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Aripiprazole lauroxil (Intramuscular route)

Pronunciation:

ar-i-PIP-ra-zole lawr-OX-il

Brand Names:

  • Aristada

Dosage Forms:

  • Suspension, Extended Release

Warnings:

Intramuscular route(Suspension, Extended Release)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole lauroxil is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • 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.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Bedaquiline
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

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.

  • Boceprevir
  • Bupropion
  • Cobicistat
  • Conivaptan
  • Enzalutamide
  • Idelalisib
  • Indinavir
  • Ketoconazole
  • Lopinavir
  • Lumacaftor
  • Mitotane
  • Nefazodone
  • Phenytoin
  • Posaconazole
  • Rifampin
  • St John's Wort
  • Terbinafine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • 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 of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It will be given as a shot into a muscle.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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 While Using This Medicine:

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 using 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. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

Check with your doctor right away if you have any of the following symptoms while using 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 using 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 using 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 using 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 of This Medicine:

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
Convulsions
fast heartbeat
high fever
increased sweating
lip smacking or puckering
loss of bladder control
muscle spasm or jerking of all extremities
puffing of the cheeks
rapid or worm-like movements of the tongue
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 sex organs
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
Acid or sour stomach
belching
difficulty having a bowel movement (stool)
dry mouth
fear
fever
headache
heartburn
hyperventilation
inability to sit still
indigestion
irritability
lightheadedness
need to keep moving
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 aching or cramping
muscle pains 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.


Last Updated: 9/4/2017
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