45 kg or morewith any degree of hepatic impairment is 15 mg daily taken orally in divided doses. Therecommended starting dosage for pediatric patients weighing less than 45 kg with any degree ofhepatic impairment is 7.5 mg daily taken orally in divided doses [see Dosage and Administration(2.1) and Use in Specific Populations (8.7)].
2.5 Known N-acetyltransferase 2 (NAT2) Poor Metabolizers
The recommended starting dosage of RUZURGI in pediatric patients weighing 45 kg or morewho are known N-acetyltransferase 2 (NAT2) poor metabolizers is 15 mg daily taken orally individed doses. The recommended starting dosage in pediatric patients weighing less than 45 kgwho are known NAT2 poor metabolizers is 7.5 mg daily taken orally in divided doses [seeDosage and Administration (2.1), Use in Specific Populations (8.8), and Clinical Pharmacology(12.5)].
3 DOSAGE FORMS AND STRENGTHS
RUZURGI 10 mg functionally scored tablets are oval, white to off-white, and debossed“10 │ 110” on one side and “JACOBUS” on the other side.
4 CONTRAINDICATIONS
RUZURGI is contraindicated in patients with:
A history of seizures [see Warnings and Precautions (5.1)]
Hypersensitivity to amifampridine or another aminopyridine [see Warnings andPrecautions (5.2)]
5 WARNINGS AND PRECAUTIONS
5.1 Seizures
RUZURGI can cause seizures. Seizures have been observed in patients with and without a historyof seizures taking RUZURGI at the recommended doses, and at various times after initiation oftreatment. Many of the patients were taking medications or had comorbid medical conditions thatmay have lowered the seizure threshold [see Drug Interactions (7.1)]. Seizures may be dosedependent.
Because seizure events were captured retrospectively from expanded access programs,it is not possible to reliably estimate their frequency with use of RUZURGI. Considerdiscontinuation or dose-reduction of RUZURGI in patients who have a seizure while ontreatment. RUZURGI is contraindicated in patients with a history of seizures.
5.2 Hypersensitivity
In clinical trials, hypersensitivity reactions and anaphylaxis associated with RUZURGIadministration have not been reported. Anaphylaxis has been reported in patients taking another
aminopyridine; therefore, it may occur with RUZURGI. If anaphylaxis occurs, administration of RUZURGI should be discontinued and appropriate therapy initiated.
6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
Seizures [see Warnings and Precautions (5.1)]
Hypersensitivity [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical studies of a drug cannot be directly compared to rates in the clinicalstudies of another drug and may not reflect the rates observed in practice.
In a double-blind, 3-way crossover, pharmacology study to assess the effects of RUZURGI onQTc interval prolongation, RUZURGI was administered at doses greater than the maximumrecommended dose (120 mg administered as 4 equal doses of 30 mg at 4-hour intervals) to 52healthy adult volunteers [see Clinical Pharmacology (12.2)]. Adverse reactions that occurred inat least 5% of subjects during RUZURGI treatment and with incidence at least 2% greater thanduring placebo treatment are displayed in Table 2.
Table 2: Adverse Reactions Occurring in at Least 5% of Subjec |
