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 (aripiprazolum)
Please read this leaflet carefully before receiving this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

What Abilify Maintena is and what it is used for
What you need to know before receiving Abilify Maintena
How Abilify Maintena is administered
Possible side effects
How to store Abilify Maintena
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 in the treatment of schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, suspiciousness, false beliefs, disorganized speech and behaviour, and flattened emotions. People affected by this condition may also feel depressed, guilty, anxious, or tense. Abilify Maintena is intended for adult patients with schizophrenia who have been adequately stabilized during treatment with oral aripiprazole.

2. What you need to know before receiving Abilify Maintena

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 receiving Abilify Maintena.
Suicidal thoughts and behaviours have been reported during treatment with this medicine.
Inform your doctor immediately if you experience any self-harming thoughts or feelings before or after receiving Abilify Maintena.

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

acute agitation or severe psychotic state;
heart problems or previous stroke, especially if you know you have other risk factors for stroke;
high blood sugar levels (characterised by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
epilepsy (seizures), as your doctor may decide to monitor you more closely;
involuntary, irregular muscle movements, especially of the face;
a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness or lethargy (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 transient ischaemic attack, or blood pressure abnormalities;
irregular heartbeat, or if someone else in your family has a history of irregular heartbeat (including so-called QT prolongation seen on electrocardiogram (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 excessive gambling;
severe liver problems.

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsiness that interferes with normal daily activities, if you have difficulty swallowing, or if you experience allergic symptoms, please inform your doctor immediately.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as gambling addiction, binge eating, compulsive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the dose or discontinue treatment.
This medicine may cause drowsiness, low blood pressure when standing up, dizziness, and changes in mobility and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

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.

Other medicines and Abilify Maintena
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Medicines that lower blood pressure: Abilify Maintena may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking a medicine to control your blood pressure.
Using Abilify Maintena together with certain medicines may mean that your doctor needs to change the dose of Abilify Maintena or of the other medicines. It is especially important to inform your doctor about the following medicines:

medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide);
antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, St. John’s wort);
antifungal medicines (e.g. itraconazole);
ketoconazole (used to treat Cushing's syndrome, when the body produces excess cortisol);
certain medicines used to treat HIV infection (e.g. efavirenz, nevirapine, and protease inhibitors such as indinavir and ritonavir);
anticonvulsants used to treat epilepsy (e.g. 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 side effects or reduce the effect of Abilify Maintena; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Abilify Maintena.
Medicines that increase serotonin levels are typically used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

triptans, tramadol, and tryptophan, used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
SSRIs (e.g. paroxetine and fluoxetine), used for depression, OCD, panic, and anxiety;
other antidepressants (e.g. venlafaxine and tryptophan), used in major depression;
tricyclics (e.g. clomipramine and amitriptyline), used for depressive illness;
St. John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression;
painkillers (e.g. tramadol and pethidine), used to relieve pain;
triptans (e.g. sumatriptan and zolmitriptan), used to treat migraine.

These medicines may increase the risk of side effects; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Abilify Maintena.

Abilify Maintena and alcohol
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor before receiving this medicine.
Do not use Abilify Maintena if you are pregnant, unless you have discussed this with your doctor. If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor immediately.
Newborn babies whose mothers received Abilify Maintena during the last three months of pregnancy (third trimester) may experience the following symptoms:
tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty sucking.
If your baby shows any of these symptoms, contact your doctor.
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breast-feed, considering the benefit of the treatment for you and the benefit of breast-feeding for the baby. One choice excludes the other.
If you are receiving Abilify Maintena, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account when full alertness is required, for example when driving a vehicle or operating machinery.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Abilify Maintena is administered

This medicine is supplied as a powder, which the doctor or nurse will use to prepare a suspension.
Your doctor will decide the appropriate dose of Abilify Maintena for you. The recommended starting dose is 400 mg, unless your doctor decides to prescribe a lower starting or follow-up dose.
There are two ways to initiate treatment with Abilify Maintena; your doctor will determine which one is suitable for you.

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

Afterwards, treatment will continue with monthly injections of Abilify Maintena, unless otherwise directed by your doctor.
Your doctor will administer it as a single injection into the gluteal or deltoid muscle (buttock or shoulder) once a month. You may experience mild pain during the injection. The doctor will alternate injections between the right and left side. Injections will not be given intravenously.
If you receive 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 consult more than one doctor, make sure to inform them that you are being treated with Abilify Maintena.
Patients who have received an excessive amount of this medicine have experienced the following symptoms:

rapid heartbeat, agitation/aggression, speech problems;
unusual movements (especially of the face or tongue), and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
muscle rigidity and drowsiness or sedation, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.
If you miss an injection 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 previous injection. If you miss an injection, contact your doctor as soon as possible to schedule the next one.
If you stop receiving Abilify Maintena
Do not stop treatment just because you feel better. It is important to continue taking Abilify Maintena for the entire duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
If you experience any of the following serious side effects, contact your doctor immediately.

a combination of any of the following symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle stiffness or tremor, fever, weakness, irritability, aggression, anxiety, increased blood pressure, or seizures which may lead to loss of consciousness;
unusual movements, mainly affecting the face or tongue, after which your doctor may decide to reduce your dose;
symptoms such as swelling, pain and redness in the leg, which may indicate the presence of a blood clot capable of travelling through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately;
a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy, as this may be a sign of a condition called neuroleptic malignant syndrome (NMS);
increased thirst, increased need to urinate, intense hunger, feeling weak or tired, nausea, confusion or fruity-smelling breath, as these could be signs of diabetes;
suicidal thoughts, or behaviours, thoughts and feelings of self-harm.

After taking Abilify Maintena, the following side effects may also occur.
Contact your doctor or nurse if you experience any of these side effects:
Common side effects (may affect up to 1 in 10 people):

weight gain;
diabetes mellitus;
weight loss;
feeling of restlessness;
feeling anxious;
inability to stay still, difficulty remaining seated;
difficulty sleeping (insomnia);
spasmodic resistance to passive movement, while muscles contract and relax, abnormal increase in muscle tone, slow body movements;
akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving);
shaking or tremor;
uncontrollable movements characterised by contractions, jerks or twisting;
changes in level of alertness, drowsiness;
drowsiness;
dizziness;
headache;
dry mouth;
muscle stiffness;
inability to achieve or maintain an erection during sexual intercourse;
pain at injection site, hardening of the skin at injection site;
weakness, loss of strength or extreme fatigue;
blood tests may show increased levels of creatine phosphokinase (an enzyme important for muscle function);

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

low levels of a specific type of white blood cells (neutropenia), haemoglobin or red blood cells and platelets;
allergic reactions (hypersensitivity);
increased or decreased plasma levels of the hormone prolactin;
hyperglycaemia;
increased blood fats, such as high cholesterol, high triglycerides, but also low levels of cholesterol and triglycerides;
increased levels of insulin, a hormone that regulates blood sugar levels;
reduced or increased appetite;
thoughts related to suicide;
mental disorder characterised by poor or absent contact with reality;
hallucinations;
delirium;
increased sexual interest;
panic reaction;
depression;
emotional lability;
state of indifference with lack of emotions, feelings of emotional and mental discomfort;
sleep disorder;
teeth grinding or clenched jaw;
reduced sexual interest (libido is reduced);
mood alteration;
muscular problems;
uncontrollable muscle movements such as grimacing, lip-smacking and tongue movements. These usually affect the face and mouth first, but may also affect other parts of the body. These could be signs of a condition called "tardive dyskinesia";
parkinsonism: a medical condition with many different symptoms, including reduced or slowed movements, slowed thinking, jerky movements when bending limbs (cogwheel rigidity), shuffling gait, hurried steps, tremor, limited or absent facial expression, muscle stiffness, drooling;
difficulty moving;
extreme restlessness and leg agitation;
altered sense of taste and smell;
eyes fixed in one position;
blurred vision;
eye pain;
double vision;
eye sensitivity to light;
irregular heartbeat, slow or fast heartbeat, abnormalities in the heart's electrical conduction, abnormalities on electrocardiogram;
high blood pressure;
dizziness upon standing up from a lying or sitting position, due to a drop in blood pressure;
cough;
hiccups;
gastroesophageal reflux. An excessive amount of gastric juice flows back (refluxes) into the oesophagus (the tube connecting the mouth to the stomach, through which food passes), causing heartburn and, sometimes, damaging the oesophagus;
heartburn;
vomiting;
diarrhoea;
nausea;
stomach ache;
stomach discomfort;
constipation;
frequent bowel movements;
reduced saliva production, excessive saliva production;
abnormal hair loss;
acne, a skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening;
muscle stiffness, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), pain in extremities;
joint pain (arthralgia), back pain, reduced joint mobility, neck stiffness, limited mouth opening;
kidney stones, sugar (glucose) in urine;
spontaneous milk discharge from breasts (galactorrhoea);
breast enlargement in men, tender breasts, vaginal dryness;
fever;
loss of strength;
gait disturbances;
chest discomfort;
injection site reactions such as redness, swelling, discomfort and itching;
thirst;
lethargy;
liver function tests may show abnormal results;
blood tests may show
- increased levels of liver enzymes;
- increased levels of alanine aminotransferase;
- increased levels of gamma-glutamyltransferase;
- increased levels of bilirubin in the blood;
- increased levels of aspartate aminotransferase;
- increased or decreased blood sugar levels;
- increased levels of glycated haemoglobin;
- reduced levels of cholesterol in the blood;
- reduced levels of triglycerides in the blood;
- increased abdominal circumference.

The following side effects have been reported after marketing of medicines
containing the same active substance taken orally, but their frequency is unknown (from available data it is not possible to estimate the frequency):

low levels of white blood cells;
allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives), skin rash;
irregular heartbeat, unexplained sudden death, heart attack;
diabetic ketoacidosis (ketones in blood and urine) or diabetic coma;
loss of appetite (anorexia), difficulty swallowing;
low sodium levels in the blood;
suicide and attempted suicide;
inability to resist the impulse, urge or temptation to carry out an action that could be harmful to you or others, which may include:
- strong urge to gamble excessively despite serious personal or family consequences;
- altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased sexual drive;
- excessive and uncontrollable shopping;
- uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy appetite);
- tendency to wander off. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.
nervousness;
aggression;
neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle stiffness, rapid breathing, sweating, reduced level of consciousness, and sudden changes in blood pressure and heart rate);
seizures (convulsive attacks);
serotonin syndrome (a reaction that may cause feelings of extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness);
speech disorders;
heart problems including torsades de pointes, cardiac arrest, irregular heart rhythm that may be caused by abnormal nerve impulses reaching the heart, abnormalities in electrocardiogram (ECG) readings, QT prolongation;
fainting;
symptoms related to blood clot formation in veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties;
spasm of muscles surrounding the vocal cords;
accidental inhalation 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);
inflammation of the liver;
skin rash;
skin sensitivity to light;
excessive sweating;
severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a skin rash on the face which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests and increase in a type of white blood cells (eosinophilia).
weakness, tenderness or muscle pain, especially if accompanied by a feeling of malaise, high body temperature and dark urine. This may be caused by abnormal muscle breakdown, potentially fatal and which may lead to kidney problems (a condition called rhabdomyolysis).
difficulty urinating;
involuntary loss of urine (incontinence);
drug withdrawal symptoms in the newborn;
prolonged and/or painful erection;
difficulty controlling internal body temperature or conditions of excessive heat;
chest pain;
swelling of hands, ankles or feet;
blood tests may show
- increased levels of alkaline phosphatase;
- fluctuating results in blood sugar tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 vial.
The expiry date refers to the last day of that month.
Do not freeze.
The reconstituted suspension must be used immediately, but may be stored below 25 °C for up to 4 hours in the vial. Do not store the reconstituted suspension in the syringe.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Abilify Maintena contains

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), monosodium phosphate monohydrate (E339), sodium hydroxide (E524)
Solvent: Water for injections

Description of the appearance of Abilify Maintena and contents of the pack
Abilify Maintena consists of a powder and solvent for a prolonged-release injectable suspension.
The powder of Abilify Maintena is white to off-white in colour and is contained in a clear glass vial. The healthcare professional will reconstitute the suspension for injection using the solvent vial of Abilify Maintena, which is a clear solution contained in a clear glass vial.

Single pack
Each single pack contains: one vial of powder, one 2 mL solvent vial, one 3 mL syringe with Luer-lock connector with pre-attached 38 mm 21 gauge safety hypodermic needle with needle shield, one single-use 3 mL syringe with Luer-lock connector, one 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
Pack of 3 single packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
The Netherlands

Manufacturer
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby
Denmark

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S
Tél/Tel: +32 2 535 79 79 Tel: +45 36301311

България Luxembourg/Luxemburg
Lundbeck Export A/S Representative Office Lundbeck S.A.
Tel: +359 2 962 4696 Tél: +32 2 535 79 79

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980

Danmark Malta
Otsuka Pharma Scandinavia AB H. Lundbeck A/S
Tel: +46 8 54528660 Tel: +45 36301311

Deutschland Nederland
Otsuka Pharma GmbH Lundbeck B.V.
Tel: +49 69 1700860 Tel: +31 20 697 1901

Eesti Norge
H. Lundbeck A/S Otsuka Pharma Scandinavia AB
Tel: +45 36301311 Tel: +46 8 54528660

Ελλάδα Österreich
Lundbeck Hellas S.A. Lundbeck Austria GmbH
Τηλ: +30 210 610 5036 Tel: +43 1 253 621 6033

España Polska
Otsuka Pharmaceutical S.A. Lundbeck Poland Sp. z o.o.
Tel: +34 93 208 10 20 Tel.: +48 22 626 93 00

France Portugal
Otsuka Pharmaceutical France SAS Lundbeck Portugal – Produtos Farmacêuticos, Unipessoal Lda.
Tél: +33 (0)1 47 08 00 00 Tel: +351 21 00 45 900

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Romania SRL
Tel.: +385 1 644 82 63 Tel: +40 21319 88 26

Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Vistor hf. Lundbeck Slovensko s.r.o.
Sími: +354 535 7000 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Otsuka Pharmaceutical Italy S.r.l Otsuka Pharma Scandinavia AB
Tel: +39 02 00 63 27 10 Tel: +46 8 54528660

Κύπρος Sverige
Lundbeck Hellas A.E. Otsuka Pharma Scandinavia AB
Τηλ.: +357 22490305 Tel: +46 8 54528660

Latvija United Kingdom (Northern Ireland)
H. Lundbeck A/S Otsuka Pharmaceutical Netherlands B.V.
Tel: +45 36301311 Tel: +31 (0) 20 85 46 555

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Unused medicinal product and waste materials derived from this medicinal product must be disposed of 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
aripiprazole

Step 1: Preparation prior to reconstitution of the powder
Gather the components and verify the presence of those listed below:

Abilify Maintena package leaflet and instructions for healthcare professionals
Vial of powder
Vial of solvent containing 2 mL Important: the solvent vial contains a device to prevent overfilling.
One 3 mL syringe with Luer-lock connector and pre-attached 21 gauge 38 mm (1.5 inch) hypodermic safety needle with needle shield
One disposable 3 mL syringe with Luer-lock connector
A vial adapter
One 23 gauge 25 mm (1 inch) hypodermic safety needle with needle shield
One 22 gauge 38 mm (1.5 inch) hypodermic safety needle with needle shield
One 21 gauge 51 mm (2 inch) hypodermic safety needle with needle shield
Instructions for syringe and needle

Step 2: Reconstitution of the powder
a) Remove the caps from the solvent vial and the powder vial, and clean the tops of the containers with a sterile alcohol swab.
b) Using the syringe with pre-attached needle, withdraw the predetermined volume of solvent from the solvent vial.
For the 300 mg vial:
Add 1.5 mL of solvent to reconstitute the powder.
For the 400 mg vial:
Add 1.9 mL of solvent to reconstitute the powder.
After withdrawal, a small amount of residual solvent will remain in the solvent vial. Any excess must be discarded.

Stylized black and white diagram of a syringe with an upper vial and a downward arrow indicating piston movement

Water
c) Slowly inject the solvent into the vial containing the powder.
d) To equalize pressure in the vial, withdraw air by gently pulling back the plunger.

Black and white illustration of a syringe with a needle drawing liquid from a vial labeled 'Maintona'

e) Next, remove the needle from the vial.
Engage the needle shield using the one-handed technique.
Gently press the sheath against a flat surface until the needle is securely locked into the needle shield.
Visually confirm that the needle is fully engaged in the needle shield and dispose of the entire unit.

Used syringe with a curved arrow indicating disposal into a biohazard waste container

A hand holding a syringe with the needle being inserted into a flat surface at an angle of approximately 45 degrees

Cover Dispose
f) Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.

A hand holding a vial of Abilify Maintena with arrows and curved lines indicating vertical shaking motion

g) Prior to administration, visually inspect the reconstituted suspension for particulate matter and discoloration. The reconstituted medicinal product is a fluid suspension ranging from white to off-white in color. Do not use if the reconstituted suspension contains particulate matter or shows any discoloration.
h) If the injection is not administered immediately after reconstitution, store the vial at temperatures below 25 °C for up to 4 hours. Shake vigorously for at least 60 seconds immediately before injection to resuspend the product.
i) Do not store the reconstituted suspension in the syringe.

Step 3: Preparation prior to injection
a) Remove the cover, but not the adapter, from the packaging.
b) Handle the vial adapter through its packaging, and attach the syringe with pre-attached Luer-lock connector to the adapter.

Illustration showing a hand holding a vial while a syringe is inserted from above

c) Remove the vial adapter from its packaging using the Luer-lock syringe, and discard the adapter packaging. Never touch the piercing end of the adapter.

Diagram showing a syringe with liquid being pushed downward with an arrow indicating injection

Abilify Maintena
d) Determine the recommended volume for injection.

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

e) Clean the top of the vial of the reconstituted suspension using a sterile alcohol swab.
f) Place and hold the vial of the reconstituted suspension on a firm surface. Attach the syringe-adapter assembly to the vial by grasping the outer surface of the adapter and firmly push the adapter's piercing pin through the rubber stopper until the adapter clicks into place.
g) To allow injection, slowly withdraw the recommended volume from the vial into the Luer-lock syringe.
A small amount of product will remain in the vial.

Stylized black and white line drawing of a syringe filled with liquid

Abilify Maintena
Step 4: Injection procedure
a) Detach from the vial the Luer-lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension.
b) Select one of the following hypodermic safety needles depending on the injection site and patient weight, and attach the needle to the Luer-lock syringe containing the injectable suspension. Ensure the needle is securely inserted into the needle shield by pushing and simultaneously turning clockwise, then immediately remove the cap from the needle.

Body type	Injection site	Needle size
Non-obese	Deltoid Gluteal	25 mm (1 inch) 23 gauge 38 mm (1.5 inches) 22 gauge
Obese	Deltoid Gluteal	38 mm (1.5 inches) 22 gauge 51 mm (2 inches) 21 gauge

c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle. Do not massage the injection site. Take care to avoid accidental injection into a blood vessel. Do not inject in areas showing signs of inflammation, skin lesions, nodules, and/or bruising.
For deep intramuscular injection only in the gluteal or deltoid muscle.

Line drawing of a stylized human torso with a syringe pointing toward the gluteal area

Schematic drawing of a syringe injecting medication into the body

deltoid gluteal
Remember to alternate injection sites between the two gluteal or deltoid muscles.
If treatment is initiated according to the two-injection regimen, administer in two different sites in two separate muscles. DO NOT administer both injections simultaneously into the same deltoid or gluteal muscle.
In patients known to be CYP2D6 poor metabolizers, administer into two separate deltoid muscles or into one deltoid and one gluteal muscle. DO NOT inject into both gluteal muscles.
Monitor for any signs or symptoms of accidental intravenous administration.

Step 5: Post-injection procedures
Attach the needle cap as described in Step 2 e). After injection, dispose of vials, adapter, needles, and syringe appropriately.
The vials for powder and solvent are for single use only.

Diagram showing a used syringe being discarded into a biohazard waste container with a biohazard symbol

A hand holding a syringe with the needle tilted downward for air expulsion

Cover Dispose

Package leaflet: Information for the user

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
aripiprazole
Please read this leaflet carefully before receiving this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

What Abilify Maintena is and what it is used for
What you need to know before receiving Abilify Maintena
How Abilify Maintena is given
Possible side effects
How to store Abilify Maintena
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 pre-filled syringe. Aripiprazole
belongs to a group of medicines called antipsychotics. Abilify Maintena is used in the treatment of
schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that
are not there, suspiciousness, false beliefs, disorganized speech and behaviour, and blunted emotions.
People with this condition may also feel depressed, guilty, anxious, or tense.
Abilify Maintena is intended for use in adult patients with schizophrenia who are sufficiently stabilized
on oral aripiprazole treatment.

2. What you should know before receiving Abilify Maintena

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 receiving Abilify Maintena.
Suicidal thoughts and behaviours have been reported during treatment with this medicine.
Immediately inform your doctor if you experience any self-harming thoughts or feelings, either before or after receiving Abilify Maintena.
Before starting treatment with Abilify Maintena, inform your doctor if you have:

acute agitation or severe psychotic state;
heart problems or previous stroke, especially if you have other risk factors for stroke;
high blood sugar levels (characterized by symptoms such as excessive thirst, production of large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes;
epilepsy (seizures), as your doctor may decide to monitor you more closely;
involuntary, irregular muscle movements, especially of the face;
a combination of fever, sweating, rapid breathing, muscle stiffness, and lethargy or drowsiness (which 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 transient ischaemic attack, or blood pressure abnormalities;
irregular heartbeat, or if anyone else in your family has a history of irregular heartbeat (including so-called QT prolongation observed on electrocardiogram (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 excessive gambling;
severe liver problems.

If you notice that you are gaining weight, developing unusual movements, feeling drowsy to the point that it interferes with normal daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor immediately.
Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, binge eating, compulsive spending, unusually high sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the dose or discontinue treatment.
This medicine may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

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.

Other medicines and Abilify Maintena
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Medicines that lower blood pressure: Abilify Maintena may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking any medicine to control your blood pressure.
Using Abilify Maintena together with certain medicines may require your doctor to adjust the dose of Abilify Maintena or of the other medicines. It is particularly important to inform your doctor about the following medicines:

medicines used to regulate heart rhythm (e.g., quinidine, amiodarone, flecainide);
antidepressants or herbal remedies used to treat depression and anxiety (e.g., fluoxetine, paroxetine, St. John’s wort);
antifungal medicines (e.g., itraconazole);
ketoconazole (used to treat Cushing's syndrome, when the body produces excess cortisol);
certain medicines used to treat HIV infection (e.g., efavirenz, nevirapine, and protease inhibitors such as indinavir and ritonavir);
anticonvulsants used to treat epilepsy (e.g., 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 side effects or reduce the effect of Abilify Maintena. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Abilify Maintena.
Medicines that increase serotonin levels are typically used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as for 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 (e.g., paroxetine and fluoxetine) used for depression, OCD, panic and anxiety;
other antidepressants (e.g., venlafaxine and tryptophan) used for major depressive disorder;
tricyclics (e.g., clomipramine and amitriptyline) used for depressive illness;
St. John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression;
painkillers (e.g., tramadol and pethidine) used to relieve pain;
triptans (e.g., sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Abilify Maintena.

Abilify Maintena and alcohol
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before receiving this medicine.
You must not use Abilify Maintena if you are pregnant unless you have discussed this with your doctor. If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor immediately.
Newborn babies whose mothers received Abilify Maintena during the last three months of pregnancy (third trimester) may experience the following symptoms:
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If your baby shows any of these symptoms, contact your doctor.
If you are receiving 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 the baby. One choice excludes the other.
If you are receiving Abilify Maintena, discuss with your doctor the best way to feed your baby.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.