Aripiprazole lauroxil

Generic name: Aripiprazole Lauroxil
Drug class: Atypical antipsychotics

Usage of Aripiprazole lauroxil

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.

Aripiprazole lauroxil 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.

Before taking Aripiprazole lauroxil

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.

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.

Interactions with 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.

Bepridil

Cisapride

Dronedarone

Fluconazole

Levoketoconazole

Mesoridazine

Metoclopramide

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.

Adagrasib

Alfuzosin

Alprazolam

Amiodarone

Amisulpride

Amitriptyline

Anagrelide

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azithromycin

Bedaquiline

Buprenorphine

Buserelin

Cannabis

Ceritinib

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clonazepam

Clothiapine

Clozapine

Codeine

Crizotinib

Cyclobenzaprine

Dabrafenib

Daridorexant

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Dexmedetomidine

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Droperidol

Ebastine

Efavirenz

Encorafenib

Entrectinib

Eribulin

Erythromycin

Escitalopram

Etrasimod

Famotidine

Felbamate

Fexinidazole

Fingolimod

Flecainide

Fluoxetine

Formoterol

Foscarnet

Fostemsavir

Galantamine

Gatifloxacin

Gemifloxacin

Gepirone

Glasdegib

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibutilide

Iloperidone

Imipramine

Inotuzumab Ozogamicin

Itraconazole

Ivabradine

Ivosidenib

Lacosamide

Lapatinib

Lefamulin

Lenvatinib

Leuprolide

Levocetirizine

Levofloxacin

Lofexidine

Lumefantrine

Macimorelin

Mefloquine

Methadone

Methotrimeprazine

Metronidazole

Mifepristone

Mirtazapine

Mizolastine

Mobocertinib

Moricizine

Moxifloxacin

Nafarelin

Nelfinavir

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Osilodrostat

Osimertinib

Oxaliplatin

Oxycodone

Ozanimod

Pacritinib

Paliperidone

Panobinostat

Papaverine

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Perphenazine

Phenobarbital

Pimavanserin

Pipamperone

Pitolisant

Ponesimod

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Ranolazine

Relugolix

Remimazolam

Ribociclib

Risperidone

Ritonavir

Ropeginterferon Alfa-2b-njft

Selpercatinib

Sertindole

Sertraline

Sevoflurane

Siponimod

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sulpiride

Sultopride

Sunitinib

Tacrolimus

Tamoxifen

Tapentadol

Telaprevir

Telavancin

Telithromycin

Tetrabenazine

Tolterodine

Topiramate

Toremifene

Trazodone

Triclabendazole

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Vemurafenib

Venlafaxine

Vilanterol

Vinflunine

Voclosporin

Voriconazole

Vorinostat

Zolpidem

Zotepine

Zuclopenthixol

Zuranolone

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

Carbamazepine

Cobicistat

Conivaptan

Enzalutamide

Idelalisib

Indinavir

Ketoconazole

Lopinavir

Lumacaftor

Mitotane

Nefazodone

Phenytoin

Posaconazole

Rifampin

St John's Wort

Terbinafine

Interactions with Food/Tobacco/Alcohol

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.

Relate drugs

How to use Aripiprazole lauroxil

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.

Warnings

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.

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