Safety and side effects of INGREZZA for HD chorea
INGREZZA SAFETY PROFILE
Nearly all people (9 out of 10) taking INGREZZA completed the full 12-week clinical study, with 4 out of 5 able to tolerate the highest dose.
In the clinical trial, INGREZZA was shown to be generally well tolerated.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:
- Allergic reactions, including an allergic reaction that causes sudden swelling (angioedema)
- Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation)
- Heart rhythm problems (QT prolongation)
- Neuroleptic Malignant syndrome (NMS)
- Parkinson-like symptoms including body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington’s disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
People with Huntington’s disease have a higher risk of depression and suicidal thoughts or actions. INGREZZA is a VMAT2 inhibitor. VMAT2 inhibitors are a group of medicines that all include the warning that they could increase this risk.
Learn more about the INGREZZA clinical study
128 PEOPLE enrolled
64 PEOPLE
randomly selected
to take INGREZZA
64 PEOPLE
randomly selected
to take placebo
The goal of the study was to see if people taking INGREZZA experienced improvements in their HD chorea as measured by changes in TMC (Total Maximal Chorea) score. Approximately 120 people who completed the study were then enrolled in a 3-year extension to evaluate the long-term safety and effectiveness of INGREZZA in the treatment of HD chorea.
PEOPLE TAKING INGREZZA CAN STAY ON MOST OF THEIR STABLE MENTAL HEALTH MEDICATIONS
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Here’s why INGREZZA is unlike other medications approved to treat HD chorea
INGREZZA offers simple dosing that’s always one capsule, once daily
