Abilify Maintena Caution For Usage

Pre-filled Dual Chamber Syringe: Preparation and Administration Instructions: Preparation Prior to Reconstitution: For deep intramuscular deltoid or gluteal injection by healthcare professionals only. Do not administer by any other route. Inject full syringe contents immediately following reconstitution. Administer once monthly.
Lay out and confirm that components listed as follows are provided in the kit: One Aripiprazole (Abilify Maintena) pre-filled dual chamber syringe (400 mg or 300 mg as appropriate) for extended release injectable suspension containing lyophilized powder and Sterile Water for Injection.
One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients.
One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients.
One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients.
Reconstitution of Lyophilized Powder in Pre-filled Dual Chamber Syringe: Reconstitute at room temperature: a) Push plunger rod slightly to engage threads. And then, rotate plunger rod until the rod stops rotating to release diluent. After plunger rod is at complete stop, middle stopper will be at the indicator line.
b) Vertically shake the syringe vigorously for 20 seconds until drug is uniformly milky-white.
c) Visually inspect the syringe for particulate matter and discoloration prior to administration. The reconstituted Aripiprazole (Abilify Maintena) suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color.
Injection Procedure: Use appropriate aseptic techniques throughout injection procedure. For deep intramuscular injection only.
a) Twist and pull off Over-cap and Tip-cap.
b) Select appropriate needle.
For deltoid administration: 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for non-obese patients; 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for obese patients.
For gluteal administration: 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for non-obese patients; 21 gauge, 2 inch (51 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.
d) Then PULL needle-cap straight up.
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 plunger rod is rotated to a complete stop.
f) Inject slowly into the deltoid or gluteal muscle. Do not massage the injection site.
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.
If initiating with the two injection start, inject into two different sites in two different muscles. DO NOT inject both injections concomitantly into the same deltoid or gluteal muscle. For known CYP2D6 poor metabolisers administer in either two separate deltoid muscles or one deltoid and one gluteal muscle. DO NOT inject into two gluteal muscles.
Disposal Procedure: a) Engage the needle safety device and safely discard all kit components. Aripiprazole (Abilify Maintena) pre-filled dual chamber is for single-use only.
b) Rotate sites of injections between the two deltoid or gluteal muscles.
How Supplied: Aripiprazole (Abilify Maintena) pre-filled dual chamber syringe for extended-release injectable suspension in single-use syringes is available in 300 mg or 400 mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injection.
The 300 mg kit includes: 300 mg single-dose pre-filled dual chamber syringe containing Aripiprazole (Abilify Maintena) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection; One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients; One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients.
The 400 mg kit includes: 400 mg single-dose pre-filled dual chamber syringe containing Aripiprazole (Abilify Maintena) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection; One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients; One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients; One 21 gauge, 2 inch (51 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients.