Description
Aripiprazole lauroxil extended-release injection is used to treat schizophrenia (a mental disorder). It works in the brain to change how certain chemicals affect patients. Aripiprazole is an antipsychotic agent.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole lauroxil injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of this medicine in the geriatric population. Safety and efficacy have not been established. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Isocarboxazid
- Ketoconazole
- Levoketoconazole
- Mavorixafor
- Mesoridazine
- Metoclopramide
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfuzosin
- Alprazolam
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Bentazepam
- Benzhydrocodone
- Boceprevir
- Buprenorphine
- Bupropion
- Buserelin
- Butalbital
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Ceritinib
- Chlordiazepoxide
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clonazepam
- Clorazepate
- Clothiapine
- Cloxazolam
- Clozapine
- Cobicistat
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tizanidine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Aspiration pneumonia (swelling of the lungs or airways) or
- Blood vessel disease or
- Dehydration or
- Heart attack or stroke, history of or
- Heart disease or
- Heart failure, history of or
- Heart rhythm problems or
- Hypotension (low blood pressure) or
- Hypovolemia (decrease in the volume of blood) or
- Ischemic heart disease, history of or
- Trouble with swallowing—Use with caution. May cause side effects to become worse.
- Depression or
- Diabetes, or family history of or
- Dyslipidemia (high cholesterol or fats in the blood) or
- Hyperglycemia (high blood sugar) or
- Neuroleptic malignant syndrome (NMS), history of or
- Neutropenia (low white blood cells) or
- Seizures, history of—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It will be given as a shot into a muscle of your arm or buttock.
Your doctor will give you Aristada Initio™ as a one-time injection together with oral aripiprazole before you start Aristada® treatment or restart Aristada® treatment after a missed dose. You may also receive your first injection of Aristada® on the same day or up to 10 days after you receive Aristada Initio™.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Be sure to keep all appointments for the injections.
Precautions
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and help reduce any unwanted effects. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase risk for stroke in elderly patients with dementia. Tell your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move the arms, legs, or facial muscles, double vision, or headache while receiving this medicine.
This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
This medicine may add to the effects of alcohol and other medicines that make you drowsy or less alert. Some examples of these medicines are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (medicines that numb), including some dental anesthetics. If you are taking any of these medicines, make sure you tell your doctor before you receive aripiprazole injection.
Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor right away if you have any of the following symptoms while receiving this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while receiving this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are receiving this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Difficulty with speaking
- drooling
- loss of balance control
- muscle trembling, jerking, or stiffness
- restlessness
- shuffling walk
- stiffness of the limbs
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
Less common
- Blurred vision
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- headache
- inability to move the eyes
- increased blinking or spasms of the eyelid
- nervousness
- pounding in the ears
- sticking out the tongue
- trouble breathing or swallowing
- unusual facial expressions
Rare
- Fast heartbeat
- high fever
- increased sweating
- lip smacking or puckering
- loss of bladder control
- muscle spasm or jerking of the arms or legs
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- seizures
- severe muscle stiffness
- sudden loss of consciousness
- tiredness
- uncontrolled chewing movements
- uncontrolled movements of the arms and legs
- unusually pale skin
Incidence not known
- Hives or welts, itching, or skin rash
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- redness of the skin
- tightness in the chest
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Belching
- deep or fast breathing with dizziness
- difficulty having a bowel movement
- dry mouth
- fear
- fever
- headache
- heartburn
- inability to sit still
- indigestion
- irritability
- lightheadedness
- need to keep moving
- numbness of the feet, hands, and around the mouth
- runny nose
- shaking
- sore throat
- stomach discomfort, upset, or pain
- trouble sleeping
- weight gain
Less common
- Accidental injury
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- congestion
- coughing
- difficulty with moving
- hoarseness
- increased appetite
- joint pain
- muscle ache, cramps, pain, or stiffness
- sneezing
- stuffy nose
- swollen joints
- tender, swollen glands in the neck
- tingling of the hands or feet
- tremor
- unusual weight gain or loss
- voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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