Medicinal Products

ABILIFY MAINTENA 300 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Aripiprazole
laboratory: Otsuka Pharma France Sas

Powder and solvent for injectable suspension for sustained release
box of 1 bottle of powder + solvent bottle (+ set) of 150 ml
All forms

Indication

ABILIFY MAINTENA is indicated for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

Dosage ABILIFY MAINTENA 300 mg powder and solvent for suspension for injection for prolonged release box of 1 vial of powder + vial of solvent (+ set) of 150 ml

ABILIFY MAINTENA is indicated for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Adverse effects Abilify Maintena Lp

Summary of the security profile

The most commonly reported adverse events, reported in at least 5% of patients in two controlled clinical trials and double-blind with Abilify Maintena, are weight gain (9.0%), akathisia (7.9%), insomnia (5.8%) and pain at the injection site (5.1%).

List of adverse reactions presented in tabular form

The incidence of adverse events associated with aripiprazole therapy is presented below in tabular form. The table is based on adverse events reported during clinical trials and / or post-marketing use.

All adverse reactions are listed by organ system class and frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1 / 100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), and indeterminate frequency (can not be estimated from the available data). Within each frequency class, adverse effects are presented in order of decreasing severity.

The frequency of adverse reactions reported during post-marketing use can not be determined since they are derived from spontaneous reports. As a result, the frequency of these adverse events is described as "undetermined".

Frequent

Rare

Not known frequency

Hematological disorders

and the lymphatic system

neutropenia

Anemia

thrombocytopenia

Reduced neutrophils

Decreased white blood cells

leukopenia

Affections of

system

immune

hypersensitivity

Allergic reaction (eg anaphylactic reaction, edema

of Quincke including swelling of the tongue, edema of the tongue, edema of the face, pruritus

or hives)

affections

endocrine

Prolactinemia decreased Hyperprolactinemia

Hyperosmolar diabetic coma

Diabetic ketoacidosis

Metabolism and nutrition disorders

Diabetes weight gain

Weightloss

hyperglycemia

hypercholesterolemia

hyperinsulinemia

hyperlipidemia

hypertriglyceridemia

Appetite disorder

Anorexia

hyponatremia

affections

psychiatric

agitation

Anxiety

impatiences

Insomnia

Suicidal ideation

Hallucination psychotic disorder

Delusional idea

hypersexuality

Panic Depression Reaction

Affective Lability

Apathy

dysphoria

Sleep disorder

bruxism

Decreased libido Altered mood

Suicide

Suicide attempt

Pathological gambling

Nervousness

Aggressiveness

Nervous system disorders

Trouble

extrapyramidal

akathisia

tremor

dyskinesia

Sedation

Drowsiness

Sensation

breakneck

cephalalgia

dystonia

Late dyskinesia Parkinsonism

Movement Disruption Psychomotor Hyperactivity Restless Legs Syndrome

Pallid stiffness

hypertonia

bradykinesia

hypersalivation

dysgeusia

parosmia

Malignant syndrome of

neuroleptics

State of great evil

epileptic

Syndrome

serotonin

Language disorder

affections

eye

Oulogyric crisis

Blurry vision

Eye pain

diplopia

affections

heart

Ventricular extrasystoles

bradycardia

tachycardia

Amplitude wave T

decreased to

electrocardiogram

Electrocardiogram

unnatural

Inverted wave T at

electrocardiogram

Unexplained sudden death

Cardiac arrest

Torsades de pointes Ventricular arrhythmias

QT lengthened

affections

vascular

Hypertension

Orthostatic hypotension Increased blood pressure

Syncope

thromboembolism

venous (including

pulmonary embolism and deep vein thrombosis)

Respiratory, thoracic and mediastinal disorders

Cough

Oropharyngeal Spasm Laryngospasm

Swallowing pneumonia

affections

gastrointestinal

intestinal

Dry mouth

Gastroesophageal reflux

Dyspepsia

Vomiting

Diarrhea

nausea

Abdominal pain high Abdominal discomfort

Constipation

Frequent stools

ptyalism

pancreatitis

dysphagia

affections

Hepatobiliary

Abnormal liver function Enhanced hepatic enzymes

Alanine aminotransferase increased

Gamma-glutamyltransferase

increased

Bilirubinemia increased Aspartate aminotransferase increased

Hepatic failure

icterus

Hepatitis

Increased alkaline phosphatase

Skin and subcutaneous tissue disorders

Alopecia

Acne

rosacea

Eczema

Induration of the skin

rash

Reaction

photosensitivity

Hyperhidrosis

Musculoskeletal and systemic disorders

Muscular stiffness

skeletal

Muscle stiffness Muscle contractures Fascicular contractions Muscle tension

myalgia

Painful extremities

arthralgia

Back pain

Joint amplitude

decreased

Rigidity of the neck

lockjaw

rhabdomyolysis

Renal and urinary disorders

nephrolithiasis

glycosuria

Urinary retention Urinary incontinence

Pregnancy, puerperium and perinatal disorders

Negative drug withdrawal syndrome (see section Pregnancy and lactation )

Reproductive system disorders and

breast

erectile dysfunction

galactorrhoea

gynecomastia

Breast hypersensitivity Vulvovaginal dryness

priapism

General disorders and administration site conditions

Pain at the injection site

Induration at the injection site

Tired

Fever

Asthenia

Walking disorders

Chest discomfort

Reaction to the site

injection

Erythema developed

injection

Swelling in focus

injection

Injury at the injection site

Pruritus at the injection site

Thirst

Indolence

Disturbance of thermoregulation (eg hypothermia,

fever)

Chest pain

Peripheral edema

investigations

creatine

phosphokinase

sanguine

increased

Increased blood sugar

Decreased blood glucose Increased glycosylated hemoglobin

Increased waist circumference

Fluctuation of blood glucose

Decreased cholesterolemia Triglyceridemia decreased

Description of selected adverse reactions

Injection site reactions

During the double-blind controlled phases of two trials, reactions at the injection site were observed; they were generally of mild to moderate intensity and disappeared over time. Pain at the injection site (incidence 5.1%) occurs within a median time of 2 days after injection and persists for a median of 4 days.

In an open-label study comparing the bioavailability of Abilify Maintena administered in the deltoid or gluteal muscle, injection site-related reactions were slightly more frequent in the deltoid muscle. They were generally mild and improved during subsequent injections. When compared to studies in which Abilify Maintena was injected into the gluteal muscle, the repeated occurrence of pain at the injection site is more common in the deltoid muscle.

leukopenia

Cases of neutropenia have been reported during the clinical development of Abilify Maintena; it usually begins around the 16th day after the first injection and persists for a median of 18 days.

Extrapyramidal symptoms

In trials in patients with stable schizophrenia, Abilify Maintena was associated with a higher frequency of extrapyramidal symptoms (18.4%) than with oral aripiprazole (11.7%). Akathisia was the most commonly observed symptom (8.2%); it usually appears around the 10th day after the first injection and persists for a median of 56 days.

Patients with akathisia have generally received anticholinergic therapy, including benzatropine mesylate and trihexyphenidyl. Drugs such as propranolol and benzodiazepines (clonazepam and diazepam) have also been administered to control akathisia, but at a lower frequency.

In terms of frequency, parkinsonism came in second (respectively 6.9% in the Abilify Maintena group, 4.15% in the aripiprazole group tablets [10 to 30 mg] and 3.0% in the placebo group).

dystonia

Class effect: symptoms of dystonia, prolonged abnormal contractions of a muscle group, may occur during the first days of treatment in patients who are predisposed. Dystonic symptoms include spasm of the neck muscles that may progress to throat tightness, swallowing difficulties, breathing difficulties and / or protrusion of the tongue. Although these symptoms may occur at low doses, they occur more frequently and with greater severity with powerful, high-dose, first-generation antipsychotics. A high risk of acute dystonia is observed in men and young patients.

Weight

During the double-blind controlled- versus- active phase (aripiprazole tablet 10 to 30 mg) of the 38-week trial, the incidence of weight gain ≥ 7% between baseline and last visit was 9, 5% in the Abilify Maintena group and 11.7% in the oral aripiprazole tablet group (10 to 30 mg). The incidence of weight loss ≥ 7% between baseline and 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 trial, the incidence of ≥7% weight gain between baseline and last visit was 6.4% in the Abilify Maintena group and 5.2% in the placebo group. The incidence of weight loss ≥ 7% between baseline and last visit was 6.4% in the Abilify Maintena group and 6.7% in the placebo group. During the double-blind treatment, the change in body weight between baseline and last visit was -0.2 kg for Abilify Maintena and -0.4 kg for placebo (p = 0.812).

hyperprolactinemia

In clinical trials for approved and post-marketing indications, an increase and a decrease in serum prolactin levels were both observed compared to the initial value after treatment with aripiprazole (section Pharmacodynamic properties ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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