Abilify Asimtufi PR 960mg3.2ml 1 Syringe

Abilify Asimtufii 960 mg / 3.2 ml is a sterile, extended-release injectable suspension for intramuscular administration. It contains 960 mg of aripiprazole in a 3.2 ml prefilled syringe, with a concentration of 300 mg/ml. It belongs to the class of atypical antipsychotics and is used in adults for the treatment of schizophrenia, as well as for maintenance monotherapy to prevent recurrence of manic or mixed episodes associated with Bipolar I Disorder. It is administered as an intramuscular injection into the gluteal muscle by a healthcare professional.

What is Abilify injection used for?

• Contains 960 mg of extended-release aripiprazole.

• Designed to provide extended-release treatment through one injection every two months for appropriate patients.

• Used for the maintenance treatment of schizophrenia in adults.

• Used as monotherapy for maintenance treatment and prevention of recurrence of manic or mixed episodes associated with Bipolar I Disorder in adults.

• Comes in a single-use prefilled syringe, facilitating administration of the prescribed dose under the supervision of a healthcare professional.

How to Use Abilify Asimtufii 960 mg

• Abilify Asimtufii 960 mg must be administered by a healthcare professional only, by intramuscular injection into the gluteal muscle. It must not be administered by any other route.

• The recommended dose is 960 mg once every two months. The dose may be reduced to 720 mg every two months when required due to drug interactions.

• Tolerability of oral aripiprazole should be established before starting treatment in patients who have not previously taken aripiprazole. Patients should never attempt to administer the injection themselves.

Precautions and Warnings

• Abilify Asimtufii is available by prescription only and must be used under medical supervision. It should only be administered by a healthcare professional by intramuscular injection into the gluteal muscle.

• Do not use if you are allergic to aripiprazole or any of the other ingredients in the medicine.

• Tolerability of oral aripiprazole should be established before starting treatment. Your doctor may recommend continuing oral aripiprazole for 14 days after the first injection.

• It is not indicated for the treatment of dementia-related psychosis in elderly patients, as antipsychotic medicines are associated with an increased risk of death and stroke in this population.

• Seek immediate medical attention if serious symptoms occur, such as high fever, severe muscle stiffness, confusion, changes in consciousness, or rapid heartbeat.

• It may cause involuntary movements, increased blood sugar and blood lipid levels, or weight gain. Your doctor may therefore need to monitor your weight, blood glucose, and lipid levels regularly.

• It may cause dizziness, drowsiness, low blood pressure, or fainting. Rise slowly and avoid driving or operating machinery until you know how the medicine affects you.

• Tell your doctor if you have a history of seizures, low white blood cell counts, or cardiovascular disease.

• It may cause unusual impulsive or compulsive behaviors, such as gambling, excessive spending, or excessive eating. Tell your doctor if these behaviors occur.

• Avoid dehydration and excessive exposure to heat, and tell your doctor if you experience difficulty swallowing or other unusual symptoms.

• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Abilify Asimtufii side effects

The most commonly reported side effects include:

• Weight gain, akathisia (restlessness), injection-site pain, and drowsiness.

Other possible side effects include:

• Dizziness, nausea, headache, constipation, fatigue, or low blood pressure.

Seek immediate medical attention if severe symptoms occur, such as fever with muscle stiffness and confusion, signs of a severe allergic reaction, or persistent involuntary movements.

Drug Interactions

• Aripiprazole is affected by medicines that influence the CYP2D6 and CYP3A4 enzymes.

• Strong CYP2D6 or CYP3A4 inhibitors may require an adjustment of the Abilify Asimtufii dose.

• Concomitant use with certain CYP3A4 inducers should be avoided according to the approved prescribing information.

• When more than one medicine affecting CYP2D6 and CYP3A4 is used together, concomitant use may need to be avoided.

• Tell your doctor and pharmacist about all medicines and dietary supplements you are taking before receiving the injection.

Storage

• Store at 25°C. Do not freeze.

• Storage at temperatures between 15°C and 30°C is permitted under the specified storage conditions.

• Keep in the original package until ready for use.

• Do not use the syringe if there is a noticeable change in the color of the suspension or if unusual particles are present.

• The syringe is for single use only and should be disposed of safely after use.

Ingredients of Abilify Asimtufii 960 mg

Active Ingredient:

• Aripiprazole 960 mg / 3.2 ml, equivalent to a concentration of 300 mg/ml.

Inactive Ingredients:

• Sodium carboxymethylcellulose, polyethylene glycol 400, povidone, sodium chloride, sodium phosphate monobasic monohydrate, sodium hydroxide, and water for injection.