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Aristada

Aristada (Aripiprazole Lauroxil Extended-release Injection) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Aristada Side Effects Center

What Is Aristada?

Aristada (aripiprazole lauroxil) is an atypical antipsychotic indicated for the treatment of schizophrenia.

What Are Side Effects of Aristada?

Common side effects of Aristada include:

  • feeling the urge to move constantly (akathisia),
  • injection site reactions (pain, swelling, redness, a hard lump),
  • weight gain,
  • headache,
  • insomnia,
  • restlessness, or
  • increased blood creatine phosphokinase (CPK).

Dosage for Aristada

Aristada is administered by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg or 882 mg) muscle by a healthcare professional. Aristada may interact with oral aripiprazole, carbamazepine, antihypertensive drugs, and benzodiazepines. Tell your doctor all medications and supplements you use.

What Drugs, Substances, or Supplements Interact with Aristada?

Tell your doctor if you are pregnant or plan to become pregnant before taking Aristada.

Aristada During Pregnancy and Breastfeeding

Aristada may cause extrapyramidal and/or withdrawal symptoms in neonates in women exposed during the third trimester of pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Aristada during pregnancy. Aristada passes into breast milk but its effects on a nursing infant are unknown. Consult your doctor before breastfeeding.

Additional Information

Our Aristada (aripiprazole lauroxil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Aristada Consumer Information

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

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use aripiprazole, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • feeling uncomfortably warm or hot;
  • trouble swallowing;
  • a seizure;
  • 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, painful mouth sores, 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.

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

Common side effects may include:

  • feeling restless;
  • pain where the injection was given;
  • weight gain; or
  • drowsiness.

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.

Read the entire detailed patient monograph for Aristada (Aripiprazole Lauroxil Extended-release Injection)

 

Aristada Professional Information

SIDE EFFECTS

The following are discussed in more details in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-related Psychosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Cerebrovascular Adverse Reactions, Including Stroke [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
  • Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Metabolic Changes [see WARNINGS AND PRECAUTIONS]
  • Pathological Gambling and Other Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Falls [see WARNINGS AND PRECAUTIONS]
  • Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
  • Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
  • Dysphagia [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

ARISTADA

Patient Exposure

ARISTADA has been evaluated for safety in 1180 adult patients in clinical trials in schizophrenia.

Commonly Observed Adverse Reactions

The most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with ARISTADA) was akathisia.

Adverse Reactions Occurring At An Incidence Of 2% Or More In ARISTADA-Treated Patients

Adverse reactions associated with the use of ARISTADA (incidence of 2% or greater, rounded to the nearest percent and ARISTADA incidence greater than placebo) that occurred are shown in Table 8.

Table 8: Adverse Reaction in 2% or More of ARISTADA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the 12-Week, Placebo-Controlled, Fixed-Dose Schizophrenia Trial

Adverse Reaction System Organ Class Preferred Term Placebo
N=207 (%)		 Aripiprazole Lauroxil
441 mg
N=207 (%)		 882 mg
N=208 (%)
General disorders and administration site conditions
Injection site pain 2 3 4
Investigations
Increased weight 1 2 2
Increased blood creatine phosphokinase 0 2 1
Nervous system disorders
Akathisia 4 11 11
Headache 3 3 5
Psychiatric disorders
Insomnia 2 3 4
Restlessness 1 3 1

In an open label pharmacokinetic study, the adverse reactions associated with the use of 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months were similar across the dose groups.

Injection Site Reactions

Injection site reactions were reported by 4% of patients treated with 441 mg ARISTADA and 5% of patients treated with 882 mg ARISTADA compared to 2% of patients treated with placebo. Most of these were injection site pain (3%, 4% and 2% in the 441 mg ARISTADA, 882 mg ARISTADA and placebo groups, respectively) and most were associated with the first injection, and decreased with each subsequent injection to less than or equal to 1% for both doses of ARISTADA and placebo. Other injection site reactions (induration, swelling and redness) occurred at less than 1%. In an open label pharmacokinetic study evaluating 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months, injection site reactions were similar across the dose groups.

Extrapyramidal Symptoms

In the 12-week schizophrenia efficacy study [see Clinical Studies], for ARISTADA-treated patients, the incidence of other EPS-related events, excluding akathisia and restlessness, was 5% and 7% for patients on 441 mg and 882 mg, respectively, versus 4% for placebo-treated patient (Table 9).

Table 9: Incidence of EPS Compared to Placebo

Adverse Reaction Term Placebo
N=207 (%)		 ARISTADA
441 mg
N=207 (%)		 882 mg
N=208 (%)
Akathisia 4 11 11
Restlessness 1 3 1
Other EPS 4 5 7
Dystonia 1 2 2
Parkinsonism 3 3 4

Dystonia

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Other Adverse Reactions Observed In Clinical Studies

The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Cardiac - angina pectoris, tachycardia, palpitations

Gastrointestinal disorders - constipation, dry mouth

General disorders - asthenia

Musculoskeletal - muscular weakness

Nervous system disorders - dizziness

Psychiatric disorders - anxiety, suicide

Adverse Reactions Reported In Clinical Trials With Oral Aripiprazole

The following is a list of additional adverse reactions that have been reported in clinical trials with oral aripiprazole and not reported above for ARISTADA.

Blood and Lymphatic System Disorders: thrombocytopenia

Cardiac Disorders: bradycardia, atrial flutter, cardiorespiratory arrest, atrioventricular block, atrial fibrillation, myocardial ischemia, myocardial infarction, cardiopulmonary failure

Eye Disorders: photophobia, diplopia

Gastrointestinal Disorders: gastroesophageal reflux disease

General Disorders and Administration Site Conditions: peripheral edema, chest pain, face edema

Hepatobiliary Disorders: hepatitis, jaundice

Immune System Disorders: hypersensitivity

Injury, Poisoning, and Procedural Complications: fall, heat stroke

Investigations: weight decreased, hepatic enzyme increased, blood glucose increased, blood lactate dehydrogenase increased, gamma glutamyl transferase increased, blood prolactin increased, blood urea increased, blood creatinine increased, blood bilirubin increased, electrocardiogram QT prolonged, glycosylated hemoglobin increased

Metabolism and Nutrition Disorders: anorexia, hypokalemia, hyponatremia, hypoglycemia

Musculoskeletal and Connective Tissue Disorders: muscle tightness, rhabdomyolysis, mobility decreased

Nervous System Disorders: memory impairment, cogwheel rigidity, hypokinesia, myoclonus, bradykinesia, akinesia, coordination abnormal, speech disorder, choreoathetosis

Psychiatric Disorders: aggression, loss of libido, delirium, libido increased, anorgasmia, tic, homicidal ideation, catatonia, sleep walking

Renal and Urinary Disorders: urinary retention, nocturia

Reproductive System and Breast Disorders: erectile dysfunction, gynaecomastia, menstruation irregular, amenorrhea, breast pain, priapism

Respiratory, Thoracic, and Mediastinal Disorders: nasal congestion, dyspnea

Skin and Subcutaneous Tissue Disorders: rash, hyperhidrosis, pruritus, photosensitivity reaction, alopecia, urticaria

Vascular Disorders: hypotension, hypertension

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of oral aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups, blood glucose fluctuation, oculogyric crisis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With ARISTADA

Table 10: Clinically Important Drug Interactions with ARISTADA

Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors
Clinical Impact: The concomitant use of oral aripiprazole with strong C YP3A4 or C YP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone [see CLINICAL PHARMACOLOGY].
Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inhibitor or CYP2D6 inhibitor for more than 2 weeks, reduce the ARISTADA dose [see DOSAGE AND ADMINISTRATION].
Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine
Strong CYP3A4 Inducers
Clinical Impact: The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone [see CLINICAL PHARMACOLOGY].
Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inducer for more than 2 weeks consider increasing the ARISTADA dose [see DOSAGE AND ADMINISTRATION].
Examples: carbamazepine, rifampin
Antihypertensive Drugs
Clinical Impact: Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
Intervention: Monitor blood pressure and adjust dose accordingly [see WARNINGS AND PRECAUTIONS].
Examples: carvedilol, lisinopril, prazosin
Benzodiazepines
Clinical Impact: 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].
Intervention: Monitor sedation and blood pressure. Adjust dose accordingly.
Example: lorazepam

Drugs Having No Clinically Important Interactions With ARISTADA

Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of ARISTADA is required when administered concomitantly with famotidine, valproate, or lithium [see CLINICAL PHARMACOLOGY].

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 ARISTADA. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, or sertraline when co-administered with ARISTADA [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Aristada (Aripiprazole Lauroxil Extended-release Injection)

&Copy; Aristada Patient Information is supplied by Cerner Multum, Inc. and Aristada Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.