IFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 NAT2 Poor Metabolizers
10 Overdosage
11 Description
12 Clinical Pharmacology
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.5 Pharmacogenomics
13 Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
14 Clinical Studies
16 How Supplied/Storage and Handling
16.1 How Supplied
16.2 Storage and Handling
17 Patient Counseling Information
* Sections or subsections omitted from the full prescribinginformation are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) inpatients 6 to less than 17 years of age.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended oral dosage for pediatric patients 6 to less than 17 years of age is dependent onbody weight and is included in Table 1. Dosage should be increased based on clinical responseand tolerability.
If a dose is missed, patients should not take double or extra doses.
Table 1: Recommended Dosage for Pediatric Patients 6 to Less Than 17 Years of Age
Age and Body
Weight
Initial Dosage Titration Regimen Maximum
Single Dose
Maximum
Total Daily
Maintenance
Dosage
Pediatric patients
6 to less than 17
years of age
weighing 45 kg
or more
15 mg to 30 mg
daily, in divided
doses (2 to 3 times
per day)
Increase daily in
5 mg to 10 mg
increments, divided
in up to 5 doses per
day
30 mg 100 mg
Pediatric patients
6 to less than 17
years of age
weighing less
than 45 kg
7.5 mg* to 15 mg
daily, in divided
doses (2 to 3 times
per day)
Increase daily in
2.5 mg* to 5 mg
increments, divided
in up to 5 doses per
day
15 mg 50 mg
*see Dosage and Administration (2.2) for method to achieve these doses
2.2 Administration Instructions
RUZURGI can be taken without regard to food.
Preparation of 1 mg/mL Suspension
When patients require a dosage in less than 5 mg increments, have difficulty swallowing tablets,or require feeding tubes, a 1 mg/mL suspension can be prepared (e.g., by placing three 10 mgtablets in a 30 mL container, adding 30 mL of sterile water, and shaking well for 30 seconds).
Crushing the tablets prior to making the suspension is not necessary. After preparation of thesuspension, an oral syringe can be used to draw up and administer the correct dose by mouth orby feeding tube. Refrigerate the suspension between doses and shake well before drawing upeach dose. The suspension can be stored under refrigeration for up to 24 hours. Discard anyunused portion of the suspension after 24 hours.
2.3 Patients with Renal Impairment
The recommended starting dosage of RUZURGI in pediatric patients weighing 45 kg or morewith renal impairment (creatinine clearance 15 to 90 mL/min) is 15 mg daily taken orally individed doses. The recommended starting dosage for pediatric patients weighing less than 45 kgwith renal impairment is 7.5 mg daily taken orally individed doses [see Dosage andAdministration (2.1) and Use in Specific Populations (8.6)]. No dosage recommendations for RUZURGI can be made for patients with end-stage renal disease.
2.4 Patients with Hepatic Impairment
The recommended starting dosage of RUZURGI in pediatric patients weighing |
