Medicinal Products

ABILIFY 7.5 mg / mL

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: Otsuka Pharma Europe Ltd

Injectable solution
Carton of 1 bottle of 1.3 ml
All forms

Indication

ABILIFY solution for injection is indicated for the rapid control of agitation and behavioral disturbances in schizophrenic patients or patients with a manic episode in bipolar I disorder when oral therapy is not available. adapted. Treatment with aripiprazole solution for injection should be discontinued and replaced with oral aripiprazole as soon as the clinical condition of the patient permits.

Dosage ABILIFY 7.5 mg / mL Solution for injection Carton of 1 vial of 1.3 ml

Dosage

The recommended initial dose of aripiprazole solution for injection is 9.75 mg (1.3 ml), administered as a single intramuscular injection. The effective dose range of aripiprazole solution for injection is 5.25 to 15 mg in a single injection. A lower dose of 5.25 mg (0.7 ml) may be administered depending on the clinical status of the patient and any drugs already administered as maintenance therapy or acute treatment (see section 4.5). and other forms of interaction ). A second injection may be given 2 hours after the first depending on the clinical condition of the patient. No more than three injections of aripiprazole per 24 hours.

The maximum daily dose of aripiprazole is 30 mg (including all galenic forms of aripiprazole).

For further information on continuing oral aripiprazole therapy, refer to the summary of the characteristics of ABILIFY tablets, ABILIFY orodispersible tablets or ABILIFY oral solution.

Pediatric population: There is no experience in children and adolescents under 18 years of age.

Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, there is insufficient data to make recommendations. Administration should be cautious in these patients. However, the maximum daily dose of 30 mg may be used with caution in patients with severe hepatic impairment (see section 5.2 ).

Patients with renal impairment: No dose adjustment is required in patients with renal impairment.

Elderly patients: The efficacy of ABILIFY solution for injection in patients 65 years of age and older has not been established. Due to the greater sensitivity of this population, a lower initial dose should be considered when clinical reasons warrant (see Warnings and Precautions ) section.

Gender: No dosage adjustment is required in women over men (see section 5.2 ).

Smokers: No dose adjustment is required for smokers in view of ABILIFY metabolism (see section 4.5).

Dose adjustments related to interactions:

When concomitant use of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole, the aripiprazole dose should be reduced. When the CYP3A4 inhibitor or CYP2D6 is discontinued, the aripiprazole dose should be increased (see section 4.5 ).

When co-administering CYP3A4 inducers with aripiprazole, the aripiprazole dose should be increased. When the CYP3A4 inducer is stopped, the aripiprazole dose should be reduced to the recommended dosage (see section 4.5 ).

Administration mode

ABILIFY solution for injection is used intramuscularly.

To increase absorption and reduce variability, it is recommended to inject into the deltoid muscle or to make a deep intramuscular injection into the gluteus maximus, avoiding the fat regions.

ABILIFY solution for injection should not be administered intravenously or subcutaneously. ABILIFY solution for injection is ready for use and is intended for short-term use only (see section 5.1 Pharmacodynamic properties ).

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Abilify side effects

Adults:

The most commonly reported adverse events in placebo-controlled clinical trials were nausea, dizziness, and somnolence, each occurring in more than 3% of patients treated with aripiprazole solution for injection.


The following side effects have been reported more frequently (≥ 1/100) than with placebo or have been identified as clinically significant adverse events (*) in clinical studies with aripiprazole solution for injection (see section 5.1 ).

The frequencies below are defined using the following convention: frequent (≥ 1/100 to <1/10) and infrequent (≥ 1/1000 to <1/100).

Nervous system disorders

Common: drowsiness, dizziness, headache, akathisia

Heart conditions

Uncommon: tachycardia *

Vascular disorders

Low: orthostatic hypotension *, increased diastolic blood pressure *

Gastrointestinal disorders

Common: nausea, vomiting

Uncommon: dry mouth *

General disorders and administration site conditions

Uncommon: fatigue *

The following side effects have been reported more frequently (> 1/100) than placebo, or have been identified as clinically significant adverse events (*) in clinical studies with oral aripiprazole (see section 5.1). ):

Psychiatric disorders

Frequent: agitation, insomnia, anxiety

Uncommon: depression *

Nervous system disorders

Common: extrapyramidal disorders, akathisia, tremor, dizziness, somnolence, sedation, headache

Eye disorders

Common: vision disorder

Heart conditions

Uncommon: tachycardia *

Vascular disorders

Uncommon: orthostatic hypotension *

Gastrointestinal disorders

Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion

General disorders and administration site conditions

Frequency: tiredness


Extrapyramidal symptoms: Schizophrenia: In a 52-week long-term controlled clinical trial, the incidence of extrapyramidal symptoms, including parkinsonism, akathisia, dystonia and dyskinesia, was lower overall in aripiprazole-treated patients (25.8%). %) compared to patients treated with haloperidol (57.3%). In a 26-week long-term, placebo-controlled clinical study, the incidence of extrapyramidal symptoms was 19% in the aripiprazole-treated patients and 13.1% in the placebo-treated patients. In another 26-week long-term controlled clinical study, the incidence of extrapyramidal symptoms was 14.8% in the aripiprazole-treated patients and 15.1% in the olanzapine-treated patients. Manic episodes in bipolar I disorder - in a 12-week controlled clinical trial, the incidence of extrapyramidal symptoms was 23.5% in aripiprazole-treated patients and 53.3% in haloperidol-treated patients. In another 12-week clinical study, the incidence of extrapyramidal symptoms was 26.6% in patients treated with aripiprazole and 17.6% in patients treated with lithium. In the 26 - week long - term placebo controlled clinical trial, the incidence of extrapyramidal symptoms was 18.2% in aripiprazole - treated patients and 15.7% in placebo - treated patients.


In placebo-controlled clinical studies, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo. In schizophrenic patients, the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.


Dystonia: Class effect: symptoms of dystonia, prolonged abnormal contractions of a muscle group have been reported in patients predisposed during the first days of treatment. Dystonic symptoms include spasm of the neck muscles, sometimes progressing to oppression of the throat, difficulty swallowing, difficulty breathing, and / or protrusion of the tongue. While these symptoms may occur at low doses, they have been reported more frequently and with greater severity with high-potency and higher-dose first-generation antipsychotics. A high risk of acute dystonia has been observed in groups of men and youth.


Among patients who experienced changes in standard and lipid parameters that could be clinically significant (see section 5.1 ), there was no significant difference in clinical status between the aripiprazole group and the placebo group. Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole-treated patients and 2.0% of placebo-treated patients.


Other data:

Adverse reactions known to be associated with antipsychotic medications have also been reported during treatment with aripiprazole (neuroleptic malignant syndrome, tardive dyskinesia, convulsions, cerebrovascular adverse events and increased mortality in elderly patients with dementia, hyperglycaemia and diabetes) (see section Warnings and precautions for use ).


Pediatric population:


Schizophrenia in adolescents aged 15 and over:

In a short-term placebo-controlled clinical trial in 302 schizophrenic adolescents (aged 13 to 17 years), the frequency and nature of adverse events were similar to those of adults, with the exception of the following reactions that were reported more frequently in adolescents taking oral aripiprazole compared to adults taking oral aripiprazole (and more frequently than placebo): drowsiness / sedation and extrapyramidal disorder were very common (≥ 1/10), dry mouth, increased appetite and orthostatic hypotension have been reported frequently (≥ 1/100, <1/10).

The safety profile in an open-label 26-week extension trial was similar to that seen in the short-term placebo-controlled trial.

Pooled analysis of a population of adolescents (aged 13 to 17 years) with schizophrenia, exposed to the product for up to 2 years, reveals low plasma prolactin incidence in girls (<3 ng / ml) and boys (<2 ng / ml) of 29.5% and 48.3%, respectively.


Manic Episodes in Bipolar I Disorder in Adolescents Aged 13 Years and Older: The frequency and nature of adverse events in adolescents with bipolar I disorder were similar to those seen in adults at baseline. exception of the following reactions: very frequently (≥ 1/10) drowsiness (23.0%), extrapyramidal disorders (18.4%), akathisia (16.0%) and fatigue (11.8%); frequently (≥ 1/100, <1/10) upper abdominal pain, increased heart rate, weight gain, increased appetite, muscle contractions and dyskinesia.


The following adverse events had a possible dose-effect relationship: extrapyramidal disorders (the incidence was 9.1% at a dose of 10 mg, 28.8% at a dose of 30 mg and 1.7% for placebo) ; and akathisia (the incidence was 12.1% at a dosage of 10 mg, 20.3% at a dosage of 30 mg and 1.7% for placebo).


Mean weight changes in adolescents with bipolar I disorder after 12 and 30 weeks were 2.4 kg and 5.8 kg with aripiprazole and 0.2 kg and 2.3 kg, respectively. placebo.


In the pediatric population, somnolence and fatigue were observed more frequently in patients with bipolar disorder compared to those with schizophrenia.


In the pediatric population with bipolar disorder (patients aged 10 to 17 years), exposed to the product for periods up to 30 weeks, the incidence of low plasma prolactin levels was 28.0% in females ( <3 ng / ml) and 53.3% in boys.


Adverse reactions reported after marketing:

The following side effects have been reported after marketing. The frequency of these effects is considered unknown (can not be estimated from the available data).

Hematological and lymphatic system disorders:

leukopenia, neutropenia, thrombocytopenia

Immune system disorders:

allergic reactions (eg anaphylactic reaction, angioedema including swelling of the tongue, edema of the tongue, edema of the face, pruritus or urticaria)

Endocrine disorders:

hyperglycemia, diabetes mellitus, ketoacidosis diabetes, hyperosmolar diabetic coma

Metabolism and nutrition disorders:

weight gain, weight loss, anorexia, hyponatremia

Psychiatric disorders:

agitation, nervousness, pathological gambling; suicide attempt, suicidal ideation, suicide accomplished (see Warnings and Precautions for Use section ).

Nervous system disorders:

slurred speech, neuroleptic malignant syndrome (NMS), epilepticus, serotonin syndrome

Heart conditions:

QT prolongation, ventricular arrhythmia, unexplained sudden death, cardiac arrest, torsades de pointes, bradycardia

Vascular disorders:

syncope, hypertension, thromboembolic events (including pulmonary embolism and deep vein thrombosis)

Respiratory, thoracic and mediastinal disorders:

oropharyngeal spasm, laryngeal spasm, swallowing pneumonia

Gastrointestinal disorders:

pancreatitis, dysphagia, discomfort in the abdomen, discomfort in the stomach, diarrhea

Hepatobiliary disorders:

liver failure, jaundice, hepatitis, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased gamma glutamyl transferase (GGT), increased alkaline phosphatase

Skin and subcutaneous tissue disorders:

rash, photosensitivity reaction, alopecia, hyperhidrosis

Musculoskeletal and systemic disorders:

rhabdomyolysis, myalgia, stiffness

Pregnancy, puerperium and perinatal disorders:

neonatal drug withdrawal syndrome (see section Pregnancy and breastfeeding )

Renal and urinary disorders:

urinary incontinence, urinary retention

Disorders of the reproductive organs and the breast:

priapism

General disorders and administration site defects:

disorder of temperature regulation (eg hypothermia, fever), chest pain, peripheral edema

investigations:

increased creatine phosphokinase, increased blood glucose, change in blood glucose, increased glycosylated hemoglobin

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