Cariprazine

What it is used for

• Treatment of schizophrenia in adult and pediatric patients 13 years of age and older

• Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older

• Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients

• Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients

Side effects, and when to stop

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis
• Suicidal Thoughts and Behaviors
• Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
• Neuroleptic Malignant Syndrome
• Tardive Dyskinesia
• Late Occurring Adverse Reactions
• Metabolic Changes
• Leukopenia, Neutropenia, and Agranulocytosis
• Orthostatic Hypotension and Syncope
• Falls
• Seizures [ see Warnings and Precautions ( 5.11 )]
• Potential for Cognitive and Motor Impairment
• Body Temperature Dysregulation
• Dysphagia

Who should not take it

VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and reactions suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face).

Other medicines and interactions

Table 15 displays clinically significant drug interactions with VRAYLAR.

Storing it

Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.