WHEN ADDED TO AN ANTIDEPRESSANT IN ADULT
PATIENTS WITH MDD, VRAYLAR DELIVERS:
THE POWER OF BOTH
FDA APPROVED
FOR ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
FDA APPROVED
FOR ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
WHEN ADDED TO AN ANTIDEPRESSANT IN ADULT
PATIENTS WITH MDD, VRAYLAR DELIVERS:
THE POWER OF BOTH
When added to an antidepressant in adult patients with MDD, VRAYLAR delivers THE POWER OF BOTH:
*In a 6-week, placebo-controlled trial, mean change from baseline in MADRS total score at 6 weeks: VRAYLAR 1.5 mg/day + ADT (n=250): -14.1 (baseline mean: 32.8, P=0.0050); VRAYLAR 3 mg/day + ADT (n=252): -13.1 (baseline mean: 32.7, P=0.0727); placebo + ADT (n=249): -11.5 (baseline mean: 31.9).1,2
†In an 8-week, placebo-controlled trial, mean change from baseline in MADRS total score at 8 weeks: VRAYLAR 1 -2 mg/day + ADT (n=273): -13.4 (baseline mean: 29.0, P=0.2404); VRAYLAR 2 -4.5 mg/day + ADT (n=271): -14.6 (baseline mean: 29.3, P=0.0114); placebo + ADT (n=264): -12.5 (baseline mean: 28.9).1,2
‡The most common adverse reactions observed in the two 6-week MDD studies (≥5% and at least twice the rate of placebo) were akathisia, nausea, and insomnia. In the 6-week studies, 4% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 2% of placebo-treated patients in these trials.1,4
§Weight gain may occur. In two 6-week MDD studies, 2% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day + ADT (n=502) = +1.54 lb; VRAYLAR 3 mg/day + ADT (n=503) = +1.54 lb; placebo + ADT (n=503) = +0.44 lb. In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) = +1.98 lb; VRAYLAR 2 -4.5 mg/day + ADT (n=273) = +1.98 lb; placebo + ADT (n=266) = 0 lbs. Monitor weight at baseline and frequently thereafter.1
||In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts was similar to placebo. Shift defined as: total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL).1
¶In 6-week studies, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg per day + ADT = 2%; VRAYLAR 3 mg per day + ADT = 3.2%; placebo-treated = 1.3%. The proportion of patients with shifts in fasting glucose from normal to borderline (≥100 and <126 mg/dL) or from borderline to high was similar in patients treated with VRAYLAR and placebo. In the 8-week study, the shifts in fasting glucose were similar among the VRAYLAR and placebo + ADT groups.1
ADT=antidepressant therapy; MADRS=Montgomery-Asberg Depression Rating Scale; MDD=major depressive disorder.
Evaluated in 12 clinical trials1#
~6,700 clinical trial patients1
~7 years of real-world experience1
More than 100,000 clinicians have prescribed VRAYLAR2**
#The most common adverse reactions observed in VRAYLAR trials (≥5% and at least twice the rate of placebo): major depressive disorder (two 6-week studies) (VRAYLAR 1.5 mg/day + ADT or 3 mg/day + ADT vs placebo + ADT)—akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%); bipolar I depression (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo)—nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%); bipolar I mania (VRAYLAR 3-6 mg/day vs placebo)—EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%); schizophrenia (VRAYLAR 1.5-3 mg/day and 4.5-6 mg/day vs placebo)—EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%).1
**Inclusive of all indications.
ADT=antidepressant therapy; EPS=extrapyramidal symptoms.
VRAYLAR has #1 unrestricted commercial access among branded oral atypical antipsychotics.2*†‡
*Excluding branded products that have available generics.
†Unrestricted access is defined as a product covered on formulary that does not require a prior authorization and/or step therapy.
‡As of July 2023. Applicable to the atypical antipsychotic market basket. Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
INDICATIONS AND USAGE
VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression), for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia.
Contraindication: VRAYLAR is contraindicated in patients with known hypersensitivity. Reactions have included rash, pruritus, urticaria, and reactions suggestive of angioedema.
Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with antipsychotic drugs, elderly patients with dementia had a higher incidence of cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible may increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. If signs and symptoms of TD appear, drug discontinuation should be considered.
Late-Occurring Adverse Reactions: Adverse reactions may first appear several weeks after initiation of VRAYLAR, 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. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug.
Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused metabolic changes, such as:
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been reported with antipsychotics, including VRAYLAR. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope, with the greatest risk during initial titration and with dose increases. Monitor orthostatic vital signs in patients predisposed to hypotension and in those with cardiovascular/cerebrovascular diseases.
Falls: VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotics and recurrently for patients on long-term therapy.
Seizures: Use VRAYLAR with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Somnolence was reported with VRAYLAR. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).
Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics).
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used cautiously in patients at risk for aspiration.
Drug Interactions: Strong CYP3A4 inhibitors increase VRAYLAR concentrations, so VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is not recommended.
Adverse Reactions: The most common adverse reactions in clinical trials ( 5% and at least twice the rate of placebo) are listed below:
US-VRA-220402