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About Qudexy® XR

Start prescribing Qudexy® XR

Give your patients options.

A smooth,
pharmacokinetic profile

The release of the topiramate occurs continuously over an extended time frame.1,2

Pharmacokinetic Data

No change

In total daily dose when converting from immediate-release topiramate to once-daily dosing with Qudexy® XR.2

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Sprinkle option

All strengths of Qudexy® XR capsules may be opened and the contents sprinkled onto a spoonful of soft food.2

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Once-daily dosing

When dosed once daily, the formulation of Qudexy® XR provides smooth topiramate levels over a 24-hour period,* without the need for an immediate-release component.1,2

Dosing and Administration

*Mean peak-to-trough fluctuation of TPM plasma concentration at steady-state for Qudexy® XR was 40% vs 53% for IR TPM in a multiple-dose, crossover, bioavailability study in 36 healthy volunteers.

Give Your Patients Options, Start With Qudexy® XR

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 $0 Co-Pay Offer** Plus Sign Minus Sign
5 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.

Extended-Release Options

Qudexy® XR (topiramate)
Extended-Release Capsules1,2
Trokendi XR® (topiramate)
Extended-Release Capsules1,3
Once-Daily Topiramate Plus Sign Plus Sign
100% Extended-Release Bead Formulation Plus Sign Minus Sign
More Affordable*** Plus Sign Minus Sign
Smaller Capsule Size Plus Sign
FDA-Approved Sprinkle Administration Option Plus Sign Minus Sign
5 Dosage Strengths, Including 150 mg Plus Sign Minus Sign

***Based on wholesale acquisition costs as of April 5, 2018, for all branded extended-release topiramate products.
† 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.

    • arrow
    • arrow
    • arrow
    • arrow
  • 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.

Dosing Flexibility

Qudexy® XR is carefully formulated with patient adherence in mind.

Open up possibilities for your patients with dosing flexibility:2

  • Taken once daily
  • Work with your patients to choose the time of day they will take Qudexy® XR
  • Can be taken with or without food
Capsules shown are not exact size or color. Proportions are to scale.
† Recommended dose for migraine prophylaxis: 100 mg once daily.

Sprinkle Administration Option

Qudexy® XR is the only extended-release topiramate formulation approved for sprinkle administration.

All strengths of Qudexy® XR capsules may be opened and the contents sprinkled onto a spoonful of soft food. Sprinkle administration is bioequivalent to the intact capsule.2

Instructions for patients:

  • Swallow mixture immediately
  • Do not store for later use
  • Do not chew or crush
  • Drink fluids right after eating the mixture to make sure it is all swallowed

For illustrative purposes only. Capsule shown is not exact size or color.

Dosing and Titration2

  Initial Dose Titration Recommended Dose

 

Migraine Prophylaxis

Adults and adolescents 12 years of age and older 25 mg once daily at nighttime for the first week Increase dose weekly to an effective dose by increments of 25 mg 100 mg once daily

Monotherapy: Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Adults and pediatric patients 10 years and older 50 mg orally once daily Increase dose weekly by increments of 50 mg for first 4 weeks then 100 mg for weeks 5 to 6 400 mg once daily
Pediatric patients 2 to less than 10 years 25 mg orally once daily at nighttime for the first week Titrate the dosage
over 5 to 7 weeks
Once-daily doses
based on weight §

Adjunctive Therapy

Adults with partial-onset seizures or Lennox-Gastaut syndrome (LGS) 25 mg to 50 mg
orally once daily
Increase dose weekly by increments of 25 mg to 50 mg to achieve
an effective dose
200 mg to 400 mg once daily
Adults with primary generalized tonic-clonic seizures 25 mg to 50 mg
orally once daily
Increase dose weekly to an effective dose by increments of 25 mg to 50 mg 400 mg once daily
Pediatric patients 2 years and older with partial-onset seizures, primary generalized tonic-clonic seizures or LGS 25 mg orally once daily at nighttime for the first week Increase dosage at 1 or 2 week intervals by increments of 1 mg/kg to 3 mg/kg. Dose titration should be guided by clinical outcome 5 mg/kg to 9 mg/kg
once daily

 

§ See Table 2 in the Qudexy® XR Prescribing Information.


References:

1. Data on file. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2017.
2. Qudexy® XR [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: March 2017.
3. Trokendi XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.: April 2017.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Qudexy® XR is contraindicated in patients with metabolic acidosis who are taking concomitant metformin (Glucophage®).

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. Hyperchloremic, non-anion gap metabolic acidosis has been reported in patients treated with topiramate, 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) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with Qudexy XR 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. Adverse reactions most often associated with use of topiramate were related to the central nervous system (CNS) and were observed in the epilepsy and migraine populations. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence or fatigue. Additional nonspecific CNS events commonly observed with topiramate in the adjunctive epilepsy population include dizziness or ataxia. In migraine prophylaxis controlled trials, the most common cognitive adverse reaction was difficulty with concentration/attention. These adverse reactions typically occurred in isolation as a single type of cognitive adverse reaction. 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. Use during pregnancy and 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, as appropriate.
  • 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. Hyperammonemia, with and without encephalopathy, has been observed in post-marketing reports in patients who were taking topiramate. Hyperammonemia appears more common 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 is associated with the development of kidney stones. The concomitant use of Qudexy XR with other carbonic anhydrase inhibitors, any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may increase the risk of kidney stone formation, and should therefore be avoided. Hydration is recommended.
  • 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.
  • Paresthesia. Paresthesia, an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of topiramate.
  • Interaction with Other CNS Depressants. Topiramate is a CNS depressant. Concomitant administration of topiramate with other CNS depressant drugs or alcohol can result in significant CNS depression.

USE IN SPECIFIC POPULATIONS
  • Nursing Mothers: Topiramate is excreted in human milk. Caution should be exercised when administered to a nursing mother as the effects of topiramate exposure to infants are unknown.
  • Females and Males 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.
  • 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
  • Oral Contraceptives: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Qudexy XR, especially at doses >200 mg/day.
  • Lithium: Monitor lithium levels when co-administered with high-dose topiramate.
  • Phenytoin or carbamazepine: Concomitant administration with topiramate decreased plasma concentrations of topiramate.
  • Other carbonic anhydrase inhibitors: Monitor for the appearance or worsening of metabolic acidosis.
  • Concomitant use of alcohol should be avoided.

ADVERSE REACTIONS
  • The most common (≥10% more frequent than placebo or low-dose topiramate in monotherapy) adverse reactions in adult and pediatric controlled, epilepsy clinical trials of immediate-release topiramate were paresthesia, anorexia, weight decrease, speech disorders and related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever.
  • The most common (≥5% more frequent than placebo) adverse reactions at recommended dosing in adult and adolescent controlled, migraine clinical trials were paresthesia, anorexia, weight decrease, difficulty with memory, taste perversion, upper respiratory tract infection, abdominal pain, diarrhea, hypoesthesia, and nausea.
  • 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 and other clinical trials conducted under widely varying conditions.
  • The most serious adverse reactions are listed above in the WARNINGS AND PRECAUTIONS section.


Refer to the DOSAGE AND ADMINISTRATION section of the full Prescribing Information for recommended dosing guidelines for Qudexy XR, including specific populations.

INDICATIONS
Qudexy® XR (topiramate) Extended-Release Capsules are indicated for:
  • Migraine: Prophylaxis of migraine headache in adults and adolescents 12 years of age and older.
  • Partial-Onset Seizures and Primary Generalized Tonic-Clonic Seizures: Initial monotherapy in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures.
  • Lennox-Gastaut Syndrome (LGS): Adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.


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.

Full Prescribing
Information
Medication
Guide

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