Launch Webinar
Lundbeck Ireland Ltd are pleased to announce that Abilify Maintena® 960 mg every two months, prolonged-release suspension for injection in pre-filled syringe will be available from the 10th June . Please join us for the Abilify Maintena® 960 mg Ireland Launch webinar with Dr Leslie Citrome.
Abilify Maintena® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. Prescribing information is available on Medicines.ie
This is a promotional webinar organised and financially supported by Lundbeck Ireland Ltd.
Healthcare professionals attending this meeting will have the opportunity to acquire useful knowledge that educates themselves and their peers, ultimately improving patient outcomes.
For further information, please contact your local Lundbeck representative.
Martin Dunican – DUNI@Lundbeck.com +353 86 8329 749
Tim Mulcahy – timm@lundbeck.com +353 87 2408 001
Peter Gray – PGRY@Lundbeck.com +353 86 3882 596
- Job bag number: IE-ASMT-0044
- Date of preparation: Date of preparation: June 2024
- ABBREVIATED PRESCRIBING INFORMATION ABILIFY MAINTENA® (aripiprazole) POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION ABILIFY MAINTENA® POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. PRESENTATIONS: Powder and solvent for prolonged-release suspension for injection: Vial with 400mg aripiprazole. Powder and solvent for prolonged-release suspension for injection in pre-filled syringe: Pre-filled syringe with 400mg aripiprazole. Prolonged-release suspension for injection in pre-filled syringe: Pre-filled syringe with 720mg aripiprazole; Pre-filled syringe with 960mg aripiprazole. INDICATION: Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. DOSAGE AND ADMINISTRATION: For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiation. Titration of the dose for Abilify Maintena is not required. For patients transitioning from 400mg once monthly, the 960mg is recommended no sooner than 26 days after previous injection of 400mg, and every 2 months (56 days) thereafter. Starting dose can be administered as one injection start or as two injection start. One injection start: Following oral therapy, one injection of Abilify Maintena® 400mg or 960mg should be administered. Continue daily treatment with 10mg to 20mg oral aripiprazole for 14 consecutive days to maintain therapeutic aripiprazole concentration during initiation of therapy. Two injection start for 400mg: Two separate injections of Abilify Maintena® 400mg should be administered at two different injection sites, along with one 20mg dose of oral aripiprazole. Maintenance: After either the one or the two injection start with Abilify Maintena® 400mg, the recommended maintenance dose of Abilify Maintena® is 400mg once monthly as a single injection (no sooner than 26 days after the previous injection). Consider dose reduction if adverse reactions experienced. See SmPC for further details. Two injection start for 960mg: Following oral therapy, one injection of Abilify Maintena® 960mg and one injection of Abilify Maintena® 400mg should be administered at two different injection sites (see method of administration), along with one 20mg dose of oral aripiprazole. Maintenance: After one or two 960mg injection start, the recommended maintenance dose is one injection of Abilify Maintena® 960mg every second month (once every two months as a single injection 56 days after the previous injection). Consider reducing the dose to 720mg once every two months if adverse reactions experienced. See SmPC for further details. Method of Administration: Intramuscular injection. Suspension should be injected slowly as a single injection (doses must not be divided) into gluteal or deltoid muscle (care should be taken to avoid inadvertent injection into a blood vessel). DO NOT inject two injections concomitantly into the same deltoid or gluteal muscle. 960mg/720mg: For gluteal intramuscular injection only (alternate between right and left side). 400mg: For known CYP2D6 poor metabolisers administer in either two separate deltoid muscles, or one deltoid and one gluteal muscle. DO NOT inject into two gluteal muscles. Special populations: Hepatic impairment: No dose adjustment required for mild-moderate hepatic impairment. Manage dose cautiously in severe hepatic impairment. Oral formulation should be preferred. Renal impairment: No dose adjustment required. Elderly: Safety and efficacy not established in patients ≥65 years old. Paediatrics: Safety and efficacy in children and adolescents aged 0-17 not established. For advice on use with known CYP2D6 poor metabolisers, or concomitant use with CYP3A4 inhibitors/inducers or CYP2D6 inhibitors, see SmPC. See SmPC for instructions on missed doses, reconstitution and injection procedure. CONTRAINDICATIONS: Hypersensitivity to active substance or excipients. WARNINGS AND PRECAUTIONS: During antipsychotic treatment, improvement in clinical condition may take days to weeks – monitor closely. Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted. Suicidality: Reported early after initiation or switch of antipsychotic treatment – closely supervise high risk patients. Cardiovascular disorders: Use with caution in patients with known cardiovascular disease, cerebrovascular disease, conditions which would predispose patients to hypotension or hypertension, including accelerated or malignant. Cases of venous thromboembolism (VTE) have been reported with antipsychotics. All possible VTE risk factors should be identified before and during treatment and preventive measures taken. QT prolongation: Use with caution in patients with a family history of QT prolongation. Tardive dyskinesia: Discontinuation or dose reduction should be considered if patient experiences signs/symptoms of tardive dyskinesia. Symptoms can temporally deteriorate or even arise after treatment discontinuation. Neuroleptic malignant syndrome (NMS): Rare cases reported during clinical trials. If patient develops signs and symptoms indicative of NMS or unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued. Seizure: Use with caution in patients who have a history of seizure disorder or have conditions associated with seizures. Elderly patients with dementia-related psychosis: Not indicated for 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, have been reported. Observe for signs and symptoms of hyperglycaemia and monitor diabetes mellitus patients, or those at risk of diabetes mellitus, regularly for worsening glucose control. Hypersensitivity: Hypersensitivity reactions may occur. Weight gain: Has been reported post-marketing with oral aripiprazole, usually in those with significant risk factors . Dysphagia: Use with caution in patients at risk for aspiration pneumonia. Oesophageal dysmotility and aspiration have been associated with the use of aripiprazole. Gambling disorder and other impulse control disorders: Increased urges can be experienced while taking aripiprazole, and inability to control urges e.g. gambling, sexual urges, compulsive shopping, binge or compulsive eating. Patients or caregivers should be asked about development of new or increased urges. If urges develop during treatment, consider dose reduction or treatment cessation. Falls: May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. Caution should be taken when treating patients at higher risk (e.g., elderly or debilitated patients), and a lower starting dose should be considered. Sodium: Abilify Maintena contains sodium (<1 mmol/dose). INTERACTIONS: Aripiprazole has potential to enhance effect of certain antihypertensives. Caution when administering with alcohol or CNS medicines with overlapping effects such as sedation. Caution if administered with medicines known to cause QT prolongation or electrolyte imbalance. Monitor for serotonin syndrome if aripiprazole is used concomitantly with serotonergic medicines such as Selective Serotonin Reuptake Inhibitors (SSRI)/ Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) or medicines known to increase aripiprazole concentrations. Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided. For advice on use with CYP2D6 inhibitors or CYP3A4 inhibitors or inducers see SmPC. ABILITY TO DRIVE AND USE MACHINES: 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. FERTILITY, PREGNANCY AND LACTATION: Should not be used in pregnancy, or in women planning to become pregnant, unless clearly necessary. Neonates exposed to antipsychotics during third trimester of pregnancy at risk of reactions including extrapyramidal and/or withdrawal symptoms: monitor carefully. Aripiprazole/metabolites are excreted in breast milk. Patients currently under treatment or who have been treated in the past 34 weeks should not breast feed. OVERDOSE: Supportive therapy, maintain an adequate airway, oxygenation and ventilation, management of symptoms with cardiovascular monitoring, including continuous electrocardiographic monitoring with close medical supervision and monitoring. UNDESIRABLE EFFECTS: Refer to Section 4.8 of the SPC for complete information on side effects. Common (≥1/100 to <1/10): Weight increaseda , diabetes mellitus, weight decreased, agitation, anxiety, restlessness, insomnia, extrapyramidal disorder, akathisia, tremor, dyskinesia, sedation, somnolence, dizziness, headache, dry mouth, musculoskeletal stiffness, erectile dysfunction, injection site paina, injection site induration, fatigue, blood creatine phosphokinase increased. a Reported as very common in Abilify Maintena 960mg/720mg clinical trials. LEGAL CATEGORY: Prescription Only Medicine (POM) MARKETING AUTHORISATION (MA) NUMBERS: Abilify Maintena® powder and solvent for prolonged-release suspension for injection: Single pack vial of 400mg powder, 2mL vial of solvent and syringes, (EU/1/13/882/002); Single pack of pre-filled syringe of 400mg, (EU/1/13/882/006); Single pack of pre-filled syringe of 960mg, (EU/1/13/882/010). MA HOLDER: Otsuka Pharmaceutical Netherlands B.V, Herikerbergweg 292, 1101 CT, Amsterdam, The Netherlands. FURTHER INFORMATION AVAILABLE ON REQUEST FROM: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin. Tel. 01 4689800 DATE OF REVISION: June 2025 REFERENCE: IE-ABIM-0350
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Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck (Ireland) Ltd on: 01 4689800 or by email to: SafetyLuIreland@lundbeck.com
Hourly Schedule
New Day
- 12:00 - 13:00
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Speakers:
Dr Leslie Citrome
- 13:00
- Meeting Close
Dr Leslie Citrome
clinical professor of psychiatry and behavioral sciences
Dr. Citrome is clinical professor of psychiatry and behavioral sciences at New York Medical College in Valhalla, New York, clinical professor of psychiatry at SUNY Upstate Medical University, and adjunct clinical professor of psychiatry, Icahn School of Medicine at Mount Sinai in New York City, New York. He is a Distinguished Life Fellow of the American Psychiatric Association and a Fellow of the American Society of Clinical Psychopharmacology where he currently serves as Immediate Past-President. In addition to his academic positions, he has a private practice in psychiatry in Pomona, New York and is a volunteer consultant to the Assertive Community Treatment team/Mental Health Association of Rockland County.
Date
- 21 Jun 2024
- Expired!
Time
- 12:00 pm - 1:00 pm
Location
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This event will be Online only