Vraylar
- Generic Name: cariprazine capsules
- Brand Name: Vraylar
Vraylar (Cariprazine Capsules) side effects drug center
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- extrapyramidal symptoms (muscle spasms, muscle rigidity, tremor, jerking movements),
- agitation,
- indigestion,
- nausea,
- vomiting,
- sleepiness,
- restlessness,
- weight gain,
- headache,
- insomnia,
- abdominal pain,
- constipation,
- toothache,
- anxiety,
- diarrhea,
- pain in the extremities,
- dry mouth,
- loss of appetite,
- back pain,
- dizziness, and
- cough.
- sudden numbness or weakness (especially on one side of the body);
- problems with vision or speech,
- a light-headed feeling, like you might pass out;
- severe distress or agitation;
- a seizure;
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
- trouble swallowing, or accidentally inhaling food or drink;
- low white blood cell counts--fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed;
- high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
- involuntary muscle movements;
- upset stomach, vomiting;
- drowsiness; or
- feeling restless.
- Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Suicidal Thoughts and Behaviors [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see WARNINGS AND PRECAUTIONS]
- Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
- Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Late Occurring Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Metabolic Changes [see WARNINGS AND PRECAUTIONS]
- Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
- Body Temperature Dysregulation [see WARNINGS AND PRECAUTIONS]
- Dysphagia [see WARNINGS AND PRECAUTIONS]
What Is Vraylar?
Vraylar (cariprazine) is an atypical antipsychotic indicated for the treatment of schizophrenia, and the acute treatment of manic or mixed episodes associated with bipolar I disorder.
What Are Side Effects of Vraylar?
Common side effects of Vraylar include:
Dosage for Vraylar
The starting dose of Vraylar is 1.5 mg once daily.
What Drugs, Substances, or Supplements Interact with Vraylar?
Vraylar may interact with CYP3A4 inducers and inhibitors. Tell your doctor all medications and supplements you use.
Vraylar During Pregnancy and Breastfeeding
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vraylar during pregnancy. Talk to your doctor about the National Pregnancy Registry for Atypical Antipsychotics. Vraylar causes extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. It is unknown if Vraylar passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Vraylar (cariprazine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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:
Cariprazine can have long lasting effects on your body. Some side effects could occur for several weeks after you stop using this medicine. You may also have new side effects whenever your dose is changed.
Common side effects may include:
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 Vraylar (Cariprazine Capsules)
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
Clinical Trials 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.
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. This experience corresponds with a total experience of 940.3 patient-years. A total of 2568 VRAYLAR-treated patients had at least 6 weeks and 296 VRAYLAR-treated patients had at least 48 weeks of exposure.
Patients With Schizophrenia
The following findings are based on four placebo-controlled, 6-week schizophrenia trials with VRAYLAR doses ranging from 1.5 to 12 mg once daily. The maximum recommended dosage is 6 mg daily.
Adverse Reactions Associated with Discontinuation of Treatment
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.
Common Adverse Reactions (≥ 5% and at least twice the rate of placebo): extrapyramidal symptoms and akathisia.
Adverse Reactions with an incidence of ≥ 2% and greater than placebo, at any dose are shown in Table 5.
Table 5. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and >
Placebo-treated Adult Patients in 6-Week Schizophrenia Trials
| System Organ Class / Preferred Term | Placebo (N= 584) (%) |
VRAYLAR* | ||
| 1.5 -3 mg/day (N=539 ) (%) |
4.5 -6 mg/day (N=575) (%) |
9 -12 mg/day° (N=203) (%) |
||
| Cardiac Disorders | ||||
| Tachycardiaa | 1 | 2 | 2 | 3 |
| Gastrointestinal Disorders | ||||
| Abdominal painb | 5 | 3 | 4 | 7 |
| Constipation | 5 | 6 | 7 | 10 |
| Diarrheac | 3 | 1 | 4 | 5 |
| Dry Mouth | 2 | 1 | 2 | 3 |
| Dyspepsia | 4 | 4 | 5 | 5 |
| Nausea | 5 | 5 | 7 | 8 |
| Toothache | 4 | 3 | 3 | 6 |
| Vomiting | 3 | 4 | 5 | 5 |
| General Disorders/Administration Site Conditions | ||||
| Fatigued | 1 | 1 | 3 | 2 |
| Infections and infestations | ||||
| Nasopharyngitis | 1 | 1 | 1 | 2 |
| Urinary tract infection | 1 | 1 | <1 | 2 |
| Investigations | ||||
| Blood creatine phosphokinase increased | 1 | 1 | 2 | 3 |
| Hepatic enzyme increasede | <1 | 1 | 1 | 2 |
| Weight increased | 1 | 3 | 2 | 3 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2 | 1 | 3 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||||
| Arthralgia | 1 | 2 | 1 | 2 |
| Back pain | 2 | 3 | 3 | 1 |
| Pain in extremity | 3 | 2 | 2 | 4 |
| Nervous System Disorders | ||||
| Akathisia | 4 | 9 | 13 | 14 |
| Extrapyramidal Symptomsf | 8 | 15 | 19 | 20 |
| Headacheg | 13 | 9 | 11 | 18 |
| Somnolenceh | 5 | 5 | 8 | 10 |
| Dizziness | 2 | 3 | 5 | 5 |
| Psychiatric Disorders | ||||
| Psychiatric Disorders | 4 | 3 | 5 | 3 |
| Insomniai | 11 | 12 | 13 | 11 |
| Restlessness | 3 | 4 | 6 | 5 |
| Anxiety | 4 | 6 | 5 | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2 | 1 | 2 | 4 |
| Skin and subcutaneous disorders | ||||
| Rash | 1 | <1 | 1 | 2 |
| Vascular Disorders | ||||
| Hypertensionj | 1 | 2 | 3 | 6 |
| Note: Figures rounded to the nearest integer * Data shown by modal daily dose, defined as most frequently administered dose per patient aTachycardia terms: heart rate increased, sinus tachycardia, tachycardia bAbdominal pain terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain cDiarrhea terms: diarrhea, frequent bowel movements dFatigue terms: asthenia, fatigue eHepatic enzyme increase terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased fExtrapyramidal 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 gHeadache terms: headache, tension headache hSomnolence terms: hypersomnia, sedation, somnolence iInsomnia terms: initial insomnia, insomnia, middle insomnia, terminal insomnia jHypertension terms: blood pressure diastolic increased, blood pressure increased, blood pressure systolic increased, hypertension ° 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. |
||||
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.
Adverse Reactions Associated with Discontinuation of Treatment
The adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo was akathisia (2%). Overall, 12% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 7% of placebo-treated patients in these trials.
Common Adverse Reactions (≥ 5% and at least twice the rate of placebo): extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.
Adverse Reactions with an incidence of ≥ 2% and greater than placebo at any dose are shown in Table 6.
Table 6. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in 3-Week Bipolar Mania Trials
| System Organ Class / Preferred Term | Placebo (N= 442) (%) |
VRAYLAR* | |
| 3 -6 mg/day (N=263) (%) |
9 -12 mg/day° (N=360) (%) |
||
| Cardiac Disorders | |||
| Tachycardiaa | 1 | 2 | 1 |
| Eye Disorders | |||
| Vision blurred | 1 | 4 | 4 |
| Gastrointestinal Disorders | |||
| Nausea | 7 | 13 | 11 |
| Constipation | 5 | 6 | 11 |
| Vomiting | 4 | 10 | 8 |
| Dry mouth | 2 | 3 | 2 |
| Dyspepsia | 4 | 7 | 9 |
| Abdominal painb | 5 | 6 | 8 |
| Diarrheac | 5 | 5 | 6 |
| Toothache | 2 | 4 | 3 |
| General Disorders/Administration Site Conditions | |||
| Fatigued | 2 | 4 | 5 |
| Pyrexiae | 2 | 1 | 4 |
| Investigations | |||
| Blood creatine phosphokinase increased | 2 | 2 | 3 |
| Hepatic enzymes increasedf | <1 | 1 | 3 |
| Weight increased | 2 | 2 | 3 |
| Metabolism and Nutrition Disorders | |||
| Decreased appetite | 3 | 3 | 4 |
| Musculoskeletal and Connective Tissue Disorders | |||
| Pain in extremity | 2 | 4 | 2 |
| Back pain | 1 | 1 | 3 |
| Nervous System Disorders | |||
| Akathisia | 5 | 20 | 21 |
| Extrapyramidal Symptomsg | 12 | 26 | 29 |
| Headacheh | 13 | 14 | 13 |
| Dizziness | 4 | 7 | 6 |
| Somnolencei | 4 | 7 | 8 |
| Psychiatric Disorders | |||
| Insomniaj | 7 | 9 | 8 |
| Restlessness | 2 | 7 | 7 |
| Respiratory, thoracic and mediastinal disorders | |||
| Oropharyngeal pain | 2 | 1 | 3 |
| Vascular Disorders | |||
| Hypertensionk | 1 | 5 | 4 |
| Note: Figures rounded to the nearest integer *Data shown by modal daily dose, defined as most frequently administered dose per patient aTachycardia terms: heart rate increased, sinus tachycardia, tachycardia bAbdominal pain terms: abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, cDiarrhea: diarrhea, frequent bowel movements dFatigue terms: asthenia, fatigue ePyrexia terms: body temperature increased, pyrexia fHepatic enzymes increased terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, transaminases increased gExtrapyramidal Symptoms terms: bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, musculoskeletal stiffness, oromandibular dystonia, parkinsonism, salivary hypersecretion, tremor hHeadache terms: headache, tension headache iSomnolence terms: hypersomnia, sedation, somnolence jInsomnia terms: initial insomnia, insomnia, middle insomnia kHypertension terms: blood pressure diastolic increased, blood pressure increased, hypertension ° 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. |
|||
Patients With Bipolar Depression
The following findings are based on three placebo-controlled, two 6-week and one 8-week bipolar depression trials with VRAYLAR doses of 1.5 mg and 3 mg once daily.
Adverse Reactions Associated with Discontinuation of Treatment
There were no adverse reaction leading to discontinuation that occurred at a rate of ≥ 2% in VRAYLAR-treated patients and at least twice the rate of placebo. Overall, 6% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 5% of placebo-treated patients in these trials.
Common Adverse Reactions
(≥ 5% and at least twice the rate of placebo): nausea, akathisia, restlessness, and extrapyramidal symptoms.
Adverse Reactions with an incidence of ≥ 2% and greater than placebo at 1.5 mg or 3 mg doses are shown in Table 7.
Table 7. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in two 6-week trials and one 8-week trial
| Placebo (N=468) (%) |
VRAYLAR | ||
| 1.5 mg/day (N=470) (%) |
3 mg/day (N=469) (%) |
||
| Restlessness | 3 | 2 | 7 |
| Akathisia | 2 | 6 | 10 |
| Extrapyramidal symptomsa | 2 | 4 | 6 |
| Dizziness | 2 | 4 | 3 |
| Somnolenceb | 4 | 7 | 6 |
| Nausea | 3 | 7 | 7 |
| Increased appetite | 1 | 3 | 3 |
| Weight increase | <1 | 2 | 2 |
| Fatiguec | 2 | 4 | 3 |
| Insomniad | 7 | 7 | 10 |
| aExtrapyramidal symptoms terms: akinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, hypokinesia,
muscle tightness, musculoskeletal stiffness, myoclonus, oculogyric crisis, salivary hypersecretion, tardive dyskinesia,
tremor bSomnolence terms: hypersomnia, sedation, somnolence cFatigue terms: asthenia, fatigue, malaise dInsomnia terms: initial insomnia, insomnia, insomnia related to another mental condition, middle insomnia, sleep disorder terminal insomnia |
|||
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. Although these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Extrapyramidal Symptoms (EPS) And Akathisia
In schizophrenia, bipolar mania, and bipolar depression trials, data were objectively collected using the Simpson Angus Scale (SAS) for treatment-emergent EPS (parkinsonism) (SAS total score ≤ 3 at baseline and > 3 post-baseline) and the Barnes Akathisia Rating Scale (BARS) for treatment-emergent akathisia (BARS total score ≤ 2 at baseline and > 2 post-baseline).
In 6-week schizophrenia trials, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness was 17% for VRAYLAR-treated patients versus 8% for placebo-treated patients. These events led to discontinuation in 0.3% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of akathisia was 11% for VRAYLAR-treated patients versus 4% for placebo-treated patients. These events led to discontinuation in 0.5% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of EPS is shown in Table 8.
Table 8. Incidence of EPS Compared to Placebo in 6-Week Schizophrenia Studies
| Adverse Event Term | Placebo (N= 584) (%) |
VRAYLAR* | ||
| 1.5 -3 mg/day (N=539) (%) |
4.5 -6 mg/day (N=575) (%) |
9-12 mg/day° (N=203) (%) |
||
| All EPS events | 14 | 24 | 32 | 33 |
| All EPS events, excluding Akathisia/Restlessness | 8 | 15 | 19 | 20 |
| Akathisia | 4 | 9 | 13 | 14 |
| Dystonia** | <1 | 2 | 2 | 2 |
| Parkinsonism§ | 7 | 13 | 16 | 18 |
| Restlessness | 3 | 4 | 6 | 5 |
| Musculoskeletal stiffness | 1 | 1 | 3 | 1 |
| Note: Figures rounded to the nearest integer *Data shown by modal daily dose, defined as most frequently administered dose per patient ** Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, trismus, torticollis § Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, masked facies, muscle rigidity, muscle tightness, parkinsonism, tremor, salivary hypersecretion ° 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. |
||||
In 3-week bipolar mania trials, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 28% for VRAYLAR-treated patients versus 12% for placebo-treated patients. These events led to a discontinuation in 1% of VRAYLAR-treated patients versus 0.2% of placebo-treated patients. The incidence of akathisia was 20% for VRAYLAR-treated patients versus 5% for placebo-treated patients. These events led to discontinuation in 2% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of EPS is provided in Table 9.
Table 9. Incidence of EPS Compared to Placebo in 3-Week Bipolar Mania Trials
| Adverse Event Term | Placebo (N= 442) (%) |
VRAYLAR* | |
| 3 -6 mg/day (N=263) (%) |
9 -12 mg/day° (N=360) (%) |
||
| All EPS events | 18 | 41 | 45 |
| All EPS events, excluding Akathisia/Restlessness | 12 | 26 | 29 |
| Akathisia | 5 | 20 | 21 |
| Dystonia** | 1 | 5 | 3 |
| Parkinsonism§ | 10 | 21 | 26 |
| Restlessness | 2 | 7 | 7 |
| Musculoskeletal stiffness | 1 | 2 | 2 |
|
Note: Figures rounded to the nearest integer *Data shown by modal daily dose, defined as most frequently administered dose per patient ** Dystonia includes adverse event terms: dystonia, oromandibular dystonia § Parkinsonism includes adverse event terms: bradykinesia, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, muscle rigidity, muscle tightness, parkinsonism, salivary hypersecretion, tremor ° 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. |
|||
In the two 6-week and one 8-week bipolar depression trials, the incidence of reported events related to EPS, excluding akathisia and restlessness was 4% for VRAYLAR-treated patients versus 2% for placebo-treated patients. These events led to discontinuation in 0.4% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of akathisia was 8% for VRAYLAR-treated patients versus 2% for placebo-treated patients. These events led to discontinuation in 1.5% of VRAYLAR-treated patients versus 0% of placebo-treated patients. The incidence of EPS is shown in Table 10.
Table 10. Incidence of EPS Compared to Placebo in two 6-Week and one 8-Week Bipolar Depression Trials
| Adverse Event Term | Placebo (N=468) (%) |
VRAYLAR* | |
| 1.5 mg/day (N=470) (%) |
3 mg/day (N=469) (%) |
||
| All EPS events | 7 | 10 | 19 |
| All EPS events, excluding Akathisia/Restlessness | 2 | 4 | 6 |
| Akathisia | 2 | 6 | 10 |
| Dystonia* | <1 | <1 | <1 |
| Parkinsonism§ | 2 | 3 | 4 |
| Restlessness | 3 | 2 | 7 |
| Musculoskeletal stiffness | <1 | <1 | 1 |
| Tardive Dyskinesia | 0 | 0 | <1 |
| Note: Figures rounded to the nearest integer *Dystonia includes adverse event terms: dystonia, myoclonus, oculogyric crisis § Parkinsonism includes adverse event terms: akinesia, drooling, dyskinesia, extrapyramidal disorder, hypokinesia, muscle tightness, salivary hypersecretion, and tremor. |
|||
Cataracts
In the long-term uncontrolled schizophrenia (48-week) and bipolar mania (16-week) trials, the incidence of cataracts was 0.1% and 0.2%, respectively. The development of cataracts was observed in nonclinical studies [see Nonclinical Toxicology]. The possibility of lenticular changes or cataracts cannot be excluded at this time.
Vital Signs Changes
There were no clinically meaningful differences between VRAYLAR-treated patients and placebo-treated patients in mean change from baseline to endpoint in supine blood pressure parameters except for an increase in supine diastolic blood pressure in the 9 -12 mg/day VRAYLAR-treated patients with schizophrenia.
Pooled data from 6-week schizophrenia trials are shown in Table 11 and from 3-week bipolar mania trials are shown in Table 12.
Table 11. Mean Change in Blood Pressure at Endpoint in 6-Week Schizophrenia Trials
| Placebo (N=574) |
VRAYLAR* | |||
| 1.5 -3 mg/day (N=512) |
4.5 -6 mg/day (N=570) |
9-12 mg/day° (N=203) |
||
| Supine Systolic Blood Pressure (mmHg) | +0.9 | +0.6 | +1.3 | +2.1 |
| Supine Diastolic Blood Pressure (mmHg) | +0.4 | +0.2 | +1.6 | +3.4 |
| 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. |
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Table 12. Mean Change in Blood Pressure at Endpoint in 3-Week Bipolar Mania Trials
| Placebo (N=439) |
VRAYLAR* | ||
| 3 -6 mg/day (N=259) |
9 – 12 mg/day° (N=360) |
||
| Supine Systolic Blood Pressure (mmHg) | -0.5 | +0.8 | +1.8 |
| Supine Diastolic Blood Pressure (mmHg) | +0.9 | +1.5 | +1.9 |
| * 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. |
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In the two 6-week and one 8-week bipolar depression trials, there were no clinically meaningful differences between VRAYLAR-treated patients and placebo-treated patients in mean change from baseline to endpoint in supine systolic and diastolic blood pressure.
Pooled data from two 6-week and one 8-week bipolar depression trials are shown in Table 13.
Table 13. Mean Change in Blood Pressure at Endpoint in two 6-Week and one 8-Week Bipolar Depression Trials
| Placebo (N=468) |
VRAYLAR* | ||
| 1.5 mg/day (N=572) |
3 mg/day (N=426) |
||
| Supine Systolic Blood Pressure (mmHg) | -0.2 | 0.2 | -0.1 |
| Supine Diastolic Blood Pressure (mmHg) | 0.2 | 0.1 | -0.3 |
Changes In Laboratory Tests
The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 6-week schizophrenia trials ranged between 1% and 2% for VRAYLAR-treated patients, increasing with dose, and was 1% for placebo-treated patients. The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 3-week bipolar mania trials ranged between 2% and 4% for VRAYLAR-treated patients depending on dose group administered and 2% for placebo-treated patients. The proportions of patients with transaminase elevations of ≥3 times the upper limits of the normal reference range in 6-week and 8-week bipolar depression trials ranged between 0% and 0.5% for VRAYLAR-treated patients depending on dose group administered and 0.4% for placebo-treated patients.
The proportions of patients with elevations of creatine phosphokinase (CPK) greater than 1000 U/L in 6-week schizophrenia trials ranged between 4% and 6% for VRAYLAR-treated patients, increasing with dose, and was 4% for placebo-treated patients. The proportions of patients with elevations of CPK greater than 1000 U/L in 3-week bipolar mania trials was about 4% in VRAYLAR and placebo-treated patients. The proportions of patients with elevations of CPK greater than 1000 U/L in 6-week and 8-week bipolar depression trials ranged between 0.2% and 1% for VRAYLAR-treated patients versus 0.2% for placebo-treated patients.
Other Adverse Reactions Observed During The Pre-Marketing Evaluation Of Vraylar
Adverse reactions listed below were reported by patients treated with VRAYLAR at doses of ≥ 1.5 mg once daily within the premarketing database of 3988 VRAYLAR-treated patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions that appear elsewhere in the VRAYLAR label are not included.
Reactions are further categorized by organ class and listed in order of decreasing frequency, according to the following definition: those occurring in at least 1/100 patients (frequent) [only those not already listed in the tabulated results from placebo-controlled studies appear in this listing]; those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).
Gastrointestinal Disorders: Infrequent: gastroesophageal reflux disease, gastritis
Hepatobiliary Disorders: Rare: hepatitis
Metabolism and Nutrition Disorders: Frequent: decreased appetite; Infrequent: hyponatremia
Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis
Nervous System Disorders: Rare: ischemic stroke
Psychiatric Disorders: Infrequent: suicide attempts, suicide ideation; Rare: completed suicide
Renal and Urinary Disorders: Infrequent: pollakiuria
Skin and Subcutaneous Tissue Disorders: Infrequent: hyperhidrosis
Postmarketing Experience
The following adverse reaction has been identified during post approval use of VRAYLAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous Tissue Disorders – Stevens-Johnson syndrome
Read the entire FDA prescribing information for Vraylar (Cariprazine Capsules)
© Vraylar Patient Information is supplied by Cerner Multum, Inc. and Vraylar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
