First Extended Release Oxcarbazepine Is Approved By The FDA
December 19, 2012
A New Epilepsy Drug is Now Approved: Oxtellar XR™ is the first and only FDA-approved once-daily oxcarbazepine product and will be available in the first quarter 2013.
To introduce physicians to Oxtellar XR™, our approved epilepsy product, Supernus Pharmaceuticals will host local educational dinner meetings conducted by recognized experts.
Visit SEEN™ (Supernus Epilepsy Education Network) to register for an invitation and to learn about the benefit Oxtellar XR™ may offer your patients. Programs begin in March 2013.
About Supernus Pharmaceuticals
Supernus Pharmaceuticals is at the forefront in developing new medications to treat central nervous system (CNS) disorders. Our innovative XR technologies were used to develop Carbatrol® (carbamazepine) extended-release capsules and Adderall XR® (mixed salts of a single-entity amphetamine product), and Supernus continues to create novel customized-release profiles for additional compounds. Our goal is to help patients experience more satisfaction with their therapy and gain greater disease control with fewer side effects.
IMPORTANT SAFETY INFORMATION
Oxtellar XR™ (oxcarbazepine) extended-release tablet for oral use
Oxtellar XR (oxcarbazepine) extended-release tablet is indicated as adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age.
Oxtellar XR (oxcarbazepine) is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components.
- 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 (oxcarbazepine), 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 (oxcarbazepine), the drug should be discontinued and an alternative treatment started. Do not rechallenge these patients with Oxtellar XR.
- Patients who have had hypersensitivity reactions to carbamazepine should be informed that approximately 25% - 30% of them will experience hypersensitivity reactions with Oxtellar XR (oxcarbazepine).
- Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred in both children and adults in association with oxcarbazepine use.
- Antiepileptic drugs, including Oxtellar XR (oxcarbazepine), increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
- As with all AEDS, withdrawal of Oxtellar XR (oxcarbazepine) should be done gradually to minimize the potential of increased seizure frequency.
- Multi-organ hypersensitivity reactions have occurred in patients being treated with oxcarbazepine therapy. While there have been a limited number of reports, many of these cases resulted in hospitalization and some were life-threatening.
- Rare reports of hematologic reaction 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 reactions develop.
- Due to physiological changes during pregnancy, plasma concentrations of the active metabolite of oxcarbazepine, the 10-monohydroxy derivative may gradually decrease throughout pregnancy. It is recommended that patients be monitored carefully during pregnancy and through delivery and the postpartum period because the active metabolite concentrations or levels may increase. It is recommended that patients taking Oxtellar XR (oxcarbazepine) be enrolled in the NAAED Pregnancy Registry.
- The most commonly observed (= 5%) adverse reactions seen in association with Oxtellar XR and more frequent than in placebo-treated patients were: dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, and asthenia.
Please see the full prescribing information for complete information on Oxtellar XR™ (oxcarbazepine) extended-release tablets by clicking the link at the top of the page.
Adderall XR and Carbatrol are registered trademarks of and are marketed by Shire LLC.
SEEN is a trademark of Supernus Pharmaceuticals, Inc.
Oxtellar XR is a trademark of Supernus Pharmaceuticals, Inc.