Latest Industry News

Rx Medications-Abilify®

INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY® (aripiprazole)

INDICATIONS: ABILIFY is indicated for the treatment of:
Schizophrenia, including maintaining stability in patients who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer and observed for relapse during a period of up to 26 weeks.

IMPORTANT SAFETY INFORMATION:
Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability to perform daily activities as a result of increased memory loss), and who are treated with atypical antipsychotic medicines including ABILIFY, are at an increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

Serious side effects can occur with any antipsychotic medicine, including ABILIFY (aripiprazole).
Tell your healthcare provider right away if you have any conditions or side effects, including the following:

• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome, a rare but serious side effect which could be fatal
• Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia which may be permanent
• Elderly: An increased risk of stroke and ministroke has been reported in a clinical study of elderly patients with dementia-related psychosis
• Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking medicines like ABILIFY. Ask your healthcare provider about the need to monitor your blood sugar level before and during treatment.

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

Medicines like ABILIFY can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Since medicines like ABILIFY can impact your body's ability to reduce body temperature, you should avoid overheating and dehydration.

Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare provider.

If you have suicidal thoughts, you should tell your healthcare provider right away.

While taking ABILIFY, avoid:

• Drinking alcohol
• Breast-feeding an infant

Tell your healthcare provider if you have a history of seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take.

Other common side effects include: constipation, an inner sense of restlessness or need to move (akathisia), headache, nausea, upset stomach, vomiting, agitation, anxiety, insomnia, sleepiness, lightheadedness, and tremor.

For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.

If you have questions about your health or medicines, talk to your healthcare provider.

Please see IMPORTANT SAFETY INFORMATION and FULL PRODUCT INFORMATION including Boxed WARNING for ABILIFY (aripiprazole)