HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RUZURGI safely and effectively. See full prescribinginformation for RUZURGI.
RUZURGI(amifampridine)tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND US AGE
RUZURGI is a potassiumchannel blocker indicated for thetreatment of Lambert-Eaton myasthenic syndrome (LEMS) inpatients 6 to less than 17 years of age. (1)
DOSAGE AND ADMINIS TRATION
•Patients 6 to less than 17 years of age weighing 45 kg or more:
oInitial dosage is 15 mg to 30 mg daily, in divided doses
oIncrease daily in 5 mg to 10 mg increments, divided inup to 5 doses dailyoMaximum single dose is 30 mg; maximum daily dosageis 100 mg (2.1)
•Patients 6 to less than 17 years of age weighing less than 45 kg:
oInitial dosage is 7.5 mg to 15 mg daily, in divided doses
oIncrease daily in 2.5 mg to 5 mg increments, divided inup to 5 doses daily
oMaximum single dose is 15 mg; maximum daily dosageis 50 mg (2.1)
•When patients require a dosage in less than 5 mg increments,have difficulty swallowing, or require feeding tubes, a 1 mg/mLsuspension can be prepared. (2.2)
•For patients with renal or hepatic impairment or who areknown N-acetyltransferase 2 poor metabolizers, use thelowest recommended initial dosage. (2.3, 2.4, 2.5)
DOSAGE FORMS AND S TRENGTHS
Tablets: 10 mg, functionally scored (3)
CONTRAINDICATIONS
•History of seizures (4)
•Hypersensitivity to amifampridine or other aminopyridine (4)
WARNINGS AND PRECAUTIONS
•RUZURGI can cause seizures. Consider discontinuation ordose-reduction of RUZURGI in patients who have a seizurewhile on treatment. (5.1)
•Hypersensitivity reactions: If a hypersensitivity reaction suchas anaphylaxis occurs, RUZURGI should be discontinued andappropriate therapy initiated. (5.2)
ADVERS E REACTIONS
The most common adverse reactions (incidence at least 10% and atleast 2% greater than placebo) are paresthesia/dysesthesia,abdominal pain, dyspepsia, dizziness, and nausea. (6.1)
To report SUSPECTED ADVERS E REACTIONS, contactJacobus at 609-921-7447 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
•Drugs that lower seizure threshold: The concomitant use of RUZURGI and drugs that lower seizure threshold may leadto an increased risk of seizures. (7.1)
•Drugs with cholinergic effects: The concomitant use of RUZURGI and drugs with cholinergic effects (e.g., direct orindirect cholinesterase inhibitors) may increase the
cholinergic effects of RUZURGI and of those drugs, andincrease the risk of adverse reactions. (7.2)
See 17 for PATIENT COUNSELING INFORMATION andMedication Guide.
Revised: 5/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
2.3 Patients with Renal Impairment
2.4 Patients with Hepatic Impairment
2.5 Known N-acetyltransferase 2 (NAT2) Poor Metabolizers
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Seizures
5.2 Hypersensitivity
6 ADVERS E REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Drugs that Lower Seizure Threshold
7.2 Drugs with Cholinergic Effects
8 USE IN SPEC |
