Elepsia XR (levetiracetam)

Call your healthcare provider right away if you have any of these symptoms:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)
• allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
• a skin rash. Serious skin rashes can happen after you start taking Elepsia XR. There is no way to tell if a mild rash will become a serious reaction.

Common side effects seen in people who take Elepsia XR:

• flu
• sleepiness
• irritability
• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• dizziness
• nausea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Elepsia XR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosing

• Elepsia XR is administered orally once daily.
• Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks, to a maximum recommended daily dose of 3000 mg/day.
• Elepsia XR should be taken whole; do not split or cut tablets.

Dosage Adjustment In Adult Patients With Renal Impairment

• Elepsia XR is not recommended for use in patients with moderate or severe renal impairment. Recommended doses and adjustment for patients with mild renal impairment are shown in Table 1.
• In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated.

To do this, an estimate of the patient’s creatinine clearance (CL_cr) in mL/min must first be calculated using the following formula:              

CL_cr  =    [140-age (years)] x weight (kg)
              ____________________________    (x 0.85 for female patients)
               72 x serum creatinine (mg/dL)

Then CL_cr is adjusted for body surface area (BSA) as follows:

CL_cr (mL/min/1.73m² )   =   CL_cr (mL/min)
                                             _______________   x 1.73                                       
                                              BSA subject (m²)

Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function

Discontinuation Of Elepsia XR

When discontinuing Elepsia XR, reduce the dosage gradually and avoid abrupt discontinuation because of the risk of increased seizure frequency and status epilepticus.

• Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Elepsia XR, during pregnancy.
• Women who are taking Elepsia XR during pregnancy should enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.