Levetiracetam Injection Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION.

LEVETIRACETAM injection, for intravenous use
Initial U.S. Approval: 1999

INDICATIONS AND USAGE

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. (1.1)
Levetiracetam injection is indicated for adjunctive therapy for the treatment of:
o
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. (1.2)
o
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. (1.3)
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. (1.4)

DOSAGE AND ADMINISTRATION

Levetiracetam injection is for intravenous use only (2.1)

Partial-Onset Seizures (monotherapy or adjunctive therapy)

1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily. (2.1)
6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily. (2.1)
4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily. (2.1)
Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1,500 mg twice daily. (2.1)

Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily. (2.2)

Primary Generalized Tonic-Clonic Seizures

6 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily. (2.3)
Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily. (2.3)

Switching From or To Oral Levetiracetam

When switching from or to oral levetiracetam, the total daily dosage/frequency of Levetiracetam injection should be equivalent to those of oral Levetiracetam. (2.4, 2.5)

See full prescribing information for preparation and administration instructions (2.6) and dosage adjustment in adults with renal impairment. (2.7)

DOSAGE FORMS AND STRENGTHS

Injection: 500 mg/5 mL single-dose vial. (3)

CONTRAINDICATIONS

Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred. (4, 5.3)

WARNINGS AND PRECAUTIONS

Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms. (5.1)
Monitor for somnolence and fatigue; advise patients not to drive or operate machinery until they have sufficient experience on levetiracetam. (5.2)
Serious Dermatological Reactions: Discontinue Levetiracetam injection at the first sign of rash unless clearly not drug related. (5.4)
Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. (5.5)
Withdrawal Seizures: Levetiracetam must be gradually withdrawn. (5.6)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5% more than placebo) include:

Adults: somnolence, asthenia, infection, and dizziness. (6.1)
Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Plasma levels of levetiracetam may be decreased; monitor closely during pregnancy. Based on animal data, may cause fetal harm. (5.9, 8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LEVETIRACETAM INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM INJECTION.

LEVETIRACETAM injection, for intravenous use
Initial U.S. Approval: 1999

INDICATIONS AND USAGE

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. (1.1)
Levetiracetam injection is indicated for adjunctive therapy for the treatment of:
o
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. (1.2)
o
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. (1.3)
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. (1.4)

DOSAGE AND ADMINISTRATION

Levetiracetam injection is for intravenous use only (2.1)

Partial-Onset Seizures (monotherapy or adjunctive therapy)

1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily. (2.1)
6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily. (2.1)
4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily. (2.1)
Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1,500 mg twice daily. (2.1)

Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily. (2.2)

Primary Generalized Tonic-Clonic Seizures

6 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily. (2.3)
Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily. (2.3)

Switching From or To Oral Levetiracetam

When switching from or to oral levetiracetam, the total daily dosage/frequency of Levetiracetam injection should be equivalent to those of oral Levetiracetam. (2.4, 2.5)

See full prescribing information for preparation and administration instructions (2.6) and dosage adjustment in adults with renal impairment. (2.7)

DOSAGE FORMS AND STRENGTHS

Injection: 500 mg/5 mL single-dose vial. (3)

CONTRAINDICATIONS

Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred. (4, 5.3)

WARNINGS AND PRECAUTIONS

Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms. (5.1)
Monitor for somnolence and fatigue; advise patients not to drive or operate machinery until they have sufficient experience on levetiracetam. (5.2)
Serious Dermatological Reactions: Discontinue Levetiracetam injection at the first sign of rash unless clearly not drug related. (5.4)
Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. (5.5)
Withdrawal Seizures: Levetiracetam must be gradually withdrawn. (5.6)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 5% more than placebo) include:

Adults: somnolence, asthenia, infection, and dizziness. (6.1)
Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Plasma levels of levetiracetam may be decreased; monitor closely during pregnancy. Based on animal data, may cause fetal harm. (5.9, 8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2023

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