REAGILA

What it is

REAGILA contains cariprazine, a novel atypical antipsychotic agent. REAGILA is available in hard capsules containing cariprazine hydrochloride corresponding to 1.5 mg, 3 mg, 4.5 mg or 6 mg of cariprazine.

Approved indications

— Treatment of schizophrenia in adult patients.

Dosing overview

The recommended starting dose of REAGILA is 1.5 mg once daily. Thereafter the dose can be increased in 1.5 mg increments according to efficacy and tolerability to a maximum dose of 6 mg per day, if needed. REAGILA is to be taken once daily at the same time of the day with or without food. Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Patients should be monitored for adverse reactions and treatment response for several weeks after starting REAGILA and after each dosage change.

Key safety warnings

The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy. Close supervision of high-risk patients should accompany antipsychotic therapy. REAGILA causes akathisia and restlessness and should be used cautiously in patients who are prone to or already exhibit symptoms of akathisia. Akathisia develops early in treatment. Therefore, close monitoring in the first phase of treatment is important. A potentially fatal symptom complex referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic treatment. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, REAGILA must be discontinued immediately. REAGILA should be used cautiously in patients with history of seizures or with conditions that potentially lower the seizure threshold. REAGILA can cause orthostatic hypotension as well as hypertension. REAGILA should be used with caution in patients with known cardiovascular disease predisposing to blood pressure changes. Blood pressure should be monitored. Patients with an established diagnosis of diabetes mellitus or patients with risk factors for diabetes mellitus (such as obesity or family history of diabetes) who are starting treatment with atypical antipsychotics should be assessed for fasting plasma glucose before, or soon after, initiation of antipsychotic medication, and monitored periodically during long-term treatment.

Contraindications

REAGILA is contraindicated in any patient with a known hypersensitivity to cariprazine or any component in the formulation. REAGILA is contraindicated with concomitant administration of strong or moderate CYP3A4 inhibitors and strong or moderate CYP3A4 inducers.

PBS listing

REAGILA is listed on the PBS in capsule strengths of 1.5 mg, 3 mg, 4.5 mg and 6 mg, each with one PBS item. All strengths have streamlined restriction and an ex-manufacturer price of A$82.76.

Regulatory history

REAGILA was first listed on the ARTG on 2020-11-18 with registrations for 1.5 mg, 3 mg, 4.5 mg and 6 mg hard capsules. The TGA approved REAGILA on 2020-11-12 for the treatment of schizophrenia in adult patients. PBAC recommended REAGILA for schizophrenia in November 2020.