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VRAYLAR is a brand name for Cariprazine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Schizophrenia VRAYLAR (cariprazine) is indicated for: • the treatment of schizophrenia in adults. In controlled clinical trials, VRAYLAR was found to improve both positive and negative symptoms. Bipolar I disorder VRAYLAR is indicated as monotherapy for: • Bipolar Mania: acute management of manic or mixed episodes…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations, Women of childbearing potential 03/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 Missed Dose ............................................................................................................ 8 5 OVERDOSAGE...............................................................................................................
8
1 Adverse Reaction Overview The information below is derived from an integrated clinical study database for VRAYLAR consisting of 4753 adult patients exposed to one or more doses of VRAYLAR for the treatment of schizophrenia, manic or mixed episodes associated with bipolar I disorder, and bipolar depression in placebo-controlled studies.
3 patient-years. A total of 2568 VRAYLAR (cariprazine, capsules) Page 18 of 61 VRAYLAR-treated patients had at least 6 weeks and 296 VRAYLAR-treated patients had at least 48 weeks of exposure. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
5 to 12 mg once daily. The maximum recommended dosage is 6 mg daily. 5 mg/day to 12 mg/day) and 12% (71/584) of patients that received placebo in 6-week clinical trials discontinued due to adverse events. There was no single adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo.
Akathisia, insomnia, restlessness, aggression, headache and hypertension were the only treatment emergent adverse events that led to discontinuation of treatment for > 2 patients treated with VRAYLAR and more frequently than in patients that received placebo.
Most common treatment emergent adverse events:
The most common treatment emergent adverse events, reported in ≥ 5% of patients treated with VRAYLAR and at least twice the rate of placebo in the 6-week schizophrenia clinical trials were extrapyramidal symptoms and akathisia. Treatment emergent adverse events with an incidence of ≥ 2% and greater than placebo, at any dose are shown below in Table 2.
, Reproductive Health: Female and Male Potential 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
8 5 OVERDOSAGE............................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ...................................................................................
VRAYLAR is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• With concomitant use of strong and moderate CYP3A4 inhibitors. 5 Drug-Food Interactions. Due to the slow elimination of cariprazine and its metabolites, treatment with strong and moderate CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR discontinuation.
• With concomitant use of strong and moderate CYP3A4 inducers. 6 Drug-Herb Interactions. VRAYLAR (cariprazine, capsules) Page 5 of 61
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 - 6 mg/day n = 575 (%) 9 - 12 mg/day** n = 203 (%) Vascular Disorders Hypertensionk 2 3 6 1 * Data shown by modal daily dose, defined as most frequently administered dose per patient ** The maximum recommended daily dose is 6 mg.
Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. a. Tachycardia terms: heart rate increased, sinus tachycardia, tachycardia b. Abdominal pain terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain c.
Diarrhea terms: diarrhea, frequent bowel movements d. Fatigue terms: asthenia, fatigue e. Hepatic enzyme increase terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased f. Extrapyramidal Symptoms terms: bradykinesia, cogwheel rigidity, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, Musculoskeletal stiffness, oculogyric crisis, oromandibular dystonia, parkinsonism, salivary hypersecretion, tardive dyskinesia, torticollis, tremor, trismus g.
Headache terms: headache, tension headache h. Somnolence terms: hypersomnia, sedation, somnolence i. Insomnia terms: initial insomnia, insomnia, middle insomnia, terminal insomnia j. Percentages for sex-specific AEs are relative to the number of patients of the appropriate sex.
k. Hypertension terms: blood pressure diastolic increased, blood pressure increased, blood pressure systolic increased, hypertension Patients with Bipolar Mania The following findings are based on three placebo-controlled, 3-week bipolar mania trials with VRAYLAR doses ranging from 3 to 12 mg once daily.
The maximum recommended dosage is 6 mg daily.
Treatment Emergent Adverse Events Associated with Discontinuation of Treatment:
The adverse […]
1 Special Populations................................................................................................ 1 Pregnant Women ...................................................................................................
2 Breastfeeding ......................................................................................................... 3 Pediatrics ................................................................................................................
4 Geriatrics ................................................................................................................ 17 VRAYLAR (cariprazine, capsules) Page 3 of 61 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 5 Post-Market Adverse Reactions ............................................................................
29 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
33 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics .........................................................................................
3 Pharmacokinetics ............................................................................................ 34 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 37 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
37 PART II: SCIENTIFIC INFORMATION ........................................................................................ 38 13 PHARMACEUTICAL INFORMATION .............................................................................
38 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ..............................................................................
39 Schizophrenia .................................................................................................................. 39 Bipolar Mania ..................................................................................................................
44 Bipolar Depression […]