INDICATIONS AND USAGE
ROWEEPRA is indicated for adjunctive therapy in the treatment of:
- Partial onset seizures in patients one month of age and older with epilepsy
- Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
- Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms
- Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior
- Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on ROWEEPRA
- Withdrawal Seizures: ROWEEPRA must be gradually withdrawn
- Serious Dermatological Reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
- Coordination Difficulties
- Hematological abnormalities; cases of agranulocytosis have been reported in the post-marketing setting
- Increase in blood pressure; patients 1 month to
- Seizure control during pregnancy: ROWEEPRA plasma levels may gradually decrease throughout pregnancy; monitor carefully patients during pregnancy and through the postpartum period
- Psychiatric Symptoms
- Suicidal Behavior and Ideation
- Somnolence and Fatigue
- Serious Dermatological Reactions
- Coordination Difficulties
- Hematologic Abnormalities
- Increase in Blood Pressure
When used for partial onset seizures
In adult patients:
most common adverse reactions: asthenia, somnolence, headache, infection, dizziness
In pediatric patients:
most common adverse reactions: headache, nasopharyngitis, vomiting, somnolence, fatigue, aggression
In pediatric patients 1 month
most common adverse reactions: somnolence, irritability
When used for myoclonic seizures
Most common adverse reactions:
somnolence, neck pain, pharyngitis, depression
When used for primarily generalized tonic-clonic seizures
Most common adverse reactions: nasopharyngitis, fatigue, diarrhea
USE IN SPECIFIC POPULATIONS
ROWEEPRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
To provide information regarding the effects of in utero exposure to ROWEEPRA , physicians are advised to recommend that pregnant patients taking ROWEEPRA 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 the patients themselves. Information on the registry can also be found at the website
ROWEEPRA is excreted in human milk. A decision whether discontinuing the drug or discontinuing nursing should be made.
The safety and effectiveness of ROWEEPRA in the adjunctive treatment of partial onset seizures in pediatric patients age 1 month to 16 years old with epilepsy have been established.
The safety and effectiveness of ROWEEPRA as adjunctive treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established.
The safety and effectiveness of ROWEEPRA as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established.
No overall differences in safety were observed between these subjects and younger subjects.
Clearance of ROWEEPRA is decreased in patients with renal impairment and is correlated with creatinine clearance.