are given Abilify Maintena 
3. How Abilify Maintena is given 
4. Possible side effects 
5. How to store Abilify Maintena 
6. Contents of the pack and other information 
 
 
1. What Abilify Maintena is and what it is used for 
 
Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called 
antipsychotics. It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or 
sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour 
and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. 
 
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised 
during treatment with oral aripiprazole. 
 
 
2. What you need to know before you are given Abilify Maintena 
 
Do not use Abilify Maintena: 
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor or nurse before you are given Abilify Maintena. 
 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor 
immediately if you are having any thoughts or feelings about hurting yourself. 
 
Before treatment with Abilify Maintena, tell your doctor if you suffer from 
 
• an acutely agitated state or a severely psychotic state 
• heart problems or have a history of stroke, especially if you know that you have other risks 

factors for stroke 
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts 

of urine, increase in appetite and feeling weak) or family history of diabetes 
• fits (seizures) since your doctor may want to monitor you more closely 
• involuntary, irregular muscle movements, especially in the face 
• experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness 

or sleepiness (may be signs of neuroleptic malignant syndrome) 



70 

• dementia (loss of memory and other mental abilities) especially if you are elderly 
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular 

disease, stroke or "mini" stroke, abnormal blood pressure 
• irregular heart beat or if someone else in your family has a history of irregular heart beat 

(including so called QT prolongation seen with ECG monitoring). 
• blood clots, or family history of blood clots, as antipsychotics have been associated with 

formation of blood clots 
• have any difficulty in swallowing 
• past experience with excessive gambling 
• severe liver problems. 
 
If you notice you are gaining weight, develop unusual movements, experience sleepiness that 
interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please 
talk to your doctor immediately. 
 
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to 
behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry 
out certain activities that could harm yourself or others. These are called impulse control disorders and 
can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high 
sex drive or preoccupation with an increase in sexual thoughts or feelings. 
Your doctor may need to adjust or stop your dose. 
 
Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in 
your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you 
are an elderly patient or have some debility. 
 
Children and adolescents 
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe 
and effective in these patients. 
 
Other medicines and Abilify Maintena 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 
Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to 
lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood 
pressure under control. 
 
Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose 
of Abilify Maintena or the other medicines. It is especially important to mention the following to your 
doctor: 
 
• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide) 
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, 

paroxetine, St. John's Wort) 
• antifungal medicines (such as ketoconazole, itraconazole) 
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors 

e.g. indinavir, ritonavir) 
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 
• medicines that are known to prolong QT prolongation. 
 
These medicines may increase the risk of side effects or reduce the effect of Abilify Maintena; if you 
get any unusual symptom taking any of these medicines together with Abilify Maintena, you should 
see your doctor. 
 



71 

Medicines that increase the level of serotonin are typically used in conditions including depression, 
generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as 
migraine and pain: 
 
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety 

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 
• SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety 
• other anti-depressants (such as venlafaxine and tryptophan) used in major depression 
• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness 
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression 
• painkillers (such as tramadol and pethidine) used for pain relief 
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine. 
 
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of 
these medicines together with Abilify Maintena, you should see your doctor. 
 
Abilify Maintena with alcohol 
Alcohol should be avoided. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before receiving this medicine. 
 
You should not be given Abilify Maintena if you are pregnant unless you have discussed this with 
your doctor. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, 
or if you are planning to become pregnant. 
 
The following symptoms may occur in new-born babies, of mothers that have received Abilify 
Maintena in the last trimester (last three months of their pregnancy): 
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in 
feeding. 
 
If your baby develops any of these symptoms you need to contact your doctor. 
 
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breast-
feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You 
should not do both. Talk to your doctor about the best way to feed your baby if you are receiving 
Abilify Maintena. 
 
Driving and using machines 
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This 
should be considered in cases where full alertness is required, e.g., when driving a car or handling 
machines. 
 
Abilify Maintena contains sodium 
Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is 
essentially ‘sodium-free’. 
 
 
3. How Abilify Maintena is given 
 
Abilify Maintena comes as a powder which your doctor or nurse will make into a suspension. 
 
Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended and 
starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose 
(300 mg, 200 mg or 160 mg). Treatment with aripiprazole by mouth is continued for 14 days after the 



72 

first injection. After that, treatment is given with injections of Abilify Maintena unless your doctor 
tells you otherwise. 
 
Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or 
shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the 
injections between your right and left side. The injections will not be given intravenously. 
 
If you are given more Abilify Maintena than you should 
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be 
given too much. If you see more than one doctor, be sure to tell them that you are receiving Abilify 
Maintena. 
 
Patients who have been given too much aripiprazole have experienced the following symptoms: 
 
• rapid heartbeat, agitation/aggressiveness, problems with speech. 
• unusual movements (especially of the face or tongue) and reduced level of consciousness. 
 
Other symptoms may include: 
 
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, 
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood 

pressure, abnormal rhythms of the heart. 
 
Contact your doctor or hospital immediately if you experience any of the above. 
 
If you miss an injection of Abilify Maintena 
It is important not to miss your scheduled dose. You should be given an injection every month but not 
before the 26 days has passed from the last injection. If you miss an injection, you should contact your 
doctor to arrange your next injection as soon as you can. 
 
If you stop receiving Abilify Maintena 
Do not stop your treatment just because you feel better. It is important that you carry on receiving 
Abilify Maintena for as long as your doctor has told you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Tell your doctor immediately if you have any of the following serious side effects: 
 
• a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, 

disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, 
weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to 
unconsciousness. 

• unusual movement mainly of the face or tongue, since your doctor may want to lower your 
dose. 

• if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you 
have a blood clot, which may travel through blood vessels to the lungs causing chest pain and 
difficulty in breathing. If you notice any of these symptoms seek medical advice immediately. 

• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness 
since this may be a sign of a condition called neuroleptic malignant syndrome (NMS). 

• thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, 
feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes. 

 



73 

The side effects listed below may also occur after receiving Abilify Maintena. 
 
Common side effects (may affect up to 1 in 10 people): 
 
• weight gain 
• diabetes mellitus 
• weight loss 
• feeling restless 
• feeling anxious 
• unable to keep still, difficulty sitting still 
• difficulty sleeping (insomnia) 
• jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle 

tone, slow body movement 
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move 

constantly) 
• shaking or trembling 
• uncontrollable twitching, jerking or writhing movements 
• changes in your level of alertness, drowsiness 
• sleepiness 
• dizziness 
• headache 
• dry mouth 
• muscle stiffness 
• inability to have or maintain an erection during sexual intercourse 
• pain at the injection site, hardening of the skin at the injection site 
• weakness, loss of strength or extreme tiredness 
• during blood tests your doctor may find higher amounts of creatine phosphokinase in your 

blood (enzyme important for muscle function) 
 
Uncommon side effects (may affect up to 1 in 100 people): 
 
• low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood 

cell count, low level of blood platelets 
• allergic reactions (hypersensitivity) 
• decreased or increased blood levels of the hormone prolactin 
• high blood sugar 
• increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol 

and low level of triglycerides 
• increased levels of insulin, a hormone regulating blood sugar levels 
• decreased or increased appetite 
• thoughts about suicide 
• mental disorder characterized by defective or lost contact with reality 
• hallucination 
• delusion 
• increased sexual interest 
• panic reaction 
• depression 
• affect lability 
• state of indifference with lack of emotion, feelings of emotional and mental discomfort 
• sleep disorder 
• grinding of teeth or clenching of the jaw 
• reduced sexual interest (libido is decreased) 
• altered mood 
• muscle problems 
• muscle movements that you cannot control such as grimacing, lip-smacking and tongue 

movements. They usually affect the face and mouth first but can affect other parts of the body. 
These could be signs of a condition called “tardive dyskinesia”. 



74 

• parkinsonism - medical condition with many various symptoms which include decreased or 
slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), 
shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling 

• movement problems 
• extreme restlesness and restless legs 
• distortion of the senses of taste and smell 
• fixation of the eyeballs in one position 
• blurred vision 
• eye pain 
• double vision 
• eye sensitivity to light, 
• abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, 

abnormal reading (ECG) of the heart 
• high blood pressure 
• dizziness when getting up from a lying or sitting position due to a drop in blood pressure 
• cough 
• hiccups 
• gastroesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the 

esophagus (gullet or the tube that goes from mouth to stomach through which food passes), 
causing heartburn and possibly damaging the esophagus 

• heartburn 
• vomiting 
• diarrhoea 
• feeling sick 
• stomach ache 
• stomach discomfort 
• constipation 
• frequent bowel movement 
• drooling, more saliva in mouth than normal 
• abnormal hair loss 
• acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin 

hardening 
• muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain 

in extremity 
• ,joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited 

opening of mouth 
• kidney stones, sugar (glucose) in urine 
• spontaneous flow of milk from the breasts (galactorrhoea) 
• enlargement of breast in men, breast tenderness, vaginal dryness 
• fever 
• loss of strength 
• gait disturbance 
• chest discomfort 
• injection site reactions such as redness, swelling discomfort and injection site itching 
• thirst 
• sluggishness 
• liver function tests may show abnormal results 
• during tests your doctor may find 

- higher amounts of liver enzymes 
- higher amounts of alanine aminotransferase 
- higher amounts of gamma-glutamyl transferase 
- higher amounts of bilirubin in your blood 
- higher amounts of aspartate aminotransferase 
- higher or lower amounts of blood glucose 
- higher amounts of glycosylated haemoglobin 
- lower amounts of cholesterol in your blood 
- lower amounts of triglycerides in your blood 



75 

- a higher waist circumference 
 
The following side effects have been reported since the marketing of oral aripiprazole but the 
frequency for them to occur is not known (frequency cannot be estimated from the available data): 
 
• low levels of white blood cells 
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash 
• unusual heartbeat, sudden unexplained death, heart attack 
• diabetic ketoacidosis (ketones in the blood and urine) or coma 
• loss of appetite (anorexia), difficulty in swallowing 
• low sodium level in the blood 
• suicide attempt and suicide 
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to 

you or others, which may include: 
- strong impulse to gamble excessively despite serious personal or family consequences 
- altered or increased sexual interest and behaviour of significant concern to you or to 

others, for example, an increased sexual drive 
- uncontrollable excessive shopping 
- binge eating (eating large amounts of food in a short time period) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger) 
- a tendency to wander away 
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of 
managing or reducing the symptoms. 

• nervousness 
• aggression 
• neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness, 

faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and 
heart rate) 

• seizure (fits) 
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles) 
• speech disorders 
• heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm 

that may be due to abnormal nerve impulses in the heart, abnormal readings during heart 
examination (ECG) QT prolongation 

• fainting 
• symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, 

pain and redness in the leg), which may travel through blood vessels to the lungs causing chest 
pain and difficulty in breathing 

• spasm of the muscles around the voice box 
• accidental inhalation of food with risk of pneumonia (lung infection) 
• inflammation of the pancreas 
• difficulty swallowing 
• liver failure 
• jaundice (yellowing of the skin and white part of eyes) 
• inflammation of the liver 
• rash 
• skin sensitivity to light 
• excessive sweating 
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have 

a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown 
which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) 

• difficulty in passing urine 
• involuntary loss of urine (incontinence) 
• drug withdrawal symptoms in new-born infant 
• prolonged and/or painful erection 
• difficulty controlling core body temperature or overheating 



76 

• chest pain 
• swelling of hands, ankles or feet 
• during tests your doctor may find 

- higher amounts alkaline phosphatase 
- fluctuating results during tests to measure glucose in your blood 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Abilify Maintena 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the vial. The expiry 
date refers to the last day of that month. 
 
Do not freeze. 
 
The reconstituted suspension should be used immediately but may be stored below 25°C for up to 
4 hours in the vial. Do not store the reconstituted suspension in the syringe. 
 
 
6. Contents of the pack and other information 
 
What Abilify Maintena contains 
- The active substance is aripiprazole. 

Each vial contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
Each vial contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 

- The other ingredients are 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
Solvent 
Water for injections 

 
What Abilify Maintena looks like and contents of the pack 
Abilify Maintena is a powder and solvent for prolonged-release suspension for injection. 
 
Abilify Maintena comes as a white to off-white powder in a clear glass vial. Your doctor or nurse will 
make it into a suspension that will be given as an injection using the vial of solvent for Abilify 
Maintena that comes as a clear solution in a clear glass vial. 
 
Single pack 
Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with 
pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 
3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 
25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge. 
 
Multipack 
Bundle pack of 3 single packs. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


77 

Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
Manufacturer 
H. Lundbeck A/S 
Ottiliavej 9, 2500 Valby 
Denmark 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Lundbeck S.A./N.V. 
Tél/Tel: +32 2 535 79 79 

Lietuva 
H. Lundbeck A/S 
Tel: +45 36301311 
 

България 
Lundbeck Export A/S Representative Office 
Tel: +359 2 962 4696 
 

Luxembourg/Luxemburg 
Lundbeck S.A. 
Tél: +32 2 535 79 79 

Česká republika 
Lundbeck Česká republika s.r.o. 
Tel: +420 225 275 600 

Magyarország 
Lundbeck Hungaria Kft. 
Tel: +36 1 4369980 
 

Danmark 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 
 

Malta 
H. Lundbeck A/S 
Tel: +45 36301311 

Deutschland 
Otsuka Pharma GmbH 
Tel: +49 69 1700860 
 

Nederland 
Lundbeck B.V. 
Tel: +31 20 697 1901 
 

Eesti 
H. Lundbeck A/S 
Tel: +45 36301311 
 

Norge 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 

Ελλάδα 
Lundbeck Hellas S.A. 
Τηλ: +30 210 610 5036 

Österreich 
Lundbeck Austria GmbH 
Tel: +43 1 266 91 08 
 

España 
Otsuka Pharmaceutical S.A. 
Tel: +34 93 208 10 20 
 

Polska 
Lundbeck Poland Sp. z o. o. 
Tel.: +48 22 626 93 00 

France 
Otsuka Pharmaceutical France SAS 
Tél: +33 (0) 1 47 08 00 00 
 

Portugal 
Lundbeck Portugal Lda 
Tel: +351 21 00 45 900 
 

Hrvatska 
Lundbeck Croatia d.o.o. 
Tel.: +385 1 644 82 63 
 

România 
Lundbeck Export A/S 
Reprezentanta din Romania 
Tel: +40 21319 88 26 
 



78 

Ireland 
Lundbeck (Ireland) Limited 
Tel: +353 1 468 9800 
 

Slovenija 
Lundbeck Pharma d.o.o. 
Tel.: +386 2 229 4500 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Lundbeck Slovensko s.r.o. 
Tel: +421 2 5341 42 18 
 

Italia 
Otsuka Pharmaceutical Italy S.r.l 
Tel: +39 02 00 63 27 10 
 

Suomi/Finland 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 

Κύπρος 
Lundbeck Hellas A.E 
Τηλ.: +357 22490305 

Sverige 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 
 

Latvija 
H. Lundbeck A/S 
Tel: +45 36301311 

United Kingdom 
Otsuka Pharmaceuticals (UK) Ltd. 
Tel: +44 203 747 5300 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


79 

--------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 

 
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection 
aripiprazole 
 
Step 1: Preparation prior to reconstitution of the powder 
Lay out and confirm that components listed below are provided: 
- Abilify Maintena package leaflet and instructions for healthcare professionals. 
- Vial of powder. 
- 2 ml vial of solvent. 
 Important: the solvent vial contains an overfill. 
- One 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety 

needle with needle protection device. 
- One 3 ml disposable syringe with luer lock tip. 
- One vial adapter. 
- One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device. 
- One 38 mm (1.5 inch) 22 gauge hypodermic safety needle with needle protection device. 
- One 51 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device. 
- Syringe and needle instructions. 
 
Step 2: Reconstitution of the powder 
a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab. 
b) Using the syringe with pre-attached needle, withdraw the pre-determined solvent volume from 

the vial of the solvent into the syringe. 
300 mg vial: 
Add 1.5 ml solvent to reconstitute the powder. 
400 mg vial: 
Add 1.9 ml solvent to reconstitute the powder. 
A small amount of residual solvent will remain in the vial following withdrawal. Any excess 
should be discarded. 

 
 

 

 
Water 
 

c) Slowly inject the solvent into the vial containing the powder. 
d) Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger. 
 



80 

 
 
e) Subsequently, remove the needle from the vial. 
 Engage the needle safety device by using the one-handed technique. 

Gently press the sheath against a flat surface until the needle is firmly engaged in the needle 
protection sheath. 

 Visually confirm that the needle is fully engaged into the needle protection sheath, and discard. 
 

  
Cover Discard 

 
f) Shake the vial vigorously for 30 seconds until the suspension appears uniform. 

 

 
 

g) Visually inspect the reconstituted suspension for particulate matter and discolouration prior to 
administration. The reconstituted medicine is a white to off-white, fluid suspension. Do not use 
if reconstituted suspension contains particulate matter or any discolouration. 

h) If the injection is not performed immediately after reconstitution, keep the vial below 25 °C for 
up to 4 hours and shake it vigorously for at least 60 seconds to re-suspend prior to injection. 

i) Do not store the reconstituted suspension in the syringe. 
 
Step 3: Preparation prior to injection 
a) Remove the cover, but not the adapter from the package. 
b) Using the vial adapter package to handle the vial adapter, attach the pre-packaged luer lock 

syringe to the vial adapter. 
 

 
 
c) Use the luer lock syringe to remove the vial adapter from the package and discard the vial 

adapter package. Do not touch the spike tip of the adapter at any time. 
 



81 

 
 
d) Determine the recommended volume for injection. 
 

Abilify Maintena 300 mg Vial 
Dose Volume to Inject 

--- --- 
300 mg 1.5 ml 
200 mg 1.0 ml 
160 mg 0.8 ml 

 
Abilify Maintena 400 mg Vial 

Dose Volume to Inject 
400 mg 2.0 ml 
300 mg 1.5 ml 
200 mg 1.0 ml 
160 mg 0.8 ml 

 
e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab. 
f) Place and hold the vial of the reconstituted suspension on a hard surface. Attach the adapter-

syringe assembly to the vial by holding the outside of the adapter and pushing the adapter’s 
spike firmly through the rubber stopper, until the adapter snaps in place. 

g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for 
injection. 

 A small amount of excess product will remain in the vial. 
 

 
 
Step 4: Injection procedure 
a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify 

Maintena suspension from the vial. 
b) Select one of the following hypodermic safety needles depending on the injection site and 

patient’s weight and attach the needle to the luer lock syringe containing the suspension for 
injection. Ensure the needle is firmly seated on the needle protection device with a push and 
clockwise twist and then pull the needle cap straight away from the needle. 

 
Body type Injection site Needle size 
 
Non-obese 

 
Deltoid 

 
25 mm (1 inch) 23 gauge 

 Gluteal 
 

38 mm (1.5 inch) 22 gauge 

   



82 

Obese Deltoid 38 mm (1.5 inch) 22 gauge 
 Gluteal 

 
51 mm (2 inch) 21 gauge 

 
c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or 

deltoid muscle. Do not massage the injection site. Care must be taken to avoid inadvertent 
injection into the blood vessel. Do not inject into an area with signs of inflammation, skin 
damage, lumps and/or bruises. 
For deep intramuscular gluteal or deltoid injection only. 

 

  
deltoid gluteal 

 
Remember to rotate sites of injections between the two gluteal or deltoid muscles. Look for 
signs or symptoms of inadvertent intravenous administration. 

 
Step 5: Procedures after injection 
Engage the needle safety device as described in Step 2 e). Dispose of the vials, adapter, needles, and 
syringe appropriately after injection. The powder and solvent vials are for single-use only. 
 

  
Cover Discard 

 



83 

Package leaflet: Information for the user 
 

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 

Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 

aripiprazole 
 
Read all of this leaflet carefully before you receive this medicine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Abilify Maintena is and what it is used for 
2. What you need to know before you are given Abilify Maintena 
3. How Abilify Maintena is given 
4. Possible side effects 
5. How to store Abilify Maintena 
6. Contents of the pack and other information 
 
 
1. What Abilify Maintena is and what it is used for 
 
Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called 
antipsychotics. It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or 
sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour 
and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. 
 
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised 
during treatment with oral aripiprazole. 
 
 
2. What you need to know before you are given Abilify Maintena 
 
Do not use Abilify Maintena: 
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor or nurse before you are given Abilify Maintena. 
 
Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor 
immediately if you are having any thoughts or feelings about hurting yourself. 
 
Before treatment with Abilify Maintena, tell your doctor if you suffer from 
 
• an acutely agitated state or a severely psychotic state 
• heart problems or have a history of stroke, especially if you know that you have other risks 

factors for stroke 
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts 

of urine, increase in appetite and feeling weak) or family history of diabetes 
• fits (seizures) since your doctor may want to monitor you more closely 
• involuntary, irregular muscle movements, especially in the face 



84 

• experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness 
or sleepiness (may be signs of neuroleptic malignant syndrome) 

• dementia (loss of memory and other mental abilities) especially if you are elderly 
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular 

disease, stroke or "mini" stroke, abnormal blood pressure 
• irregular heart beat or if someone else in your family has a history of irregular heart beat 

(including so called QT prolongation seen with ECG monitoring). 
• blood clots, or family history of blood clots, as antipsychotics have been associated with 

formation of blood clots 
• have any difficulty in swallowing 
• past experience with excessive gambling 
• severe liver problems. 
 
If you notice you are gaining weight, develop unusual movements, experience sleepiness that 
interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please 
talk to your doctor immediately. 
 
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to 
behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry 
out certain activities that could harm yourself or others. These are called impulse control disorders and 
can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high 
sex drive or preoccupation with an increase in sexual thoughts or feelings. 
Your doctor may need to adjust or stop your dose. 
 
Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in 
your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you 
are an elderly patient or have some debility. 
 
Children and adolescents 
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe 
and effective in these patients. 
 
Other medicines and Abilify Maintena 
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
 
Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to 
lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood 
pressure under control. 
 
Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose 
of Abilify Maintena or the other medicines. It is especially important to mention the following to your 
doctor: 
 
• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide) 
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, 

paroxetine, St. John's Wort) 
• antifungal medicines (such as ketoconazole, itraconazole) 
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors 

e.g. indinavir, ritonavir) 
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin) 
• medicines that are known to prolong QT prolongation. 
 
These medicines may increase the risk of side effects or reduce the effect of Abilify Maintena; if you 
get any unusual symptom taking any of these medicines together with Abilify Maintena, you should 
see your doctor. 
 



85 

Medicines that increase the level of serotonin are typically used in conditions including depression, 
generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as 
migraine and pain: 
 
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety 

disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 
• SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety 
• other anti-depressants (such as venlafaxine and tryptophan) used in major depression 
• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness 
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression 
• painkillers (such as tramadol and pethidine) used for pain relief 
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine. 
 
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of 
these medicines together with Abilify Maintena, you should see your doctor. 
 
Abilify Maintena with alcohol 
Alcohol should be avoided. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before receiving this medicine. 
 
You should not be given Abilify Maintena if you are pregnant unless you have discussed this with 
your doctor. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, 
or if you are planning to become pregnant. 
 
The following symptoms may occur in new-born babies, of mothers that have received Abilify 
Maintena in the last trimester (last three months of their pregnancy): 
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in 
feeding. 
 
If your baby develops any of these symptoms you need to contact your doctor. 
 
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breast-
feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You 
should not do both. Talk to your doctor about the best way to feed your baby if you are receiving 
Abilify Maintena. 
 
Driving and using machines 
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This 
should be considered in cases where full alertness is required, e.g., when driving a car or handling 
machines. 
 
Abilify Maintena contains sodium 
Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose. This means that the medicine is 
essentially ‘sodium-free’. 
 
 
3. How Abilify Maintena is given 
 
Abilify Maintena comes as a pre-filled syringe. 
 
Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended and 
starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose 
(300 mg, 200 mg or 160 mg). Treatment with aripiprazole by mouth is continued for 14 days after the 



86 

first injection. After that, treatment is given with injections of Abilify Maintena unless your doctor 
tells you otherwise. 
 
Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or 
shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the 
injections between your right and left side. The injections will not be given intravenously. 
 
If you are given more Abilify Maintena than you should 
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be 
given too much. If you see more than one doctor, be sure to tell them that you are receiving Abilify 
Maintena. 
 
Patients who have been given too much aripiprazole have experienced the following symptoms: 
 
• rapid heartbeat, agitation/aggressiveness, problems with speech. 
• unusual movements (especially of the face or tongue) and reduced level of consciousness. 
 
Other symptoms may include: 
 
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, 
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood 

pressure, abnormal rhythms of the heart. 
 
Contact your doctor or hospital immediately if you experience any of the above. 
 
If you miss an injection of Abilify Maintena 
It is important not to miss your scheduled dose. You should be given an injection every month but not 
before the 26 days has passed from the last injection. If you miss an injection, you should contact your 
doctor to arrange your next injection as soon as you can. 
 
If you stop receiving Abilify Maintena 
Do not stop your treatment just because you feel better. It is important that you carry on receiving 
Abilify Maintena for as long as your doctor has told you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Tell your doctor immediately if you have any of the following serious side effects: 
 
• a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, 

disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, 
weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to 
unconsciousness. 

• unusual movement mainly of the face or tongue, since your doctor may want to lower your 
dose. 

• if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you 
have a blood clot, which may travel through blood vessels to the lungs causing chest pain and 
difficulty in breathing. If you notice any of these symptoms seek medical advice immediately. 

• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness 
since this may be a sign of a condition called neuroleptic malignant syndrome (NMS). 

• thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, 
feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes. 

 



87 

The side effects listed below may also occur after receiving Abilify Maintena. 
 
Common side effects (may affect up to 1 in 10 people): 
 
• weight gain 
• diabetes mellitus 
• weight loss 
• feeling restless 
• feeling anxious 
• unable to keep still, difficulty sitting still 
• difficulty sleeping (insomnia) 
• jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle 

tone, slow body movement 
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move 

constantly) 
• shaking or trembling 
• uncontrollable twitching, jerking or writhing movements 
• changes in your level of alertness, drowsiness 
• sleepiness 
• dizziness 
• headache 
• dry mouth 
• muscle stiffness 
• inability to have or maintain an erection during sexual intercourse 
• pain at the injection site, hardening of the skin at the injection site 
• weakness, loss of strength or extreme tiredness 
• during blood tests your doctor may find higher amounts of creatine phosphokinase in your 

blood (enzyme important for muscle function) 
 
Uncommon side effects (may affect up to 1 in 100 people): 
 
• low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood 

cell count, low level of blood platelets 
• allergic reactions (hypersensitivity) 
• decreased or increased blood levels of the hormone prolactin 
• high blood sugar 
• increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol 

and low level of triglycerides 
• increased levels of insulin, a hormone regulating blood sugar levels 
• decreased or increased appetite 
• thoughts about suicide 
• mental disorder characterized by defective or lost contact with reality 
• hallucination 
• delusion 
• increased sexual interest 
• panic reaction 
• depression 
• affect lability 
• state of indifference with lack of emotion, feelings of emotional and mental discomfort 
• sleep disorder 
• grinding of teeth or clenching of the jaw 
• reduced sexual interest (libido is decreased) 
• altered mood 
• muscle problems 
• muscle movements that you cannot control such as grimacing, lip-smacking and tongue 

movements. They usually affect the face and mouth first but can affect other parts of the body. 
These could be signs of a condition called “tardive dyskinesia”. 



88 

• parkinsonism - medical condition with many various symptoms which include decreased or 
slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), 
shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling 

• movement problems 
• extreme restlesness and restless legs 
• distortion of the senses of taste and smell 
• fixation of the eyeballs in one position 
• blurred vision 
• eye pain 
• double vision 
• eye sensitivity to light, 
• abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, 

abnormal reading (ECG) of the heart 
• high blood pressure 
• dizziness when getting up from a lying or sitting position due to a drop in blood pressure 
• cough 
• hiccups 
• gastroesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the 

esophagus (gullet or the tube that goes from mouth to stomach through which food passes), 
causing heartburn and possibly damaging the esophagus 

• heartburn 
• vomiting 
• diarrhoea 
• feeling sick 
• stomach ache 
• stomach discomfort 
• constipation 
• frequent bowel movement 
• drooling, more saliva in mouth than normal 
• abnormal hair loss 
• acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin 

hardening 
• muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain 

in extremity 
• ,joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited 

opening of mouth 
• kidney stones, sugar (glucose) in urine 
• spontaneous flow of milk from the breasts (galactorrhoea) 
• enlargement of breast in men, breast tenderness, vaginal dryness 
• fever 
• loss of strength 
• gait disturbance 
• chest discomfort 
• injection site reactions such as redness, swelling discomfort and injection site itching 
• thirst 
• sluggishness 
• liver function tests may show abnormal results 
• during tests your doctor may find 

- higher amounts of liver enzymes 
- higher amounts of alanine aminotransferase 
- higher amounts of gamma-glutamyl transferase 
- higher amounts of bilirubin in your blood 
- higher amounts of aspartate aminotransferase 
- higher or lower amounts of blood glucose 
- higher amounts of glycosylated haemoglobin 
- lower amounts of cholesterol in your blood 
- lower amounts of triglycerides in your blood 



89 

- a higher waist circumference 
 
The following side effects have been reported since the marketing of oral aripiprazole but the 
frequency for them to occur is not known (frequency cannot be estimated from the available data): 
 
• low levels of white blood cells 
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash 
• unusual heartbeat, sudden unexplained death, heart attack 
• diabetic ketoacidosis (ketones in the blood and urine) or coma 
• loss of appetite (anorexia), difficulty in swallowing 
• low sodium level in the blood 
• suicide attempt and suicide 
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to 

you or others, which may include: 
- strong impulse to gamble excessively despite serious personal or family consequences 
- altered or increased sexual interest and behaviour of significant concern to you or to 

others, for example, an increased sexual drive 
- uncontrollable excessive shopping 
- binge eating (eating large amounts of food in a short time period) or compulsive eating 

(eating more food than normal and more than is needed to satisfy your hunger) 
- a tendency to wander away 
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of 
managing or reducing the symptoms. 

• nervousness 
• aggression 
• neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness, 

faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and 
heart rate) 

• seizure (fits) 
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 

clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles) 
• speech disorders 
• heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm 

that may be due to abnormal nerve impulses in the heart, abnormal readings during heart 
examination (ECG) QT prolongation 

• fainting 
• symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, 

pain and redness in the leg), which may travel through blood vessels to the lungs causing chest 
pain and difficulty in breathing 

• spasm of the muscles around the voice box 
• accidental inhalation of food with risk of pneumonia (lung infection) 
• inflammation of the pancreas 
• difficulty swallowing 
• liver failure 
• jaundice (yellowing of the skin and white part of eyes) 
• inflammation of the liver 
• rash 
• skin sensitivity to light 
• excessive sweating 
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have 

a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown 
which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) 

• difficulty in passing urine 
• involuntary loss of urine (incontinence) 
• drug withdrawal symptoms in new-born infant 
• prolonged and/or painful erection 
• difficulty controlling core body temperature or overheating 



90 

• chest pain 
• swelling of hands, ankles or feet 
• during tests your doctor may find 

- higher amounts alkaline phosphatase 
- fluctuating results during tests to measure glucose in your blood 

 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Abilify Maintena 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the pre-filled syringe. 
The expiry date refers to the last day of that month. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C 
for up to 2 hours. 
 
 
6. Contents of the pack and other information 
 
What Abilify Maintena contains 
- The active substance is aripiprazole. 

Each pre-filled syringe contains 300 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
Each pre-filled syringe contains 400 mg aripiprazole. 
After reconstitution each ml of suspension contains 200 mg aripiprazole. 
 

- The other ingredients are 
Powder 
Carmellose sodium, mannitol, sodium dihydrogen phosphate monohydrate, sodium hydroxide 
Solvent 
Water for injections 

 
What Abilify Maintena looks like and contents of the pack 
Abilify Maintena comes in a pre-filled syringe containing a white to off-white powder in the front 
chamber and a clear solvent in the rear chamber. Your doctor will make it into a suspension that will 
be given as an injection. 
 
Single pack 
Each single pack containing one pre-filled syringe and three hypodermic safety needles: one 25 mm 
(1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge. 
 
Multipack 
Bundle pack of 3 single packs. 
 
Not all pack sizes may be marketed. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


91 

Marketing Authorisation Holder 
Otsuka Pharmaceutical Netherlands B.V. 
Herikerbergweg 292 
1101 CT, Amsterdam 
Netherlands  
 
Manufacturer 
H. Lundbeck A/S 
Ottiliavej 9, 2500 Valby 
Denmark 
 
Elaiapharm 
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis 
06550 Valbonne 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Lundbeck S.A./N.V. 
Tél/Tel: +32 2 535 79 79 

Lietuva 
H. Lundbeck A/S 
Tel: +45 36301311 
 

България 
Lundbeck Export A/S Representative Office 
Tel: +359 2 962 4696 
 

Luxembourg/Luxemburg 
Lundbeck S.A. 
Tél: +32 2 535 79 79 

Česká republika 
Lundbeck Česká republika s.r.o. 
Tel: +420 225 275 600 

Magyarország 
Lundbeck Hungaria Kft. 
Tel: +36 1 4369980 
 

Danmark 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 
 

Malta 
H. Lundbeck A/S 
Tel: +45 36301311 

Deutschland 
Otsuka Pharma GmbH 
Tel: +49 69 1700860 
 

Nederland 
Lundbeck B.V. 
Tel: +31 20 697 1901 
 

Eesti 
H. Lundbeck A/S 
Tel: +45 36301311 
 

Norge 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 

Ελλάδα 
Lundbeck Hellas S.A. 
Τηλ: +30 210 610 5036 

Österreich 
Lundbeck Austria GmbH 
Tel: +43 1 266 91 08 
 

España 
Otsuka Pharmaceutical S.A. 
Tel: +34 93 208 10 20 
 

Polska 
Lundbeck Poland Sp. z o. o. 
Tel.: +48 22 626 93 00 

France 
Otsuka Pharmaceutical France SAS 
Tél: +33 (0) 1 47 08 00 00 
 

Portugal 
Lundbeck Portugal Lda 
Tel: +351 21 00 45 900 
 



92 

Hrvatska 
Lundbeck Croatia d.o.o. 
Tel.: +385 1 644 82 63 
 

România 
Lundbeck Export A/S 
Reprezentanta din Romania 
Tel: +40 21319 88 26 
 

Ireland 
Lundbeck (Ireland) Limited 
Tel: +353 1 468 9800 
 

Slovenija 
Lundbeck Pharma d.o.o. 
Tel.: +386 2 229 4500 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Lundbeck Slovensko s.r.o. 
Tel: +421 2 5341 42 18 
 

Italia 
Otsuka Pharmaceutical Italy S.r.l 
Tel: +39 02 00 63 27 10 
 

Suomi/Finland 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 

Κύπρος 
Lundbeck Hellas A.E 
Τηλ.: +357 22490305 

Sverige 
Otsuka Pharma Scandinavia AB 
Tel: +46 8 54528660 
 

Latvija 
H. Lundbeck A/S 
Tel: +45 36301311 

United Kingdom 
Otsuka Pharmaceuticals (UK) Ltd. 
Tel: +44 203 747 5300 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


93 

--------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 

 
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in 
pre-filled syringe 
aripiprazole 
 
Step 1: Preparation prior to reconstitution of the powder 
Lay out and confirm that components listed below are provided: 
- Abilify Maintena package leaflet and instructions for healthcare professionals. 
- One Abilify Maintena pre-filled syringe. 
- One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device. 
- One 38 mm (1.5 inch) 22 gauge hypodermic safety needle with needle protection device. 
- One 51 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device. 
- Syringe and needle instructions. 
 
Step 2: Reconstitution of the powder 
a) Push plunger rod slightly to engage threads. And then, rotate plunger rod until the rod stops 

rotating to release diluent. After plunger rod is at complete stop, middle stopper will be at the 
indicator line. 

 
 

 

 
 
 
 
 

Indicator line 

 

 

Plunger Rod 

 
b) Vertically shake the syringe vigorously for 20 seconds until the reconstituted suspension 

appears uniform. The suspension should be injected immediately after reconstitution. 
 

 

 

 

 
 
uniform 
milky white 
 

20 seconds 

 
c) Visually inspect the syringe for particulate matter and discoloration prior to administration. The 

reconstituted product suspension should appear to be a uniform, homogeneous suspension that 
is opaque and milky-white in colour. 



94 

 
d) If the injection is not performed immediately after reconstitution, the syringe can be kept below 

25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior 
to injection if the syringe has been left for more than 15 minutes. 

 
Step 3: Injection procedure 
a) Twist and pull off Over-cap and Tip-cap. 
 

 

 

 
Twist + 
Pull Off 
 
Over-cap 

 

 

Tip-cap 
 

Twist + Pull Off 
 

 
b) Select one of the following hypodermic safety needles depending on the injection site and 

patient’s weight. 
 

Body type Injection site Needle size 
 
Non-obese 

 
Deltoid 

 
25 mm (1 inch) 23 gauge 

 Gluteal 38 mm (1.5 inch) 22 gauge 
 
Obese 

 
Deltoid 

 
38 mm (1.5 inch) 22 gauge 

 Gluteal 51 mm (2 inch) 21 gauge 
 
c) While holding the needle cap, ensure the needle is firmly seated on the safety device with a 

push. Twist clockwise until snugly fitted. 
 

 

 

 
 
Needle cap 

 
d) Then pull needle-cap straight up. 
 

 
 

Needle cap 

 

 
 
Pull 
 



95 

 
e) Hold syringe upright and advance plunger rod slowly to expel the air. If it's not possible to 

advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop. It is 
not possible to re-suspend after the air in the syringe is expelled. 

 

*If there’s resistance or 
difficulty expelling air, check 
that plunger rod is rotated to a 

complete stop.  

 
 
Expel air until suspension fills needle 
base* 

 
 
f) Slowly inject into the gluteal or deltoid muscle. Do not massage the injection site. Care must be 

taken to avoid inadvertent injection into the blood vessel. Do not inject into an area with signs 
of inflammation, skin damage, lumps and/or bruises. For deep intramuscular gluteal or deltoid 
injection only. 

 

 
deltoid gluteal 

 
Remember to rotate sites of injections between the two gluteal or deltoid muscles. Look for 
signs or symptoms of inadvertent intravenous administration. 

 
Step 4: Procedures after injection 
Engage the needle safety device. Dispose of the needle and pre-filled syringe appropriately after 
injection. 
 

 
Cover Discard 

 

 



96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX IV 
 

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS 
OF THE MARKETING AUTHORISATION(S) 

 



97 

Scientific conclusions 
 
Taking into account the PRAC Assessment Report on the PSUR(s) for aripiprazole, the scientific 
conclusions of CHMP are as follows: 
 
The cumulative review of post-marketing cases indicates there is an existence of potential association 
of aripiprazole and photophobia and the comparison of reference safety information documents, 
showed that photophobia is not a new ADR. Of the 97 post-marketing cases, in 33 cases (34 %) a 
possible role of aripiprazole could not be excluded (this is based on temporal association, and 
improvement/recovery of symptoms either on discontinuation or dose reduction of aripiprazole), and 
there were 25 (26 %) cases in which there was a positive dechallenge, and 2 cases with a rechallenge 
positive. Moreover, results of the medical safety review of Abilify and Abilify Maintena cases from 
the clinical trials indicated that the incidence rate for aripiprazole was 0.2 % (52/28729) compared to 
placebo 0.0 % (4/9234). 
 
Of note, the CCDS for the originator product already mentions the ADR photophobia following 
administration of oral Abilify during clinical trials. Also, the US-SmPC includes photophobia. 
 
The PRAC considers that Photophobia should be listed in SmPC section 4.8 of all aripiprazole 
containing products, with frequency “Uncommon”, under SOC Eye disorders. 
 
The CHMP agrees with the scientific conclusions made by the PRAC. 
 
Grounds for the variation to the terms of the marketing authorisation(s) 
 
On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefit-
risk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed 
changes to the product information. 
 
The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)