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Follow these instructions for proper administration of ARISTADA INITIO and ARISTADA

IMPORTANT: FOLLOW ADMINISTRATION STEPS EXACTLY AS THEY APPEAR BELOW1,2

ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) are both extended-release injectable suspensions.1,2 ARISTADA INITIO is only to be used as a single dose to initiate ARISTADA treatment or as a single dose to reinitiate ARISTADA treatment following a missed dose of ARISTADA. ARISTADA INITIO is not for repeated dosing.1 ARISTADA INITIO and ARISTADA are not interchangeable because of differing pharmacokinetic profiles.1,2 Both products require a RAPID injection without hesitation.1,2

1

Tap and shake the syringe

TAP the syringe 10 times and VIGOROUSLY SHAKE for 30 seconds

1a.

Tap the syringe at least 10 times to dislodge any material that may have settled.

1b.

Then after tapping, shake the syringe vigorously for a minimum of 30 seconds to ensure a uniform suspension.

It's very important to do both steps. If the syringe is not used within 15 minutes, shake again for 30 seconds.

2

Select injection needle

2a.

Select your injection site; deltoid (only ARISTADA INITIO and ARISTADA 441 mg) or gluteal (ARISTADA INITIO and all ARISTADA doses).

2b.

Select needle length based on injection site. For patients with larger amount of subcutaneous tissue overlaying the injection-site muscle, use the longer of the needles provided.

Avoid injecting both ARISTADA and ARISTADA INITIO concomitantly into the same deltoid or gluteal muscle.

3

Attach injection needle

DO NOT OVERTIGHTEN

Attach the appropriate needle securely with a clockwise twisting motion without overtightening, which could cause the needle hub to crack.

4

Prime syringe to remove air (needle must be attached)

4a.

Bring the syringe into upright position and tap the syringe to bring air to the top.

4b.

Depress the plunger rod to remove air until a few drops are released. It is normal to see small air bubbles remaining in the syringe.

5

Inject in a rapid and continuous manner

PRODUCT REQUIRES A RAPID INJECTION. DO NOT HESITATE.

Administer the entire content intramuscularly.

DO NOT INJECT BY ANY OTHER ROUTE.

6

Dispose of the needle

Cover the needle by pressing the safety device. Dispose of used and unused items in a proper waste container.

Images shown are not actual size

Please report any product complaints to Medical Information at 1-866-ARISTADA (1-866-274-7823) (Option 1)

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References: 1. ARISTADA INITIO [package insert]. Waltham, MA: Alkermes, Inc; 2019. 2. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2019.