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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

aripiprazole

Read the entire leaflet carefully before receiving this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Abilify Maintena is and what it is used for
2. What you need to know before you are given Abilify Maintena
3. How Abilify Maintena is administered
4. Possible side effects
5. How to store Abilify Maintena
6. Contents of the pack and other information

1. What Abilify Maintena is and what it is used for

Abilify Maintena contains the active substance aripiprazole in a vial. Aripiprazole belongs to a group of medicines called antipsychotics. Abilify Maintena is used to treat schizophrenia – a condition characterized by symptoms such as hearing, seeing, or sensing things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People with this illness may also feel depressed, guilty, restless, or tense.

Abilify Maintena is indicated for adult patients with schizophrenia who are sufficiently stabilized on oral aripiprazole therapy.

2. What you need to know before Abilify Maintena is administered to you

Do not use Abilify Maintena

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

Warnings and precautions

Talk to your doctor or nurse before you are given Abilify Maintena.

Cases of patients experiencing suicidal thoughts and behaviours during treatment with this medicine have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself before or after receiving Abilify Maintena.

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

• acute agitation or an intensely psychotic state.
• heart problems or a history of stroke, especially if you know you have other risk factors for stroke.
• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes.
• seizures, as your doctor may wish to monitor you more closely.
• involuntary and irregular muscle movements, especially of the face.
• a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness or numbness (these may be signs of neuroleptic malignant syndrome).
• dementia (loss of memory and other mental abilities), especially if you are elderly.
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke (transient ischaemic attack), or abnormal blood pressure.
• irregular heartbeats, or if anyone else in your family has a history of irregular heartbeats (including QT interval prolongation observed on ECG monitoring).
• blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation.
• difficulty swallowing.
• a history of gambling addiction.
• severe liver problems.

If you notice that you are gaining weight, developing unusual movements, feeling drowsy to the point of interfering with your normal daily activities, any difficulty swallowing, or experiencing symptoms of allergy, speak to 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 way and are unable to resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

This medicine may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution should be taken, especially if you are an elderly patient or have some degree of weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age. It is not known whether it is safe and effective in these patients.

Using Abilify Maintena with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines to lower blood pressure: Abilify Maintena may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking medicines to control your blood pressure.

If you are using Abilify Maintena with any other medicine, it may mean that your doctor needs to adjust the dose of Abilify Maintena or the other medicines. It is especially important that you tell your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John’s wort)
• medicines for fungal infections (antifungals) (such as itraconazole)
• ketoconazole (used to treat Cushing’s syndrome when the body produces excess cortisol)
• certain medicines for 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)
• medicines known to prolong the QT interval.

These medicines may increase the risk of adverse effects or reduce the effect of Abilify Maintena; if you notice any unusual symptoms while taking any of these medicines together with Abilify Maintena, you must inform your doctor.

Medicines that increase serotonin levels are generally used for conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain
• SSRIs (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive disorders
• St. John’s wort (Hypericum perforatum) used in herbal medicines for mild depression
• analgesics (such as tramadol and pethidine) used to relieve pain
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with Abilify Maintena, you must inform your doctor.

Use of Abilify Maintena with alcohol

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use Abilify Maintena if you are pregnant unless you have discussed this with your doctor. Make sure to 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 whose mothers used Abilify Maintena during the last three months of pregnancy (third trimester): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing 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, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with Abilify Maintena, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are using Abilify Maintena.

Driving and using machines

Dizziness and vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account when full attention is required, for example, when driving or operating machinery.

Abilify Maintena contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; that is, essentially “sodium-free”.

3. How Abilify Maintena is administered

Abilify Maintena is supplied as a powder, which your doctor or nurse will prepare into a suspension.

Your doctor will decide the most appropriate dose of Abilify Maintena for you. The recommended initial dose is 400 mg, unless your doctor decides to administer a lower or follow-up dose.

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

• If you receive an injection of Abilify Maintena on your first day, oral aripiprazole treatment 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 during this visit.

Afterwards, treatment will be continued with Abilify Maintena injections unless your doctor advises otherwise.

Your doctor will administer it as a single injection into the gluteal or deltoid muscle (buttock or shoulder) once a month. You may experience some pain during the injection. Your doctor will alternate injections between the right and left side. Injections will not be given intravenously.

If you are given more Abilify Maintena than you should

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

Patients who have received an overdose of this medicine have experienced the following symptoms:

• Rapid heartbeat, agitation/aggression, speech problems.
• Unusual movements (especially of the face or tongue), and decreased level of consciousness.

Other symptoms may include:

• Acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating,
• Muscle rigidity and drowsiness, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

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

If you missed your dose of Abilify Maintena

It is important not to miss your scheduled dose. You should receive an injection every month, but not sooner than 26 days after the last injection. If you miss an injection, contact your doctor to schedule the next injection as soon as possible.

If administration of Abilify Maintena is stopped

Do not stop your treatment just because you feel better. It is important that you continue receiving Abilify Maintena for as long as your doctor has instructed.

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

4. Possible adverse effects

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

Serious adverse effects

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

• a combination of any of the following symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or tremor, fever, weakness, irritability, aggression, anxiety, elevated blood pressure, or seizures that may lead to loss of consciousness.
• unusual movements mainly of the face or tongue, as your doctor may wish to reduce the dose.
• if you have symptoms such as swelling, pain, and redness in the leg, you may have a blood clot, which can travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or lethargy, as this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
• increased thirst, need to urinate more than usual, increased appetite, feeling weak or tired, nausea, confusion, or fruity-smelling breath, as these may be signs of diabetes.
• suicidal thoughts, behaviors, or thoughts and feelings of harming yourself.

The following adverse effects may also occur after administration of Abilify Maintena.

Talk to your doctor or nurse if you experience any of these adverse effects:

Common adverse effects (may affect up to 1 in 10 people):

• weight gain
• diabetes mellitus
• weight loss
• feeling restless
• feeling anxious
• inability to stay still, difficulty remaining seated
• trouble sleeping (insomnia)
• spastic resistance to passive movements such as tensing and relaxing muscles, abnormally increased muscle tone, slow body movements
• akathisia (a distressing sensation of inner restlessness and an urgent need to keep moving)
• seizures or tremors
• uncontrollable tics, jerks, or twisting movements
• changes in level of alertness, numbness
• somnolence
• dizziness
• headache
• dry mouth
• muscle stiffness
• inability to achieve or maintain an erection during sexual intercourse
• pain at the injection site, skin hardening at the injection site
• weakness, loss of strength, or extreme fatigue
• during blood tests, your doctor may find elevated levels of creatine phosphokinase in the blood (an enzyme important for muscle function)

Uncommon adverse effects (may affect up to 1 in 100 people):

• low levels of a certain type of white blood cells (neutropenia), low hemoglobin or low red blood cell count, low platelet count in the blood

• allergic reaction (hypersensitivity)

• increased or decreased blood levels of the hormone prolactin

• increased blood sugar

• increased blood fats such as cholesterol, elevated triglycerides, as well as low cholesterol and low triglyceride levels

• increased levels of insulin, a hormone that regulates blood sugar levels

• increased or decreased appetite

• suicidal thoughts

• mental disorder characterized by defective perception or loss of reality

• hallucinations

• delusions

• increased sexual interest

• panic reaction

• depression

• emotional instability

• state of indifference with lack of emotion, feelings of emotional and mental discomfort

• sleep disorder

• teeth grinding or jaw clenching

• decreased sexual interest (reduced libido)

• mood changes

• muscle problems

• uncontrolled muscle movements such as grimacing, lip smacking, or tongue movements. These usually affect the face and mouth first but may affect other parts of the body. These may be signs of a disorder called "tardive dyskinesia."

• parkinsonism: a condition with various symptoms including slow or reduced movements, slowed thinking, jerking when bending limbs (cogwheel rigidity), shuffling gait, rapid small steps, tremors, reduced or absent facial expression, muscle stiffness, drooling

• movement problems

• extreme resistance and restless legs

• distortion of taste and smell sensations

• fixation of the eyeballs in one position

• blurred vision

• eye pain

• double vision

• ocular photosensitivity

• abnormal heartbeat, fast or slow heart rate, abnormal electrical conduction of the heart, abnormal electrocardiogram (ECG)

• high blood pressure

• dizziness upon standing up after lying down or sitting, due to a drop in blood pressure

• cough

• hiccups

• gastroesophageal reflux disease. Excessive gastric juice flowing back (reflux) into the esophagus (throat or the tube from the mouth to the stomach through which food passes), causing heartburn and possibly damaging the esophagus

• heartburn

• vomiting

• diarrhea

• nausea

• stomach pain

• stomach discomfort

• constipation

• frequent bowel movements

• drooling, more saliva in the mouth than normal

• abnormal hair loss

• acne, skin condition where the nose and cheeks are unusually red, eczema, skin hardening

• muscle stiffness, muscle spasms, muscle tics, muscle tension, muscle pain (myalgia), limb pain

• joint pain (arthralgia), back pain, reduced joint mobility, stiff neck, limited mouth opening

• kidney stones or sugar (glucose) in the urine

• spontaneous milk secretion from the breasts (galactorrhea)

• enlarged breasts in men, painful breasts, vaginal dryness

• fever

• loss of strength

• gait disturbance

• chest discomfort

• injection site reactions such as redness, swelling, discomfort, and itching at the injection site

• thirst

• slowness

• liver function tests may show abnormal results

• during testing, your doctor may find:

• elevated liver enzyme levels

• elevated alanine aminotransferase levels

• elevated γ-glutamyl transferase levels

• elevated bilirubin levels in the blood

• elevated aspartate aminotransferase levels

• elevated or reduced blood glucose levels

• elevated glycated hemoglobin levels

• reduced cholesterol levels in the blood

• reduced triglyceride levels in the blood

• increased waist circumference

The following adverse effects have been reported since the marketing of oral medications containing the same active substance, but their frequency is unknown (frequency cannot be estimated from available data):

• low white blood cell count

• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, hives), rash

• unusual heartbeat, unexplained sudden death, heart attack

• diabetic ketoacidosis (ketones in blood and urine) or coma

• loss of appetite (anorexia), difficulty swallowing

• low sodium levels in the blood

• suicide attempt and completed suicide

• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong urge to gamble excessively despite serious personal or family consequences

• altered or increased sexual interest and concerning behavior for yourself or others, e.g., increased sexual appetite

• uncontrollable excessive shopping

• binge eating (consuming large amounts of food in a short period) 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; they will explain how to manage or reduce the symptoms.

• Restlessness

• Aggression

• neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate)

• seizures (fits)

• serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, muscle stiffness)

• speech disorders

• heart problems, including torsades de pointes ventricular tachycardia, cardiac arrest, irregular heart rhythms due to abnormal nerve impulses in the heart, abnormal readings during cardiac examination (ECG), QT interval prolongation

• fainting

• symptoms related to blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing

• spasm of muscles around the glottis

• accidental aspiration of food with risk of pneumonia (lung infection)

• inflammation of the pancreas

• difficulty swallowing

• liver failure

• jaundice (yellowing of the skin and whites of the eyes)

• liver inflammation

• rash

• cutaneous photosensitivity

• excessive sweating

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as flu-like symptoms with a facial rash, and later progresses to prolonged rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia)

• muscle weakness, tenderness, or pain, particularly if you also feel unwell, have a high temperature, or have dark urine. These may be caused by abnormal muscle metabolism that is potentially life-threatening and may lead to kidney problems (a condition called rhabdomyolysis)

• difficulty urinating

• involuntary loss of urine (incontinence)

• withdrawal symptoms in newborns

• prolonged and/or painful erection

• difficulty regulating core body temperature or overheating

• chest pain

• swelling of the hands, ankles, or feet

• during testing, your doctor may find:

• elevated alkaline phosphatase levels

• fluctuating results in blood glucose tests

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abilify Maintena

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

Do not use this medicine after the expiry date stated on the carton and on the vial. The expiry date is the last day of the month indicated.

Do not freeze.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abilify Maintena

• The active substance is aripiprazole.

Each vial contains 300 mg of aripiprazole.

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

Each vial contains 400 mg of aripiprazole.

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

• The other components are

Powder

Sodium carmellose, mannitol (E421), monohydrate disodium phosphate (E339), sodium hydroxide (E524)

Solvent

Water for injections

Appearance of Abilify Maintena and contents of the pack

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

Abilify Maintena is a white or almost white powder presented in a clear glass vial. Your doctor or nurse will prepare a suspension of Abilify Maintena which will be administered to you by injection. To do this, they will use the solvent vial provided in the pack, a clear solution in a clear glass vial.

Single pack

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

Multiple pack

Set of 3 single packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

The Netherlands

Manufacturer

• Lundbeck A/S

Ottiliavej 9, 2500 Valby

Denmark

More information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Lundbeck S.A./N.V. Tel/Tel: +32 2 535 79 79	Lithuania Swixx Biopharma UAB Tel: +370 (0)5 236 91 40
	Luxembourg/Luxembourg Lundbeck S.A. Tel: +32 2 535 79 79
Czech Republic Swixx Biopharma s.r.o. Tel: +420 (0)242 434 222	Hungary Swixx Biopharma Kft. Tel.: +36 (0)1 9206 570
Denmark Otsuka Pharma Scandinavia AB Tel: +46 8 54528660	Malta Lundbeck A/S Tel: +45 36301311
Germany Otsuka Pharma GmbH Tel: +49 69 1700860	Netherlands Lundbeck B.V. Tel: +31 20 697 1901
Estonia Swixx Biopharma OÜ Tel: +372 (0)640 1030	Norway Otsuka Pharma Scandinavia AB Tel: +46 8 54528660
Greece Swixx Biopharma Μ.Α.Ε Tel: +30 (0)214 444 9670	Austria Lundbeck Austria GmbH Tel: +43 1 253 621 6033
Spain Otsuka Pharmaceutical S.A. Tel: +34 93 208 10 20	Poland Swixx Biopharma Sp. z o. o. Tel.: +48 (0)22 4600 720
France Otsuka Pharmaceutical France SAS Tél: +33 (0)1 47 08 00 00	Portugal Lundbeck Portugal – Produtos Farmacêuticos, Unipessoal Lda. Tel: +351 21 00 45 900
Croatia Swixx Biopharma d.o.o. Tel: +385 (0)1 2078 500	Romania Swixx Biopharma S.R.L Tel: +40 (0)37 1530 850
Ireland Lundbeck (Ireland) Limited Tel: +353 1 468 9800	Slovenia Swixx Biopharma d.o.o. Tel: +386 (0)1 2355 100
Iceland Vistor ehf. Tel: +354 (0)535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 (0)2 20833 600
Italy Otsuka Pharmaceutical Italy S.r.l Tel: +39 02 00 63 27 10	Finland Otsuka Pharma Scandinavia AB Tel: +46 8 54528660
Cyprus Swixx Biopharma Μ.Α.Ε Tel: +30 (0)214 444 9670	Sweden Otsuka Pharma Scandinavia AB Tel: +46 8 54528660
Latvia Swixx Biopharma SIA Tel: +371 (0)6 616 47 50

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

Disposal of unused medicine and of all materials that have come into contact with it should be carried out in accordance with local regulations.

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

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

Aripiprazole

Step 1: Preparation prior to reconstituting the powder

Remove all components from the package and confirm that all items listed below are present:

• Abilify Maintena package leaflet and instructions for healthcare professionals
• Vial containing powder
• Vial containing 2 ml of solvent

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

• One 3 ml luer-lock syringe with a pre-attached 38 mm, 21-gauge safety hypodermic needle equipped with a needle protection device
• One disposable 3 ml syringe with luer-lock tip
• One vial adapter
• One 25 mm, 23-gauge safety hypodermic needle with needle protection device
• One 38 mm, 22-gauge safety hypodermic needle with needle protection device
• One 51 mm, 21-gauge safety hypodermic needle with needle protection device
• Instructions for needle and syringe

Step 2: Reconstitution of the powder

1. Remove the cap from the powder vial and the cap from the solvent vial, and clean the stoppers of both vials with a sterile alcohol-impregnated swab.
2. Using the syringe with the pre-attached needle, withdraw the predetermined volume of solvent from the appropriate vial by inverting the solvent vial to draw the solvent into the syringe.

300 mg vial:
Add 1.5 ml of solvent to reconstitute the powder.

400 mg vial:
Add 1.9 ml of solvent to reconstitute the powder.

A small amount of solvent will remain in the vial after withdrawal. Any excess must be discarded.

Water

1. Slowly inject the solvent into the vial containing the powder.
2. Withdraw the air to equalize pressure in the vial by gently pulling back the plunger.

1. Afterwards, remove the syringe from the vial.

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

Gently press the cap against a flat surface until the needle is securely seated in the needle protective cap.

Visually confirm that the needle is properly seated in the needle protective cap, then discard the syringe.

Cover	Remove

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

1. Visually inspect the reconstituted suspension for particles and discoloration before administration. The reconstituted medicinal product is a white or almost white liquid suspension. Do not use the reconstituted suspension if it contains particles or shows discoloration.
2. If the injection is not administered immediately after reconstitution, the vial may be kept for up to 4 hours at a temperature below 25 °C. Shake vigorously for at least 60 seconds to ensure resuspension prior to injection.
3. Do not store the reconstituted suspension in the syringe.

Step 3: Preparation before injection

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

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

Abilify Maintena

1. Determine the recommended volume for injection.

Abilify Maintena 300mg vial
Dose	Volume to be injected
---	---
300 mg	1.5 ml
200 mg	1.0 ml
160 mg	0.8 ml

Abilify Maintena 400mg vial
Dose	Volume to be injected
400 mg	2.0 ml
300 mg	1.5 ml
200 mg	1.0 ml
160 mg	0.8 ml

1. Clean the cap of the vial containing the reconstituted suspension with a sterile swab moistened with alcohol.
2. Place and hold the vial with the reconstituted suspension on a hard surface. Attach the vial adapter by grasping the outer part of the vial adapter and pushing the tip of the vial adapter firmly through the rubber stopper until it clicks into place.
3. Slowly withdraw the recommended volume from the vial using the Luer-lock syringe for injection. A small amount, an excess of the suspension, will remain in the vial.

Abilify Maintena

Step 4: Injection Procedure

1. Remove the luer-lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial.
2. Select one of the safety hypodermic needles described below, based on the injection site and patient weight, and attach the hypodermic needle to the luer-lock syringe containing the injectable suspension. Ensure that the hypodermic needle is securely fastened to the needle safety device by pressing and turning clockwise, then immediately remove the needle cap.

Morphological type	Injection site	Needle size
Non-obese	Deltoid	25mm gauge 23
	Gluteal	38mm gauge 22
Obese	Deltoid	38mm gauge 22
	Gluteal	51mm gauge 21

1. Slowly inject the recommended volume by means of a single intramuscular dose in the gluteal or deltoid muscle. Do not massage the injection site. Care should be taken to avoid accidental injection into a blood vessel. Do not inject in areas showing signs of inflammation, damaged skin, swelling and/or bruising.

For deep intramuscular injection only in the gluteal or deltoid muscle.

Deltoids	Gluteal

Remember to rotate injection sites in both gluteal and deltoid muscles. If treatment is started with two injections, administer the injections at two different sites in two separate muscles. DO NOT inject both injections together into the same deltoid or gluteal muscle.

For known CYP2D6 poor metabolizers, administer in two separate deltoid muscles or in one deltoid and one gluteal muscle. DO NOT inject in two gluteal muscles.

Watch for signs or symptoms of inadvertent intravenous administration.

Step 5: Procedures after injection

Engage the needle safety device as described in Step 2 e). Dispose of vials, adapter, needles, and syringe properly after injection. The vials containing powder and solvent are for single use only.

Cover	Remove