Key Points

• You do not administer Abilify Maintena to yourself. Abilify Maintena is an injection given only by a healthcare provider at the doctor’s office or a hospital once every month. It is an extended-release injection used to treat schizophrenia and bipolar I disorder in adults.
• Abilify Maintena is injected into the deltoid (upper arm) muscle or gluteal (buttock) muscle. It comes in a single-use prefilled syringe or vial for reconstitution. You may feel a little pain in your arm or buttock during your injection. It is only given into a muscle.
• The recommended starting and maintenance dose of Abilify Maintena, an atypical antipsychotic, is 400 mg monthly (no sooner than 26 days after the previous injection). Your doctor will adjust the dose as needed.

If you have never used Abilify Maintena before, your doctor may want you to take an oral form of aripiprazole (tablet or liquid) for up to two weeks before you start your injection to be sure you can tolerate the medication.

After your first injection of Abilify Maintena you should continue your current antipsychotic medicine for 2 weeks. Follow your doctor's dosing instructions very carefully.

Do not miss a dose of Abilify Maintena. If you do miss a dose, call your doctor's office right away to discuss your next steps.

How does Abilify Maintena come?

It is available as an extended-release injectable suspension of lyophilized powder for reconstitution in 300 mg and 400 mg strengths.

Abilify Maintena comes as two different types of single-dose kits:

• a prefilled dual chamber syringe, with needles
• a single use vial with needles.

The following information outlines administration for the Abilify Maintena single-use, prefilled dual chamber pen ONLY.

For the full information, directions and diagrams on how to administer Abilify Maintena prefilled dual chamber pen OR the Abilify Maintena vial/syringe see the Abilify Maintena full product information.

How is the Abilify Maintena shot given?

Prefilled Dual Chamber Pen

The prefilled pens come in 300 mg or 400 mg strengths. The kits contain extended-release aripiprazole injectable suspension (lyophilized powder) and sterile water for injection, plus various syringe sizes. The healthcare provider should inject the full syringe contents immediately following reconstitution.

Abilify Maintena prefilled dual chamber syringe is for single-use only. Rotate sites of injections between the two deltoid or gluteal muscles.

To prepare the dual chamber prefilled syringe:

1. Lay out and confirm that components listed below are provided in the kit: One Abilify Maintena (aripiprazole) pre-filled dual chamber syringe (400 mg or 300 mg as appropriate).
2. Select the appropriate size and length needle based on site (for deltoid or gluteal administration) and obesity.
3. Reconstitute the lyophilized powder in the prefilled dual chamber syringe at room temperature.
4. Push plunger rod slightly to engage threads. Then, rotate the plunger rod until the rod stops rotating to release diluent. After the plunger rod is at complete stop, the middle stopper will be at the indicator line (see Figure 1 in product label).
5. Vertically shake the syringe vigorously for 20 seconds until the drug is uniformly milky-white (see Figure 2). Use within 30 minutes after reconstitution.
6. 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 milky-white in color.

To inject:

• Twist and pull off the over-cap and tip-cap (see Figure 3).
• Select appropriate needle (see Figure 4) for deltoid or gluteal administration.
• 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). Then PULL needle-cap straight up (see Figure 6).
• Hold the syringe upright and advance the plunger rod slowly to expel the air. Expel air until suspension fills needle base. If it’s not possible to advance the plunger rod to expel the air, check that the plunger rod is rotated to a complete stop (see Figure 7).
• Inject slowly into the deltoid or gluteal muscle. Do not massage the injection site.
• Safely dispose of syringe as recommended in the product label.

For the full information, directions and diagrams on how to administer Abilify Maintena prefilled dual chamber pen OR the Abilify Maintena vial/syringe see the full product information.

Bottom Line

• You do not administer Abilify Maintena to yourself. Abilify Maintena is an injection given only by a healthcare provider at your doctor’s office or hospital one time every month.
• It comes as an extended-release injection used to treat schizophrenia and bipolar I disorder in adults.
• Abilify Maintena is injected into the deltoid (upper arm) muscle or gluteal (buttock) muscle. It comes in a single-use prefilled syringe or vial for reconstitution.

This is not all the information you need to know about Abilify Maintena for safe and effective use. Review the full Abilify Maintena information here, and discuss this information and any questions with your doctor or other health care provider.