Abilify Discmelt

Name: Abilify Discmelt

What are some things I need to know or do while I take Abilify Discmelt?

  • Tell all of your health care providers that you take Abilify Discmelt. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid drinking alcohol while taking Abilify Discmelt.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Chance of seizures may be higher. Talk with the doctor.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
  • Check your blood sugar as you have been told by your doctor.
  • Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
  • Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
  • If you are 65 or older, use Abilify Discmelt with care. You could have more side effects.
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Taking Abilify Discmelt in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Inform MD

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

  • have never taken Abilify Discmelt 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 Discmelt 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 Discmelt will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Abilify Discmelt 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 Discmelt.
  • have or had phenylketonuria. Abilify Discmelt Orally Disintegrating Tablets contain phenylalanine.

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

Abilify Discmelt Usage

Take Abilify Discmelt exactly as prescribed. Do not change the dose or stop taking Abilify Discmelt without talking to your doctor.

If you have been prescribed Abilify Discmelt, take it as follows:

  • Do not open the blister until ready to take the orally disintegrating tablet.
  • To remove one tablet, open the package and peel 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 orally disintegrating tablet on the tongue.
  • Tablet disintegration occurs rapidly in saliva. It is recommended it be taken without liquid. However, if needed, it can be taken with liquid.
  • Do not attempt to split the orally disintegrating tablet.

If you miss a dose of Abilify Discmelt, take it as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of Abilify Discmelt at the same time.

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.

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 Discmelt) 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

For Healthcare Professionals

Applies to aripiprazole: intramuscular powder for injection extended release, intramuscular solution, intramuscular suspension extended release, oral solution, oral tablet, oral tablet disintegrating

General

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension: The most commonly reported side effects included akathisia, headache, injection site reactions, and insomnia.

Aripiprazole Extended/Prolonged-Release IM Suspension: The most commonly reported side effects included increased weight, headache, akathisia, and insomnia.

Immediate-Release IM Injection: The most commonly reported side effects included extrapyramidal symptoms, headache, nausea, and dizziness.

Oral Formulations: The most commonly reported side effects included extrapyramidal disorder, headache, and somnolence.[Ref]

Psychiatric

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Insomnia, restlessness
Frequency not reported: Anxiety, other compulsive behaviors, suicide
Postmarketing reports: Pathological gambling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Insomnia (up to 10.9%)
Common (1% to 10%): Agitation, anxiety, depression, psychotic disorder, restlessness, schizophrenia
Uncommon (0.1% to 1%): Affect lability, apathy, bruxism, decreased libido, delusion, dysphoria, hallucination, hypersexuality, irritability, mood altered, panic reaction, psychotic behavior, sleep disorder, suicidal ideation
Rare (0.01% to 0.1%): Aggression, panic attack
Frequency not reported: Abnormal dreams, bulimia nervosa, completed suicide, hallucination auditory, hyposomnia, middle insomnia, neonatal drug withdrawal syndrome, nervousness, nightmare, other compulsive behaviors, poor quality sleep, suicide attempt, tension
Postmarketing reports: Eating disorder, impulse-control disorders, obsessive-compulsive disorder, pathological gambling

Immediate-Release IM Injection:
Common (1% to 10%): Anxiety, insomnia, restlessness
Uncommon (0.1% to 1%): Depression, hypersexuality
Frequency not reported: Aggression, agitation, anorgasmia, catatonia, completed suicide, delirium, homicidal ideation, libido increased, loss of libido, neonatal drug withdrawal syndrome, nervousness, pathological gambling, sleep talking, sleep walking, suicide attempt, suicidal ideation, tic

Oral Formulations:
Very common (10% or more): Agitation (up to 19%), insomnia (up to 18%), anxiety (up to 17%), restlessness (up to 12%)
Common (1% to 10%): Irritability, suicidal ideation
Uncommon (0.1% to 1%): Abnormal dreams, aggression, anger, anorgasmia, apathy, bruxism, completed suicide, confusional state, delirium, depression, hallucination, hallucination auditory, homicidal ideation, hostility, hypersexuality, intentional self-injury, libido increased, loss of libido, mania, nervousness, nightmare, self-mutilation, suicide attempt, thinking abnormal, tic
Rare (0.01% to 0.1%): Asthenia, blunted affect, bradyphrenia, catatonia, cognitive deterioration, delirium, delusional perception, depressed mood, disorientation, eating disorder, emotional distress, euphoric mood, impulsive behavior, logorrhea, mental status changes, mood altered, mood swings, panic attack, psychomotor retardation, sleep disorder, sleep walking, somatoform disorder
Frequency not reported: Drug withdrawal syndrome neonatal, sleep talking
Postmarketing reports: Impulse-control disorders, obsessive-compulsive disorders, pathological gambling[Ref]

Nervous system

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Abilify Discmelt) for the treatment of dementia-related psychosis showed an increased incidence of cerebrovascular side effects, e.g. stroke and transient ischemia attacks, including fatalities. The incidence of these effects may be dose related.

In a dose response analysis, somnolence including sedation was the only adverse reaction determined to have a dose response relationship in adult patients. Somnolence was reported in 12.6% of adult patients with schizophrenia receiving the 30 mg dose.

In pediatric patients 13 to 17 years of age, extrapyramidal disorder, somnolence, and tremor displayed possible dose response relationship in patients with schizophrenia, while extrapyramidal disorder, somnolence, and akathisia displayed possible dose response relationship in pediatric patients with bipolar mania.

Extrapyramidal symptoms were more prevalent with use of the extended-release IM injection compared with oral formulations (18.4% versus 11.7%). Akathisia was the most frequently observed adverse event with the extended-release IM injection; it typically starts around day 10 and lasts a median of 56 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Very common (10% or more): Akathisia (up to 11%)
Common (1% to 10%): Dystonia, extrapyramidal symptoms (EPS), headache, other EPS-related events, parkinsonism
Frequency not reported: Cerebrovascular adverse reactions, cognitive/motor impairment, dizziness, increased mortality in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, seizures, stroke, tardive dyskinesia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): EPS (up to 18.4%), headache (up to 14.4%), akathisia (up to 11.5%)
Common (1% to 10%): Dizziness, dyskinesia, extrapyramidal disorder, parkinsonism, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Bradykinesia, cogwheel rigidity, drooling, dysgeusia, dystonia, gait disturbance, hypersomnia, hypertonia, lethargy, movement disorder, parosmia, psychomotor hyperactivity, restless legs syndrome, tardive dyskinesia
Rare (0.01% to 0.1%): Convulsion, memory impairment, oromandibular dystonia
Frequency not reported: Cerebrovascular adverse reaction, cognitive/motor impairment, diabetic hyperosmolar coma, disturbance in attention, grand mal convulsion, hypoesthesia, increased mortality in elderly patients with dementia-related psychosis, migraine, neuroleptic malignant syndrome, seizures, serotonin syndrome, sinus headache, speech disorder, stroke, syncope, tension headache, vertigo

Immediate-Release IM Injection:
Very common (10% or more): EPS (up to 25.8%), headache (up to 12%)
Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorder, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Dystonia, tardive dyskinesia
Frequency not reported: Akinesia, bradykinesia, choreoathetosis, cogwheel rigidity, coordination abnormal, diabetic hyperosmolar coma, grand mal convulsion, hypokinesia, memory impairment, myoclonus, neuroleptic malignant syndrome, parkinsonism, serotonin syndrome, speech disorder, syncope

Oral Formulations:
Very common (10% or more): Extrapyramidal disorder (up to 27.3), headache (up to 27%), somnolence (up to 26.3%), EPS (up to 25.8%), akathisia (up to 25%), sedation (up to 21%), tremor (up to 11.8%)
Common (1% to 10%): Coordination abnormal, disturbance in attention, dizziness, drooling, dystonia, lethargy
Uncommon (0.1% to 1%): Akinesia, bradykinesia, cerebrovascular accident, cogwheel rigidity, dysarthria, gait disturbance, hypertonia, hypoesthesia, hypokinesia, hypotonia, memory impairment, myoclonus, paresthesia, parkinsonism, postural hypotension, psychomotor hyperactivity, speech disorder, tardive dyskinesia
Rare (0.01% to 0.1%): Akinesthesia, ataxia, burning sensation, choreoathetosis, coma, convulsion, depressed level of consciousness, difficulty in walking, dysgeusia, dysphagia, facial palsy, grand mal convulsion, judgement impaired, loss of consciousness, migraine, neuroleptic malignant syndrome, phase sleep rhythm disturbance, positional vertigo, serotonin syndrome, unresponsive to verbal stimuli
Frequency not reported: Diabetic hyperosmolar coma, syncope[Ref]

Metabolic

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased weight
Frequency not reported: Metabolic changes
Postmarketing reports: Blood glucose fluctuation

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Increased weight (up to 21.5%)
Common (1% to 10%): Decreased weight, decreased appetite, diabetes mellitus, waist circumference increased
Uncommon (0.1% to 1%): Appetite disorder, blood cholesterol decreased, blood glucose decreased/increased, blood triglycerides decreased, glycosylated hemoglobin increased, hypercholesterolemia, hyperglycemia, hyperinsulinemia, hyperlipidemia, hypertriglyceridemia, obesity, thirst, waist circumference increased
Frequency not reported: Anorexia, blood insulin increased, diabetic ketoacidosis, gout, hyperuricemia, hypoglycemia, hyponatremia, increased appetite, lactate dehydrogenase increased, metabolic changes, overweight, type 2 diabetes mellitus
Postmarketing reports: Blood glucose fluctuation

Immediate-Release IM Injection:
Common (1% to 10%): Diabetes mellitus
Uncommon (0.1% to 1%): Hyperglycemia
Frequency not reported: Anorexia, blood glucose fluctuated, blood glucose increased, blood insulin increased, blood lactate dehydrogenase increased, diabetic ketoacidosis, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, weight gain/loss

Oral Formulations:
Common (1% to 10%): Decreased appetite, increased appetite, weight decreased, weight increased
Uncommon (0.1% to 1%): Anorexia, blood glucose increased, carbohydrate tolerance decreased, blood insulin increased, blood lactate dehydrogenase increased, dehydration, diabetes mellitus, diabetes mellitus non-insulin-dependent, glucose tolerance impaired, glycosuria, glycosylated hemoglobin increased, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, hyponatremia, increased appetite, polydipsia
Rare (0.01% to 0.1%): Thirst
Frequency not reported: Diabetic ketoacidosis, hyponatremia
Postmarketing reports: Blood glucose fluctuation[Ref]

Reports of diabetes mellitus included increases in blood insulin, decreases in carbohydrate tolerance, non-insulin dependent diabetes mellitus, impaired glucose tolerance, and glycosuria.

Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean increase in fasting blood glucose of 4.4 mg/dL with a median exposure of 25 days. This was not significantly different from placebo (+2.5 mg/dL, median exposure 22 days). A pooled analysis in pediatric patients revealed a mean change in fasting glucose of 2.4 mg/dL compared with 0.1 mg/dL in placebo treated patients following 12 weeks of therapy. In long-term, open label schizophrenia studies with aripiprazole lauroxil, 14% of patients with HbA1c less than 5.7% at baseline developed levels of 5.7% or higher post-baseline.

Undesirable alterations in lipids have been observed in patients receiving atypical antipsychotics. Analyses of patients receiving this drug are limited due to the small number of patients who received this drug for extended periods in the clinical trials. In long-term, open label schizophrenia studies with aripiprazole lauroxil, shifts in fasting total cholesterol, LDL, and triglycerides from normal to high were reported in 1%, 1%, and 8% of patients.

Weight gain has been observed in patients receiving atypical antipsychotics. Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean change in weight of +0.3 kg (n=1673) with a median exposure of 21 to 25 days compared with a decrease of 0.1 kg in placebo treated patients (n=1100). A pooled analysis in pediatric patients (10 to 17 years) revealed a mean change in weight of +5.8 kg (n=62) compared with +1.4 kg (n=13) in placebo treated patients following 12 weeks of therapy. In a 12-week, fixed dose schizophrenia study in patients receiving with aripiprazole lauroxil, IM weight gain of 7% or greater from baseline was observed in 10% (n=207) and 9% (n=208) of patients receiving 441 mg and 882 mg IM, respectively.

During clinical trials, the percentage of pediatric and adolescent patients by indication with weight gain of 7% or more of body weight compared to placebo was (5.2% vs 1.6%), (26.3% vs 7.1%), and (20% vs 7.6%), respectively for schizophrenia/bipolar mania, irritability associated with autistic disorder, and Tourette's disorder, respectively. Treatment durations were 4 to 6 weeks, 8 weeks, and 8 to 10 weeks, respectively.[Ref]

Hypersensitivity

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Allergic reaction, anaphylactic reaction, angioedema

Aripiprazole Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Hypersensitivity
Rare (0.01% to 0.1%): Drug hypersensitivity
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema

Immediate-Release IM Injection:
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema, hypersensitivity

Oral Formulations:
Uncommon (0.1% to 1%): Angioedema
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactic reaction[Ref]

Gastrointestinal

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Frequency not reported: Constipation, difficulty swallowing, dry mouth, dysphagia, tongue protrusion

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Abdominal discomfort, constipation, diarrhea, dry mouth, dyspepsia, nausea, toothache, vomiting
Uncommon (0.1% to 1%): Frequent bowel movement, gastroesophageal reflux disease, salivary hypersecretion, upper abdominal pain
Rare (0.01% to 0.1%): Swollen tongue
Frequency not reported: Abdominal pain, anal abscess, anorectal discomfort, aphthous stomatitis, appendicitis perforated, colitis, dental caries, difficulty swallowing, diverticulum, dysphagia, gastritis, gastroenteritis, gastroenteritis viral, gingival edema, gingival pain, gingivitis, hemorrhoids, inguinal hernia, loose tooth, oral candidiasis, pancreatitis, periodontitis, poor dental condition, tongue disorder, tongue edema, tongue protrusion, tooth abscess, tooth fracture, tooth impacted, tooth infection, tooth loss

Immediate-Release IM Injection:
Common (1% to 10%): Constipation, dyspepsia, nausea, salivary hypersecretion, vomiting
Uncommon (0.1% to 1%): Dry mouth
Frequency not reported: Abdominal discomfort, diarrhea, dysphagia, gastroesophageal reflux disease, pancreatitis, swollen tongue, stomach discomfort, tongue dry, tongue edema, tongue spasm

Oral Formulations:
Very common (10% or more): Nausea (up to 15%), vomiting (up to 14%), constipation (up to 11%)
Common (1% to 10%): Abdominal discomfort, abdominal pain upper, diarrhea, dry mouth, dyspepsia, salivary hypersecretion, stomach discomfort, toothache
Uncommon (0.1% to 1%): Dysphagia, esophagitis, gastritis, gastroesophageal reflux disease, hypoesthesia oral, swollen tongue
Rare (0.01% to 0.1%): Abdominal distention, abnormal feces, eructation, feces discolored, gastroenteritis, gastroenteritis viral, gastrointestinal disorder, gastrointestinal pain, glossitis, lip dry, mouth injury, oral candidiasis, pancreatitis, paresthesia circumoral, parotid gland enlargement, parotitis, pruritus ani, tongue discoloration
Frequency not reported: Tongue dry, tongue edema, tongue spasm[Ref]

Dermatologic

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Pruritus, urticaria

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erythema, induration/skin induration, pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, eczema, folliculitis, fungal skin infection, rosacea
Frequency not reported: Acarodermatitis, blister, cellulitis, dry skin, excoriation, face edema, furuncle, herpes zoster, hyperhidrosis, hyperkeratosis, impetigo, lice infestation, photosensitivity reaction, pilonidal cyst, psoriasis, rash macula, skin laceration, skin lesion, skin striae, subcutaneous abscess, tinea pedis, urticaria, varicella

Immediate-Release IM Injection:
Frequency not reported: Alopecia, face edema, hirsutism, hyperhidrosis, photosensitivity reaction, pruritus, rash, urticaria

Oral Formulations:
Common (1% to 10%): Acneiform rash, allergic contact rash, drug eruption rash, erythematous rash, exfoliative rash, exfoliative seborrheic dermatitis, generalized rash, hyperhidrosis, macular rash, maculopapular rash, neurodermatitis, papular rah, rash
Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction, pruritus, urticaria
Rare (0.01% to 0.1%): Body tinea, decubitus ulcer, dry skin, herpes simplex, pemphigus, psoriasis
Frequency not reported: Hirsutism[Ref]

Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.[Ref]

Cardiovascular

Collective data from 17 placebo-controlled clinical studies involving the use of atypical antipsychotic agents in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although aripiprazole (the active ingredient contained in Abilify Discmelt) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Aripiprazole is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Angina pectoris, orthostatic hypotension, palpitations, tachycardia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Hemorrhage, hypertension
Uncommon (0.1% to 1%): Abnormal electrocardiogram, bradycardia, chest discomfort, decreased blood pressure, electrocardiogram QT prolonged, electrocardiogram T-wave abnormal/amplitude decreased/inversion, increased blood pressure, orthostatic hypotension, peripheral edema, tachycardia, ventricular extrasystole
Rare (0.01% to 0.1%): Sinus tachycardia
Frequency not reported: Acute myocardial infarction, cardiac arrest, chest pain, congestive cardiac failure, contusion, decreased heart rate, deep vein thrombosis, first-degree atrioventricular block, orthostatic hypertension, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Immediate-Release IM Injection:
Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Increased diastolic blood pressure, orthostatic hypotension
Frequency not reported: Angina pectoris, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, cardiac arrest, cardiopulmonary failure, cardiorespiratory arrest, chest pain, deep vein thrombosis, electrocardiogram QT prolonged, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, peripheral edema, QT prolongation, Torsade de pointes, venous thromboembolism, ventricular arrhythmia

Oral Formulations:
Common (1% to 10%): Chest pain, hypertension, peripheral edema
Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation, atrioventricular block, bradycardia, cardiopulmonary failure, cardiorespiratory arrest, chest discomfort, edema, electrocardiogram QT prolonged, extrasystole, generalized edema, heart rate increased, hot flush, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, sinus tachycardia, tachycardia
Rare (0.01% to 0.1%): Atrial flutter, electrocardiogram abnormal, electrocardiogram PR prolongation, electrocardiogram T wave inversion, flushing, heart rate irregular, hyperemia, supraventricular tachycardia, ventricular tachycardia
Frequency not reported: Cardiac arrest, deep vein thrombosis, hypotension, palpitations, Torsade de pointes, venous thromboembolism, ventricular arrhythmias[Ref]

Hematologic

Neutropenia has been reported with the extended/prolonged-release IM injection; it typically starts around day 16 and lasts a median of 18 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Neutropenia
Uncommon (0.1% to 1%): Anemia, neutrophil count decreased, thrombocytopenia, white blood cell count decreased
Frequency not reported: Agranulocytosis, bicytopenia, leukopenia, lymphadenopathy

Immediate-Release IM Injection:
Frequency not reported: Leukopenia, neutropenia, thrombocytopenia

Oral Formulations:
Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia
Rare (0.01% to 0.1%): Eosinophil count increased, eosinophilia, lymphadenopathy, white blood cell count increased[Ref]

Endocrine

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Prolactin levels greater than 1 times the upper limit of normal
Uncommon (0.1% to 1%): Blood prolactin decreased, gynecomastia, hyperprolactinemia
Rare (0.01% to 0.1%): Hypoprolactinemia

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hyperprolactinemia
Frequency not reported: Blood prolactin increased, gynecomastia

Oral Formulations:
Very common (10% or more): Serum prolactin levels less than 2 ng/mL (up to 53.3%), serum prolactin levels less than 3 ng/mL (up to 29.5%)
Uncommon (0.1% to 1%): Blood prolactin increased, hyperprolactinemia
Rare (0.01% to 0.1%): Early menarche, gynecomastia[Ref]

Musculoskeletal

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased blood creatine phosphokinase
Frequency not reported: Abnormal/prolonged muscle contractions, muscular weakness, neck muscle spasms

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Arthralgia, back pain, increased blood creatine phosphokinase, musculoskeletal pain, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): Joint range of motion decreased, joint stiffness, muscle rigidity, muscle spasms, muscle tightness, muscle twitching, nuchal rigidity, trismus
Rare (0.01% to 0.1%): Rhabdomyolysis, thrombocytopenia
Frequency not reported: Abnormal/prolonged muscle contractions, ankle fracture, arthritis, foot fracture, joint dislocation, joint sprain, joint swelling, muscle injury, muscle strain, neck muscle spasms, radius fracture, rotator cuff syndrome, skeletal injury, stiffness

Immediate-Release IM Injection:
Frequency not reported: Increased creatine phosphokinase, mobility decreased, muscle tightness, muscular weakness, myalgia, rhabdomyolysis, stiffness

Oral Formulations:
Common (1% to 10%): Arthralgia, blood creatinine phosphokinase increased/creatine phosphokinase increase, muscle rigidity, muscle spasms, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): mobility decreased, muscle tightness, musculoskeletal rigidity
Rare (0.01% to 0.1%): Bone pain, clavicle fracture, femoral neck fracture, flank pain, hip fracture, humerus fracture, jaw disorder, kyphosis, muscle strain, nuchal rigidity, osteoarthritis, rhabdomyolysis
Frequency not reported: Muscular weakness, stiffness[Ref]

Other

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Frequency not reported: Asthenia, body temperature regulation, falls

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Fatigue, inflammation, swelling
Frequency not reported: Accident, body temperature regulation, carbon monoxide poisoning, deafness, drug toxicity, ear infection, face injury, falls, fungal infection, gunshot wound, herpes virus infection, hypothermia, injury, multiple injuries, pain, procedural pain, sudden unexplained death, temperature regulation disorder, thermal burn, wound

Immediate-Release IM Injection:
Common (1% to 10%): Fatigue
Frequency not reported: Asthenia, fall, heat stroke, hypothermia, pyrexia, sudden unexplained death, temperature regulation disorder

Oral Formulations:
Very common (10% or more): Fatigue (up to 18.5%)
Common (1% to 10%): Asthenia, fall, feeling jittery, pain, pyrexia
Uncommon (0.1% to 1%): Adverse event, chills, discomfort, feeling abnormal
Rare (0.01% to 0.1%): Ear canal erythema, energy increased, facial pain, feeling cold, head lag abnormal, heat stroke, hypoacusis, hypothermia, injury, malaise, open wound, physical examination, sensation of heaviness, smoker, swelling, tenderness, tinnitus, xerosis
Frequency not reported: Sudden unexplained death, temperature regulation disorder[Ref]

In a dose response analysis, fatigue was determined to have a dose response relationship in pediatric patients with incidences of fatigue reported at 3.8%, 22%, and 18.5% in those receiving 5 mg, 10 mg, and 15 mg respectively.[Ref]

Respiratory

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Frequency not reported: Difficulty breathing, throat tightness
Postmarketing reports: Hiccups, laryngospasm, oropharyngeal spasm

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Bronchitis, cough, nasal congestion, nasopharyngitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups, pharyngitis
Frequency not reported: Acute respiratory distress syndrome, allergic rhinitis, aspiration pneumonia, difficulty breathing, dysphonia, dyspnea, epistaxis, laryngospasm, nasal septum deviation, oropharyngeal spasm, paranasal sinus hypersecretion, pulmonary embolism, respiratory tract congestion, rhinalgia, sinus congestion, throat tightness, wheezing

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hiccups
Frequency not reported: Aspiration pneumonia, dyspnea, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary embolism

Oral Formulations:
Common (1% to 10%): Cough, dyspnea, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, pneumonia aspiration, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups
Rare (0.01% to 0.1%): Dry throat, hoarseness, lower respiratory tract infection, nasal dryness, painful respiration, paranasal sinus hypersecretion, rhinorrhea, sinus congestion, sinusitis
Frequency not reported: Laryngospasm, oropharyngeal spasm pulmonary embolism[Ref]

Ocular

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Blurred vision, diplopia, eye pain, oculogyric crisis
Frequency not reported: Allergic conjunctivitis, eye irritation, eyelid ptosis, hordeolum

Immediate-Release IM Injection:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia
Frequency not reported: Oculogyric crisis, photophobia

Oral Formulations:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, eyelid edema, photophobia, photopsia
Rare (0.01% to 0.1%): Chromotopsia, conjunctivitis, eye disorder, eye movement disorder, eye redness, gaze palsy, lacrimation increased
Frequency not reported: Oculogyric crisis[Ref]

Genitourinary

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erectile dysfunction
Uncommon (0.1% to 1%): Breast tenderness, ejaculation delayed, galactorrhea, vulvovaginal dryness
Rare (0.01% to 0.1%): Glycosuria, pollakiuria, urinary incontinence
Frequency not reported: Adnexa uteri pain, breast mass, Escherichia urinary tract infection (UTI), mastitis, micturition urgency, ovarian cyst, priapism, protein urine, suprapubic pain, urinary retention, UTIs, vaginal infections, vulvovaginal mycotic infection, white blood cells urine

Immediate-Release IM Injection:
Frequency not reported: Amenorrhea, breast pain, enuresis, erectile dysfunction, priapism, menstruation irregular, nocturia, urinary incontinence, urinary retention

Oral Formulations:
Uncommon (0.1% to 1%): Amenorrhea, breast pain, erectile dysfunction, glucose urine/glucose urine present, incontinence/urinary incontinence, menstruation irregular, nocturia, pollakiuria, polyuria, urinary retention
Rare (0.01% to 0.1%): Bladder discomfort, blood urine present, breast discharge, chromaturia, enuresis, genital pruritus female, micturition urgency, pelvic pain, priapism, proteinuria, sexual dysfunction, urethral discharge, urinary hesitation, urinary tract infection, urine ketone body present, urine output increased, vulvovaginal discomfort[Ref]

Hepatic

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Abnormal liver function test, ALT increased, AST increased, blood bilirubin increased, gamma-glutamyl transferase increased, increased hepatic enzymes
Rare (0.01% to 0.1%): Drug induced liver injury
Frequency not reported: Alkaline phosphatase increased, cholecystitis chronic, cholelithiasis, hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis, hepatosplenomegaly, jaundice

Immediate-Release IM Injection:
Frequency not reported: Blood bilirubin increased, hepatic enzyme increased, hepatic failure, hepatitis, increased alkaline phosphatase, increased ALT, increased AST, increased gamma glutamyl transferase, jaundice

Oral Formulations:
Uncommon (0.1% to 1%): Blood bilirubin increased, hepatic enzyme increased
Rare (0.01% to 0.1%): Gamma glutamyl transferase increased, hepatitis, jaundice
Frequency not reported: Hepatic failure, increased alkaline phosphatase, increased ALT, increased AST[Ref]

Local

Aripiprazole (the active ingredient contained in Abilify Discmelt) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Injection site pain
Frequency not reported: Induration, redness, swelling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Injection site induration, injection site pain, injection site reactions
Uncommon (0.1% to 1%): Injection site discomfort, injection site erythema, injection site pruritus, injection site swelling
Frequency not reported: Infusion site hematoma, infusion site swelling, localized infection, vessel puncture site hematoma, vessel puncture site pain

Immediate-Release IM Injection:
Frequency not reported: Injection site reaction, venipuncture site bruise

Oral Formulations:
Rare (0.01% to 0.1%): Local swelling, localized infection[Ref]

Injection site reactions reported with the aripiprazole extended-release IM suspension included pain, erythema, induration, pruritus, swelling, rash, inflammation, and hemorrhage. The mean intensity of injection pain reported with the first injection was 7.1 (visual analog scale 0=no pain to 100=unbearably painful) and 4.8 with the second injection. Injection site reactions with aripiprazole lauroxil extended-release IM suspension were mostly associated with the first injection and decreased with each subsequent injection.[Ref]

Renal

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Glycosuria, nephrolithiasis
Frequency not reported: Cystitis, glucose urine present

Immediate-Release IM Injection:
Frequency not reported: Blood creatinine increased, blood urea increased

Oral Formulations:
Uncommon (0.1% to 1%): Blood creatinine increased, blood urea increased
Rare (0.01% to 0.1%): Oliguria[Ref]

Oncologic

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma

Oral Formulations:
Rare (0.01% to 0.1%): Cyst, oral neoplasm, skin papilloma[Ref]

Immunologic

Aripiprazole (the active ingredient contained in Abilify Discmelt) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Influenza
Frequency not reported: Influenza-like illness, viral infection

Oral Formulations:
Rare (0.01% to 0.1%): Decreased immune responsiveness[Ref]

Some side effects of Abilify Discmelt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Agitated State

For agitation associated with schizophrenia or bipolar mania:
Initial dose: 9.75 mg IM
Doses ranging from 5.25 mg to 15 mg may be considered when clinical factors warrant; no additional benefit has been demonstrated for 15 mg compared to 9.75 mg
Repeat doses: If additional doses are needed, allow at least 2 hours to elapse between dosing; the efficacy of repeated doses has not been studied.
Maximum dose: 30 mg per day

Comments: If ongoing therapy is clinically indicated, oral therapy should replace injections as soon as possible.

Use: For the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed.

Usual Pediatric Dose for Schizophrenia

Age: 13 years or older:
Initial Dose: 2 mg orally once a day
After 2 days: Titrate to 5 mg orally once a day
After 4 days: Titrate to 10 mg orally once a day
Target Dose: 10 mg orally once a day; effective dose range 10 to 30 mg per day; however, clinical trials have not found doses exceeding 10 mg per day to be more effective; dose increases, if needed should be in 5 mg increments at 2-week intervals in order to allow time to achieve steady state
Maximum Dose: 30 mg per day

Comments:
-Maintenance treatment in the adolescent population has not been evaluated; extrapolating from adult data, it is recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission.
-Periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: For the treatment of schizophrenia

Renal Dose Adjustments

No adjustment recommended

How should I take Abilify Discmelt?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not take Abilify Discmelt for longer than 6 weeks unless your doctor has told you to.

Abilify Discmelt can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Abilify Discmelt):

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

  • Use dry hands to remove the tablet and place it in your mouth.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Use Abilify Discmelt regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

You should not stop using Abilify Discmelt suddenly. Stopping suddenly may make your condition worse.

Your doctor will need to check your progress while you are using Abilify Discmelt.

Store at room temperature away from moisture and heat. Abilify Discmelt liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

Abilify Discmelt 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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