Dosing & Uses
Dosage Forms & Strengths
tablet
- 2mg
- 5mg
- 10mg
- 15mg
- 20mg
- 30mg
tablet, embedded with ingestible event marker (IEM) sensor (Abilify MyCite)
- 2mg
- 5mg
- 10mg
- 15mg
- 20mg
- 30mg
- Abilify MyCite system is composed of the following components:
- Aripiprazole tablet embedded with an ingestible event marker (IEM) sensor
- MyCite patch (wearable sensor) that detects the signal from the IEM sensor after ingestion and transmits data to a smartphone
- MyCite APP, a smartphone application (app) which is used with a compatible smartphone to display information for the patient
- Web-based portal for healthcare professionals and caregivers
oral disintegrating tablet
- 10mg
- 15mg
oral solution
- 1mg/mL
extended-release injectable IM suspension (Abilify Maintena)
- 300mg/vial or prefilled dual chamber syringe
- 400mg/vial or prefilled dual chamber syringe
extended-release injectable IM suspension (aripiprazole lauroxil [Aristada])
- 441mg/prefilled syringe (300 mg of aripiprazole)
- 662mg/prefilled syringe (450 mg of aripiprazole)
- 882mg/prefilled syringe (600 mg of aripiprazole)
- 1064mg/prefilled syringe (724 mg of aripiprazole)
extended-release injectable IM suspension (aripiprazole lauroxil [Aristada Initio])
- 675mg/2.4mL prefilled syringe (459 mg of aripiprazole)
Schizophrenia
Also see Administration
PO
- 10-15 mg/day PO initially; may increase after 2 weeks at each dose strength; not to exceed 30 mg/day PO when administered as tablet formulation; efficacy not significantly greater above 15 mg/day
Abilify Maintena
- Patients who have never taken aripiprazole
- 400 mg IM once monthly initially
- Establish tolerability with aripiprazole PO prior to initiating treatment with Abilify Maintena; may take up to ~ 2 weeks to fully assess tolerability
- Continue aripiprazole PO (10-20 mg/day) or other antipsychotics PO in patients with known aripiprazole tolerance for 14 consecutive days after initial injection
- Patients stabilized or aripiprazole tolerant
- 400 mg IM once monthly
- Administer monthly dose no sooner than 26 days after previous injection (also see Dosage Modifications)
- Consider dose reduction to 300 mg/month if adverse reaction occurs
Aristada
- Establish tolerability with PO aripiprazole before initiating Aristada; may take up to 2 weeks to fully assess tolerability
- Base initial Aristada dose on current aripiprazole PO dose; coadminister aripiprazole PO for 21 consecutive days
- 10 mg/day PO: 441 mg IM once monthly
- 15 mg/day PO: 662 mg IM once monthly or 882 mg IM q6wk or 1064 mg IM q2mo
- ≥20 mg/day PO: 882 mg IM once monthly
- Adjust dose and dosing interval as needed; take into consideration the pharmacokinetics and prolonged-release characteristics of Aristada In the event of early dosing, Aristada should not be given earlier than 14 days after the previous injection
Aristada Initio
- Indicated in combination with aripiprazole PO for the initiation of Aristada when used for the treatment of schizophrenia
- Used a single dose to initiate Aristada treatment or as a single dose to re-initiate Aristada treatment following a missed dose of Aristada
- Establish tolerability with aripiprazole PO prior to initiating treatment with Aristada Initio; may take up to ~ 2 weeks to fully assess tolerability
- After establishing tolerability with aripiprazole PO, administer the first Aristada IM injection (441 mg, 662 mg, 882 mg, or 1064 mg) in conjunction with both: One dose of Aristada Initio 675 mg IM and one dose of aripiprazole 30 mg PO
- Aristada Initio is only to be used as a single dose and is not for repeated dosing
- First Aristada extended-release IM injection may be administered on the same day as Aristada Initio or up to 10 days thereafter (Refer to Aristada for prescribing information)
- Also see Dosing Considerations
Bipolar Mania
PO
- Indicated for acute and maintenance treatment of manic or mixed episodes associated with bipolar I disorder, either as monotherapy or as adjunct to lithium or valproate
- Monotherapy: 15 mg/day PO initially; may be increased gradually; not to exceed 30 mg/day
- Adjunct to lithium or valproate: 10-15 mg/day PO initially; recommended daily dose is 15 mg/day; may be gradually increased; not to exceed 30 mg/day
- Continue stabilization dose for up to 6 weeks; treatment >6 weeks not studied
Abilify Maintena
- Patients who have never taken aripiprazole
- 400 mg IM once monthly initially
- Administer only by deep IM injection into deltoid or gluteal muscle by healthcare professional
- Establish tolerability with aripiprazole PO prior to initiating treatment with Abilify Maintena; may take up to ~ 2 weeks to fully assess tolerability
- Continue aripiprazole PO (10-20 mg/day) or other PO antipsychotics in patients with known aripiprazole tolerance for 14 consecutive days after initial injection
- Patients stabilized or aripiprazole tolerant
- 400 mg IM once monthly
- Administer monthly dose no sooner than 26 days after previous injection (also see Dosage Modifications)
- Consider dose reduction to 300 mg/month if adverse reaction occurs
Major Depressive Disorder
2-5 mg/day PO initially; increased weekly PRN by ≤5 mg/day to dose range of 2-15 mg/day
Used adjunctively with other antidepressants
Dosage Modifications (Oral)
Poor metabolizers and drugs that affect cytochrome-P 450
- Known CYP2D6 poor metabolizers: Administer half of recommended dose
- Known CYP2D6 poor metabolizers taking concomitant strong
- CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%)
- Strong CYP2D6 or CYP3A4 inhibitors: Administer half of recommended dose
- Strong CYP2D6 AND CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%)
- Strong CYP3A4 inducers: double recommended dose over 1-2 weeks
Dosage Modifications (Abilify Maintena)
CYP2D6 poor metabolizers: 300 mg IM
CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitor: 200 mg IM
Patients taking 400 mg IM
- Strong CYP2D6 OR CYP3A4 inhibitors: 300 mg IM
- CYP2D6 AND CYP 3A4 inhibitors: 200 mg IM
- CYP3A4 inducers: Avoid use
Patients taking 300 mg IM
- Strong CYP2D6 OR CYP3A4 inhibitors: 200 mg IM
- CYP2D6 AND CYP3A4 inhibitors: 160 mg IM
- CYP3A4 inducers: Avoid use
Dosage Modifications (Aristada)
No dosage changes if CYP450 modulators are added for <2 wk
Strong CYP3A4 inhibitor for >2 wk
- Reduce the dose to the next lower strength No dosage adjustment necessary in patients taking 441 mg, if tolerated
- Poor CYP2D6 metabolizers: Reduce dose to 441 mg from 662 mg, 882 mg, or 1064 mg; no dosage adjustment necessary in patients taking 441 mg, if tolerated
Strong CYP2D6 inhibitor for >2 wk
- Reduce the dose to the next lower strength
- No dosage adjustment necessary in patients taking 441 mg, if tolerated
- Poor CYP2D6 metabolizers: No dose adjustment required
Both strong CYP3A4 and CYP2D6 inhibitors for >2 wk
- Avoid use for patients taking 662 mg, 882 mg, or 1064 mg
- No dosage adjustment necessary in patients taking 441 mg, if tolerated
CYP3A4 inducers for >2 wk
- No dose adjustment for 662 mg, 882 mg, or 1064 mg
- Increase the 441 mg dose to 662 mg
Dosage Modifications (Aristada Initio)
Only available at a single strength as a single-dose prefilled syringes, so no dosage adjustments are possible
CYP2D6 poor metabolizers, strong CYP3A4 inhibitors, and strong CYP3A4 inducers: Avoid use
Hepatic impairment
- Mild-to-severe (Child-Pugh score 5-15): No dosage adjustment necessary
Renal impairment
- Mild-to-severe (GFR 15-90 mL/min): No dosage adjustment necessary
Dosing Considerations
Aristada Initio
- Not interchangeable with Aristada due to differing pharmacokinetic profiles
Abilify MyCite indications
- Treatment of adults with schizophrenia
- Adjunctive treatment of adults with major depressive disorder Treatment of bipolar I disorder
- Treatment of bipolar I disorder
- Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate
- Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate
Abilify MyCite detection
- Most ingestions will be detected within 30 minutes, although it may take up to 2 hr for the smartphone app and web portal to detect the ingested tablet
- In some cases, the ingested tablet may not be detected
- If the tablet is not detected after ingestion, do not repeat the dose
Dosage Forms & Strengths
tablet
- 2mg
- 5mg
- 10mg
- 15mg
- 20mg
- 30mg
tablet, orally disintegrating
- 10mg
- 15mg
oral solution
- 1mg/mL
Schizophrenia
Indicated for treatment of schizophrenia in adolescents aged13-17 years
<13 years: Safety and efficacy not established
13-17 years: 2 mg/day PO initially; increase to 5 mg/day after 2 days; may further increase to recommended dose of 10 mg/day after additional 2 days; subsequent doses may increase by 5 mg/day; maintenance: 10-30 mg/day
Bipolar Mania
Indicated for acute manic or mixed episodes, either as monotherapy or as adjunct to lithium or valproate
10-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; may further increase to recommended dosage of 10 mg/day after additional 2 days; subsequent doses may increase by 5 mg/day; maintenance: 10-30 mg/day
Autism
Indicated for irritability associated with autistic disorder
<6 years: Safety and efficacy not established
6-17 years: 2 mg/day PO initially; increase gradually at ≥1 week intervals to target dosage of 5 mg/day; may gradually be further increase PRN to 10 mg/day or higher; not to exceed 15 mg/day
Tourette Disorder
Indicated for treatment of Tourette disorder
<6 years: Safety and efficacy not established
6-18 years (<50 kg)
- Initiate at 2 mg/day PO with a target dose of 5 mg/day after 2 days
- The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics
- Dosage adjustments should occur gradually at intervals of no less than 1 week
6-18 years (≥50 kg)
- Initiate at 2 mg/day PO for 2 days, and then increase to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8
- The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics
- Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week
Dosage Modifications (Oral)
Poor metabolizers and drugs that affect cytochrome-P 450
- Known CYP2D6 poor metabolizers: Administer half of recommended dose
- Known CYP2D6 poor metabolizers taking concomitant strong
- CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%)
- Strong CYP2D6 or CYP3A4 inhibitors: Administer half of recommended dose
- Strong CYP2D6 AND CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%)
- Strong CYP3A4 inducers: double recommended dose over 1-2 weeks
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Weight gain (8-30%)
Headache (27%)
Agitation (19%)
Insomnia (18%)
Anxiety (17%)
Nausea and vomiting (11-15%)
Akathisia (10-13%)
Lightheadedness (11%)
Constipation (10-11%)
1-10%
Dizziness (10%)
Dyspepsia (9%)
Somnolence (5-8%)
Fatigue (6%)
Restlessness (6%)
Tremor (6%)
Dry mouth/xerostomia (5%)
Extrapyramidal disorder (5%)
Orthostatic hypotension (1-5%)
Musculoskeletal stiffness (4%)
Abdominal discomfort (3%)
Blurred vision (3%)
Cough (3%)
Pain (3%)
Myalgia (2%)
Rash
Rhinitis
Aripiprazole lauroxil
- Extrapyramidal symptoms (5-7%)
- Injection site reactions (4%)
- Pain at injection site (<2%)
- Increased weight (<2%)
- Increased creatinine phosphokinase (<2%)
- Akathisia (<2%)
- Headache (<2%)
- Insomnia (<2%)
- Restlessness (<2%)
<1%
Altered mental status
Autonomic instability
Dysphagia
Hyperpyrexia
Muscle rigidity
Neuroleptic malignant syndrome (NMS)
Seizure
Tardive dyskinesia
Aripiprazole lauroxil
- Cardiac – Angina pectoris, tachycardia, palpitations
- Gastrointestinal disorders – Constipation, dry mouth
- General disorders – Asthenia
- Musculoskeletal – Muscular weakness
- Nervous system disorders – Dizziness
- Psychiatric disorders – Anxiety, suicide
Postmarketing Reports
Pathological gambling
Hiccups
Falls
Aripiprazole lauroxil
- Occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups and blood glucose fluctuation
Warnings
Black Box Warnings
Dementia-related Psychosis
- Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths reported in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
Suicidal thoughts and behaviors
- Aripiprazole PO and Abilify injection only
- Antidepressants increased risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses, as shown in short-term studies; monitor for worsening and emergence of suicidal thoughts and behaviors
Contraindications
Hypersensitivity to aripiprazole
Cautions
Risk of extrapyramidal symptoms (EPS) (eg, pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia; monitor
Tardive dyskinesia may occur; may consider discontinuation of therapy if clinically indicated
Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability
May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Use caution in patients with known cardiovascular disease, cerebrovascular disease, or predisposition to hypotension; may increase incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack, including fatalities)
Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope
Use caution in patients with Parkinson disease; may aggravate motor disturbances
May increase risk of suicidal tendencies in children and adolescents (see Black Box Warnings)
FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings)
Patients may act on dangerous impulses (eg, gambling)
Monitor for orthostatic hypotension
May cause seizures or convulsions; use cautiously in patients with history of seizures or with conditions that lower the seizure threshold
May cause CNS depression, which may impair physical or mental abilities; use caution when operating heavy machinery
Use caution in patients at risk of pneumonia; antipsychotic therapy has been associated with esophageal dysmotility and aspiration
Impairment of core body temperature regulation possible; use caution in dehydration, heat exposure, strenuous exercise, and concomitant medication possessing anticholinergic effects
Potential dosing and medication errors
- Aristada and Aristada Initio
- Medication errors (eg, substitution, dispensing errors) between Aristada and Aristada Initio may occur
- Aristada Initio is intended only for single administration
- Do not substitute Aristada Initio for Aristada because of differing pharmacokinetic profiles
Leukopenia, neutropenia, and agranulocytosis
- Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
- If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/mcL in absence of other causative factors, and continue monitoring WBC count until recovery
Metabolic changes
- Atypical antipsychotics have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk, including dyslipidemia and body weight gain
- Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death; monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness; monitor glucose regularly in patients with and at risk for diabetes
- Significant weight gain reported with therapy; monitor waist circumference and BMI
Drug interaction overview
- See Dosage Modifications
- Strong CYP3A4 and CYP2D6 inhibitors: Coadministration of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone
- Strong CYP3A4 inducers: Coadministration of oral aripiprazole with strong CYP3A4 inducers decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone
- Antihypertensives: Due to its alpha adrenergic antagonism, aripiprazole may potentiate the effects of certain antihypertensive agents; avoid concomitant use with Aristada Initio
- Benzodiazepines: Orthostatic hypotension and the intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone; avoid concomitant use with Aristada Initio
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy; For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; limited published data on aripiprazole use in pregnant women are not sufficient to inform any drug-associated risks for birth defects or miscarriage; no teratogenicity observed in animal reproductive studies with intramuscular administration of drug
Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder reported in neonates exposed to antipsychotic drugs during the third trimester of pregnancy; symptoms have varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recover within hours or days without specific treatment; others required prolonged hospitalization
Lactation
Aripiprazole is present in human breast milk; however, there are insufficient data to assess amount in human milk, effects on breastfed infant, or effects on milk production; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Atypical antipsychotic; partial agonist at dopamine D2 and serotonin type 1 (5-HT1A) receptors; antagonist at serotonin type 2 (5-HT2A) receptor; also has alpha-blocking activity
Aristada Initio
- Prodrug of aripiprazole and its activity is primarily due to aripiprazole, and to a lesser extent dehydro-aripiprazole (major metabolite of aripiprazole), which has been shown to have affinities for D2 receptors similar to aripiprazole and represents 30-40% of the aripiprazole exposure in plasma
Absorption
Bioavailability: 87% (tablet); 100% (IM)
Peak plasma time: 1-3 hr (IR); 5-7 hr (ER); 3-5 hr (tablet); ~27 days (Aristada Initio)
Distribution
Protein bound: 99%
Vd: 404 L (aripiprazole IV); 268 L (Aristada Initio)
Metabolism
Metabolized by CYP2D6 and CYP3A4
Metabolites: Dehydroaripiprazole (40%)
Elimination
Half-life: 75 hr (parent drug); 94 hr (metabolite); 30-47 days (IM); 146 hr (poor metabolizers)
Half-life, Aristada Initio: 15-18 days
Excretion: Feces (55%), urine (25%)
Administration
Oral Administration
Oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level; patient receiving 30 mg tablets should receive 25 mg of solution
Tablet
- May take with or without food
- Swallow tablet whole; do not divide, crush, or chew
ODT
- Dosing for orally disintegrating tablets (ODT) is the same as for the oral tablets
- May take with or without food
- Do not open the blister until ready to take the ODT
- Remove 1 ODT by opening the package and peeling back the foil on the blister to expose the tablet
- Do not push the tablet through the foil because this could damage the tablet
- Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ODT on tongue
- Tablet disintegration occurs rapidly in saliva; recommended to take without liquid, however, if needed, it can be taken with liquid
- Do not attempt to split the tablet
Abilify MyCite
- May take with or without food
- Swallow tablet whole; do not divide, crush, or chew
- MyCite Patch
- Apply the MyCite patch only when instructed by the app to the left side of the body just above the lower edge of the rib cage
- Do not place the patch in areas where the skin is scraped, cracked, inflamed, or irritated, or in a location that overlaps the area of the most recently removed patch
- Instruct patients to keep the patch on when showering, swimming, or exercising
- Change patch weekly or sooner as needed
- The app will prompt patient to change the patch and will direct patient to apply and remove the patch correctly
- Patients undergoing an MRI need to remove their patch and replace with a new one as soon as possible
- If there is skin irritation, instruct patients to remove the patch
IM Preparation (Abilify Maintena)
Do no substitute IM long-acting depot suspension formulations
Vial
- Reconstitute lyophilized power with sterile water for injection (SWI); discard any unused portion of diluent
- 400 mg/vial: 1.9 mL SWI
- 300 mg/vial: 1.5 mL SWI
- Final concentration for either vial is 200 mg/mL following reconstitution
- Slowly inject SWI into vial; shake the vial vigorously for 30 seconds until the reconstituted suspension appears uniform, homogeneous suspension that is opaque and milky-white.
- Do not store reconstituted suspension in syringe Refer to manufacturer’s labeling for full preparation technique
- Inject full syringe contents immediately following reconstitution
- Immediate use is recommended; maintain vial at room temperature if dose is not immediately given; shake for 60 seconds to resuspend particles prior to injection; discard unused portion
Prefilled syringe
- Reconstitute at room temperature
- Rotate the syringe plunger rod to release diluent
- Shake vigorously for 20 seconds or until the suspension is uniform; the resulting suspension will be milky white and opaque (refer to manufacturer’s labeling for full preparation technique)
- Inject full syringe contents immediately following reconstitution
For both formulations, select appropriate hypodermic needle after completing IM preparation
Needle for gluteal injection
- Nonobese patient: 22-ga, 1.5-in
- Obese patient: 21-ga, 2-in
Needle for deltoid injection
- Nonobese patient: 23-ga, 1-in
- Obese patient: 22-ga, 1.5-in
IM Preparation (Aristada)
Tap syringe at least 10 times to dislodge any material which may have settled
Shake the syringe vigorously for a minimum of 30 secs to ensure a uniform suspension; if the syringe is not used within 15 min, shake again for 30 secs
Injection site and associated needle length
- 441 mg dose (deltoid): 21-ga, 1-in or 20-ga, 1.5-in
- 441 mg, 662 mg, 882 mg, or 1064 mg doses (gluteal): 20-ga, 1.5-in or 20-ga 2-in
Attach appropriate needle with a clockwise twisting motion; do not overtighten (could lead to needle hub cracking)
Prime syringe to remove air by bringing the syringe into upright position and tap the syringe to bring air to the top; remove air by depressing the plunger rod; a few drops of suspension will be released
Administer the entire content IM; inject in a rapid and continuous manner in <10 seconds
Cover the needle by pressing the safety device, then dispose the needle, and used and unused items in proper waste container
IM Preparation (Aristada Initio)
Tap syringe at least 10 times to dislodge any material which may have settled
Shake the syringe vigorously for a minimum of 30 secs to ensure a uniform suspension
If syringe is not used within 15 min, shake again for 30 secs
Injection site and associated needle length
- Deltoid: 21 gauge, 1-in or 20 gauge 1.5-in
- Gluteal: 20 gauge, 1-in or 20 gauge 1.5-in
Attach appropriate needle securely with a clockwise twisting motion; do NOT overtighten; overtightening could lead to needle hub cracking
Prime syringe to remove air
Bring syringe into upright position and tap the syringe to bring air to the top Inject in a rapid and continuous manner
Product requires a RAPID injection; do not hesitate
Administer the entire content IM; do not inject by any other route
Dispose of needle and any unused items
IM Administration
Must be administered by a healthcare professional
For IM use only; do not administer IV or SC
Abilfy Maintena
- Slowly inject dosage volume as a single IM injection into the deltoid or gluteal muscle
- Do not massage the injection site
- Missed doses (Abilify Maintena)
- 2nd or 3rd dose missed (>4 wk but <5 wk since last injection): Administer injection as soon as possible
- 2nd or 3rd dose missed (>5 wk since last injection): Restart concomitant oral aripiprazole for 14 days with next administered injection
- 4th or subsequent doses missed (>4 wk but <6 wk since last injection): Administer injection as soon as possible
- 4th or subsequent doses missed (>6 wk since last injection): Restart concomitant oral aripiprazole for 14 days with next administered injection
Aristada
- Administer the entire syringe content IM; inject in a rapid and continuous manner in <10 seconds
- 441 mg once monthly: Administer in deltoid or gluteal muscle
- 662 mg monthly, 882 mg monthly or q6wk: Administer in gluteal muscle
- 1064 mg q2mo: Administer in gluteal muscle
Missed doses (Aristada)
- When a dose is missed, administer the next injection as soon as possible, unless the time has exceed 6-8 wk
- Supplemental PO doses should be the same as when the patient initiated Aristada
- See the following for recommendations for missed doses based on last injection dose
- Monthly 441 mg
- ≤6 wk: No PO supplementation required
- >6 wk and ≤7 wk: Supplement with 7 days of PO aripiprazole OR single dose of Aristada Initio
- >7 wk: Supplement with 21 days of PO aripiprazole OR reinitiate with a single dose of Aristada Initio and a single dose of aripiprazole 30 mg PO
- Monthly 662 mg, monthly 882 mg, or 882 mg q6wk
- ≤8 wk: No PO supplementation required
- >8 wk and ≤12 wk: Supplement with 7 days of PO aripiprazole OR single dose of Aristada Initio
- >12 wk: Supplement with 21 days of PO aripiprazole OR reinitiate with a single dose of Aristada Initio and a single dose of aripiprazole 30 mg PO
- 1064 mg q2mo
- ≤10 wk: No PO supplementation required
- >10 wk and ≤12 wk: Supplement with 7 days of PO aripiprazole OR single dose of Aristada Initio
- >12 wk: Supplement with 21 days of PO aripiprazole OR reinitiate with a single dose of Aristada Initio and a single dose of aripiprazole 30 mg PO
Storage
PO solution and tablets: Store 25°C (77°F), excursions permitted between 15- 30°C (59-86°F); use oral solution within 6 months after opening
Abilify Maintena (prefilled dual chamber syringe): Store below 30°C (86°F); do not freeze; protect the syringe from light by storing in the original package until time of use
Abilify Maintena (vial): Store at room temperature 25°C (77°F), excursions permitted between 15- 30°C (59-86°F)
Aristada: Store at room temperature 25°C (77°F), excursions permitted between 15-30°C (59-86°F)
Aristada Initio: Store at room temperature 20-25°C (68-77°F) with excursions permitted between 15-30°C (between 59-86°F); do not freeze
Abilify MyCite
- Tablets
- Store 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)
- Do not store in humid conditions (eg, bathroom)
- Patch (wearable sensor)
- Store between 15-30°C (59-86°F) and 15-93% relative humidity
Images
Patient Handout
Formulary
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