SPRITAM^® Important Safety Information

Indications and Usage

SPRITAM (levetiracetam) is a prescription medicine taken by mouth that is used to treat partial-onset seizures in patients 4 years of age and older. SPRITAM is also used as adjunctive therapy to treat myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. SPRITAM is recommended for use in patients weighing more than 20 kg (44 lbs).

Important Safety Information

SPRITAM may not be for everyone. SPRITAM is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema.

Warnings and Precautions

SPRITAM may cause behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability and aggressive behavior. Patients treated with SPRITAM should be monitored for psychiatric signs and symptoms.

Antiepileptic drugs, including SPRITAM, may cause suicidal thoughts or actions in a very small number of patients, about 1 in 500. Advise patients to contact you right away if they experience new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self-harm they have never had before or which may be worse than before.

SPRITAM may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. Patients should be instructed not to drive, operate machinery or do other dangerous activities until they know how SPRITAM affects them.

SPRITAM can cause anaphylaxis or angioedema after the first dose or at any time during treatment. Advise your patients to discontinue SPRITAM and seek immediate medical attention if they have allergic reactions such as swelling of the face, lips, eyes, tongue and throat, trouble swallowing or breathing, and hives.

Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur after your patients start taking SPRITAM. There is no way to tell if a mild rash will become a serious reaction. SPRITAM should be discontinued at the first sign of rash unless clearly not drug related.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, can occur in patients taking SPRITAM, and can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS may present with symptoms of fever, rash, lymphadenopathy and/or facial swelling associated with signs of other organ system involvement (e.g., hepatitis, nephritis, myocarditis, myositis, or hematological abnormalities [eosinophilia]). Advise your patients to seek immediate medical attention if any of these symptoms develop. SPRITAM should be discontinued immediately if a serious hypersensitivity reaction is suspected.

Advise patients not to stop SPRITAM unless instructed by you. Stopping a seizure medication suddenly can cause more frequent seizures or seizures that will not stop.

SPRITAM can cause hematologic abnormalities. A complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders.

Instruct patients to contact you right away if they become pregnant or intend to become pregnant.

Common Adverse Reactions

In clinical trials, the most common side effects seen in adults who take SPRITAM include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take SPRITAM include tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability.

To report SUSPECTED ADVERSE REACTIONS, contact Aprecia Pharmaceuticals, LLC at 1-844-882-7732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Administration

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, instruct patients to place a tablet on their tongue with a dry hand, and then take a sip of liquid. SPRITAM should be swallowed only after the tablet disintegrates in the mouth. SPRITAM should not be swallowed intact. Partial tablet(s) should not be administered.

Alternately, patients can add whole SPRITAM tablet(s) to a small volume of liquid in a cup, swirl gently and swallow immediately after the tablet(s) disintegrate. If there is any medicine left in the cup, instruct patients to rinse with a small volume of liquid, swirl and swallow the remaining contents.

For additional safety information, please see US Full Prescribing Information and Medication Guide.

Manufactured by Aprecia Pharmaceuticals, LLC, Blue Ash, OH 45242 USA Distributed by Prasco, LLC, Mason, OH 45040 USA

SPRITAM® is a registered trademark of Aprecia Pharmaceuticals, LLC.

© 2024 Prasco LLC all rights reserved.

LB-SI-0002.E

Revised 04/2024