Abilify

Name: Abilify

Abilify Side Effects

Common Side Effects of Abilify

Tell your doctor if any of the following side effects become severe or don’t go away:

  • Headache
  • Drowsiness
  • Dizziness
  • Heartburn
  • Nervousness
  • Diarrhea or constipation
  • Stomach pain
  • Increased appetite
  • Pain
  • Increased saliva

Abilify and Weight Gain

Weight gain is a common side effect of Abilify.

However, adopting a healthy lifestyle that includes a well-balanced diet and an exercise routine can minimize this unwanted effect.

Serious Side Effects of Abilify

Call your doctor right away if you experience any of the mood or behavior effects listed in the Warning section or any of the following serious symptoms:

  • Fast, slow, or irregular heartbeat
  • Difficulty breathing
  • Tightening in the throat or difficulty swallowing
  • Seizures
  • Chest pain
  • Vision changes
  • High fever
  • Uncontrollable face or body movements
  • Confusion
  • Sweating
  • Rash, hives, or itching
  • Swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or legs
  • Muscle stiffness

Abilify Dosage

Abilify comes as a tablet, disintegrating tablet, liquid, injection solution, and extended-release injection.

The starting oral dose for adults with schizophrenia or bipolar disorder is typically 10 milligrams (mg) to 15 mg daily. This dose can be increased to up to 30 mg a day.

You should take Abilify around the same time each day, with or without food.

To remove the disintegrating tablet from the packaging, use dry hands to peel back the foil and take the tablet out immediately. Do not try to push the tablet through the foil packaging.

Place the entire tablet on your tongue. It will quickly dissolve and can be taken without liquid. Do not try to split the tablet.

Your doctor may start you on a low dose of Abilify and gradually increase or decrease the dose depending on your response to the drug.

Abilify Overdose

Symptoms of an overdose include the following:

  • Muscle twitches or tremors
  • Nausea or vomiting
  • Drowsiness

If you suspect an overdose, you should contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Abilify

If you miss a dose of Abilify, take it as soon as you remember.

However, if it’s almost time for your next dose, skip the missed dose and continue on your regular medication schedule.

Don’t double up on doses to make up for a missed one.

Abilify Dosage and Administration

General

  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 76 77 78 (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

  • When switching from other antipsychotic agents to aripiprazole, abrupt discontinuance of previous agent may be acceptable for some patients with schizophrenia, but gradual discontinuance may be most appropriate for others.1 In all cases, minimize period of overlapping antipsychotic administration.1

Administration

Administer aripiprazole orally1 or by IM injection.1 118 Administer aripiprazole lauroxil by IM injection.119

Establish tolerability with oral aripiprazole prior to initiating IM therapy with extended-release aripiprazole or aripiprazole lauroxil.118 119

Oral Administration

Administer orally as conventional tablets, orally disintegrating tablets, or oral solution once daily without regard to meals.1 (See Food under Pharmacokinetics.)

Orally Disintegrating Tablets

Just prior to administration, peel open blister package; with dry hands, remove orally disintegrating tablet.1 Do not push tablet through foil.1

Place tablet on tongue to dissolve; manufacturer recommends taking without liquid, but may take with liquid, if necessary.1

Do not divide orally disintegrating tablet.1

IM Administration of Immediate-release Aripiprazole Injection

Immediate-release aripiprazole (9.75 mg per 1.3-mL vial) is used for agitation associated with schizophrenia or bipolar mania; do not confuse with extended-release formulations of aripiprazole (Abilify Maintena; available in 300- and 400-mg vials and prefilled syringes) or aripiprazole lauroxil (Aristada; available in 441-, 662-, and 882-mg prefilled syringes) used for schizophrenia.1 118 119

Administer immediate-release aripiprazole injection only by IM injection slowly and deeply into the muscle mass.1

Do not administer IV or sub-Q.1

IM Administration of Extended-release Aripiprazole (Abilify Maintena)

Extended-release IM aripiprazole is available in 300- and 400-mg vials and prefilled syringes; do not confuse this formulation with extended-release aripiprazole lauroxil (Aristada; available in 441-, 662-, and 882-mg prefilled syringes) or the immediate-release IM aripiprazole formulation (9.75 mg/vial) used for agitation associated with schizophrenia and bipolar mania.1 118

Must be administered by a healthcare professional.118

Administer extended-release aripiprazole injection only by deep IM injection slowly into the deltoid or gluteal muscle.118 Do not massage injection site following IM administration.118 Rotate injection sites.118

Administer monthly; allow at least 26 days to elapse between doses.118

Reconstitution

Abilify Maintena is commercially available in 2 types of kits that contain aripiprazole lyophilized powder in either single-use vials or prefilled dual-chamber syringes with all the components required for reconstitution and administration (e.g., sterile water for injection diluent, needles, syringes); consult manufacturer's instructions for use for specific information on preparation, reconstitution, and administration.118

Because entire contents of prefilled dual-chamber syringes should be administered after reconstitution, use single-use vials for dosages <300 mg.118

Following reconstitution, shake prefilled syringe or vials vigorously for 20 or 30 seconds, respectively, to ensure a uniform and homogeneous suspension, which appears opaque and milky-white.118 If using vials, withdraw the appropriate dose of aripiprazole using the syringe supplied by the manufacturer.118 If a vial of reconstituted suspension is not administered immediately, shake the vial vigorously for at least 60 seconds to resuspend the drug; do not store in syringe after reconstitution.118 If using prefilled syringes, inject entire contents immediately following reconstitution (i.e., within 30 minutes).118

IM Administration of Extended-release Aripiprazole Lauroxil (Aristada)

Extended-release aripiprazole lauroxil is available in 441-, 662-, and 882-mg prefilled syringes; do not confuse this formulation with extended-release aripiprazole (Abilify Maintena; available in 300- and 400-mg vials and prefilled syringes) or the immediate-release aripiprazole formulation (9.75 mg/vial) used for agitation associated with schizophrenia and bipolar mania.1 118 119

Must be administered by a healthcare professional.119

Available as kits containing extended-release aripiprazole lauroxil injectable suspension in prefilled syringes and safety needles for IM injection.119 Prior to use, tap the prefilled syringe ≥10 times to dislodge any material that may have settled, then shake vigorously for ≥30 seconds to ensure a uniform suspension.119 If not administered within 15 minutes, shake the syringe again for 30 seconds.119

Administer only by IM injection rapidly and continuously (i.e., within <10 seconds) into the deltoid (for 441-mg doses only) or gluteal muscle (for 441-, 662-, and 882-mg doses).119 Select needle based on injection site; use longer needles in patients with a larger amount of subcutaneous tissue overlaying the injection site muscle.119

Administer monthly; may administer the 882-mg dose monthly or every 6 weeks.119 Allow at least 14 days to elapse between doses.119

Dosage

Aripiprazole oral solution may be given at same dose on mg-per-mg basis as the tablet strengths of the drug up to a dose of 25 mg.1 However, if oral solution is used in patients receiving 30-mg tablets, use a dose of 25 mg of the oral solution.1

Dosing of aripiprazole orally disintegrating tablets is the same as for conventional tablets of the drug.1

Dosage of aripiprazole lauroxil expressed in terms of aripiprazole lauroxil.119

Extended-release aripiprazole lauroxil (Aristada) dosages of 441, 662, and 882 mg IM once monthly correspond to extended-release aripiprazole (Abilify Maintena) dosages of 300, 450, and 600 mg IM once monthly, respectively.119

If used with CYP3A4 inhibitors, CYP2D6 inhibitors, and/or CYP3A4 inducers, dosage adjustment may be required.1 (See Interactions.)

Pediatric Patients

Schizophrenia Oral

Adolescents ≥13 years of age: Recommended target dosage for acute treatment is 10 mg once daily.1 Therapy has been initiated at 2 mg once daily, with subsequent titration to 5 mg once daily after 2 days and to 10 mg once daily after 2 additional days.1 75 91

Subsequent dosage increases should be made in 5-mg, once-daily increments.1

Dosages of 10 and 30 mg once daily evaluated in clinical trials; the 30-mg daily dosage was not more effective than the 10-mg daily dosage.1 75 91

Although efficacy as maintenance treatment not systematically evaluated in adolescents with schizophrenia, the manufacturer states that such efficacy can be extrapolated from adult data in addition to comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients.1 Periodically reassess need for continued therapy.1 (See Pediatric Use under Cautions.)

Bipolar Disorder Manic or Mixed Episodes: Monotherapy or Combination Therapy Oral

Children and adolescents ≥10 years of age: Target dosage for acute treatment is 10 mg once daily.1 Recommended initial dosage when given as monotherapy is 2 mg once daily, with subsequent titration to 5 mg once daily after 2 days and to the target dosage of 10 mg once daily after 2 additional days.1

Recommended dosage when aripiprazole is given as adjunctive therapy with lithium or valproate is the same as that for monotherapy.1

Daily dosage may be increased, if necessary, in 5-mg increments.1 In pediatric clinical studies, dosages of 10 and 30 mg daily were effective.1

Irritability Associated with Autistic Disorder Oral

Children and adolescents 6–17 years of age: Initially, 2 mg once daily, then increase dosage to 5 mg daily, with subsequent increases to 10 or 15 mg daily, if necessary.1 Increase dosage gradually, at intervals of ≥1 week.1 Efficacy established within a dosage range of 5–15 mg daily in clinical studies.1 109 110

Periodically reassess need for continued therapy.1

Tourette's Syndrome Oral

Children and adolescents 6–18 years of age weighing <50 kg: Initially, 2 mg once daily for 2 days, then increase dosage to 5 mg once daily.1 If optimal control of tics not achieved, may increase dosage to 10 mg once daily.1 Adjust dosage gradually at intervals of ≥1 week.1

Children and adolescents 6–18 years of age weighing ≥50 kg: Initially, 2 mg once daily for 2 days, then increase to 5 mg once daily for 5 days, with a recommended target dosage of 10 mg once daily on day 8.1 If optimal control of tics not achieved, may increase dosage up to 20 mg once daily.1 Adjust dosage gradually in increments of 5 mg daily at intervals of ≥1 week.1

Periodically reassess need for continued maintenance therapy.1

Adults

Schizophrenia Oral

Initial and target dosage for acute treatment is 10 or 15 mg once daily.1

Dosages ranging from 10–30 mg once daily were effective in clinical trials; dosages exceeding 10–15 mg daily did not result in greater efficacy.1

Adjust dosage at intervals of ≥2 weeks, the time needed to achieve steady-state concentrations.1

Efficacy as maintenance therapy for ≤26 weeks has been demonstrated;1 other clinical experience indicates may be effective for up to 52 weeks.2 9 10 Optimum duration of therapy is not known, but maintenance therapy with antipsychotics is well established.1 28

Periodically reassess need for continued therapy.1

In patients with remitted first or multiple episodes, APA recommends either indefinite maintenance therapy or gradual discontinuance of the antipsychotic with close follow-up and a plan to reinstitute treatment upon symptom recurrence.28 Consider antipsychotic therapy discontinuance only after ≥1 year of symptom remission or optimal response while taking antipsychotic.28 Indefinite maintenance treatment is recommended if multiple previous psychotic episodes or 2 episodes within 5 years.28

IM, Extended-release Aripiprazole (Abilify Maintena)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating extended-release IM aripiprazole therapy; may take up to 2 weeks to fully assess tolerability due to the half-life of oral aripiprazole.118

Usual initial and maintenance dosage: 400 mg IM every month.118 May reduce dosage to 300 mg every month in patients experiencing adverse effects.118

Administer oral aripiprazole 10–20 mg daily (or another oral antipsychotic agent in patients already stable on another oral antipsychotic and known to tolerate aripiprazole) with the first extended-release IM aripiprazole injection and continue oral therapy for 14 days thereafter to ensure adequate therapeutic plasma concentrations are maintained.118

If a dose of extended-release aripiprazole injection is missed, administer the next dose as soon as possible.118 Supplementation with oral aripiprazole may be required depending on the time elapsed (see Table 1).118

Table 1. Recommended Oral Aripiprazole Supplementation Following Missed Doses of Extended-release Aripiprazole Injection118

Dose Missed

No Oral Supplementation Required

Supplementation with Oral Aripiprazole for 14 Days Required with Next IM Dose

2nd or 3rd IM dose

≤5 weeks since last injection

>5 weeks since last injection

4th or subsequent IM doses

≤6 weeks since last injection

>6 weeks since last injection

IM, Extended-release Aripiprazole Lauroxil (Aristada)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating extended-release IM aripiprazole lauroxil therapy; may take up to 2 weeks to fully assess tolerability due to the half-life of oral aripiprazole.119

Depending on individual patient's needs, may initiate therapy at a dosage of 441, 662, or 882 mg every month or 882 mg every 6 weeks by IM injection.119

Administer oral aripiprazole daily with the first IM aripiprazole lauroxil injection and continue oral aripiprazole therapy for 21 days thereafter.119

For patients established on oral aripiprazole 10 mg daily, recommended IM dosage of aripiprazole lauroxil is 441 mg every month.119

For patients established on oral aripiprazole 15 mg daily, recommended IM dosage of aripiprazole lauroxil is 662 mg every month.119

For patients established on oral aripiprazole ≥20 mg daily, recommended IM dosage of aripiprazole lauroxil is 882 mg every month.119

Adjust dosage as needed.119 Consider pharmacokinetics and prolonged-release characteristics of extended-release aripiprazole lauroxil injection when adjusting dose and dosing interval.119

If a dose is missed, administer the next dose as soon as possible.119 Supplementation with oral aripiprazole may be required depending on the dosage and the time elapsed (see Table 2).119

Dosage of oral aripiprazole supplementation should be same as when patient began extended-release aripiprazole lauroxil therapy.119

Table 2. Recommended Oral Aripiprazole Supplementation Following Missed Doses of Aripiprazole Lauroxil Injection119

Dosage of Patient's Last Injection

No Oral Supplementation Required

Supplement with Oral Aripiprazole for 7 Days

Supplement with Oral Aripiprazole for 21 Days

441 mg monthly

≤6 weeks since last injection

>6 and ≤7 weeks since last injection

>7 weeks since last injection

662 mg monthly

≤8 weeks since last injection

>8 and ≤12 weeks since last injection

>12 weeks since last injection

882 mg monthly

≤8 weeks since last injection

>8 and ≤12 weeks since last injection

>12 weeks since last injection

882 mg every 6 weeks

≤8 weeks since last injection

>8 and ≤12 weeks since last injection

>12 weeks since last injection

Bipolar Disorder Manic or Mixed Episodes: Monotherapy or Combination Therapy Oral

Monotherapy: Initially, 15 mg once daily.1

Adjunctive therapy to lithium or valproate: Initial dosage of 10–15 mg once daily.1

Recommended target dosage is 15 mg once daily whether the drug is given as monotherapy or as adjunctive therapy with lithium or valproate.1 Based on patient response, may increase dosage to 30 mg once daily.1

Safety of dosages >30 mg daily not established.1

Major Depressive Disorder Oral

Initially, 2–5 mg once daily as adjunctive acute therapy.1

Gradually adjust dosage in increments of ≤5 mg daily at ≥1-week intervals; the recommended dosage is 5–10 mg once daily.1 Dosages of 2–15 mg daily were effective in clinical trials.1

Periodically reassess need for continued therapy.1

Manufacturer does not recommend aripiprazole dosage adjustment when administered as adjunctive therapy for major depressive disorder concurrently with CYP2D6 inhibitors.1 (See Interactions.)

Acute Agitation in Schizophrenia and Bipolar Mania IM, Immediate-release Aripiprazole

Initially, 9.75 mg as a single dose.1 Consider lower dose of 5.25 mg when clinically warranted.1

In clinical trials, efficacy was demonstrated with doses of 5.25–15 mg.1 86 87 88 Additional benefit not demonstrated with 15-mg dose compared with 9.75-mg dose.1

Efficacy of repeated doses not systematically evaluated.1 If agitation persists following the initial dose, may administer subsequent doses up to a cumulative daily dose of 30 mg.1 Safety of total doses >30 mg daily or administration more frequently than every 2 hours not systematically evaluated in controlled trials.1

If continued aripiprazole therapy is clinically indicated, oral therapy should replace IM therapy as soon as possible.1

Prescribing Limits

Pediatric Patients

Schizophrenia Oral

Safety and efficacy of dosages >30 mg daily not established.1 91

Bipolar Disorder Manic or Mixed Episodes Oral

Safety and efficacy of dosages >30 mg daily not established.1

Irritability Associated with Autistic Disorder Oral

Safety and efficacy of dosages >15 mg daily not established.1

Tourette's Syndrome Oral

Weight <50 kg: Maximum 10 mg daily.1

Weight ≥50 kg: Maximum 20 mg daily.1

Adults

Schizophrenia Oral

Safety and efficacy of dosages >30 mg daily not established.1

IM, Extended-release Aripiprazole (Abilify Maintena)

Safety and efficacy of dosages >400 mg every month not established.118

IM, Extended-release Aripiprazole Lauroxil (Aristada)

Safety and efficacy of dosages >882 mg every month not established.119

Bipolar Disorder Manic or Mixed Episodes Oral

Safety and efficacy of dosages >30 mg daily not established.1

Adjunctive Therapy of Major Depressive Disorder Oral

Safety and efficacy of dosages >15 mg daily not established.1

Acute Agitation in Schizophrenia and Bipolar Mania IM

Safety of total dosages >30 mg daily or IM doses given more frequently than every 2 hours not established.1

Special Populations

Hepatic Impairment

Dosage adjustment not required.1 95 118 119

Renal Impairment

Dosage adjustment not required.1 95 118 119

Geriatric Patients

Dosage adjustment not required.1 118 119

Gender, Race, or Smoking Status

Dosage adjustment not required.1 118 119

Poor CYP2D6 Metabolizer Phenotype

For dosage adjustments related to CYP-mediated interactions in populations other than patients with poor CYP2D6 metabolizer phenotype, see Interactions.

Oral Aripiprazole

Reduce oral dosage to 50% of the usual dosage; dosage adjustment not required when used as adjunctive treatment of major depressive disorder.1

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce oral aripiprazole dosage to 25% of the usual dosage.1 (See Interactions.)

Extended-release IM Aripiprazole Injection (Abilify Maintena)

Reduce dosage to 300 mg every month.118

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce dosage of extended-release IM aripiprazole injection to 200 mg every month.118 Dosage adjustment not required for concomitant use <2 weeks.118 (See Interactions.)

Extended-release IM Aripiprazole Lauroxil Injection (Aristada)

Reduce dosage based on patient's established oral dosage.119

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce dosage of extended-release IM aripiprazole lauroxil injection from 662 or 882 mg to 441 mg every month.119 Dosage adjustment not necessary in patients already receiving 441 mg every month, if tolerated.119 Dosage adjustment not required for concomitant use <2 weeks.119 (See Interactions.)

No further dosage adjustment required in patients who are poor CYP2D6 metabolizers receiving a concomitant potent CYP2D6 inhibitor.119 (See Interactions.)

Proper Use of aripiprazole

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (tablets and orally disintegrating tablets):
    • For bipolar mania:
      • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    • For depression:
      • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For irritability in children with autistic disorder:
      • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For schizophrenia:
      • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • For Tourette's disorder:
      • Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drug Interactions

Drugs Having Clinically Important Interactions with Abilify

Table 25: Clinically Important Drug Interactions with Abilify:

Concomitant Drug Name or Drug Class

Clinical Rationale

Clinical Recommendation

Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)

The concomitant use of Abilify with strong CYP 3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of Abilify alone [see CLINICAL PHARMACOLOGY (12.3)].

With concomitant use of Abilify with a strong CYP3A4 inhibitor or CYP2D6 inhibitor, reduce the Abilify dosage [see DOSAGE AND ADMINISTRATION (2.7)].

Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin)

The concomitant use of Abilify and carbamazepine decreased the exposure of aripiprazole compared to the use of Abilify alone [see CLINICAL PHARMACOLOGY (12.3)].

With concomitant use of Abilify with a strong CYP3A4 inducer, consider increasing the Abilify dosage [see DOSAGE AND ADMINISTRATION (2.7)].

Antihypertensive Drugs

Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.

Monitor blood pressure and adjust dose accordingly [see WARNINGS AND PRECAUTIONS (5.8)].

Benzodiazepines (e.g., lorazepam)

The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone [see WARNINGS AND PRECAUTIONS (5.8)].

Monitor sedation and blood pressure. Adjust dose accordingly.

Drugs Having No Clinically Important Interactions with Abilify

Based on pharmacokinetic studies, no dosage adjustment of Abilify is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.

In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with Abilify. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Abilify [seeCLINICAL PHARMACOLOGY (12.3)].

What is the dosage for Abilify?

  • This dose for this medication usually is once a day.
  • The usual adult starting oral dose for patients with schizophrenia or bipolar disorder is 10 to 15 mg once daily. The dose may be increased over time up to 30 mg daily to achieve the desired effect.
  • The recommended dose for patients with Tourette's disorder is 5 to 20 mg once daily.

Is this drug safe to take if I'm pregnant or breastfeeding my baby?

  • Aripiprazole has not been adequately studied during pregnancy. Neonates exposed to antipsychotic drugs in the third trimester may experience withdrawal symptoms and other side effects. Your doctor or other healthcare provider may choose to use this medication if he or she feels that its benefits outweigh this potential concern.
  • It is not known if this medicine is excreted in breast milk; however, since most medicines are excreted in breast milk, doctors and other health care professionals recommend that women should not breastfeed their infant/baby while taking this drug.

Indications

ABILIFY Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of:

  • Schizophrenia [see Clinical Studies]
  • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies]
  • Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies]
  • Irritability Associated with Autistic Disorder [see Clinical Studies]
  • Treatment of Tourette's Disorder [see Clinical Studies]

ABILIFY Injection is indicated for the treatment of:

  • Agitation associated with schizophrenia or bipolar mania [see Clinical Studies]

Abilify Drug Class

Abilify is part of the drug class:

  • Other antipsychotics

Side Effects of Abilify

Oral and Immediate-Release Injectable:

Common side effects in adults include the following:

  • nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • an inner sense of restlessness/the need to move (akathisia)
  • anxiety
  • insomnia
  • restlessness
  • pain at injection site

Common side effects in children include the following:

  • sleepiness
  • headache
  • vomiting
  • tiredness
  • increased appetite
  • insomnia
  • nausea
  • stuffy nose
  • weight gain
  • uncontrolled movement (restlessness, tremor, muscle stiffness)
  • pain at injection site

This is not a complete list of Abilify side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Abilify. See "Abilify Precautions" section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Inform MD

Before you receive Abilify, tell your healthcare provider if you:

  • have never taken Abilify before
  • have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify and during your treatment.
  • have or had seizures (convulsions)
  • have or had low or high blood pressure
  • have or had heart problems or a stroke
  • have or had a low white blood cell count
  • have any other medical problems including problems that may affect you receiving an injection in your buttocks
  • are pregnant or plan to become pregnant. It is not known if Abilify will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Abilify can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify.

Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

 

Important information

Abilify is not approved for use in psychotic conditions related to dementia. Abilify may increase the risk of death in older adults with dementia-related conditions.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using Abilify. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

For the Consumer

Applies to aripiprazole: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

  • intramuscular powder for suspension extended release, intramuscular solution

Along with its needed effects, aripiprazole (the active ingredient contained in Abilify) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aripiprazole:

More common
  • Difficulty with speaking
  • drooling
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • restlessness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Less common
  • Blurred vision
  • dizziness
  • headache
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sticking out the tongue
  • trouble with breathing or swallowing
  • unusual facial expressions
Rare
  • Convulsions
  • fast heartbeat
  • high fever
  • high or low blood pressure
  • increased sweating
  • lip smacking or puckering
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • severe muscle stiffness
  • sudden loss of consciousness
  • tiredness
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin
Incidence not known
  • Hives or welts, itching, or skin rash
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • tightness in the chest
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking aripiprazole:

Symptoms of overdose
  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • diarrhea
  • fast, pounding, or irregular heartbeat or pulse
  • increased sensitivity of the eyes to light
  • lack or loss of strength
  • nausea
  • sleepiness or unusual drowsiness
  • vomiting

Some side effects of aripiprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • anxiety
  • belching
  • blurred vision
  • difficulty having a bowel movement (stool)
  • dry mouth
  • fear
  • fever
  • headache
  • heartburn
  • hyperventilation
  • inability to sit still
  • indigestion
  • irritability
  • lightheadedness
  • need to keep moving
  • nervousness
  • rash
  • runny nose
  • shaking
  • sore throat
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • weight gain
Less common
  • Accidental injury
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • congestion
  • coughing
  • difficulty with moving
  • dryness or soreness of the throat
  • hoarseness
  • increased appetite
  • increased salivation
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • rapid weight gain
  • sneezing
  • stuffy nose
  • swollen joints
  • tender, swollen glands in the neck
  • tingling of the hands or feet
  • tremor
  • unusual weight gain or loss
  • voice changes

Aripiprazole Identification

Substance Name

Aripiprazole

CAS Registry Number

129722-12-9

Drug Class

Antipsychotic Agents

Administrative Information

LactMed Record Number

17

Last Revision Date

20170808

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

What is aripiprazole?

Aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Aripiprazole is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression). It is not known if aripiprazole is safe or effective in children younger than 13 with schizophrenia, or children younger than 10 with bipolar disorder.

Aripiprazole is also used together with other medicines to treat major depressive disorder in adults.

Aripiprazole is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Aripiprazole may also be used for purposes not listed in this medication guide.

Before taking this medicine

You should not take aripiprazole if you are allergic to it.

Aripiprazole is not approved for use in psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related conditions.

To make sure aripiprazole is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • heart disease, high or low blood pressure, heart rhythm problems;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • a history of low white blood cell (WBC) counts;

  • a history of heart attack or stroke;

  • seizures or epilepsy;

  • trouble swallowing;

  • a personal or family history of diabetes; or

  • a history of obsessive-compulsive disorder, impulse-control disorder, or addictive behaviors.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking aripiprazole oral solution, tell your doctor if you have diabetes.

Aripiprazole may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking aripiprazole.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant, do not stop taking aripiprazole without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of aripiprazole on the baby.

Aripiprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Aripiprazole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe agitation, distress, or restless feeling;

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • mask-like appearance of the face, trouble swallowing, problems with speech;

  • seizure (convulsions);

  • thoughts about suicide or hurting yourself;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • weight gain;

  • blurred vision;

  • nausea, vomiting, changes in appetite, constipation;

  • drooling;

  • headache, dizziness, drowsiness, feeling tired;

  • anxiety, feeling restless;

  • sleep problems (insomnia); or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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