March 24, 2023

Watch Patricia Dean, ARNP, MSN and Clinical Coordinator of the Comprehensive Epilepsy Center at Nicklaus Children’s Hospital in Miami, Florida discuss the benefits of EPRONTIA™ (topiramate) oral solution.

My name is pat dean and i’m a nurse practitioner who specializes in epilepsy i’m happy to have been asked by azeri to share my own experiences observing and treating patients with epilepsy over the course of my career i have been seeing patients with epilepsy at nicholas children’s hospital in miami florida for 40 years now and have been very active in epilepsy patient

Organizations on the local state and national level i’m currently board chair of epilepsy alliance florida and have close ties with many other organizations people ask me how i got so involved in epilepsy did i have a family member or was i personally affected but i don’t think i chose epilepsy i think epilepsy chose me i got a job as a nurse on a neuroscience

Floor with an epilepsy monitoring unit i just found it so impactful what these children and their families went through having the experience of working in the hospital with patients and their family when they are in crisis and then spending time on walks at camp and in conferences i really got the full picture of what patients and their family go through on

A daily basis and the impact it has on their daily lives it’s constant pressure they worry about seizures when the next one will take place and how severe it will be they worry about medication schedules and keeping track epilepsy creates so many challenges especially when children are affected it’s hard to get children to take their medicine especially when

It’s required more than once per day some kids may not take pills that’s just a fact if there isn’t a palatable liquid formulation available it may be quite difficult for caregivers and their families having a medication in a liquid form is important in pediatrics but also for adult patients who have difficulty swallowing pills crushing pills mixing them with

Food that’s one more step a parent or patient has to take while it’s inconvenient enough to have to do this at home imagine when you’re out at dinner or at disney world the flexible dosing available in liquid formulations may help balance efficacy and side effects i have found in my experience that with compounding medications quality and potency may vary as

A result it may be hard to figure out the correct dose that patients have been taking a ready-to-use liquid formulation such as a prontea may make managing epilepsy and its treatment easier on all of us but especially for parents and may lead to better adherence this is a general observation i do have to point out that aprantea does not have head-to-head data on

Adherence it’s simple to give and take especially for children who have difficulty swallowing pills it’s convenient it does not have to be mixed into food or drink and perhaps most important it offers the provider and patient the ability for tailored dosing and consistent potency to optimally customize a treatment plan i have worked with patients with epilepsy

In all age groups and levels of severity i have patients i followed from infancy to adulthood i stay in touch even attend weddings i have seen what parents and families go through a liquid formulation may make the difference in treatment success for patients taking medication daily and having to give your child medication daily is hard enough if there is a way

To lessen the burden on these families i welcome it important safety information aprontia to pyramid oral solution 25 milligram per milliliter indications initial monotherapy for the treatment of partial onset or primary generalized tonic clonic seizures in patients two years of age and older adjunctive therapy for the treatment of partial onset seizures primary

Generalized tonic clonic seizures or seizures associated with lennox gusto syndrome in patients 2 years of age and older preventive treatment of migraine in patients 12 years of age and older inform patients that a calibrated measuring device is recommended to measure and deliver the prescribed dose accurately a household teaspoon or tablespoon is not an adequate

Measuring device additional important safety information warnings and precautions acute myopia and secondary angle closure glaucoma a syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving aprontia to pyramid symptoms typically occur within one month of initiation of a prontia therapy symptoms

Include acute onset of decreased visual acuity and or ocular pain ophthalmologic findings include myopia anterior chamber shallowing ocular hyperemia redness and increased intraocular pressure primary treatment to reverse symptoms is discontinuation of aprontia visual field defects visual field defects have been reported in clinical trials and post-marketing

Experience in patients receiving topiramate in clinical trials most of these events were found to be reversible after topiramate discontinuation if visual problems occur consideration should be given to discontinuing the drug oligohydrosis decreased sweating and hyperthermia oligohydrosis infrequently resulting in hospitalization has been reported in association

With aprontia use the majority of these reports have been in pediatric patients patients especially pediatric patients should be monitored for evidence of decreased sweating and increase in body temperature especially in hot weather caution should be used when a prontia is prescribed with other drugs that predispose patients to heat related disorders these drugs

Include but are not limited to other carbonic anhydrase inhibitors and other drugs with anticholinergic activity metabolic acidosis metabolic acidosis was commonly observed in adults and pediatric patients in clinical trials and is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by topiramate conditions or therapies that predispose patients

To acidosis such as renal disease severe respiratory disorders status epilepticus diarrhea ketogenic diet or specific drugs may be additive to the bicarbonate lowering effects of tapiramate aprontia treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate

From possible transfer of to pyramid to the fetus baseline and periodic serum bicarbonate measurements are recommended during a prontia treatment baseline and periodic serum bicarbonate measurements are recommended during a prontia treatment if metabolic acidosis develops consideration should be given to either dose reduction or discontinuation of therapy using

Dose tapering suicidal behavior and ideation anti-epileptic drugs aeds including aprontia increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication patients treated with any aed should be monitored for the emergence or worsening of depression suicidal thoughts or behavior and or any unusual changes in mood or behavior

Cognitive neuropsychiatric adverse reactions aprontia can cause cognitive neuropsychiatric adverse reactions the most frequent adverse reaction can be classified into three categories one cognitive related dysfunction confusion difficulty with concentration difficulty with memory speech or language problems two psychiatric behavior disorders 3. somnolence or

Fatigue fetal toxicity iprontea can cause fetal harm when administered to pregnant women the benefits and risks should be considered when administering this drug in women of childbearing potential withdrawal of anti-epileptic drugs eprontia should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency if rapid withdrawal

Is required appropriate monitoring is recommended serious skin reactions serious skin reactions stevens-johnson syndrome sjs and toxic epidermal necrolysis ten have been reported ifrontia should be discontinued at the first sign of a rash unless the rash is clearly unrelated to the drug if signs or symptoms suggest sjs or ten use of this drug should not be

Resumed and alternative therapy should be considered inform patients about the signs of serious skin reactions hyperamminemia and encephalopathy without and with concomitant vaporic acid use topiramate treatment can cause hyperammonemia with or without encephalopathy the risk of which appears to be dose-related and which has been reported more frequently with

Concomitant use of valproic acid in patients who develop unexplained lethargy vomiting or changes in mental status associated with topiramate hyperammonemic encephalopathy should be considered and an ammonia level should be measured kidney stones eprontea can cause an increased risk of kidney stones the concomitant use of tapiramate with any other drug producing

Metabolic acidosis or potentially in patients on a ketogenic diet may increase the risk of kidney stone formation instruct patients to stay well hydrated while taking aprontia hypothermia with concomitant valproic acid use hypothermia has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in

The absence of hyperammonemia consider discontinuation of topiramate or valproate in patients who develop hypothermia blood ammonia levels should be assessed during clinical management adverse reactions the most common side effects for aprontia include tingling of the arms and legs not feeling hungry nausea a change in the way foods taste diarrhea weight loss

Nervousness upper respiratory tract infections speech problems tiredness dizziness sleepiness or drowsiness slow reactions difficulty with memory pain in the abdomen fever abnormal vision decreased feeling or sensitivity especially in the skin these are not all the possible side effects of a prontea use in specific populations women of reproductive potential

Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks of oral clefts and small for gestational age sga renal impairment the clearance of a branchia is reduced in patients with moderate creatinine clearance 30 to 69 milliliter per minute per 1.73 m square and severe creatinine clearance greater

Than 30 milliliter per minute per 1.73 m square renal impairment a dosage adjustment is recommended in patients with moderate or severe renal impairment patients undergoing hemodialysis eprontia is cleared by hemodialysis at a rate that is four to six times greater than in a normal individual a dosage adjustment may be required the important safety information

Does not include all the information needed to use aprontia safely and effectively visit for full prescribing information to report suspected adverse reactions contact azurity pharmaceuticals inc at 1-855-379 or fda at 1-800-fda 1088 or medwatch hcp epr dash 1.6

Transcribed from video
Benefits of EPRONTIA (topiramate) oral solution By Azurity Pharmaceuticals