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warnings and cautions
5 WARNINGS AND PRECAUTIONS RUZURGI can cause seizures. Consider discontinuation or dose-reduction of RUZURGI in patients who have a seizure while on treatment. ( 5.1 ) Hypersensitivity reactions: If a hypersensitivity reaction such as anaphylaxis occurs, RUZURGI should be discontinued and appropriate therapy initiated. ( 5.2 ) 5.1 Seizures RUZURGI can cause seizures. Seizures have been observed in patients with and without a history of seizures taking RUZURGI at the recommended doses, and at various times after initiation of treatment. Many of the patients were taking medications or had comorbid medical conditions that may have lowered the seizure threshold [see Drug Interactions ( 7.1 )]. Seizures may be dose-dependent. Because seizure events were captured retrospectively from expanded access programs, it is not possible to reliably estimate their frequency with use of RUZURGI. Consider discontinuation or dose-reduction of RUZURGI in patients who have a seizure while on treatment. RUZURGI is contraindicated in patients with a history of seizures. 5.2 Hypersensitivity In clinical trials, hypersensitivity reactions and anaphylaxis associated with RUZURGI administration 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 )] The most common adverse reactions (incidence at least 10% and at least 2% greater than placebo) are paresthesia/dysesthesia, abdominal pain, dyspepsia, dizziness, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jacobus at 609-921-7447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies 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 on QTc interval prolongation, RUZURGI was administered at doses greater than the maximum recommended dose (120 mg administered as 4 equal doses of 30 mg at 4-hour intervals) to 52 healthy adult volunteers [see Clinical Pharmacology ( 12.2 )]. Adverse reactions that occurred in at least 5% of subjects during RUZURGI treatment and with incidence at least 2% greater than during placebo treatment are displayed in Table 2 . Table 2: Adverse Reactions Occurring in at Least 5% of Subjects During RUZURGI Treatment and With at Least 2% Greater Incidence Than Placebo * Includes paresthesia, dysesthesia, and oral dysesthesias. ** Includes abdominal pain and upper abdominal pain. RUZURGI (N=52) % Placebo Adverse Reaction (N=49) % Paresthesia/Dysesthesia* 69 25 2 Abdominal pain** 0 Dyspepsia 17 2 Dizziness 12 0 Nausea 10 2 Back pain 8 2 Hypoesthesia 6 0 Muscle spasms 6 2 Subjects classified as poor metabolizers based on rate of metabolism were more likely to experience adverse reactions during RUZURGI treatment than intermediate or normal metabolizers [see Clinical Pharmacology ( 12.5 )] . Expanded Access Experience In expanded access programs, 162 patients with LEMS (54% female) were treated with RUZURGI. Among patients with available exposure data, the median duration of treatment was 1.7 years (range 1 day to 27.6 years) for a total of 766.4 person years. Patient age at the time RUZURGI was initiated ranged from 21 to 84 years (mean 58.7 years). The median of the maximum total daily dosage was 75 mg/day. In general, the most frequent adverse reactions observed in the expanded access programs were similar to those observed in the QT study. Additionally, the following adverse reactions were reported in ≥5% of patients: falls, diarrhea, pneumonia, dyspnea, arthralgia, asthenia, depression, dysphagia, headache, insomnia, vision blurred, anemia, anxiety, constipation, feeling cold, gastroesophageal reflux disease, and pain. Because these reactions were captured retrospectively from expanded access programs, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Pediatric Patients (6 to Less than 17 Years of Age) Safety of RUZURGI was evaluated in pediatric LEMS and non-LEMS patients 6 to less than 17 years of age who were treated in expanded access programs. There were 15 patients ages 6 to less than 17 years who received RUZURGI, of whom 9 received RUZURGI for at least 1 year. Adverse reactions reported in pediatric patients 6 to less than 17 years of age were similar to those seen in adult patients.