Posology : מינונים

4.2   Posology and method of administration

Posology
For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with Abilify Maintena.

The recommended starting and maintenance dose of Abilify Maintena is 400 mg.

Titration of the dose of this medicinal product is not required. It should be administered once monthly as a single injection (no sooner than 26 days after the previous injection).

After the first injection, treatment with 10 mg to 20 mg oral aripiprazole per day should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.

If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.

Missed doses

Missed doses
If2nd or 3rd dose is missed and                               Action time since last injection is:
> 4 weeks and < 5 weeks             The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
> 5 weeks                           Concomitant oral aripiprazole should be restarted for 14 days with next administered injection.

If 4th or subsequent doses are                             Action missed (i.e., after attainment of steady state) and time since last injection is:
> 4 weeks and < 6 weeks           The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
> 6 weeks                         Concomitant oral aripiprazole should be restarted for 14 days with next administered injection and then resume monthly injection schedule.

Special populations

Elderly
The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4).

Renal impairment
No dosage adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment
No dosage 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).

Known CYP2D6 poor metabolisers
In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300 mg. When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200 mg (see section 4.5).

Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers

Dosage 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 dosage may need to be increased to the previous dose (see section 4.5). In case of adverse reactions despite dose adjustments of Abilify Maintena, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed.

Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels (see section 4.5).

Dose adjustments of Abilify Maintena in patients who are taking concomitant strong CYP2D6 inhibitors, strong CYP3A4 inhibitors, and/or CYP3A4 inducers for more than 14 days

Adjusted dose
Patients taking 400 mg of Abilify Maintena
Strong CYP2D6 or strong CYP3A4 inhibitors                                          300 mg Strong CYP2D6 and strong CYP3A4 inhibitors                                        200 mg* CYP3A4 inducers                                                                   Avoid use Patients taking 300 mg of Abilify Maintena
Strong CYP2D6 or strong CYP3A4 inhibitors                                         200 mg* Strong CYP2D6 and strong CYP3A4 inhibitors                                        160 mg* CYP3A4 inducers                                                                   Avoid use * 200 mg and 160 mg can be achieved via adjustment of the injection volume only by using Abilify Maintena powder and solvent for prolonged-release suspension for injection.

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

Method of administration

Abilify Maintena is only intended for intramuscular use and should not be administered intravenously or subcutaneously. It should only be administered by a healthcare professional.


The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle. Care should be taken to avoid inadvertent injection into a blood vessel.

Full instructions for use and handling of Abilify Maintena are provided in the package leaflet (information intended for healthcare professionals).

For instructions on reconstitution of the medicinal product before administration, see section 6.6.