Pragmatic Assessment of Trokendi XR (Extended-Release Topiramate) Use in Clinical Practice (P2.256)
Objective: Evaluate Trokendi XR (Supernus Pharmaceuticals, Inc.) use in clinical practice. Background: Available in the US for >2 decades, topiramate (TPM) has a unique profile with demonstrated efficacy in epilepsy, migraine, and obesity. Based on its bioequivalence to immediate-release TPM (TPM-IR, Topamax), Trokendi XR is currently approved for epilepsy. A medical record review was undertaken to provide stakeholders with information about Trokendi XR in the real-world clinical setting. Methods: Retrospective, HIPAA-compliant review of de-identified chart data of patients prescribed Trokendi XR. Study approved by central IRB. Inclusion: Trokendi XR initiated between 08/2013 and 09/2014 in patients ≥6 yrs; record of initiating visit and ≥1 post-initiation visit. Key data: primary diagnosis, patient characteristics; dosage; adverse events (AEs). Subset analysis also examined AEs in patient cohort previously treated with TPM-IR. Results: Primary diagnosis associated with Trokendi XR treatment (n=485): Epilepsy, n=83; Migraine, n=285; Obesity, n=117. Age (median), yrs: Epilepsy, 23; Migraine, 41; Obesity, 43.5. Female: Epilepsy, 61; Migraine, 90; Obesity, 89. Dosage, mg/day (median): Epilepsy, 200 mg; Migraine, 100 mg; Obesity, 50 mg. Data from previous TPM-IR treatment were available for a subset analysis of AEs (N=187: Epilepsy, n=42; Migraine, n=112; Obesity, n=33). Overall mean dosage, mg/day: TPM-IR, 237; Trokendi XR, 201. Notable between-treatment differences (≥2) in AEs: fewer patients reported cognitive dysfunction (2 vs. 7), paresthesia (3 vs. 6), or somnolence (0 vs. 3) during Trokendi XR vs. TPM-IR treatment; more patients reported fatigue (4 vs. 2) during Trokendi XR treatment. Conclusions: Use of Trokendi XR (eg, target disorder, age/gender, dosage) in clinical practice was consistent with empirical evidence from randomized controlled trials evaluating TPM in Epilepsy, Migraine, and Obesity. Use of Trokendi XR skewed towards younger patients in Epilepsy; lower dosages were used in Migraine and Obesity. Subset analysis suggested fewer AEs with Trokendi XR. Study sponsor: Supernus Pharmaceuticals, Inc.
Disclosure: Dr. O’Neal has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Hur has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Liranso has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Barr has received personal compensation fro activities with Indegene TTM as an employee.
IMPORTANT SAFETY INFORMATION
Do not take Trokendi XR if you have recently consumed or plan to consume alcohol (i.e., within 6 hours prior to and 6 hours after Trokendi XR use)
Swallow Trokendi XR capsules whole. Do not sprinkle on food, chew, or crush.
What are the possible side effects of Trokendi XR?
Trokendi XR can cause serious side effects, including: Eye problems. Serious eye problems include sudden decrease in vision with or without eye pain or redness, a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). Call your healthcare provider right away if you have new eye symptoms, including any new problems with your vision.
Decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Increased levels of acid in the blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients.
High levels of ammonia in the blood. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. Blood ammonia levels have been shown to rise when Trokendi XR is taken with a medicine called valproic acid (e.g., DEPAKENE® and DEPAKOTE®).
Kidney stones. Drink plenty of fluids when taking Trokendi XR to decrease your chances of getting kidney stones.
Low body temperature. Taking Trokendi XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.
Effects on thinking and alertness. Trokendi XR may affect how you think, and can cause confusion and problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness.
Dizziness or loss of muscle coordination.
The most common side effects include tingling of the arms and legs (paresthesia), not feeling hungry, nausea, weight loss, abnormal vision, a change in the way foods taste, nervousness, speech problems, dizziness, slow reactions, upper respiratory tract infection, sleepiness, diarrhea, pain in abdomen and difficulty with memory. These are not all the possible side effects of Trokendi XR. For more information, ask your healthcare provider or pharmacist.
Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Trokendi XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying; have attempted to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, trouble sleeping (insomnia), or new or worsening irritability; feel or act more aggressive, angry, or violent; act on dangerous impulses; have an extreme increase in activity and talking (mania); or experience other unusual changes in behavior or mood.
Before taking Trokendi XR, tell your healthcare provider about any other medical conditions, including if you have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or plan to become pregnant; or if you are breastfeeding. Trokendi XR passes into your breast milk. Breastfed babies may be sleepy or have diarrhea. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR.
Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for the birth defects of cleft lip, cleft palate, and being smaller than expected at birth. These defects can begin early in pregnancy, even before you know you are pregnant. The long term effects of this are unknown.
Tell your healthcare provider about any other medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Trokendi XR and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take valproic acid (e.g., DEPAKENE or DEPAKOTE); any medicines that impair or decrease your thinking, concentration, or muscle coordination; or birth control pills. Trokendi XR may make your birth control pills less effective.
Do not stop Trokendi XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Trokendi XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Trokendi XR slowly.
Do not drive a car or operate heavy machinery until you know how Trokendi XR affects you. Trokendi XR can slow your thinking and motor skills, and may affect vision.
INDICATION Trokendi XR® (topiramate) extended-release capsules are used to prevent migraine headaches in adults and adolescents 12 years and older.
Please refer to the full Prescribing Information and Medication Guide for additional important information on Trokendi XR.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.