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About Qudexy® XR

Convenient to take

Upsher-Smith formulated Qudexy® XR with patient adherence in mind.

Once-daily dosing1,2

Qudexy® XR gives your patients all-day medication coverage with just one daily dose and a sprinkle option.

Extended-release

Qudexy® XR is an extended-release medication. It provides a slow, continuous release of medication into the body.

Direct switch2

Qudexy® XR requires no change in total daily dose when converting from immediate-release topiramate to once-daily dosing with Qudexy® XR.

Flexible dosing

Qudexy® XR comes in five dosage strengths, including a unique 150 mg capsule.

The most common topiramate adverse reactions in adult and pediatric epilepsy patients were: paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever.

The most common topiramate adverse reactions in adult and adolescent migraine patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.

†Recommended dosage for migraine prophylaxis is 100 mg once daily.

Give your patients options

Qudexy® XR gives your patients options that immediate-release topiramate tablets don’t.

Qudexy® XR2 Immediate-Release
Topiramate Tablets1
100% extended-release bead formulation Plus Sign Minus Sign
Once-daily dosing Plus Sign Minus Sign
Smooth pharmacokinetic profile Plus Sign Minus Sign
FDA-approved sprinkle administration option in all strengths Plus Sign Minus Sign
Platinum Pass® savings card $0 co-pay offer* Plus Sign Minus Sign
Five dosage strengths, including 150 mg Plus Sign Minus Sign

* Restrictions apply. Medicare, Medicaid, and other state and federal health care program patients are not eligible.
† Recommended dose for migraine prophylaxis: 100 mg once daily.

The only 100% extended-release bead formulation of topiramate.1,2

For illustrative purposes only.

Qudexy® XR capsules contain precisely engineered coated beads of topiramate. When the beads come in contact with gastrointestinal fluid, the fluid permeates through the extended-release coating, dissolving the topiramate, which allows it to slowly diffuse out through the coating to be absorbed.1,2

The release of the topiramate occurs continuously over an extended time frame. With once-daily dosing, its formulation composed of 100% extended-release beads provides smooth topiramate levels over a 24-hour period, without the need for an immediate-release component.1,2

Delivers a Smooth Pharmacokinetic (PK) Profile

Qudexy® XR is the only 100% extended-release bead formulation of topiramate, providing a smooth PK profile.1,2

  • Maintains topiramate levels for 24 hours with one dose daily
  • 25% reduction in fluctuation of topiramate plasma concentrations compared to immediate-release topiramate††
  • Reduces exposure to peak drug levels

Result from a multiple-dose, crossover, bioavailability study of Qudexy® XR and IR TPM in 36 healthy volunteers.
†† Mean peak-to-trough fluctuation of TPM plasma concentrations at steady-state for Qudexy® XR was approximately 40% compared to approximately 53% for IR TPM.
† Recommended dose for migraine prophylaxis: 100 mg once daily.
IR TPM=immediate-release topiramate; Cmax=maximum plasma concentration; Cmin=minimum plasma concentration.

Maintains Concentrations After Switching From Immediate-Release Topiramate (IR TPM)

From day 1 after switching to Qudexy® XR, criteria for bioequivalence with IR TPM were met.§ 1,2

§ Switching between Qudexy® XR and IR TPM was evaluated in a multiple-dose, crossover, bioavailability study in 36 healthy volunteers. On the first day following the switch, there were no significant differences in AUC 0-24, Cmax and Cmin; the 90% CI for the ratios were contained within the 80–125% equivalence limits.
In addition, at steady state, the 90% Ci for the ratios of AUC0-24, Cmax and Cmin, as well as partial AUC for multiple time point, were also within the 80­–125% bioequivalence limits, indicating no clinically significant difference between the formulations.
† Recommended dose for migraine prophylaxis: 100 mg once daily.
IR=immediate-release; TPM=topiramate; AUC=area under the curve; Cmax=maximum concentration; Cmin=minimum concentration; CI=confidence interval.

No Change in Total Daily Dose

Switch to a dosing schedule that works for your patients. No change in total daily dose is needed when converting from IR TPM to once-daily dosing with Qudexy‌® XR.2

  • IR TPM


    • Total Daily Dose
    • Morning
    • Evening
         
    50 mg 25 mg tablet 25 mg tablet
    100 mg 50 mg tablet 50 mg tablet
    150 mg 3x25 mg tablet 3x25 mg tablet
    200 mg 100 mg tablet 100 mg tablet

    Tablets shown are not exact size or color.

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  • QUDEXY® XR


    • Total Daily Dose
    • Once Daily
    25 mg 25 mg pill
    50 mg 50 mg pill
    100 mg 100 mg pill
    150 mg 150 mg pill
    200 mg 200 mg pill

    Capsules shown are not exact size or color.

    † Recommended dose for migraine prophylaxis: 100 mg once daily.

PREVAIL Epilepsy Trial

Qudexy® XR is the only extended-release topiramate formulation backed by PREVAIL Phase 3 data in patients with epilepsy.


References:

1. Data on file. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2019.
2. Qudexy® XR [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: February 2019.

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IMPORTANT SAFETY INFORMATION

WARNINGS & 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 topiramate, with symptoms typically occurring within 1 month of therapy initiation.  The primary treatment to reverse symptoms is discontinuation of Qudexy XR as rapidly as possible. If left untreated, elevated intraocular pressure can lead to serious sequelae, including permanent vision loss.
  • Visual Field Defects. Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.
  • Oligohydrosis and Hyperthermia. Oligohydrosis, resulting in hospitalization in some cases, has been reported in association with topiramate use. The majority of reports have been in pediatric patients, but all patients should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Qudexy XR is prescribed with other drugs that predispose patients to heat-related disorders.
  • Metabolic Acidosis. Qudexy XR can cause hyperchloremic, non-anion gap metabolic acidosis due to its inhibitory effect on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
  • Suicidal Behavior and Ideation. Antiepileptic drugs (AEDs), including Qudexy XR 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. Patients, their caregivers, and families should be informed of these risks, and behaviors of concern should be immediately reported to healthcare providers.
  • Cognitive/Neuropsychiatric Adverse Reactions. Immediate-release topiramate can cause, and therefore, Qudexy XR is expected to cause, cognitive/neuropsychiatric adverse reactions. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence/fatigue. In pediatric epilepsy trials, adverse reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. In migraine prophylaxis controlled trials, the most common cognitive adverse reaction was difficulty with memory. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur.
  • Fetal Toxicity. Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of cleft lip and/or cleft palate and of being small for gestational age. Qudexy XR should be used during pregnancy only if the potential benefit outweighs the potential risk. All women of childbearing potential should be informed of the potential hazard to the fetus and counseled to use effective contraception, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate.
  • Withdrawal of Antiepileptic Drugs. Antiepileptic drugs, including Qudexy XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
  • Hyperammonemia and Encephalopathy. Topiramate treatment can cause hyperammonemia, with and without encephalopathy. The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when used concomitantly with valproic acid. Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur.
  • Kidney Stones. Topiramate increases the risk of kidney stones. Topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH.  The concomitant use of Qudexy XR with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.  Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation.  Hydration is recommended to reduce new stone formation.
  • Hypothermia with Concomitant Valproic Acid Use. Hypothermia has been reported in association with topiramate use with concomitant valproic acid, both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia.

USE IN SPECIFIC POPULATIONS
  • Nursing Mothers: Topiramate is excreted in human milk. The effects of topiramate on milk production are unknown. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qudexy XR and any potential adverse effects on the breastfed infant from Qudexy XR or from the underlying maternal
  • Females of Reproductive Potential: Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks to the fetus of oral clefts and of being small for gestational age.
  • Pregnancy: Increased risk of cleft lip and/or palate and for being small for gestational age.
  • Patients with Renal Impairment: One-half of the usual adult dose is recommended.
  • Patients Undergoing Hemodialysis: To avoid rapid drops in topiramate plasma concentration, a supplemental dose of topiramate may be required.
  • Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function.

DRUG INTERACTIONS
  • Antiepileptic Drugs: Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate. A dosage adjustment may be needed. Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with or without encephalopathy.
  • CNS Depressants: Qudexy XR should be used with extreme caution if used in combination with alcohol and other CNS depressants.
  • Oral Contraceptives: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur.
  • Lithium: Lithium levels should be monitored when co-administered with high-dose Qudexy XR.
  • Other Carbonic Anhydrase Inhibitors: Patients should be monitored for the appearance or worsening of metabolic acidosis when Qudexy XR is given concomitantly with another carbonic anhydrase inhibitor.
  • Hydrochlorothiazide (HCTZ): The addition of HCTZ to Qudexy XR may require a decrease in the Qudexy XR dose.
  • Pioglitazone: When Qudexy XR is added to pioglitazone therapy or pioglitazone is added to Qudexy XR therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
  • Amitriptyline: Some patients may experience a large increase in amitriptyline concentration in the presence of Qudexy XR and any adjustments in amitriptyline dose should be made according to the patient’s clinical response and not on the basis of plasma levels.

ADVERSE REACTIONS
  • Epilepsy: The most common adverse reactions in adult and pediatric controlled, clinical trials of immediate-release topiramate were: paresthesia, anorexia, weight loss, speech disorders and related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever.
  • Migraine: The most common adverse reactions at recommended doses in adult and adolescent controlled, clinical trials were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.
  • Qudexy XR has been studied in a randomized, placebo-controlled, phase 3 clinical study in 249 adult patients with a history of partial-onset seizures with or without secondary generalization. See the ADVERSE REACTIONS section of the Qudexy XR full prescribing information for adverse reaction rates from this clinical trial.
  • The most serious adverse reactions are listed above in the WARNINGS AND PRECAUTIONS section.


INDICATIONS
Qudexy® XR (topiramate) Extended-Release Capsules are indicated for:
  • Migraine: Prophylaxis of migraine in patients 12 years and older.
  • Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older. Adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years and older.


This safety information is not comprehensive.  Please refer to the full Prescribing Information for Qudexy XR, WARNINGS AND PRECAUTIONS and Medication Guide.  You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC. at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC
All other marks are the property of their respective owners.



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