Aripiprazole Lauroxil (ar-i-PIP-ra-zole lawr-OX-il)

Treats schizophrenia.

Brand Name(s):

Aristada, Aristada Initio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.
• 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 should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how aripiprazole works. Tell your doctor if you are using any of the following:
  • Carbamazepine, clarithromycin, fluoxetine, itraconazole, ketoconazole, paroxetine, quinidine, rifampin
  • Benzodiazepine or sedative medicine (including lorazepam)
  • Blood pressure medicine (including carvedilol, lisinopril, prazosin)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have diabetes, heart failure, heart or blood vessel disease, heart rhythm problems, high or low blood pressure, high cholesterol, any type or infection (including aspiration pneumonia), or a history of seizures, heart attack, or stroke.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  • Increased risk of blood clots, including stroke heart attack or stroke
  • Neuroleptic malignant syndrome (NMS), a neurologic disorder than can be life-threatening
  • Tardive dyskinesia (movement disorder that may become permanent)
  • Changes in blood sugar levels
  • Unusual changes in behavior, including gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges
  • Seizures
• This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body 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. Stand or sit up slowly if you feel lightheaded or dizzy.
• You may get overheated more easily while you are receiving this medicine. Be careful when you exercise or when you are outside in hot or humid weather. Drink plenty of water to stay hydrated.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, irritability, nervousness, restlessness, trouble sleeping
• Chest pain, trouble with breathing, coughing up blood, difficulty swallowing
• Compulsive behavior or intense urges you cannot control
• Confusion, unusual behavior, depressed mood, or thoughts of hurting yourself or others
• Fever, chills, cough, sore throat, body aches
• Increased hunger or thirst, change in how much or how often you urinate
• Jerky muscle movements that you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf), sudden or severe headache, problems with vision, speech, or walking
• Seizures
• Sweating, uneven heartbeat, muscle stiffness
• Unusual tiredness or sleepiness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea, vomiting
• Redness, pain, swelling, or itching where the shot was given
• Unusual weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088