What monitoring is recommended when prescribing Vraylar (cariprazine)?

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From the FDA Drug Label

5.4 Neuroleptic Malignant Syndrome (NMS) Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with administration of antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, delirium, and autonomic instability Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue VRAYLAR and provide intensive symptomatic treatment and monitoring. 5.5 Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs, including VRAYLAR. 5.6 Late-Occurring Adverse Reactions Adverse reactions may first appear several weeks after the initiation of VRAYLAR treatment, probably because plasma levels of cariprazine and its major metabolites accumulate over time. As a result, the incidence of adverse reactions in short-term trials may not reflect the rates after longer term exposures [see Dosage and Administration (2. 1), Adverse Reactions (6.1), Clinical Pharmacology (12.3)]. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after a patient has begun VRAYLAR and after each dosage increase. 5.7 Metabolic Changes Atypical antipsychotic drugs, including VRAYLAR, have caused metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. 5.8 Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia.

The following monitoring is recommended when prescribing Vraylar (cariprazine):

  • Neuroleptic Malignant Syndrome (NMS): Monitor for clinical manifestations of NMS, including hyperpyrexia, muscle rigidity, delirium, and autonomic instability.
  • Tardive Dyskinesia: Monitor for signs and symptoms of tardive dyskinesia, including potentially irreversible, involuntary, dyskinetic movements.
  • Late-Occurring Adverse Reactions: Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, for several weeks after starting VRAYLAR and after each dosage increase.
  • Metabolic Changes: Monitor for hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.
  • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia.
  • Fasting plasma glucose: Assess before or soon after initiation of antipsychotic medication and monitor periodically during long-term treatment 1. Key points to monitor include:
  • Adverse reactions
  • Patient response
  • Extrapyramidal symptoms (EPS)
  • Akathisia
  • Metabolic changes
  • White blood cell counts (WBC)
  • Fasting plasma glucose 1.

From the Research

When prescribing Vraylar (cariprazine), monitoring should include baseline and regular assessments of metabolic parameters, cardiovascular function, and neurological status, with a focus on weight, metabolic parameters, and extrapyramidal symptoms, as supported by the most recent study 2.

Monitoring Recommendations

Before starting treatment, obtain baseline:

  • Weight
  • BMI
  • Waist circumference
  • Blood pressure
  • Fasting blood glucose
  • Lipid panel
  • Complete blood count Monitor:
  • Weight at each visit
  • Metabolic parameters quarterly for the first year, then annually
  • Assess for extrapyramidal symptoms, akathisia, and tardive dyskinesia at each visit using standardized rating scales when possible
  • Perform electrocardiogram monitoring in patients with cardiac risk factors or if using other QT-prolonging medications
  • Watch for signs of neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status) and monitor for suicidal ideation, particularly when initiating therapy or changing doses

Rationale

The most recent study 2 suggests that cariprazine has a neutral weight and metabolic profile, but regular monitoring is still necessary to detect any potential adverse effects. Additionally, the study found that cariprazine was associated with a decrease in hemoglobin A1c and triglyceride levels, but an increase in LDL levels, highlighting the importance of regular metabolic monitoring. Other studies 3, 4, 5, 6 also support the importance of monitoring for extrapyramidal symptoms, akathisia, and tardive dyskinesia, as well as cardiac effects. Regular monitoring allows for early intervention if adverse effects develop, potentially improving treatment adherence and outcomes.

References

6
Research

Use of cariprazine in psychiatric disorders: A systematic review.

Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists, 2018

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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