3TUG=Triple Timed Up and Go; A=afternoon; E=evening; M=morning.
The W-SAS score showed a significantly greater decrease in patients randomized to placebo (2.4) than in those who continued treatment with RUZURGI ( -0.2; p < 0.0001), indicating that patients who were randomized to placebo perceived a worsening of weakness compared to thosewho remained on RUZURGI.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
RUZURGI (amifampridine) 10 mg functionally scored tablets are oval, white to off-white, and
debossed “10 │ 110” on one side and “JACOBUS” on the other side. RUZURGI is supplied as
follows:
• Bottles of 100 tablets: NDC 49938-110-01
16.2 Storage and Handling
Prior to Dispensing:
Store tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). Keep container tightly closedwith desiccant canister inside after opening. Protect from moisture and light.
After Dispensing:
Store tablets at 20°C to 25°C (68°F to 77°F) for up to 3 months; excursions permitted between
15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the Food and Drug Administration-approved patientlabeling (Medication Guide and Instructions for Use).
Risk of Seizures
Inform patients and/or caregivers that RUZURGI can cause seizures, and to notify their healthcareprovider if they experience a seizure [see Warnings and Precautions (5.1)].
RUZURGI Dosing
Instruct patients to take RUZURGI exactly as prescribed. Patients should carefully follow thedose escalation schedule provided by their healthcare provider to safety achieve the therapeuticdosage [see Dosage and Administration (2.1)]. Inform patients that the tablets may be divided inhalf at the score, if needed. Refer patients and/or caregivers to the Instructions for Use if theyrequire a dosage in less than 5 mg increments, have difficulty swallowing tablets, or requirefeeding tubes [see Dosage and Administration (2.2)]. Instruct patients not to take a double doseafter they miss a dose of RUZURGI, as this may increase their risk of seizure.
Hypersensitivity
Instruct patients and/or caregivers to inform their healthcare provider if they have signs orsymptoms of hypersensitivity, and to seek emergency help if signs and symptoms of anaphylaxisoccur [see Warnings and Precautions (5.2)].
Drug Interactions
Instruct patients to notify their healthcare provider prior to starting any new medication, includingover-the-counter drugs [see Drug Interactions (7)].
Storage
Advise patients and/or caregivers to store the tablets in the pharmacy dispensed container atcontrolled room temperature, for a period not to exceed 3 months [see How Supplied/Storage andandling (16.2)].
Instruct patients and/or caregivers who prepare the 1 mg/mL suspension of RUZURGI that itshould be prepared daily and refrigerated between doses. The suspension can be stored underrefrigeration for up to 24 hours. Instruct the patient to discard any unused portion of thesuspension after 24 hours.
Distributed by Jacobus Pharmaceutical Company, Inc.
Princeton, NJ 08540
Manufactured by Jacobus Pharmaceutical Company, Inc. Plainsboro, NJRUZURGI® is a registered trademark of Jacobus Pharmaceutical Company, Inc.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf |
