Abilify maintena 400 mg polvo y disolvente para suspension de liberacion prolongada inyectable
Introduction
Prospect: 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
aripiprazol
Read this prospect carefully before receiving this medication, as it contains important information for you.
- Keep this prospect, as you may need to read 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 prospect. See section 4.
1. What is Abilify Maintena and what is it used for
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.
2. What you need to know before you receive Abilify Maintena
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
Speak with your doctor or nurse before they administer 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 (loss of memory and other mental abilities), 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 (hepatic).
If you notice that you are gaining weight, developing unusual movements, feeling drowsiness that interferes with your normal daily activities, any difficulty swallowing, or experiencing symptoms of an allergy, speak with 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 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 eating 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. Make sure to 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:
- triptans, tramadol, and tryptophan used to treat diseases such as depression, generalized anxiety disorder, OCD, and social anxiety disorder, as well as migraine and pain
- SSRIs (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety
- other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression
- tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive diseases
- St. John's Wort (Hypericum perforatum) used in herbal medications to treat mild depression
- analgesics (such as tramadol and pethidine) used to relieve pain
- triptans (such as sumatriptan and zolmitriptan) used to treat migraine.
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 spoken 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, 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. Talk to your doctor about 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".
3. How Abilify Maintena is administered
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 bit of 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:
- rapid heartbeats, agitation/aggression, language 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, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.
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 to continue receiving 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.
4. Possible Adverse Effects
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:
- a combination of any of the following symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle rigidity, or tremors, 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 want to lower the dose.
- if you experience symptoms such as swelling, pain, and redness in the leg, it may be a blood clot, which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.
- a combination of fever, rapid breathing, sweating, muscle rigidity, and drowsiness or lethargy, as this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
- increased thirst, frequent urination, excessive appetite, feeling weak or tired, feeling nauseous, feeling confused, or having bad breath, as this may be a sign of diabetes.
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):
- weight gain
- diabetes mellitus
- weight loss
- restlessness
- anxiety
- difficulty remaining still, difficulty staying seated
- sleep problems (insomnia)
- resistance to passive movements such as tensing and relaxing muscles, abnormal increase in muscle tone, slow body movements
- akathisia (an uncomfortable feeling of internal restlessness and an urgent need to move constantly)
- seizures or tremors
- involuntary movements, such as tics, spasms, or contortions
- changes in level of consciousness, numbness
- drowsiness
- dizziness
- headache
- dry mouth
- muscle rigidity
- difficulty achieving or maintaining an erection during sexual intercourse
- pain at the injection site, skin hardening at the injection site
- weakness, extreme loss of strength or fatigue
- during blood tests, your doctor may find elevated levels of creatine phosphokinase in the blood (an important enzyme for muscle function)
Rare side effects (may affect up to 1 in 100 people):
- low levels of a certain type of white blood cell (neutropenia), low hemoglobin or low red blood cell count, low platelet count in the blood
- allergic reaction (hypersensitivity)
- elevated or decreased levels of prolactin in the blood
- elevated blood sugar
- elevated levels of blood fats such as cholesterol, triglycerides, and also low levels of cholesterol and triglycerides
- elevated levels of insulin, a hormone that regulates blood sugar levels
- elevated or decreased appetite
- thoughts of suicide
- a mental disorder characterized by defective perception or loss of reality
- hallucinations
- delirium
- increased libido
- panic attack
- depression
- emotional instability
- state of indifference with lack of emotion, feelings of emotional and mental discomfort
- sleep disorder
- teeth grinding or jaw clenching
- decreased libido (libido decreases)
- altered mood
- muscle problems
- involuntary muscle movements, such as grimacing, lip smacking, or tongue movements. These usually affect the face and mouth first but can affect other parts of the body. These may be signs of a condition called tardive dyskinesia.
- parkinsonism: a condition with many and varied symptoms, including slow or decreased movements, slow thinking, joint stiffness (rigidity in ratchet gear), dragging the feet, rapid walking, tremors, reduced facial expression, muscle rigidity, drooling
- movement problems
- extreme restlessness and restless legs
- distortion of taste and smell
- fixation of the eyeballs in a position
- blurred vision
- eye pain
- double vision
- abnormal heart rate, rapid or slow heart rate, abnormal heart conduction, abnormal electrocardiogram (ECG)
- high blood pressure
- dizziness when standing up after lying down or sitting due to a drop in blood pressure
- cough
- hiccups
- gastroesophageal reflux disease. Excessive stomach acid flows back (refluxes) into the esophagus (throat or the tube that goes from the mouth to the stomach through which food passes), causing stomach acid and possibly damaging the esophagus
- heartburn
- vomiting
- diarrhea
- nausea
- stomach pain
- stomach discomfort
- constipation
- frequent bowel movements
- excessive salivation, more saliva in the mouth than normal
- abnormal hair loss
- acne, a skin disease where the nose and cheeks are unusually red, eczema, skin hardening
- muscle rigidity, muscle spasms, muscle tics, muscle tension, muscle pain (myalgia), pain in the limbs
- joint pain (arthralgia), back pain, decreased 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
- reactions at the injection site, such as redness, swelling, discomfort, and itching at the injection site
- thirst
- languor
- abnormal liver function test results may be found
- during tests, your doctor may find:
- 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 blood glucose levels
- 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 oral aripiprazole, but the frequency with which they occur is unknown (the frequency cannot be estimated from the available data):
- low white blood cell count
- allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, urticaria), hives
- unusual heart rhythm, sudden unexplained death, heart attack
- diabetic ketoacidosis (ketones in the blood and urine) or coma
- loss of appetite (anorexia), difficulty swallowing
- low sodium levels in the blood
- suicidal thoughts 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 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; they will explain how to manage or reduce symptoms.
- nervousness
- aggression
- neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate)
- seizures (attacks)
- serotonin syndrome (a reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, muscle rigidity)
- speech disorders
- cardiac problems, including ventricular helicoidal tachycardia, heart attack, irregular heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal electrocardiogram (ECG) readings, prolonged QT interval
- syncope
- symptoms related to blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing
- spasm of the muscles around the glottis
- accidental aspiration of food with risk of pneumonia (lung infection)
- pancreatitis
- difficulty swallowing
- hepatic insufficiency
- jaundice (yellowing of the skin and white part of the eyes)
- inflammation of the liver
- hives
- photosensitivity of the skin
- excessive sweating
- severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudogripal symptoms with facial rash, and later with prolonged skin rash, high temperature, enlarged lymph nodes, elevated liver enzyme levels observed in blood tests, and elevated levels of a type of white blood cell (eosinophilia)
- muscle weakness, sensitivity, or pain, and particularly if you also feel unwell, have a high temperature, or have dark urine. They may be caused by abnormal muscle metabolism, which is potentially fatal and can cause kidney problems (a condition called rhabdomyolysis)
- difficulty urinating
- involuntary loss of urine (incontinence)
- symptoms of withdrawal in newborns
- prolonged and/or painful erection
- difficulty controlling central body temperature or overheating
- chest pain
- swelling of the hands, ankles, or feet
- during tests, your doctor may find:
- elevated levels of alkaline phosphatase
- fluctuating results during blood glucose tests
Reporting side effects
If you experience side effects, consult your doctor or nurse, even if they do not appear in this prospectus. 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.
5. Conservation of Abilify Maintena
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.
6. Contents of the packaging and additional information
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 vial of solvent 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, 21 gauge, 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 23 gauge, one 38 mm and 22 gauge, and one 51 mm and 21 gauge.
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
Manufacturer
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:
België/Belgique/Belgien Lundbeck S.A./N.V. Tél/Tel: +32 2 535 79 79 | Lietuva H. Lundbeck A/S Tel: +45 36301311 |
???????? Lundbeck Export A/S Representative Office Tel: +359 2 962 4696 | Luxembourg/Luxemburg Lundbeck S.A. Tél: +32 2 535 79 79 |
Ceská republika Lundbeck Ceská republika s.r.o. Tel: +420 225 275 600 | Magyarország Lundbeck Hungaria Kft. Tel: +36 1 4369980 |
Danmark Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 | Malta H. Lundbeck A/S Tel: +45 36301311 |
Deutschland Otsuka Pharma GmbH Tel: +49 69 1700860 | Nederland Lundbeck B.V. Tel: +31 20 697 1901 |
Eesti H. Lundbeck A/S Tel: +45 36301311 | Norge Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Ελλ?δα Lundbeck Hellas S.A. Τηλ:+30 210 610 5036 | Österreich Lundbeck Austria GmbH Tel: +43 1 266 91 08 |
España Otsuka Pharmaceutical S.A. Tel: +34 93 208 10 20 | Polska Lundbeck Poland Sp. z o. o. Tel.: +48 22 626 93 0 |
France Otsuka Pharmaceutical FranceSAS Tél: +33 (0) 1 47 08 00 00 | Portugal Lundbeck Portugal Lda Tel: +351 21 00 45 900 |
Hrvatska Lundbeck Croatia d.o.o. Tel.: +385 1 644 82 63 | România Lundbeck Export A/S Reprezentanta din Romania Tel: +40 21319 88 26 |
Ireland Lundbeck (Ireland) Limited Tel: +353 1 468 980 | Slovenija Lundbeck Pharma d.o.o. Tel.: +386 2 229 4500 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Lundbeck Slovensko s.r.o. Tel: +421 2 5341 42 18 |
Italia Otsuka Pharmaceutical Italy S.r.l Tel: +39 02 00 63 27 10 | Suomi/Finland Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Κ?προς Lundbeck Hellas A.E Τηλ.: +357 22490305 | Sverige Otsuka Pharma Scandinavia AB Tel: +46 8 54528660 |
Latvija H. Lundbeck A/S Tel: +45 36301311 | United Kingdom Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 203 747 5300 |
Last review date of this leaflet: {MM/AAAA}.
Other sources of information
The detailed information about this medication is available on the website of the European Medicines Agencyhttp://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 all the items listed below are present:
- 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 38 mm, 21 gauge hypodermic safety needle, with a needle protection device.
- A disposable 3 ml syringe with luer-lock tip.
- Vial adapter.
- A 25 mm, 23 gauge hypodermic safety needle with a needle protection device.
- A 38 mm, 22 gauge hypodermic safety needle with a needle protection device.
- A 51 mm, 21 gauge hypodermic safety needle with a needle protection device.
- Instructions for the needle and syringe
Step 2: Reconstitution of the powder
- 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.
- 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 removed.
Water
- Inject the solvent slowly into the vial containing the powder.
- Extract the air to equalize the pressure in the vial by pulling the plunger back slightly.
- Then, remove the syringe from the vial.
Proceed to insert the safety needle device using the one-handed technique.
Press the safety needle device firmly against a flat surface until the needle is securely locked in place.
Visually check that the needle is perfectly locked in place and discard the syringe.
- Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.
- 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.
- If the injection is not administered immediately after reconstitution, the vial can be stored for up to 4 hours at a temperature below 25 °C and shaken vigorously for at least 60 seconds to ensure resuspension before injecting.
- Do not store the reconstituted suspension in the syringe.
Step 3: Preparation before injection
- Remove the protective cover from the vial adapter packaging, but do not remove the vial adapter from the packaging.
- Hold the vial adapter packaging and insert the luer-lock syringe into the vial adapter and turn it afterwards.
- Use the luer-lock syringe to extract the vial adapter from the packaging and discard the vial adapter packaging.Do not touch the tip of the vial adapter at any time.
d) Determine the recommended volume for injection.
Abilify Maintena vial of 300 mg | |
Dose | Volume to inject |
--- | --- |
300 mg | 1.5 ml |
200 mg | 1.0 ml |
160 mg | 0.8 ml |
Abilify Maintena vial of 400 mg | |
Dose | Volume to inject |
400 mg | 2.0 ml |
300 mg | 1.5 ml |
200 mg | 1.0 ml |
160 mg | 0.8 ml |
- Clean the cap of the vial with the reconstituted suspension with a sterile cotton swab soaked in alcohol.
- 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 clicks into place.
- Extract the recommended volume slowly from the vial with the reconstituted suspension using the luer-lock syringe to inject it.There will be a small amount of excess suspension left in the vial.
Step 4: Injection procedure
- Remove the luer-lock syringe containing the recommended volume of the reconstituted Abilify Maintena suspension from the vial.
- 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 cover from the needle immediately.
Type | Injection site | Needle size |
Non-obese | Deltoid | 25 mm, 23 gauge |
Gluteal | 38 mm, 22 gauge | |
Obese | Deltoid | 38 mm, 22 gauge |
Gluteal | 51 mm, 21 gauge |
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.
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