ABILIFY MAINTENA 400mg Injection/Powder and Solvent for Suspension for

What is ABILIFY MAINTENA 400mg

ABILIFY MAINTENA 400mg is a long-acting injectable antipsychotic medication containing the active ingredient aripiprazole monohydrate. It is supplied as a powder and solvent for suspension in two separate vials—a glass vial of powder and a glass vial containing 2 ml of solvent. This formulation is designed for intramuscular injection, providing sustained delivery of aripiprazole over an extended period, typically one month.

• It is primarily indicated for maintenance treatment of schizophrenia in adult patients who have demonstrated stability on oral aripiprazole.
• ABILIFY MAINTENA is used to improve treatment adherence by reducing the frequency of dosing compared to daily oral medications.
• The long-acting formulation helps maintain steady plasma drug concentrations, which may reduce the risk of relapse and hospitalization.
• This medicine is part of the second-generation (atypical) antipsychotics class, known for its favorable side effect profile compared to older typical antipsychotics.
• It is prescribed and administered under careful medical supervision, usually by healthcare professionals experienced in managing psychiatric conditions.

In summary, ABILIFY MAINTENA 400mg offers an effective and convenient option for long-term schizophrenia management through monthly intramuscular injections.

How to use ABILIFY MAINTENA 400mg

Correct administration of ABILIFY MAINTENA 400mg is crucial for efficacy and safety. Here are detailed instructions:

• Preparation: Reconstitute the powder with the provided 2 ml solvent using aseptic technique. Shake gently until a uniform suspension forms.
• Route of Administration: Administer the suspension via deep intramuscular injection, preferably into the gluteal muscle.
• Dosing Schedule: Given once every 4 weeks (approximately monthly). Consistency in timing is important to maintain therapeutic plasma levels.
• Oral Supplementation: When initiating ABILIFY MAINTENA, continue oral aripiprazole for 14 days to maintain effective drug levels during the transition to the injectable form.
• Injection Technique: Use appropriate needle size for deep IM injection to avoid local reactions and ensure full delivery of the dose.
• Monitoring: Monitor patients for injection site reactions, extrapyramidal symptoms, or signs of worsening mental status.
• Missed Doses: If a dose is missed, consult a healthcare provider promptly; dosing intervals should be maintained as closely as possible.
• Storage and Handling: Use immediately after reconstitution; do not shake vigorously to avoid foam formation.

Following these guidelines ensures optimal absorption, sustained drug action, and minimized adverse effects.

Mode of Action ABILIFY MAINTENA 400mg

ABILIFY MAINTENA contains aripiprazole, an atypical antipsychotic with a unique pharmacological profile:

• Partial Agonist at Dopamine D2 Receptors: Unlike traditional antipsychotics that fully block dopamine receptors, aripiprazole partially stimulates these receptors, balancing dopamine activity and reducing symptoms like psychosis without excessive blockade.
• Partial Agonist at Serotonin 5-HT1A Receptors: This action contributes to anxiolytic and antidepressant effects, improving mood and cognitive function.
• Antagonist at Serotonin 5-HT2A Receptors: Blocking these receptors helps reduce psychotic symptoms and the risk of extrapyramidal side effects commonly seen with typical antipsychotics.
• Modulation of Other Neurotransmitters: Aripiprazole has additional mild effects on adrenergic and histaminergic receptors, contributing to its overall efficacy and tolerability.
• Long-Acting Delivery: The intramuscular suspension slowly releases aripiprazole into systemic circulation, maintaining therapeutic plasma levels for approximately four weeks.

This mechanism provides symptom control in schizophrenia by stabilizing dopamine and serotonin pathways implicated in psychosis and mood regulation.

ABILIFY MAINTENA 400mg Interactions ABILIFY MAINTENA 400mg

Understanding potential drug interactions with ABILIFY MAINTENA is essential for patient safety:

• CYP3A4 and CYP2D6 Modulators: Aripiprazole is metabolized primarily via CYP3A4 and CYP2D6 enzymes. Strong inhibitors (e.g., ketoconazole, fluoxetine) can increase aripiprazole levels, raising side effect risk. Inducers (e.g., carbamazepine, rifampin) may reduce effectiveness.
• Other CNS-active Drugs: Caution when combined with other antipsychotics, antidepressants, benzodiazepines, or mood stabilizers due to additive CNS depressant or serotonergic effects.
• Antihypertensive Agents: Aripiprazole may enhance hypotensive effects, requiring blood pressure monitoring.
• Drugs Prolonging QT Interval: Combined use with other QT-prolonging drugs (e.g., certain antiarrhythmics) can increase risk of arrhythmias.
• Alcohol: Alcohol may exacerbate CNS depressant effects and impair judgment; avoidance is recommended.
• Smoking: Smoking induces CYP1A2, which does not majorly metabolize aripiprazole but can influence some concomitant drugs, requiring holistic consideration.

Always review patient medications comprehensively to anticipate and manage interactions.

Dosage of ABILIFY MAINTENA 400mg

Proper dosing of ABILIFY MAINTENA is crucial for balancing efficacy and tolerability:

• Standard Dose: 400 mg administered once every 4 weeks as a deep intramuscular injection.
• Initiation: Patients should be stabilized on oral aripiprazole before starting to ensure tolerability and efficacy.
• Oral Overlap: Continue oral aripiprazole for 14 days after the first injection to maintain therapeutic plasma concentrations.
• Dose Adjustments: In patients with hepatic or renal impairment or those taking CYP3A4/2D6 inhibitors, dose adjustments or more frequent monitoring may be needed.
• Missed Dose: If an injection is delayed beyond 6 weeks, oral supplementation is recommended until the next injection can be administered.
• Lower Doses: Available in 300 mg and Aristada Initio for flexible titration or for patients sensitive to side effects.

Dosing decisions must be individualized and guided by clinical response and tolerability.

Possible side effects of ABILIFY MAINTENA 400mg

Like all medications, ABILIFY MAINTENA may cause side effects. Common and serious effects include:

• Common Side Effects: Injection site pain or swelling, headache, insomnia, anxiety, nausea, weight gain, and dizziness.
• Extrapyramidal Symptoms: Tremors, rigidity, akathisia (restlessness), and tardive dyskinesia (involuntary movements) may occur.
• Metabolic Effects: Changes in blood glucose, lipid abnormalities, and weight changes require monitoring.
• Neuroleptic Malignant Syndrome: Rare but potentially fatal syndrome characterized by fever, muscle rigidity, altered mental status, and autonomic dysfunction.
• Orthostatic Hypotension: Can lead to dizziness and falls, especially in elderly patients.
• Increased Risk of Suicidal Thoughts: Particularly in young adults; close monitoring is essential.
• Other: Allergic reactions, seizures (rare), and increased prolactin levels.

Patients should be educated to report any unusual symptoms promptly to their healthcare provider.

ABILIFY MAINTENA 400mg Contraindications ABILIFY MAINTENA 400mg

Use of ABILIFY MAINTENA is contraindicated in the following conditions:

• Known hypersensitivity to aripiprazole or any component of the formulation.
• History of neuroleptic malignant syndrome or severe adverse reactions to other antipsychotics.
• Severe hepatic or renal impairment where metabolism or excretion may be compromised (consult specialist advice).
• Patients with untreated or unstable medical conditions that might be exacerbated by antipsychotic therapy (e.g., uncontrolled diabetes, severe cardiovascular disease).
• Use caution in elderly patients with dementia-related psychosis due to increased mortality risk.
• Pregnancy and breastfeeding unless benefits clearly outweigh risks (consult healthcare provider).

Always evaluate patient history and comorbidities before prescribing ABILIFY MAINTENA.

Storage of ABILIFY MAINTENA 400mg

Proper storage of ABILIFY MAINTENA ensures medication stability and efficacy:

• Store the powder vial and solvent vial separately in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Protect from light and moisture by keeping in the original packaging until use.
• Do not freeze the product; freezing may damage the suspension properties.
• After reconstitution, the suspension should be used immediately and not stored.
• Keep out of reach of children and pets to prevent accidental ingestion or injury.
• Check expiration dates and do not use after expiry.
• Follow local regulations for safe disposal of unused or expired medication.

Maintaining proper storage conditions is essential for preserving the drug’s therapeutic properties.