Abilify Maintena

Indications
Dosage
How Supplied

INDICATIONS

ABILIFY MAINTENA (aripiprazole) is indicated for the treatment of schizophrenia.

Efficacy was demonstrated in a placebo-controlled, randomized-withdrawal maintenance trial in patients with schizophrenia and additional support for efficacy was derived from oral aripiprazole trials [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Dosing Information

ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. The recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection).

After the first ABILIFY MAINTENA injection, continue treatment with oral aripiprazole (10 mg to 20 mg) or other oral antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.

If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg once monthly.

Dosage Adjustments for Missed Doses

If the second or third doses are missed:

  • If more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
  • If more than 5 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

If the fourth or subsequent doses are missed:

  • If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
  • If more than 6 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

CYP2D6 Poor Metabolizers and with Concomitant Use of CYP3A4 Inhibitors, CYP2D6 Inhibitors, or CYP3A4 Inducers

Dosage adjustments are recommended in patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days (see Table 1). If the CYP3A4 inhibitor, or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage may need to be increased.

Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels.

Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.

Table 1: Dose Adjustments of ABILIFY MAINTENA in Patients who are CYP2D6 Poor Metabolizers and Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, and/or CYP3A4 Inducers for Greater than 14 days

  Adjusted Dose
CYP2D6 Poor Metabolizers
CYP2D6 Poor Metabolizers 300 mg
CYP2D6 Poor Metabolizers taking concomitant CYP3A4 inhibitors 200 mg
Patients Taking 400 mg of ABILIFY MAINTENA
Strong CYP2D6 or CYP3A4 inhibitors 300 mg
CYP2D6 and CYP3A4 inhibitors 200 mg
CYP3A4 inducers Avoid use
Patients Taking 300 mg of ABILIFY MAINTENA
Strong CYP2D6 or CYP3A4 inhibitors 200 mg
CYP2D6 and CYP3A4 inhibitors 160 mg
CYP3A4 inducers Avoid use

Preparation Prior to Reconstitution of the Lyophilized ABILIFY MAINTENA Powder

For deep intramuscular gluteal injection by healthcare professionals only. Do not administer by any other route. Inject immediately after reconstitution. Administer once monthly.

  1. Lay out and confirm that components listed below are provided in the kit:
    • Vial of ABILIFY MAINTENA™ (aripiprazole) for extended-release injectable suspension lyophilized powder
    • 5 mL vial of Sterile Water for Injection, USP
    • One 3 mL Luer Lock syringe with pre-attached 21 gauge, 1.5 inch (38 mm) Hypodermic Needle-Pro® safety needle with needle protection device
    • One 3 mL BD Luer-Lok™ disposable syringe with BD Luer-Lok tip
    • One vial adapter
    • One 21 gauge, 1.5 inch (38 mm) Hypodermic Needle-Pro® safety needle with needle protection device
    • One 21 gauge, 2 inch (50 mm) Hypodermic Needle-Pro® safety needle for obese patients with needle protection device
  2. ABILIFY MAINTENA should be suspended using the Sterile Water for Injection as supplied in the kit.
  3. The Sterile Water for Injection and ABILIFY MAINTENA vials are for single-use only.
  4. Use appropriate aseptic techniques throughout reconstitution and reconstitute at room temperature.
  5. Select the amount of Sterile Water for Injection needed for reconstitution (see Table 2).

Table 2: Amount of Sterile Water for Injection Needed for Reconstitution

400 mg Vial 300 mg Vial
Dose Sterile Water for Injection Dose Sterile Water for Injection
400 mg 1.9 mL 300 mg 1.5 mL

Important: There is more Sterile Water for Injection in the vial than is needed to reconstitute ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension. The vial will have excess Sterile Water for Injection; discard any unused portion.

Reconstitution of the Lyophilized Powder

(a) Remove the cap of the vial of Sterile Water for Injection and remove the cap of the vial containing ABILIFY MAINTENA lyophilized powder and wipe the tops with a sterile alcohol swab.

(b) Using the syringe with pre-attached Hypodermic Needle-Pro needle, withdraw the pre-determined Sterile Water for Injection volume from the vial of Sterile Water for Injection into the syringe (see Figure 1). Residual Sterile Water for Injection will remain in the vial following withdrawal; discard any unused portion.

Figure 1

Withdraw the pre-determined Sterile Water - Illustration

(c) Slowly inject the Sterile Water for Injection into the vial containing the ABILIFY MAINTENA lyophilized powder (see Figure 2).

Figure 2

Slowly inject the Sterile Water - Illustration

(d) Withdraw air to equalize the pressure in the vial by pulling back slightly on the plunger. Subsequently, remove the needle from the vial. Engage the needle safety device by using the one-handed technique (see Figure 3). Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath. Visually confirm that the needle is fully engaged into the needle protection sheath, and discard.

Figure 3

Engage the needle safety device - Illustration

(e) Shake the vial vigorously for 30 seconds until the reconstituted suspension appears uniform (see Figure 4).

Figure 4

Shake the vial vigorously - Illustration

(f) Visually inspect the reconstituted suspension for particulate matter and discoloration prior to administration. The reconstituted ABILIFY MAINTENA is a uniform, homogeneous suspension that is opaque and milky-white in color.

(g) If the injection is not performed immediately after reconstitution keep the vial at room temperature and shake the vial vigorously for at least 60 seconds to re-suspend prior to injection.

(h) Do not store the reconstituted suspension in a syringe.

Preparation Prior to Injection

(a) Use appropriate aseptic techniques throughout injection of the reconstituted ABILIFY MAINTENA suspension.

(b) Remove the cover from the vial adapter package (see Figure 5). Do not remove the vial adapter from the package.

Figure 5

Remove the cover from the vial adapter - Illustration

(c) Using the vial adapter package to handle the vial adapter, attach the prepackaged BD Luer-Lok syringe to the vial adapter (see Figure 6).

Figure 6

attach the prepackaged BD Luer-Lok syringe - Illustration

(d) Use the BD Luer-Lok syringe to remove the vial adapter from the package and discard the vial adapter package (see Figure 7). Do not touch the spike tip of the adapter at any time.

Figure 7

Remove the vial adapter from the package - Illustration

(e) Determine the recommended volume for injection (Table 3).

Table 3: ABILIFY MAINTENA Reconstituted Suspension Volume to Inject

400 mg Vial 300 mg Vial
Dose Volume to Inject Dose Volume to Inject
400 mg 2 mL --- ---
300 mg 1.5 mL 300 mg 1.5 mL
200 mg 1 mL 200 mg 1 mL
160 mg 0.8 mL 160 mg 0.8 mL

(f) Wipe the top of the vial of the reconstituted ABILIFY MAINTENA suspension with a sterile alcohol swab.

(g) Place and hold the vial of the reconstituted ABILIFY MAINTENA suspension on a hard surface. Attach the adapter-syringe assembly to the vial by holding the outside of the adapter and pushing the adapter's spike firmly through the rubber stopper, until the adapter snaps in place (see Figure 8).

Figure 8

Attach the adapter-syringe assembly to the vial - Illustration

(h) Slowly withdraw the recommended volume from the vial into the BD Luer-Lok syringe to allow for injection (see Figure 9). A small amount of excess product will remain in the vial.

Figure 9

Slowly withdraw the recommended volume - Illustration

Injection Procedure

(a) Detach the BD Luer-Lok syringe containing the recommended volume of reconstituted ABILIFY MAINTENA suspension from the vial.

(b) Select one of the following Hypodermic Needle-Pro needles and attach the needle to the BD Luer-Lok syringe containing the suspension for injection. Ensure the needle is firmly seated on the Needle-Pro safety device with a push and clockwise twist and then pull the needle cap straight away from the needle (see Figure 10).

  • 21 gauge, 1.5 inch (38 mm) Hypodermic Needle-Pro needle with needle protection device for non-obese patients.
  • 21 gauge, 2 inch (50 mm) Hypodermic Needle-Pro safety needle for obese patients.

Figure 10

Ensure the needle is firmly seated - Illustration

(c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal muscle. Do not massage the injection site. Do not administer intravenously or subcutaneously.

Procedures After Injection

  1. Engage the needle safety device as described in Section 2.5, Step (d). Dispose of the vials, adapter, needles, and syringe appropriately after injection. The Sterile Water for Injection and ABILIFY MAINTENA vials are for single-use only.
  2. Rotate sites of injections between the two gluteal muscles.

Different Aripiprazole Formulations

There are two aripiprazole formulations for intramuscular use with different dosages, dosing frequencies, and indications. ABILIFY MAINTENA is a long-acting aripiprazole formulation with 4 week dosing intervals indicated for the treatment of schizophrenia. In contrast, aripiprazole injection (9.75 mg per vial) is a short-acting formulation indicated for agitation in patients with schizophrenia or mania. Do not substitute these products. Refer to the prescribing information for aripiprazole injection for more information about aripiprazole injection.

HOW SUPPLIED

Dosage Forms And Strengths

For extended-release injectable suspension

300 mg and 400 mg, lyophilized powder in a single-use vial for reconstitution. The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.

Storage And Handling

ABILIFY MAINTENA™ (aripiprazole) extended-release injectable suspension is available in 300 mg or 400 mg strength vials.

The 300 mg kit includes (NDC 59148-018-71):
  • 300 mg vial of ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension lyophilized powder
  • 5 mL vial of Sterile Water for Injection, USP
  • One 3 mL Luer Lock syringe with pre-attached 21 gauge, 1.5 inch Hypodermic Needle-Pro® safety needle with needle protection device
  • One 3 mL BD Luer-Lok™ disposable syringe with BD Luer-Lok tip
  • One vial adapter
  • One 21 gauge, 1.5 inch (38 mm) Hypodermic Needle-Pro® safety needle with needle protection device
  • One 21 gauge, 2 inch (50 mm) Hypodermic Needle-Pro® safety needle with needle protection device
The 400 mg kit includes (NDC 59148-019-71)
  • 400 mg vial of ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension lyophilized powder
  • 5 mL vial of Sterile Water for Injection, USP
  • One 3 mL Luer Lock syringe with pre-attached 21 gauge, 1.5 inch Hypodermic Needle-Pro® safety needle with needle protection device
  • One 3 mL BD Luer-Lok™ disposable syringe with BD Luer-Lok tip
  • One vial adapter
  • One 21 gauge, 1.5 inch (38 mm) Hypodermic Needle-Pro® safety needle with needle protection device
  • One 21 gauge, 2 inch (50 mm) Hypodermic Needle-Pro® safety needle with needle protection device
Storage

Store at 25 °C (77 °F), excursions permitted between 15 °C and 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA. Marketed by Lundbeck, Deerfield, IL 60015 USA. February 2013

Last reviewed on RxList: 3/14/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
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