ABILIFY ASIMTUFII PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 960MG/3.2ML [SIN17222P]

Product Info

ABILIFY ASIMTUFII PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 960MG/3.2ML

[SIN17222P]

Indication

4.1 Therapeutic indication
Abilify Asimtufii is indicated for the acute and maintenance treatment of schizophrenia in adult patients.
Abilify Asimtufii is indicated for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

Dosing

4.2 Posology and method of administration

Posology

For patients who have never taken aripiprazole, tolerability with aripiprazole must be established using oral aripiprazole prior to initiating treatment with Abilify Asimtufii.

Titration of the dose for Abilify Asimtufii is not required.

Starting regimen

The recommended starting dosing regimen when transitioning from Abilify Maintena 400 mg once monthly is Abilify Asimtufii 960 mg no sooner than 26 days after previous injection of Abilify Maintena 400 mg. Abilify Asimtufii 960 mg should then be dosed once every 2 months (every 56 days).

Initiation may also be started by following one of two additional regimens:

• One injection start: On the day of initiation following oral therapy, one injection of Abilify Asimtufii 960 mg should be administered and treatment with 10 mg to 20 mg oral aripiprazole per day for 14 consecutive days should be continued to maintain therapeutic aripiprazole concentrations during initiation of therapy.

• Two injection start: On the day of initiation following oral therapy, one injection of Abilify Asimtufii 960 mg and one injection of Abilify Maintena 400 mg should be administered at two different injection sites (see method of administration), along with one 20 mg dose of oral aripiprazole.

Dosing interval and dosing adjustments

After the injection start, the recommended maintenance dose is one injection of Abilify Asimtufii 960 mg every second month. Inject Abilify Asimtufii 960 mg once every two months as a single injection 56 days after the previous injection. Patients may be given the injection up to 2 weeks before or 2 weeks after the scheduled 2-month dose.

If there are adverse reactions with the Abilify Asimtufii 960 mg dose, reduction to Abilify Maintena 300 mg once every month should be considered.

Missed doses

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, the next dose of Abilify Asimtufii 960 mg should be administered as soon as possible. The once every two months schedule should then be resumed. If more than 14 weeks have elapsed since the last injection, the next dose of Abilify Asimtufii 960 mg should be administered with concomitant oral aripiprazole for 14 days or with 2 separate injections (one each of Abilify Asimtufii 960mg and Abilify Maintena 400 mg) administered together with one 20 mg oral aripiprazole dose. The once every two months schedule should then be resumed.

Special populations

Elderly
The safety and efficacy of Abilify Asimtufii 960mg in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No recommendations on dosing can be made.

Renal impairment
No dose adjustment is required for patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is required for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, the data available are insufficient to establish recommendations. In these patients dosing should be managed cautiously. Oral formulation should be preferred (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Known CYP2D6 poor metabolisers
In patients who are known to be CYP2D6 poor metabolisers:

• Patients transitioning from Abilify Maintena 300 mg once monthly: The starting dose should be one injection of Abilify Asimtufii 720 mg, no sooner than 26 days after previous injection of Abilify Maintena 300 mg.

• One injection start (following transition from oral therapy): The starting dose should be one injection of Abilify Asimtufii 720 mg and treatment should be continued with the prescribed dose of oral aripiprazole per day for 14 consecutive days.

• Two injection start (following transition from oral therapy): The starting dose should be 2 separate injections; one Abilify Asimtufii 720 mg and one Abilify Maintena 300 mg injection, together with a single dose of 20 mg oral aripiprazole (see method of administration).

Thereafter, a maintenance dose of Abilify Asimtufii 720 mg should be administered once every two months as a single injection.

Maintenance dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers
Maintenance dose adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the dose may need to be increased to the previous dose (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In case of adverse reactions despite dose adjustments of Abilify Asimtufii 960 mg, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed.

Concomitant use of CYP3A4 inducers with Abilify Asimtufii 960 mg for more than 14 days should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Abilify Asimtufii 960 mg should not be used in patients who are known to be CYP2D6 poor metabolisers and concomitantly use a strong CYP2D6 and/or CYP3A4 inhibitor.

Paediatric population
The safety and efficacy of Abilify Asimtufii 960 mg in children and adolescents aged 0 to 17 years have not been established. No data are available.

Method of administration

Abilify Asimtufii 960 mg is only intended for gluteal intramuscular injection and must not be administered intravenously or subcutaneously. It must only be administered by a healthcare professional.

The suspension must be injected slowly as a single injection (doses must not be divided) into the gluteal muscle, alternating the injections between the right and left side. Care must be taken to avoid inadvertent injection into a blood vessel.

If initiating with any of the options that require two injections (one Abilify Asimtufii 960 mg and one Abilify Maintena 400 mg), inject into two different sites. DO NOT inject both injections concomitantly into the same gluteal muscle.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.