INDICATION
MOTPOLY XR is a prescription medicine used to treat partial-onset seizures in adults and in children weighing at least 110 pounds (50 kg). It is not known if MOTPOLY XR is safe and effective for partial-onset seizures in children weighing less than 50 kg.
IMPORTANT SAFETY INFORMATION
Do not stop taking MOTPOLY XR without first talking to your healthcare provider. Stopping MOTPOLY XR suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
MOTPOLY XR can cause serious side effects, including:
- Suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempt to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.
- Feelings of dizziness, double vision, sleepiness, or problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how MOTPOLY XR affects you. You should not drink alcohol while taking MOTPOLY XR.
- An irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you: have a fast, slow, or pounding heartbeat or feel your heart skip a beat; have shortness of breath; have chest pain; feel lightheaded; or fainted or if you feel like you are going to faint. If you have fainted or feel like you are going to faint you should lay down with your legs raised.
- Abuse or drug dependence. MOTPOLY XR is a federally controlled substance (CV). Keep MOTPOLY XR in a safe place, to protect it from theft. Never give your MOTPOLY XR to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
- A serious allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. Call your healthcare provider right away if you have: a skin rash, hives; fever or swollen glands that does not go away; shortness of breath; tiredness (fatigue); swelling of the legs; yellowing of the eyes or whites of the eyes; or dark urine.
The most common adverse reactions are double vision, headache, dizziness, nausea, and sleepiness. These are not all the possible side effects of MOTPOLY XR. Before you take MOTPOLY XR, tell your healthcare provider about all of your medical conditions, including if you have or have had:
- depression, mood problems or suicidal thoughts or behavior
- heart, kidney or liver problems
- abused prescription medicines, street drugs or alcohol in the past.
Talk to your healthcare provider if you are pregnant or plan to become pregnant. It is not known if MOTPOLY XR can harm your unborn baby. Also talk to your healthcare provider if you are breastfeeding or are planning to breastfeed as MOTPOLY XR passes into breast milk.
Taking MOTPOLY XR with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Do not start or stop any medicines while taking MOTPOLY XR without talking to your healthcare provider.
You are encouraged to report negative side effects of prescription drugs. Contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information, including Medication Guide, for MOTPOLY XR.
References:
1. Motpoly XR [package insert]. Piscataway, NJ: Aucta Pharmaceuticals, Inc.; 2023.
2. Data on file, Aucta Pharmaceuticals; 2022.
