Aripiprazole lauroxil Intramuscular

In the U.S.

• Aristada

Available Dosage Forms:

• Suspension, Extended Release

Therapeutic Class: Antipsychotic

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.

aripiprazole lauroxil is available only with your doctor's prescription.

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:

• 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

• 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

• 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

• 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:

• 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

• 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.

See also Warning section.

Dizziness, lightheadedness, drowsiness, tiredness, blurred vision, weight gain, shaking (tremors), and redness/pain/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, trouble swallowing, restlessness (especially in the legs), seizures, signs of infection (such as fever, persistent sore throat), trouble controlling certain urges (such as gambling, sex, eating or shopping), interrupted breathing during sleep.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop any of the following: fever, muscle cramps/stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.

Notes

Laboratory and/or medical tests (such as blood sugar, weight, cholesterol/triglyceride levels) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Your doctor may direct you to also take aripiprazole by mouth again for some time if more than a certain number of weeks have passed since your last injection. Follow your doctor's instructions carefully.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.