IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine, or to any of the components of Oxtellar XR, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema.

WARNINGS & PRECAUTIONS

  • Clinically significant hyponatremia (sodium <125 mmol/L) may develop during treatment. Measurement and laboratory tests of serum sodium concentrations should be considered for patients during maintenance treatment with Oxtellar XR, particularly if the patient is receiving other medications known to decrease serum sodium levels. Discontinuation of oxcarbazepine treatment may be clinically required.
  • Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Oxtellar XR, the drug should be discontinued and an alternative treatment started. Do not rechallenge these patients with Oxtellar XR.
  • Approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with Oxtellar XR. Patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Oxtellar XR only if the potential benefit justifies the potential risk. Discontinue Oxtellar XR immediately if signs or symptoms of hypersensitivity develop.
  • Serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with oxcarbazepine use. Should a patient develop a skin reaction while using Oxtellar XR, consideration should be given to discontinuing its use. (Please see WARNINGS section of complete prescribing information.)
  • Anyone considering prescribing Oxtellar XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptic drugs 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 Oxtellar XR treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
  • Withdrawal of Oxtellar XR should be done gradually to minimize the potential of increased seizure frequency and status epilepticus.
  • Multi-organ hypersensitivity reactions have occurred in patients on oxcarbazepine therapy. Some of these cases resulted in hospitalization and some were life-threatening. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement disorders. If an alternative etiology cannot be established, discontinue Oxtellar XR.
  • Rare reports of hematologic events such as pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with oxcarbazepine and discontinuation of therapy should be considered if any evidence of these hematologic events develop.
  • Due to physiological changes during pregnancy, plasma concentrations of the active metabolite of oxcarbazepine may gradually decrease throughout pregnancy. An increase in seizure frequency may occur. Monitor patients carefully during pregnancy and through the postpartum period.
  • Exacerbation of or new onset primary generalized seizures has been reported with immediate-release oxcarbazepine. The risk is seen especially in children, but may also occur in adults. Discontinue Oxtellar XR if it occurs.
  • Data on a limited number of pregnancies from pregnancy registries suggest that oral clefts and ventricular septal defects are associated with oxcarbazepine monotherapy use.

DOSING CONSIDERATIONS

  • Enzyme inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin decrease the exposure to MHD, the active metabolite of Oxtellar XR. Dosage increases or discontinuation of enzyme inducers may be necessary.
  • In adult patients with severe renal impairment, initiate Oxtellar XR at a lower starting dose and increase, if necessary, at a slower than usual rate until the desired clinical response is achieved.
  • Use of Oxtellar XR with certain hormonal contraceptives may decrease hormone plasma levels and render these contraceptives less effective. Additional or alternative non-hormonal forms of contraception are recommended.

ADVERSE REACTIONS

The most commonly observed adverse reactions (≥ 5% and more frequent than placebo) seen in adults were (1200 mg, 2400 mg, v placebo): dizziness (20%, 41%, v 15%), somnolence (12%, 14%, v 9%), headache (8%, 15%, v 7%), balance disorder (5%, 7%, v 5%), tremor (5%, 1%, v 2%), vomiting (6%, 15%, v 9%), diplopia (10%, 13%, v 4%), asthenia (3%, 7%, v 1%), and fatigue (6%, 3%, v 1%). Adverse reactions in pediatric patients are similar to those seen in adults.

INDICATION

Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.

Please refer to the full Prescribing Information and Medication Guide for Oxtellar XR for additional important information.

Oxtellar XR (oxcarbazepine) extended-release tablets for oral use

SAFETY AND
EFFICACY

Oxtellar XR harnesses oxcarbazepine, which offers a decades-long legacy of experience.1,2

POWERFUL EVIDENCE FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES

Oxcarbazepine (OXC) is a well-studied sodium channel blocker that has a powerful body of evidence for the treatment of partial-onset seizures.2-5

The antiseizure effect of Oxtellar XR is primarily exerted through the 10-monohydroxy derivative (MHD) metabolite of oxcarbazepine. The precise mechanism by which oxcarbazepine and MHD exert antiseizure activity is unknown but is thought to involve inhibition of voltage-sensitive sodium channels.

11 POSITIVE CLINICAL TRIALS

Oxtellar XR is the only antiepileptic drug that provides 24-hour controlled delivery of OXC, the sodium channel blocker with powerful evidence for the treatment of partial-onset seizures.1-6

OXC/Oxtellar XR Adjunctive Therapy Trials3-5

3

Placebo-controlled trials (refractory partial-onset seizures)

OXC Monotherapy Trials7-14

4

Comparative/new-onset partial-onset seizures

2

Low-dose vs. high-dose therapy (refractory partial-onset seizures)

1

Placebo-controlled trial (recent partial-onset seizures)

1

Placebo-controlled trial (presurgical)

PROVEN SAFE AND EFFECTIVE

AEs occurring in ≥5% of patients receiving Oxtellar XR with concomitant AEDs and more frequent than with placebo1,3,6,15

For a complete listing of AEs ≥2%, see full Prescribing Information.

Phase 3 study design1,3,6

Efficacy and safety of Oxtellar XR were evaluated in a multinational, multicenter, double-blind, randomized placebo-controlled, 3-arm, parallel-group, Phase 3 trial of 366 adult patients having a diagnosis of epilepsy with uncontrolled partial-onset seizures with or without secondary generalization, taking a stable regimen of 1 to 3 concomitant AED(s), experiencing an average of 6 partial-onset seizures per 28 days.

Phase 3 efficacy1,3

Median percent partial-onset seizure frequency change over the 16-week double-blind treatment period.

ITT population (N=366): 29% for placebo (n=121) vs. 38% (P =0.078) for Oxtellar XR 1200 mg/day (n=122) and 43% (P =0.003) for Oxtellar XR 2400 mg/day (n=123).

North American post hoc analysis (n=116): 13% for placebo (n=41) vs. 35% (P =0.022) for Oxtellar XR 1200 mg/day (n=40) and 53% (P =0.006) for Oxtellar XR 2400 mg/day (n=35).

Discontinuation rate due to AEs in the phase 3 Oxtellar XR study was 30% in the 2400 mg/day group, 15% in the 1200 mg/day group, and 8% in the placebo group.6

OLE study design6,15

Key inclusion criteria for initial double-blind, placebo-controlled study (16 weeks): adults (aged 18 to 66 years) with inadequately controlled partial-onset seizures (baseline frequency: ≥3 seizures/28 days) despite taking 1 to 3 concomitant AED(s) at stable doses. Blinded conversion over 3 weeks to 12-months, open-label, once-daily OXtellar XR 1200 mg/day, with subsequent dose adjustments as clinically indicated (increments/decrements, 300 mg/day to 600 mg/day; maximum dosage, 2400 mg/day).

OLE study limitations15

AED additions/withdrawals may influence partial-onset seizure control. Many patients entering OLEs have already demonstrated tolerability of study medication during double-blind treatment and, therefore, may be less likely to withdraw due to AEs. Patient retention may also be influenced by the intensive follow-up that occurs in a clinical study.

Abbreviations: AEs, adverse events; AEDs, antiepileptic drugs; ITT, intention to treat; OLE, open-label extension.

CHOOSE A THERAPY THAT'S RIGHT FOR YOUR PATIENT

A majority of patients in clinical trials remained on treatment with Oxtellar XR3,6,15

PHASE 3 1200 MG/DAY GROUP

ONLY 15% OF PATIENTS

discontinued treatment due to AEs in the phase 3 trial3,6

Clinical trial patients were on 1 to 3 concommitant AEDs, which included carbamazepine, valproate, lamotrigine, levetiracetam, topiramate, and phenytoin.6

OLE (Oxtellar XR 600-2400 mg/day)

ONLY 5% OF PATIENTS

discontinued treatment due to AEs in the 1-year OLE6,15

Many patients entering OLEs have already demonstrated tolerability of study medication during double-blind treatment and, therefore, may be less likely to withdraw due to AEs.

Please see above for full discontinuation rate data.

A clear option for your patients with partial-onset seizures

IN THE PHASE 3 STUDY

COGNITIVE AEs

were similar to placebo6

were similar to placebo6

IN THE PHASE 3 STUDY

HYPONATREMIA

Incidence of clinically significant hyponatremia was similar to placebo:
0.8% (2400 mg/day), 1.6% (1200 mg/day), and 0% (placebo)1
Monitor sodium as recommended in Warning and Precaution, Section 5.1 of full Prescribing Information.

Incidence of clinically significant hyponatremia was similar to placebo:
0.8% (2400 mg/day), 1.6% (1200 mg/day), and 0% (placebo)1
Monitor sodium as recommended in Warning and Precaution, Section 5.1 of full Prescribing Information.

Abbreviations: AE, adverse events; AEDs, antiepileptic drugs; OLE, open-label extension.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine, or to any of the components of Oxtellar XR, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema.

WARNINGS & PRECAUTIONS

  • Clinically significant hyponatremia (sodium <125 mmol/L) may develop during treatment. Measurement and laboratory tests of serum sodium concentrations should be considered for patients during maintenance treatment with Oxtellar XR, particularly if the patient is receiving other medications known to decrease serum sodium levels. Discontinuation of oxcarbazepine treatment may be clinically required.
  • Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Oxtellar XR, the drug should be discontinued and an alternative treatment started. Do not rechallenge these patients with Oxtellar XR.
  • Approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with Oxtellar XR. Patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Oxtellar XR only if the potential benefit justifies the potential risk. Discontinue Oxtellar XR immediately if signs or symptoms of hypersensitivity develop.
  • Serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with oxcarbazepine use. Should a patient develop a skin reaction while using Oxtellar XR, consideration should be given to discontinuing its use. (Please see WARNINGS section of complete prescribing information.)
  • Anyone considering prescribing Oxtellar XR must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptic drugs 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 Oxtellar XR treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
  • Withdrawal of Oxtellar XR should be done gradually to minimize the potential of increased seizure frequency and status epilepticus.
  • Multi-organ hypersensitivity reactions have occurred in patients on oxcarbazepine therapy. Some of these cases resulted in hospitalization and some were life-threatening. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement disorders. If an alternative etiology cannot be established, discontinue Oxtellar XR.
  • Rare reports of hematologic events such as pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with oxcarbazepine and discontinuation of therapy should be considered if any evidence of these hematologic events develop.
  • Due to physiological changes during pregnancy, plasma concentrations of the active metabolite of oxcarbazepine may gradually decrease throughout pregnancy. An increase in seizure frequency may occur. Monitor patients carefully during pregnancy and through the postpartum period.
  • Exacerbation of or new onset primary generalized seizures has been reported with immediate-release oxcarbazepine. The risk is seen especially in children, but may also occur in adults. Discontinue Oxtellar XR if it occurs.
  • Data on a limited number of pregnancies from pregnancy registries suggest that oral clefts and ventricular septal defects are associated with oxcarbazepine monotherapy use.

DOSING CONSIDERATIONS

  • Enzyme inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin decrease the exposure to MHD, the active metabolite of Oxtellar XR. Dosage increases or discontinuation of enzyme inducers may be necessary.
  • In adult patients with severe renal impairment, initiate Oxtellar XR at a lower starting dose and increase, if necessary, at a slower than usual rate until the desired clinical response is achieved.
  • Use of Oxtellar XR with certain hormonal contraceptives may decrease hormone plasma levels and render these contraceptives less effective. Additional or alternative non-hormonal forms of contraception are recommended.

ADVERSE REACTIONS

The most commonly observed adverse reactions (≥ 5% and more frequent than placebo) seen in adults were (1200 mg, 2400 mg, v placebo): dizziness (20%, 41%, v 15%), somnolence (12%, 14%, v 9%), headache (8%, 15%, v 7%), balance disorder (5%, 7%, v 5%), tremor (5%, 1%, v 2%), vomiting (6%, 15%, v 9%), diplopia (10%, 13%, v 4%), asthenia (3%, 7%, v 1%), and fatigue (6%, 3%, v 1%). Adverse reactions in pediatric patients are similar to those seen in adults.

INDICATION

Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.

Please refer to the full Prescribing Information and Medication Guide for Oxtellar XR for additional important information.

Oxtellar XR (oxcarbazepine) extended-release tablets for oral use

References: 1. Oxtellar XR. Package insert. Supernus Pharmaceuticals Inc. 2. Glauser TA. Oxcarbazepine in the treatment of epilepsy. Pharmacotherapy. 2001;21(8):904-919. 3. French JA, Baroldi P, Brittain ST, Johnson JK; PROSPER Investigators Study Group. Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand. 2014;129(3):143-153. 4. Glauser TA, Nigro M, Sachdeo RC, et al. Adjunctive therapy with oxcarbazepine in children with partial seizures. Neurology. 2000;54(12):2237-2244. 5. Barcs G, Walker EB, Elger CE, et al. Oxcarbazepine placebo-controlled, dose-ranging trial in refractory partial epilepsy. Epilepsia. 2000;41(12):1597-1607. 6. Data on file. Supernus Pharmaceuticals Inc. 7. Christe W, Krämer G, Vigonius U, et al. A double-blind controlled clinical trial: oxcarbazepine versus sodium valproate in adults with newly diagnosed epilepsy. Epilepsy Res. 1997;26(3):451-460. 8. Bill PA, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in adults with previously untreated epilepsy. Epilepsy Res. 1997;27(3):195-204. 9. Guerreiro MM, Vigonius U, Pohlman H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in children and adolescents with epilepsy. Epilepsy Res. 1997;27(3):205-213. 10. Dam M. Oxcarbazepine in monotherapy. Behav Neurol. 1990;3(1):31-34. 11. Beydoun A, Sachdeo RC, Rosenfeld WE, et al. Oxcarbazepine monotherapy for partial-onset seizures: a multicenter, double-blind, clinical trial. Neurology. 2000;54(12):2245- 2251. 12. Sachdeo R, Beydoun A, Schachter S, et al. Oxcarbazepine (Trileptal) as monotherapy in patients with partial seizures. Neurology. 2001;57(5):864-871. 13. Sachdeo R, Edwards K, Hasegawa H, et al. Safety and efficacy of oxcarbazepine 1200 mg/day in patients with recent-onset partial epilepsy. Abstract presented at: 51st Annual AAN Meeting; April 21, 1999. Los Angeles, CA. 14. Schachter SC, Vazquez B, Fisher RS, et al. Oxcarbazepine: double-blind, randomized, placebo- control, monotherapy trial for partial seizures. Neurology. 1999;52(4):732-737. 15. Chung SS, Johnson JK, Brittain ST, Baroldi P. Long-term efficacy and safety of adjunctive extended-release oxcarbazepine (Oxtellar XR®) in adults with partial-onset seizures. Acta Neurol Scand. 2016;133(2):124-130.