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Before Initiating Treatment With REAGILA

REAGILA is indicated for the treatment of schizophrenia in adult patients1 .

Patients with different symptoms and in different stages of their disease will have different needs. This means that doses of REAGILA, switching strategies, and co-medications may differ based on the individual patient’s status. Therefore, making a thorough evaluation of the patient’s current state and current medications might be a useful way to start a treatment plan using REAGILA.

The Approved Doses For REAGILA in Schizophrenia

Based on efficacy and tolerability in clinical studies, the approved dose range of REAGILA for the treatment of schizophrenia in adult patients is 1.5-6 mg/d1. REAGILA comes in 4 different dose strengths (1.5 mg, 3 mg, 4.5 mg, and 6 mg) and all doses are effective in treating schizophrenia1.

How is REAGILA Initiated For the Treatment of Schizophrenia?

The recommended starting dose of REAGILA is 1.5 mg once daily1. Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/d, if needed1.

REAGILA dose increase.

Method of Administration

REAGILA is for oral use and it is taken once daily with or without food1. REAGILA should be taken at the same time every day – however, it is not restricted to either mornings or evenings1. Patients can take REAGILA when it’s most convenient for them, but they should be aware that REAGILA has activating qualities rather than sedating ones2, which could be a potential consideration in regard to when to take it.

When to take REAGILA.

Forgetting a Pill or Skipping a Dose

REAGILA has 2 active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR). Total cariprazine (the parent drug, DCAR, and DDCAR) reaches steady state in 3 to 4 weeks; 90% of steady state is achieved within 1 week for cariprazine and DCAR, and within 4 weeks for DDCAR1.

Reference: Adapted from Nakamura, T. et al. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment). Drug Des. Devel. Ther. 10, 327–338 (2016)3

For the management of patients treated with REAGILA, the effective half-life is more relevant than the terminal half-life. The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR, and ~1 week for total cariprazine. The plasma concentration of total cariprazine will gradually decline following dose discontinuation or interruption, and will decrease by 50% in ~1 week and by >90% in ~3 weeks1.

Therefore if steady state was reached during treatment with REAGILA, it is not expected that missing a dose will affect symptoms. Patients should not take double doses to make up for forgotten doses1.

References

  1. Reagila SmPC.
  2. Citrome, L. Activating and sedating adverse effects of second-generation antipsychotics in the treatment of schizophrenia and major depressive disorder: Absolute risk increase and number needed to harm. J. Clin. Psychopharmacol. 37, 138–147 (2017).
  3. Nakamura, T. et al. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment). Drug Des. Devel. Ther. 10, 327–338 (2016).

SCHEMES FOR SWITCHING TO REAGILA

(COD: 300020/R16. Submitted to AIFA 16/04/2020) The ultimate goal in schizophrenia treatment is recovery, which encompasses symptom remission in addition to

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MAINTENANCE DOSES FOR REAGILA

(COD: 300020/R17. Submitted to AIFA 16/04/2020) Based on efficacy and tolerability in clinical studies, the approved dose range of REAGILA for the treatment

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