Product Information for the User

Abilify Maintena 300 mg Powder and Diluent for Long-Acting Injectable Suspension

Abilify Maintena 400 mg Powder and Diluent for Long-Acting Injectable Suspension

aripiprazol

Read this entire product information carefully before receiving this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information. See section 4.

Abilify Maintena contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. It is used to treat schizophrenia – a condition with symptoms such as hearing, seeing or feeling things that do not exist, distrust, incorrect beliefs, incoherent language and monotony of emotional and behavioral behavior. People with this condition may also feel depressed, guilty, restless or tense.

Abilify Maintena is indicated for adult patients with schizophrenia who are sufficiently stabilized during treatment with oral aripiprazol.

No use Abilify Maintena:

• if you are allergic to aripiprazole or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or nurse before receiving Abilify Maintena.

Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of self-harm.

Before starting treatment with Abilify Maintena, tell your doctor if you have:

• an acute agitation state or an intensely psychotic state.

• heart problems or a history of stroke, especially if you know that other risk factors for stroke are present in you.
• high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and a feeling of weakness) or a family history of diabetes.
• seizures, as your doctor may want to monitor you more closely.
• involuntary and irregular muscle movements, especially in the face.
• a combination of fever, sweating, rapid breathing, muscle rigidity, and somnolence or numbness (which may be signs of neuroleptic malignant syndrome).
• dementia (memory loss and other mental capacity loss), especially if you are elderly.
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke, or mini-stroke, abnormal blood pressure.
• irregular heartbeats or if someone in your family has a history of irregular heartbeats (including the prolongation of the QT interval observed with ECG monitoring).
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots.
• difficulty swallowing.
• a history of addiction to gambling.
• severe liver problems (hepatitis).

If you notice that you are gaining weight, developing unusual movements, feeling drowsiness that interferes with your daily normal activities, any difficulty swallowing, or experiencing symptoms of an allergy, consult your doctor immediately.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual manner in you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive consumption or spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and Adolescents

Do not use this medication in children and adolescents under 18 years old. The safety and effectiveness of this medication in these patients are unknown.

Use of Abilify Maintena with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Blood pressure medications: Abilify Maintena may increase the effect of medications used to lower blood pressure. Ensure that you inform your doctor if you are taking blood pressure medications.

If you are using Abilify Maintena with any other medication, it may mean that your doctor needs to change your dose of Abilify Maintena or the dose of the other medications. It is especially important to mention to your doctor if you are taking:

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John's Wort)
• antifungal medications (such as ketoconazole, itraconazole)
• certain medications to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir)
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
• medications known to prolong the QT interval.

These medications may increase the risk of adverse effects or reduce the effect of Abilify Maintena; if you observe any unusual symptoms when taking any of these medications with Abilify Maintena, inform your doctor.

Medications that increase serotonin levels are generally used to treat diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social anxiety disorder, as well as migraine and pain:

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications with Abilify Maintena, inform your doctor.

Use of Abilify Maintena with alcohol

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use Abilify Maintena if you are pregnantunless you have discussed this with your doctor. Ensure that you inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant.

The following symptoms may occur in newborn babies, from mothers who have used Abilify Maintena in the last trimester of pregnancy (last three months of pregnancy): tremors, rigidity, and/or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

If you are using Abilify Maintena, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated with Abilify Maintena, do not breastfeed. Discuss with your doctor the best way to feed your baby if you are using Abilify Maintena.

Driving and operating machinery

During treatment with this medication, dizziness and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Abilify Maintena contains sodium

Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose. This is essentially "sodium-free".

Abilify Maintena is presented as a powder that your doctor or nurse prepares as a suspension.

Your doctor will decide on the most suitable dose of Abilify Maintena for you. The recommended initial dose is 400 mg, unless your doctor decides to administer a lower initial or follow-up dose (300 mg, 200 mg, or 160 mg).

There are two ways to start treatment with Abilify Maintena, and your doctor will decide which one is suitable for you.

• If you receive an injection of Abilify Maintena on your first day, treatment with oral aripiprazole will continue for 14 days after the first injection.
• If you receive two injections of Abilify Maintena on your first day, you will also take an oral aripiprazole tablet on this visit.

After that, treatment will be administered with Abilify Maintena injections unless your doctor tells you otherwise.

Your doctor will administer it as a single injection in the gluteus or deltoid (buttock or shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the injections between the right and left sides. Injections will not be administered intravenously.

If you are given more Abilify Maintena than you should

This medication will be administered under medical supervision, so it is unlikely that you will receive too much. If you see more than one doctor, make sure to tell them that you are using Abilify Maintena.

Patients who have received too much aripiprazol have experienced the following symptoms:

Other symptoms may include:

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you did not receive your Abilify Maintena dose

It is essential not to forget your scheduled dose. You should receive an injection every month, but not before 26 days have passed since the last injection. If you forget an injection, contact your doctor to schedule the next injection as soon as possible.

If Abilify Maintena administration is discontinued

Do not stop treatment just because you feel better. It is essential that you continue to receive Abilify Maintena for the time your doctor has indicated.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following serious side effects:

The following side effects listed below may also occur after administration of Abilify Maintena.

Frequent side effects (may affect up to 1 in 10 people):

Rare side effects (may affect up to 1 in 100 people):

• elevated levels of liver enzymes
• elevated levels of alanine aminotransferase
• elevated levels of γ-glutamyl transferase
• elevated levels of bilirubin in the blood
• elevated levels of aspartate aminotransferase
• elevated or decreased levels of glucose in the blood
• elevated levels of hemoglobin A1c
• decreased levels of cholesterol in the blood
• decreased levels of triglycerides in the blood
• increased waist circumference

The following side effects have been reported since the marketing of aripiprazole oral, but the frequency with which they occur is unknown (the frequency cannot be estimated from the available data):

• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased libido and concerning behavior for you or others, for example, increased sexual appetite
• uncontrollable excessive buying
• binge eating (ingesting large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)
• tendency to wander

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce symptoms.

• elevated levels of alkaline phosphatase
• fluctuating results during tests to measure blood glucose levels

Reporting side effects

If you experience side effects, consult your doctor or nurse, even if they do not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and vial. The expiration date is the last day of the month indicated.

Do not freeze.

The reconstituted suspension must be used immediately but can be stored in the vial for 4 hours at a temperature below 25 °C. Do not store the reconstituted suspension in the syringe.

Composition of Abilify Maintena

• The active ingredient is aripiprazol.

Each vial contains 300 mg of aripiprazol.

After reconstitution, each ml of suspension contains 200 mg of aripiprazol. Each vial contains 400 mg of aripiprazol.

After reconstitution, each ml of suspension contains 200 mg of aripiprazol.

• The other components are

Powder

Sodium caramel, mannitol, sodium monohydrate phosphate dehydrogenase, sodium hydroxide

Solvent

Water for injectable preparations

Appearance of Abilify Maintena and packaging contents

Abilify Maintena is a powder and solvent for the preparation of a prolonged-release injectable suspension.

Abilify Maintena is a white or off-white powder that is presented in a transparent glass vial. Your doctor or nurse will prepare a suspension of Abilify Maintena that will be administered to you by injection. To do this, they will use the solvent vial that comes in the pack, a transparent solution in a transparent glass vial.

Individual packaging

Each individual packaging contains a vial with powder, a 2 ml vial with solvent, a 3 ml syringe with luer-lock and a pre-attached hypodermic safety needle, 38 mm, calibre 21, with a needle protection device, a disposable 3 ml syringe with luer-lock tip, a vial adapter, and three hypodermic safety needles: one 25 mm and calibre 23, one 38 mm and calibre 22, and one 51 mm and calibre 21.

Multiple packaging

Batch of 3 individual packagings.

Only some packaging sizes may be commercially available.

Marketing Authorization HolderOtsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible for manufacturing

H. Lundbeck A/S Ottiliavej 9, 2500 Valby

Denmark

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/AAAA}.

Other sources of information

The detailed information about this medication is available on the European Medicines Agency websitehttp://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension

Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension

Aripiprazol

Step 1: Preparation before reconstituting the powder

Remove all components from the packaging and confirm that they are all the ones indicated in the following list:

• Abilify Maintena prospectus and instructions for healthcare professionals
• Vial with powder.
• Vial with 2 ml of solvent.

Important:The vial with solvent contains an additional amount of solvent.

• A 3 ml luer-lock syringe with a pre-attached hypodermic safety needle, 38 mm, calibre 21, with a needle protection device.
• A disposable 3 ml syringe with luer-lock tip.
• Vial adapter.
• A hypodermic safety needle, 25 mm, calibre 23, with a needle protection device.
• A hypodermic safety needle, 38 mm, calibre 22, with a needle protection device.
• A hypodermic safety needle, 51 mm, calibre 21, with a needle protection device.
• Instructions for the needle and syringe

Step 2: Reconstitution of the powder

1. Remove the cap from the vial with powder and the one from the vial with solvent and clean the stopper of both vials with a sterile cotton swab soaked in alcohol.
2. Using the syringe with the pre-attached needle, extract the predetermined volume of solvent from the corresponding vial, pouring the solvent into the syringe.

Vial of 300 mg:

Add 1.5 ml of solvent to reconstitute the powder.

Vial of 400 mg:

Add 1.9 ml of solvent to reconstitute the powder.

There will be a small amount of residual solvent left in the vial after extraction. Any excess must be eliminated.

Water

1. Inject the solvent slowly into the vial containing the powder.
2. Extract the air to equalize the pressure in the vial by pulling the plunger back slightly.

1. Then, remove the syringe from the vial.

Proceed to insert the safety needle device using the one-handed technique.

Press the cap firmly against a flat surface until the needle is securely locked in the safety needle device.

Visually check that the needle is perfectly locked in the safety needle device and discard the syringe.

1. Shake the vial vigorously for at least 30 seconds until the suspension is uniform.

1. Visually inspect the reconstituted suspension for particles and discoloration before administration. The reconstituted medication is a white or off-white liquid suspension. Do not use the reconstituted suspension if it contains particles or is discolored.
2. If the injection is not administered immediately after reconstitution, the vial can be maintained for up to 4 hours at a temperature below 25 °C and shaken vigorously for at least 60 seconds to ensure resuspension before injecting.
3. Do not store the reconstituted suspension in the syringe.

Step 3: Preparation before injection

1. Remove the protective cap from the vial adapter, but do not remove the vial adapter from the protective cap.
2. Hold the protective cap of the vial adapter, and attach the luer-lock syringe by inserting it into the vial adapter and turning it afterwards.

1. Use the luer-lock syringe to extract the vial adapter from the protective cap and discard the protective cap of the vial adapter.Do not touch the tip of the vial adapter at any time.

d) Determine the recommended volume for injection.

1. Clean the cap of the vial with the reconstituted suspension with a sterile cotton swab soaked in alcohol.
2. Place and hold the vial with the reconstituted suspension on a hard surface. Insert the vial adapter by holding the outer part of the vial adapter and pushing the tip of the vial adapter firmly, through the rubber stopper, until it is securely locked in place.
3. Extract the recommended volume from the vial with the luer-lock syringe to inject it.There will be a small amount of excess suspension left in the vial.

Step 4: Injection procedure

1. Remove the luer-lock syringe containing the recommended volume of the reconstituted Abilify Maintena suspension from the vial.
2. Select one of the hypodermic safety needles described below, depending on the injection site and the patient's weight, and attach the hypodermic safety needle to the luer-lock syringe containing the suspension to inject. Make sure the hypodermic safety needle is securely attached to the safety needle device, pressing and turning it in a clockwise direction, then remove the protective cap from the needle immediately.

c) Inject the recommended volume slowly by a single dose intramuscular injection in the gluteal or deltoid muscle. Do not massage the injection site. Be careful and avoid injecting it into a blood vessel. Do not inject into areas with signs of inflammation, damaged skin, swelling, and/or hematomas.

Only for deep intramuscular injection in the gluteal or deltoid muscle.

Deltoid Gluteal

Remember to rotate the injection sites in both gluteals and deltoids. If treatment is initiated with two injections, administer the injections in two different sites in two different muscles. DO NOT inject both injections simultaneously in the same deltoid or muscle gluteal.

In the case of known CYP2D6 slow metabolizers, administer in two separate deltoid muscles or in one deltoid muscle and one gluteal muscle. DO NOT inject in two gluteal muscles.

Look for signs or symptoms of accidental intravenous administration.

Step 5: Procedures after injection

Insert the safety needle device as described in Step 2 e) and discard the vials, adapter, needles, and syringes properly after the injection. The vials with powder and solvent are for single use.