IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TROKENDI XR is contraindicated in patients with:

  • Recent alcohol use (within 6 hours prior to and 6 hours after TROKENDI XR use).
  • A history of hypersensitivity reaction to topiramate. TROKENDI XR, or any of the inactive ingredients of TROKENDI XR. Anaphylaxis and angioedema have occurred.

WARNINGS & PRECAUTIONS

• Acute Myopia and Secondary Angle Closure Glaucoma Syndrome: Has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. The primary treatment to reverse symptoms is discontinuation of TROKENDI XR as rapidly as possible. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

• Visual field defects (independent of elevated intraocular pressure): Have been reported in patients receiving topiramate. In clinical trials, most events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment with TROKENDI XR, consideration should be given to discontinuing the drug.

• Oligohydrosis and Hyperthermia: Resulting in hospitalization in some cases, have been reported with topiramate use. Some cases were reported after exposure to elevated environmental temperatures. The majority of reports have been in pediatric patients. Patients, especially pediatric patients, should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when TROKENDI XR is given with other drugs that predispose patients to heat-related disorders (e.g., other carbonic anhydrase inhibitors and drugs with anticholinergic activity).

• Metabolic Acidosis: Hyperchloremic, non-anion gap, metabolic acidosis has been reported in adults and pediatric patients treated with topiramate. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase and can occur at any time during treatment. Conditions or therapies 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 TROKENDI XR (using dose tapering). If the decision is made to continue patients on TROKENDI XR in the face of persistent acidosis, alkali treatment should be considered.

• Interaction with Alcohol: In vitro data show that, in the presence of alcohol, the pattern of topiramate release from TROKENDI XR capsules is significantly altered. As a result, plasma levels of topiramate with TROKENDI XR may be markedly higher soon after dosing and subtherapeutic later in the day. Alcohol use should be completely avoided within 6 hours prior to and 6 hours after TROKENDI XR administration.

• 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 any AED, including TROKENDI XR for any indication, should be monitored for the emergence or worsening of depression, suicidal thoughts, or behavior, and/or any unusual changes in mood or behavior. Anyone considering prescribing TROKENDI XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Many illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

• Cognitive/Neuropsychiatric Adverse Reactions: Immediate-release topiramate can cause, and therefore expected to be caused by TROKENDI XR, cognitive/neuropsychiatric adverse reactions. The most frequent of these can be classified into three general categories: Cognitive-related dysfunction; psychiatric/behavioral disturbances; and somnolence or fatigue.

• Fetal Toxicity: TROKENDI XR can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero can have an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate, and of being small for gestational age. Consider the benefits and risks of TROKENDI XR when administering the drug in women of childbearing potential, particularly for a condition not usually associated with permanent injury or death. TROKENDI XR should only be used during pregnancy if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

• Withdrawal of Antiepileptic Drugs: In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TROKENDI XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of TROKENDI XR is medically required, appropriate monitoring is recommended.

• Decrease in Bone Mineral Density: Results of a one-year active-controlled study in pediatric patients (N=63) demonstrated negative effects of immediate-release topiramate monotherapy on bone mineral acquisition via statistically significant decreases in bone mineral density (BMD) measured in lumbar spine and in total body less head. Twenty-one percent of immediate-release topiramate-treated patients experienced clinically important reductions in BMD (Z score change from baseline of -0.5 or greater) compared to 0 patients in the control group. Decreased BMD in the lumbar spine was correlated with decreased serum bicarbonate, which commonly occurs with topiramate treatment and reflects metabolic acidosis, a known cause of increased bone resorption.

• Negative Effects on Growth (Height and Weight): Immediate-release topiramate monotherapy demonstrated negative effects on growth (height and weight) among pediatric patients in a one-year active controlled study (N=63). Negative effects on growth were seen across all immediate-release topiramate age subgroups. Growth of children receiving prolonged TROKENDI XR therapy should be carefully monitored.

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions: DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking topiramate and may be fatal or life-threatening. DRESS typically presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Other organ systems not noted here may be involved. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. TROKENDI XR should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

• Serious Skin Reactions: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients receiving topiramate. TROKENDI XR should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed, and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.

• Anaphylaxis and Angioedema: Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with topiramate in the postmarketing setting. If a hypersensitivity reaction occurs, discontinue TROKENDI XR and initiate appropriate therapy.

• Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use): Can be caused by topiramate treatment and risk appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. Monitoring for Hyperammonemia: Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, topiramate or TROKENDI XR treatment or an interaction of concomitant topiramate-based product and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. In patients who develop unexplained lethargy, vomiting, or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

• Kidney Stones: Topiramate increases the risk of kidney stones. TROKENDI XR would be expected to have the same effect. Topiramate is a carbonic anhydrase inhibitor that can promote stone formation by reducing urinary citrate excretion and increasing urinary pH. The concomitant use of TROKENDI XR with 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. Increased fluid intake increases fluid output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation.

• Hypothermia with Concomitant Valproic Acid Use: Has been reported in association with topiramate use with concomitant valproic acid both in the presence and in the absence of hyperammonemia. It can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Consideration should be given to stopping TROKENDI XR or valproate in patients who develop hypothermia; clinical management and assessment should include examination of blood ammonia levels.

ADVERSE REACTIONS

• The most common (≥5% more frequent than placebo) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain, and upper respiratory tract infection.

INDICATION

TROKEND XR® (topiramate) extended-release capsules is indicated for preventive treatment of migraine in patients 12 years of age and older.

Please see full Prescribing Information.

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The right topiramate dose may help you do more for migraine patients

GET CO-PAY CARD

Significant reductions in migraine frequency begin at 100-mg daily dose1-3

Study overview1,2:
Two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials evaluating the efficacy of immediate-release topiramate (TPM-IR) in the prophylactic treatment of migraine. Study 1 was conducted in the United States; Study 2 was conducted in the United States and Canada. Trial design was identical, enrolling patients 12 to 65 years of age with a history of migraine, with or without aura, for at least 6 months, according to IHS diagnostic criteria. Patients experiencing cluster, basilar, ophthalmoplegic, hemiplegic, or transformed migraine were excluded.

Treatment1,2:
Patients experiencing 3 to 12 migraines over a 28-day prospective baseline phase were randomized to TPM-IR 50 mg/day, 100 mg/day, 200 mg/day, or placebo and treated for 26 weeks (8-week titration period; 18-week maintenance period).

Treatment was initiated at 25 mg/day for 1 week, then daily dose was increased by 25-mg increments weekly until reaching the assigned target dose or maximum tolerated dose (administered twice daily).

Analysis1,2:
Treatment efficacy was assessed by the reduction in migraine frequency, as measured by the change in 4-week migraine rate (migraine classified by IHS criteria) from the baseline phase to double-blind treatment period in each TPM-IR treatment group, compared to placebo, in the ITT population.

Abbreviations: IHS, International Headache Society; ITT, intent-to-treat; TPM-IR, immediate-release topiramate.

Primary endpoint: Mean reduction from baseline (5.5 migraines per 28 days) in migraine frequency1-4

*Active treatment group was statistically different than placebo group in both studies.

NSNot statistically significant.

The 200-mg/day dose group was also statistically different than placebo. Mean reduction from baseline: Study 1 (n=112): 2.2; Study 2 (n=117): 2.4 (P<0.001 for both).

Have you asked your patients how they are doing on immediate-release topiramate?

Explore how once-daily Trokendi XR may be the right topiramate medication for your patients.3,5

All-day delivery of migraine prevention treatment3,5

Once-daily Trokendi XR is bioequivalent to twice-daily Topamax® (topiramate)—24-hour mean steady state plasma concentration-time profiles3,5

Primary endpoint3

Relative bioavailability of Trokendi XR and Topamax at steady state.

Study design3

Phase 1, single-center, multiple-dose, single-blind, randomized, crossover PK study of Trokendi XR (200 mg once daily) and Topamax (100 mg twice daily) in 39 healthy adults.

Subjects were titrated to a 200-mg/day dose of either Trokendi XR or Topamax over 3 weeks.

Following titration, subjects were maintained on 200 mg/day for 10 days.

Following a 32-day washout period, subjects crossed over to alternate treatment.

Ratio Trokendi XR to Topamax (90% CI) AUC0-24 97% (94%-100%) | Cmax 88% (85%-91%) | Cmin 100% (96%-104%)

Fluctuation in plasma concentration of Trokendi XR was ~26% for healthy subjects compared to ~40% for subjects taking TPM-IR.3,5

Abbreviations: CI, confidence interval; PK, pharmacokinetic; Q12H, every 12 hours; QD, daily; TPM-IR, immediate-release topiramate.

It’s important for patients to have

steady, 24-hour delivery3,5

Trokendi XR is designed and approved to be prescribed once daily; immediate-release topiramate is not.4,5

Simulated fluctuation of topiramate concentration at steady state was approximately6:

• 18% for patients with epilepsy taking once-daily Trokendi XR 200 mg

• 64% for patients with epilepsy taking once-daily TPM-IR 200 mg

Abbreviations: AED, anti-epileptic drug; PK, pharmacokinetic; TPM-IR, immediate-release topiramate.

Population PK modeling and once-daily dosing simulation based on bioavailability in patients with epilepsy*,3,6

*Randomized, controlled trials have not explored the consequences of dosing irregularities for an extended-release AED and its twice-daily counterpart. Because they can be powerful predictive tools, population PK modeling and simulation were used to compare the potential PK consequences of dosing irregularities during steady state AED treatment with once-daily Trokendi XR and twice-daily TPM-IR. In addition, simulations compared once-daily dosing of Trokendi XR and TPM-IR to address the perception that, due to the long half-life of topiramate, once-daily dosing produces relatively constant topiramate concentrations, regardless of formulation.6

Patient savings*

Help your eligible patients save with a $0 co-pay savings card.

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Trokendi XR® (topiramate) co-pay savings card
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TERMS AND CONDITIONS

*This offer is good for commercially insured and cash-paying patients purchasing Trokendi XR® (topiramate) extended-release capsules and may not be used for any other product. Maximum benefits apply. This offer is not valid for prescriptions purchased under Medicaid, Medicare, or other federal or state programs (such as medical assistance programs). Offer not valid where prohibited by law, taxed, or restricted. It is not transferable and may not be combined with any other offer. The amount of the rebate cannot exceed the patient’s actual out-of-pocket expenses. Offer must be presented along with a valid prescription for Trokendi XR® at the time of purchase. By enrolling into this program you are consenting to the collection and use of certain personal information including your phone number and/or email address and elements of pharmacy claim information. This information will be collected and used by service providers of Supernus Pharmaceuticals, Inc. (“Supernus”), in order to administer this program. This information is not provided to Supernus directly. If you do not consent, please do not enroll into the program. If you require additional assistance, please call 1-866-398-0833. Supernus reserves the right to rescind, revoke, or amend this offer without notice at any time.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TROKENDI XR is contraindicated in patients with:

  • Recent alcohol use (within 6 hours prior to and 6 hours after TROKENDI XR use).
  • A history of hypersensitivity reaction to topiramate. TROKENDI XR, or any of the inactive ingredients of TROKENDI XR. Anaphylaxis and angioedema have occurred.

WARNINGS & PRECAUTIONS

• Acute Myopia and Secondary Angle Closure Glaucoma Syndrome: Has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. The primary treatment to reverse symptoms is discontinuation of TROKENDI XR as rapidly as possible. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

• Visual field defects (independent of elevated intraocular pressure): Have been reported in patients receiving topiramate. In clinical trials, most events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment with TROKENDI XR, consideration should be given to discontinuing the drug.

• Oligohydrosis and Hyperthermia: Resulting in hospitalization in some cases, have been reported with topiramate use. Some cases were reported after exposure to elevated environmental temperatures. The majority of reports have been in pediatric patients. Patients, especially pediatric patients, should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when TROKENDI XR is given with other drugs that predispose patients to heat-related disorders (e.g., other carbonic anhydrase inhibitors and drugs with anticholinergic activity).

• Metabolic Acidosis: Hyperchloremic, non-anion gap, metabolic acidosis has been reported in adults and pediatric patients treated with topiramate. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase and can occur at any time during treatment. Conditions or therapies 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 TROKENDI XR (using dose tapering). If the decision is made to continue patients on TROKENDI XR in the face of persistent acidosis, alkali treatment should be considered.

• Interaction with Alcohol: In vitro data show that, in the presence of alcohol, the pattern of topiramate release from TROKENDI XR capsules is significantly altered. As a result, plasma levels of topiramate with TROKENDI XR may be markedly higher soon after dosing and subtherapeutic later in the day. Alcohol use should be completely avoided within 6 hours prior to and 6 hours after TROKENDI XR administration.

• 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 any AED, including TROKENDI XR for any indication, should be monitored for the emergence or worsening of depression, suicidal thoughts, or behavior, and/or any unusual changes in mood or behavior. Anyone considering prescribing TROKENDI XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Many illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

• Cognitive/Neuropsychiatric Adverse Reactions: Immediate-release topiramate can cause, and therefore expected to be caused by TROKENDI XR, cognitive/neuropsychiatric adverse reactions. The most frequent of these can be classified into three general categories: Cognitive-related dysfunction; psychiatric/behavioral disturbances; and somnolence or fatigue.

• Fetal Toxicity: TROKENDI XR can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero can have an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate, and of being small for gestational age. Consider the benefits and risks of TROKENDI XR when administering the drug in women of childbearing potential, particularly for a condition not usually associated with permanent injury or death. TROKENDI XR should only be used during pregnancy if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

• Withdrawal of Antiepileptic Drugs: In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TROKENDI XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of TROKENDI XR is medically required, appropriate monitoring is recommended.

• Decrease in Bone Mineral Density: Results of a one-year active-controlled study in pediatric patients (N=63) demonstrated negative effects of immediate-release topiramate monotherapy on bone mineral acquisition via statistically significant decreases in bone mineral density (BMD) measured in lumbar spine and in total body less head. Twenty-one percent of immediate-release topiramate-treated patients experienced clinically important reductions in BMD (Z score change from baseline of -0.5 or greater) compared to 0 patients in the control group. Decreased BMD in the lumbar spine was correlated with decreased serum bicarbonate, which commonly occurs with topiramate treatment and reflects metabolic acidosis, a known cause of increased bone resorption.

• Negative Effects on Growth (Height and Weight): Immediate-release topiramate monotherapy demonstrated negative effects on growth (height and weight) among pediatric patients in a one-year active controlled study (N=63). Negative effects on growth were seen across all immediate-release topiramate age subgroups. Growth of children receiving prolonged TROKENDI XR therapy should be carefully monitored.

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions: DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking topiramate and may be fatal or life-threatening. DRESS typically presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Other organ systems not noted here may be involved. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. TROKENDI XR should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

• Serious Skin Reactions: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients receiving topiramate. TROKENDI XR should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed, and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.

• Anaphylaxis and Angioedema: Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with topiramate in the postmarketing setting. If a hypersensitivity reaction occurs, discontinue TROKENDI XR and initiate appropriate therapy.

• Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use): Can be caused by topiramate treatment and risk appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. Monitoring for Hyperammonemia: Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, topiramate or TROKENDI XR treatment or an interaction of concomitant topiramate-based product and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. In patients who develop unexplained lethargy, vomiting, or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

• Kidney Stones: Topiramate increases the risk of kidney stones. TROKENDI XR would be expected to have the same effect. Topiramate is a carbonic anhydrase inhibitor that can promote stone formation by reducing urinary citrate excretion and increasing urinary pH. The concomitant use of TROKENDI XR with 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. Increased fluid intake increases fluid output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation.

• Hypothermia with Concomitant Valproic Acid Use: Has been reported in association with topiramate use with concomitant valproic acid both in the presence and in the absence of hyperammonemia. It can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Consideration should be given to stopping TROKENDI XR or valproate in patients who develop hypothermia; clinical management and assessment should include examination of blood ammonia levels.

ADVERSE REACTIONS

• The most common (≥5% more frequent than placebo) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain, and upper respiratory tract infection.

INDICATION

TROKEND XR® (topiramate) extended-release capsules is indicated for preventive treatment of migraine in patients 12 years of age and older.

Please see full Prescribing Information.

REFERENCES

1. Silberstein SD, Neto W, Schmitt J, Jacobs D; MIGR-001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004,614(4):490-495.

2. Brandes JL, Saper JR, Diamond M; MIGR-002 Study Group. Topiramate in migraine prevention: results of a large controlled trial. JAMA. 2004;291(8):965-973. 

3. Data on file. Supernus Pharmaceuticals, Inc.

4. Topamax. Package insert. Janssen Pharmaceuticals, Inc; May 2019.

5. Trokendi XR. Package insert. Supernus Pharmaceuticals, Inc; April 2020.

6. Brittain ST, Wheless JW. Pharmacokinetic simulations of topiramate plasma concentrations following dosing irregularities with extended-release vs. immediate-release formulations. Epilepsy Behav. 2015;52(Pt A):31-36.