Generic Name
ARIPiprazole
Brand Names
Abilify Asimtufii, Abilify, Opipza, Abilify MAINTENA
FDA approval date: November 15, 2002
Classification: Atypical Antipsychotic
Form: Injection, Tablet, Kit, Film, Solution
What is Abilify Asimtufii (ARIPiprazole)?
Aripiprazole tablets are indicated for the treatment of: Schizophrenia [ see CLINICAL STUDIES ( 1.
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Brand Information
Abilify Asimtufii (Aripiprazole)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY ASIMTUFII is not approved for the treatment of patients with dementia-related psychosis [see
1INDICATIONS AND USAGE
ABILIFY ASIMTUFII is indicated:
- for the treatment of schizophrenia in adults
- for maintenance monotherapy treatment of bipolar I disorder in adults
2DOSAGE FORMS AND STRENGTHS
Extended-release injectable suspension: sterile, white to off-white, aqueous suspension in a single-dose, pre-filled syringe.
3CONTRAINDICATIONS
ABILIFY ASIMTUFII is contraindicated in patients with a known hypersensitivity to aripiprazole, or any of the excipients. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole
4ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Increased Mortality in Elderly Patients with Dementia - Related Psychosis Use
- Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis
- Neuroleptic Malignant Syndrome
- Tardive Dyskinesia
- Metabolic Changes
- Pathological Gambling and Other Compulsive Behaviors
- Orthostatic Hypotension and Syncope
- Falls
- Leukopenia, Neutropenia, and Agranulocytosis
- Seizures
- Potential for Cognitive and Motor Impairment
- Body Temperature Regulation
- Dysphagia
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ABILIFY ASIMTUFII for the treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults is based on adequate and well-controlled studies of Abilify Maintena. The safety data from those studies is presented below.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), blood glucose fluctuation, drug reaction with eosinophilia and systemic symptoms (DRESS), hiccups, pathological gambling, and fecal incontinence.
5DESCRIPTION
Aripiprazole is an atypical antipsychotic which is present in ABILIFY ASIMTUFII as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C
ABILIFY ASIMTUFII (aripiprazole) is available as a white to off-white, sterile, aqueous extended-release suspension for intramuscular injection in 720 mg or 960 mg dose strength, pre-filled syringes. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients are carboxymethylcellulose sodium (5 mg/mL), polyethylene glycol 400 (1 mg/mL), povidone (4 mg/mL), sodium chloride (6.1 mg/mL), sodium phosphate monobasic monohydrate (0.74 mg/mL), sodium hydroxide (to adjust pH) and water for injection (q.s.).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7INSTRUCTIONS FOR USE
ABILIFY ASIMTUFII (a-BIL-i-fy AH-SIM-TUH-FYE)
(aripiprazole)
extended-release injectable suspension
The following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information.
- Read the complete instructions for preparation and administration below before administering ABILIFY ASIMTUFII.
- To be prepared and administered only by a healthcare professional once every two months
- ABILIFY ASIMTUFII pre-filled syringe is
- For gluteal intramuscular injection only. Do not administer by any other route.
- Prior to administration, visually inspect ABILIFY ASIMTUFII pre-filled syringe for particulate matter and discoloration. The suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color. Do not use ABILIFY ASIMTUFII pre-filled syringe if the suspension is discolored, or particulate matter is present.
Contents of Kit
Each kit contains one sterile pre-filled syringe containing ABILIFY ASIMTUFII (aripiprazole) 720 mg or 960 mg extended-release injectable suspension and two safety needles:
- One sterile 1 ½ inch 22 gauge needle (in black packaging)
- One sterile 2 inch 21 gauge needle (in green packaging)
Preparation Prior to Administration
- Remove the ABILIFY ASIMTUFII pre-filled syringe from the package.
- Tap the syringe on your hand at least 10 (ten) times (Figure 1).
- After tapping, shake the syringe vigorously for at least 10 (ten) seconds until the medication is uniform (Figure 2).
Select the appropriate needle
Needle selection is determined by patient body type.
For gluteal intramuscular administration only.
- For non-obese patients - 22-gauge, 1.5-inch (38 mm) safety needle with needle protection device (needle in black packaging)
- For obese patients - 21-gauge, 2-inch (51 mm) safety needle with needle protection device (needle in green packaging)
Refer to Table 1 below for needle information:
Attach the needle
- Twist and pull off the pre-filled syringe tip-cap (Figure 3).
- While holding the base of the needle, ensure the needle is firmly seated on the safety device with a push. Gently twist clockwise until SECURELY fitted (Figure 3).
Expel Air
- When you are ready to administer the injection of ABILIFY ASIMTUFII, hold the pre-filled syringe upright and remove the needle-cap straight up (Figure 4). Do not twist the needle-cap, as this may loosen the needle from the syringe.
- Slowly advance the plunger rod upward to expel the air and until the suspension fills needle base (Figure 5).
Inject the dose
- Slowly inject the entire contents of the pre-filled syringe intramuscularly into the gluteal muscle of the patient (Figure 6).
Do not administer by any other route.
Do not massage the injection site.
Disposal Procedure
- After the injection, press the safety shield on a hard surface to cover and lock shield over the needle (Figure 7 and 8)
- Immediately discard used syringe and the unused needle in an approved sharps container (Figure 9).
- The unused needle should not be saved for future use.
8PRINCIPAL DISPLAY PANEL - 720 mg/2.4 mL Syringe Carton
NDC 59148-102-80
720 mg/2.4 mL
Abilify Asimtufii
FOR GLUTEAL INTRAMUSCULAR INJECTION ONLY
Contents: 1 single-dose prefilled syringe and 2 safety needles
9PRINCIPAL DISPLAY PANEL - 960 mg/3.2 mL Syringe Carton
NDC 59148-114-80
960 mg/3.2 mL
Abilify Asimtufii
FOR GLUTEAL INTRAMUSCULAR INJECTION ONLY
Contents: 1 single-dose prefilled syringe and 2 safety needles
