S•H•A•R•E^® - Support, Help and Resources for Epilepsy

U.S. Marketed Products

Lundbeck ensures that patients have access to medically necessary prescription products that satisfy unmet medical needs in severely ill patient populations.

Lundbeck products available in the U.S. to treat epilepsy, include:

• Sabril (vigabatrin)
  • Learn more about Sabril: Sabril Resources
• Nembutal^® CII Sodium Solution (pentobarbital sodium injection, USP)
• Peganone^® (ethotoin tablets, USP)
• Tranxene^® T-TAB^® Tablets CIV (clorazepate dipotassium, USP)

For additional information and resources for epilepsy, please click here.

SABRIL^® Tablets
SABRIL^® for Oral Solution

Indication
SABRIL is indicated as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for complex partial seizures.

SABRIL is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.

Important Safety Information

SABRIL causes permanent vision loss in infants, children, and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized.

In adults, SABRIL causes permanent bilateral concentric visual field constriction in 30% or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10° of visual fixation, and can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. The onset of vision loss from SABRIL is unpredictable and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years. The lowest dose and shortest exposure to SABRIL should be used that is consistent with clinical objectives.

Because of the risk of permanent vision loss, SABRIL should be withdrawn from patients with IS who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious, or adult patients treated for refractory CPS as adjunctive therapy who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL should be periodically reassessed.

Unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the SHARE program, vision assessment is required at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months while on therapy and about 3-6 months after the discontinuation of SABRIL therapy. Once detected, vision loss is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Drug discontinuation should be considered, balancing benefit and risk, if visual loss is documented.

Symptoms of vision loss from SABRIL are unlikely to be recognized by the patient, parent or caregiver before vision loss is severe. Vision loss of milder severity, although unrecognized by the patient, parent or caregiver may still adversely affect function. The possibility that vision loss from SABRIL may be more common, more severe, or have more severe functional consequences in infants and children than in adults, cannot be excluded.

SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss or with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from SABRIL has not been well characterized, but is likely adverse.

In adult patients treated for CPS, dose adjustment is necessary in patients with renal impairment.

Abnormal MRI signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment and in a few patients the lesion resolved despite continued use.

Antiepileptic drugs (AEDs), including SABRIL, increase the risk of suicidal thoughts or behavior. Adult 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, SABRIL should be discontinued gradually to avoid withdrawal seizures.

Vigabatrin is excreted in human milk and may cause serious adverse events in nursing infants. SABRIL should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Pregnancy Registry: To provide information regarding the effects of in utero exposure to SABRIL, physicians are advised to recommend that pregnant patients taking SABRIL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/

SABRIL has been shown to cause neurotoxicity, anemia, somnolence and fatigue, peripheral neuropathy, weight gain and edema. The most commonly observed adverse reactions reported in 2 add-on clinical studies of adults with refractory CPS treated with SABRIL as adjunctive therapy with the recommended dose of 3 g/day (≥10% and at least 5% greater than placebo, respectively) were dizziness (24% vs 17%), fatigue (23% vs 16%), somnolence (22% vs 13%), tremor (15% vs 8%), blurred vision (13% vs 5%), and arthralgia (10% vs 3%). A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events.

The most common adverse events reported by >5% of infants taking SABRIL for IS occurring more frequently than placebo, respectively, in a randomized, placebo-controlled IS study with a 5-day double-blind treatment phase (n=40) were somnolence (45% vs 30%), bronchitis (30% vs 15%), ear infection (10% vs 5%), and acute otitis media (10% vs 0%).

Oral Solution: For more information, please see the full Prescribing Information including Boxed Warning, Medication Guide and Dosing Instructions.

Solución oral: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada, guía de la medicación y las instrucciones de la dosificación.

Tablets: For more information, please see the full Prescribing Information including Boxed Warning and Medication Guide.

Tabletas: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada y guía de la medicación.

NEMBUTAL^® CII (pentobarbital sodium injection, USP)

Indication: NEMBUTAL is indicated for use as a sedative, a hypnotic for short-term treatment of insomnia, preanaesthetic and as an anticonvulsant in the emergency control of certain acute convulsive episodes, such as those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus and toxic reactions to strychinne or local anesthetics.

Important Safety Information About Nembutal: NEMBUTAL is contraindicated in patients with a known hypersensitivity to any barbiturate, manifest or latent porphyria. Barbiturates including NEMBUTAL may be habit forming. Abrupt discontinuation may result in withdrawal symptoms, including delirium, convulsions and possibly death. Too rapid of an intravenous administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure.

Concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects. Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, chronic or acute pain. Barbiturates can cause fetal damage and infants may have withdrawal symptoms if mothers receive barbiturates. Withdrawal symptoms occur in infants born to mothers who receive barbiturates during the last trimester of pregnancy. Prolonged treatment with barbiturates should be monitored.

The most commonly reported adverse event (>1 in 100 patients) is somnolence.

Please see full prescribing information for NEMBUTAL. Click here.

PEGANONE^® (ethotoin tablets, USP)

Indication: PEGANONE is indicated for the control of tonic-clonic (grand-mal) and complex (psychomotor) seizures.

Important Safety Information About Peganone: PEGANONE is contraindicated in patients with hepatic abnormalities or hematologic disorders.

Antiepileptic drugs (AEDs), including PEGANONE, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, or suicidal thoughts or behavior.

PEGANONE can cause fetal harm including neonatal coagulation defect. Use during pregnancy can result in an increased incidence of birth defects. Antiepileptic drugs should not be discontinued because of the strong possibility of precipitating status epilepticus with attendant hypoxia and risk to both mother and the unborn child.

Blood dyscrasias have been reported in patients receiving PEGANONE.

Isolated cases of lymphadenopathy and systemic lupus erythromatosus have occurred with PEGANONE.

Please see full prescribing information for PEGANONE. Click here.

TRANXENE^® T-TAB^® Tablets CIV (clorazepate dipotassium, USP)

Indication: TRANXENE is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

TRANXENE tablets are indicated as an adjunctive therapy in the management of partial seizures and for the symptomatic relief of acute alcohol withdrawal.

Important Safety Information About Tranxene: TRANXENE is contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

TRANXENE tablets are not recommended for use in depressive neuroses or in psychotic reactions, and in patients less than 9 years of age.

Patients taking TRANXENE tablets should be cautioned against engaging in hazardous occupations requiring mental alertness and should be advised against the simultaneous use of other CNS depressant drugs.

Withdrawal symptoms have occurred following abrupt discontinuation of TRANXENE. Caution should be observed in patients who are considered to have a potential for drug dependence.

Antiepileptic drugs (AEDs), including TRANXENE, increase the risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, or suicidal thoughts or behavior.

During the first trimester of pregnancy and while lactating, use of TRANXENE should almost always be avoided.

Patients taking TRANXENE for a prolonged period should have blood counts and liver function tests periodically. Elderly or debilitated patients should be started on lower doses and monitored closely.

The most commonly reported adverse event was drowsiness. There have been reports of abnormal liver and kidney function, and decreases in hematocrit and systolic blood pressure.

Please see full prescribing information for TRANXENE. Click here.