Generic name: aripiprazole 300mg in 1.5mL;
Dosage form: extended-release injectable suspension
ABILIFY MAINTENA is only to be administered by intramuscular injection by a healthcare professional. The recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection).
For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.
After the first ABILIFY MAINTENA injection, administer oral aripiprazole (10 mg to 20 mg) for 14 consecutive days to achieve therapeutic aripiprazole concentrations during initiation of therapy. For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), after the first ABILIFY MAINTENA injection, continue treatment with the 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.b) Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white (See Figure 2). c) Visually inspect the syringe for particulate matter and discoloration prior to administration. The reconstituted ABILIFY MAINTENA suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color.
Use appropriate aseptic techniques throughout injection procedure. Do not administer intravenously or subcutaneously.a) Twist and pull off Over-cap and Tip-cap (See Figure 3). b) Select appropriate needle (See Figure 4). • One 21 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for non-obese patients • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for obese patients c) While holding the needle cap, ensure the needle is firmly seated on the safety device with a push. Twist clockwise until SNUGLY fitted (See Figure 5). d) Then PULL needle-cap straight up (see ). e) Hold syringe UPRIGHT and ADVANCE PLUNGER ROD SLOWLY TO EXPEL THE AIR. Expel air until suspension fills needle base. If it’s not possible to advance plunger rod to expel the air, check that plunder rod is rotated to a complete stop (See Figure 7). f) Inject slowly into the gluteal muscle. Do not massage the injection site. Do not administer intravenously or subcutaneously.
Disposal Procedurea) Engage the needle safety device and safely discard all kit components (See Figure 8). ABILIFY MAINTENA pre-filled dual chamber syringe is for single-use only. b) Rotate sites of injections between the two gluteal muscles. c) Slowly inject the Sterile Water for Injection into the vial containing the ABILIFY MAINTENA lyophilized powder (see Figure 10). 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 11). 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. e) Shake the vial vigorously for 30 seconds until the reconstituted suspension appears uniform (see Figure 12). 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 Injection1. Use appropriate aseptic techniques throughout injection of the reconstituted ABILIFY MAINTENA suspension. 2. Remove the cover from the vial adapter package (see Figure 13). Do not remove the vial adapter from the package. 3. Using the vial adapter package to handle the vial adapter, attach the prepackaged luer lock syringe to the vial adapter (see Figure 14). 4. Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package (see Figure 15). Do not touch the spike tip of the adapter at any time. 5. Determine the recommended volume for injection (Table 3). Table 3: ABILIFY MAINTENA Reconstituted Suspension Volume to Inject 400 mg Vial 300 mg Vial
Volume to Inject
Volume to Inject
0.8 mL6. Wipe the top of the vial of the reconstituted ABILIFY MAINTENA suspension with a sterile alcohol swab. 7. 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 16). 8. Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection (see Figure 17). A small amount of excess product will remain in the vial. 3. 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.