Abilify

Medication Overview

Abilify, with its active ingredient aripiprazole, is an atypical antipsychotic medication. It was first approved by the FDA in 2002 and is manufactured by Otsuka Pharmaceutical Co. and Bristol Myers Squibb.

Indications for Use

Abilify is indicated for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years. It is also approved for acute treatment and maintenance treatment of manic and mixed episodes associated with bipolar I disorder, as monotherapy and as an adjunct to lithium or valproate in adults and pediatric patients aged 10 to 17 years. It serves as an adjunctive treatment for major depressive disorder in adults and is indicated for the treatment of irritability associated with autistic disorder in pediatric patients aged 6 to 17 years. Additionally, Abilify maintains efficacy in preventing relapse in stabilized patients and for Tourette’s disorder in pediatric patients aged 6 to 18 years.

Pharmacological Action

Abilify functions primarily as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and as an antagonist at serotonin 5-HT2A receptors. The mechanism of action is complex and not fully understood, but it is thought to balance dopamine and serotonin levels to improve thinking, mood, and behavior.

Dosage Forms and Strengths

Abilify is available in several dosage forms, including tablets, orally disintegrating tablets (ODT), oral solution, and injection. The tablet strengths include 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. ODTs are available in 10 mg and 15 mg strengths. The oral solution is available as a 1 mg/mL solution, and the injectable form is available as a 9.75 mg/1.3 mL single-dose vial.

Dosing Instructions

Recommended starting dose for adults with schizophrenia is 10 to 15 mg once daily, which can be increased to a maximum of 30 mg/day. For bipolar mania, the starting dose typically ranges from 15 mg once daily as monotherapy to 10 to 15 mg once daily as adjunctive therapy, titrating as needed. For major depression adjunct therapy, the recommended starting dose is 2 to 5 mg/day with a maintenance dose of 5 to 15 mg/day. Pediatric dosing varies based on the indication and age, and should follow professional guidelines.

Administration Guidance

Abilify can be taken with or without food. Patients should not drink alcohol while taking Abilify. For ODTs, ensure hands are dry before handling the tablet and place it on the tongue to dissolve; do not push the tablet through the foil as it may break. The oral solution can be measured with a supplied syringe, and injection should only be administered by healthcare professionals.

Drug Interactions

Abilify may interact with inhibitors and inducers of CYP3A4 and CYP2D6, which can affect its metabolism. Potent inhibitors like ketoconazole can increase aripiprazole levels, while inducers such as carbamazepine can decrease them. Concomitant use with other CNS agents may increase sedation and orthostatic hypotension. Caution is advised when Abilify is used with antihypertensives, as it may enhance their effects.

Side Effects Profile

Common side effects include akathisia, headache, insomnia, and nausea. More serious side effects, albeit rare, encompass neuroleptic malignant syndrome, tardive dyskinesia, seizures, and metabolic changes, such as hyperglycemia, dyslipidemia, and weight gain. Orthostatic hypotension can occur, particularly when initiating therapy or increasing the dosage.

Special Populations Consideration

Elderly patients with dementia-related psychosis are at an increased risk of death with antipsychotic use and should not take Abilify for this indication. Caution is advised in patients with known cardiovascular disease, cerebrovascular disease, seizure disorders, or conditions predisposing them to hypotension. Adjustments in the dosing may be required for patients with hepatic and renal impairment.

Storage and Handling

Abilify tablets and ODTs should be stored at room temperature, away from light and moisture. The oral solution should be used within 6 months after opening, and stored at room temperature. The injectable form must be stored refrigerated and used shortly after opening.

Discontinuation Considerations

Sudden discontinuation can result in withdrawal symptoms or worsening of psychiatric condition. Tapering of the dose is recommended when discontinuing treatment with Abilify, rather than abrupt cessation, unless there are overriding safety concerns.

Pregnancy and Lactation

Abilify is a Category C drug for pregnant women, indicating that risk to the fetus cannot be ruled out. Patients should notify their healthcare provider if they become pregnant or intend to become pregnant while taking Abilify. The medication is excreted in human breast milk, and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Monitoring Patient Response

Ongoing monitoring is crucial for patients on Abilify. This includes monitoring for symptom improvement, side effects, weight, glucose and lipid levels, and any potential movement disorders. Blood pressure should also be monitored, particularly at the beginning of treatment or during dose changes.

Overdose Management

In case of overdose, provide immediate medical attention. Supportive measures and symptomatic treatments are recommended. Activated charcoal may be administered. Aripiprazole does not have a specific antidote, and dialysis is unlikely to be beneficial due to its high serum protein binding.