First Two-Monthly Long-Acting Injectable: Abilify Asimtufii®
On April 27, 2023:
Otsuka America Pharmaceutical, Inc. (Otsuka) and Lundbeck announced that FDA has approved the New Drug Application for Abilify Asimtufii.
This post will be summarized in the following sections:
- Indications?
- How to Dose?
- How to Switch from Abilify Maintena?
- How to Manage Missed Doses?
- Use with Hepatic & Renal Impairment
- When to Avoid?
- Drug Interactions
- Clinical Trials Data
(1) Indications:
- Schizophrenia (in adults)
- Maintenance monotherapy treatment of bipolar I disorder (in adults)
(2) How to Dose?
(A) Establish Tolerability First:
- Establish tolerability with oral aripiprazole prior to initiating treatment.
- Wait for 2 weeks to fully assess tolerability: due to the half-life of oral aripiprazole.
(B) Recommended Dose:
- 960 mg: once every 2 months (56 days after previous injection)
- 720 mg: can be reduced to 720 mg in patients with adverse reactions.
(C) Adding ABILIFY ASIMTUFII in patients receiving ORAL ARIPIPRAZOLE:
- administer first dose of Abilify Asimtufii along with oral aripiprazole (10 mg to 20 mg) for 14 consecutive days.
(D) Adding ABILIFY ASIMTUFII in patients already stable on another ORL ANTIPSYCHOTIC (and known to tolerate aripiprazole):
- administer first dose of Abilify Asimtufii along with oral antipsychotics for 14 consecutive days.
(E) Timeframe for next injection:
- up to 2 weeks before or 2 weeks after the 2-month scheduled time point.
(3) How to Switch from Abilify Maintena?
- Administer Abilify Asimtufii 960 mg (once every 2-month dosing) in place of the next scheduled injection of Abilify Maintena.
- The first Abilify Asimtufii injection may be administered in place of the second, or later injection of Abilify Maintena.
- If there are adverse reactions with the Abilify Asimtufii 960 mg dosage, the dosage may be reduced to 720 mg once every 2 months.
(4) How to Manage Missed Doses?
If >8 weeks and<14 weeks have elapsed since the last injection:
- administer the next dose of Abilify Asimtufii as soon as possible.
- The once every 2-month schedule should be resumed.
If >14 weeks have elapsed since the last injection:
- restart oral aripiprazole for 14 days with the next administered injection of Abilify Asimtufii.
(5) Use with Hepatic & Renal Impairment:
RENAL IMPAIRMENT:
- No dosage adjustment with mild to severe renal impairment.
HEPATIC IMPAIRMENT:
- No dosage adjustment with mild to severe hepatic impairment
(6) When to Avoid?
- Concomitant use of Abilify Asimtufii with Strong CYP2D6 and Strong CYP3A4 inhibitors.
- Concomitant use of Abilify Asimtufii with CYP3A4 inducers.
(7) Drug Interactions:
Strong CYP3A4 inhibitor:
- Reduce the dosage of Abilify Asimtufii
Strong CYP2D6 inhibitor:
- Reduce the dosage of Abilify Asimtufii
Strong CYP3A4 inhibitor + Strong CYP2D6 inhibitor:
- Avoid Abilify Asimtufii
Strong CYP3A4 inducers:
- Avoid Abilify Asimtufii for >14 days
Antihypertensives:
- Monitor blood pressure and adjust dose accordingly
Benzodiazepines:
- Monitor sedation and blood pressure. Adjust dose accordingly
(8) Clinical Trial Data:
Clinical Trial: NCT04030143
- n= 266 patients
- Abilify Asimtufii 960 mg met the primary endpoint criteria
- Comparable effectiveness to Abilify Maintena 400 mg over a two-month dosing interval.
- Generally safe and well tolerated in subjects with schizophrenia or bipolar I disorder
- Showed comparable safety to aripiprazole once-monthly 400 mg.
References:
- Otsuka announcement. (April 27, 2023)
- Package insert (PDF)
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