n reduces, but does not eliminate, the risk of meningococcalinfections. Monitor patients for early signs of meningococcal infections and
eva luate immediately if infection is suspected.
ULTOMIRIS is available only through a restricted program under a Riskeva luation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS,prescribers must enroll in the program [see Warnings and Precautions (5.1)].
Enrollment in the ULTOMIRIS REMS program and additional information areavailable by telephone: 1-844-259-6783 or at www.ultomirisrems.com.
1 INDICATIONS AND USAGE
ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnalhemoglobinuria (PNH).
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Vaccination and Prophylaxis
Vaccinate patients for meningococcal disease according to current ACIP guidelines toreduce the risk of serious infection [see Warnings and Precautions (5.1, 5.2)].
Provide 2 weeks of antibacterial drug prophylaxis to patients if ULTOMIRIS must beinitiated immediately and vaccines are administered less than 2 weeks before starting
ULTOMIRIS therapy.
Healthcare professionals who prescribe ULTOMIRIS must enroll in the ULTOMIRISREMS [see Warnings and Precautions (5.1)].
2.2 Recommended Weight-Based Dosage Regimen
The recommended dosing regimen for adult patients (≥ 18 years of age) with PNHconsists of a loading dose followed by maintenance dosing, administered by intravenous
infusion. Administer the doses based on the patient’s body weight, as shown in Table 1.
Starting 2 weeks after the loading dose administration, begin maintenance doses at aonce every 8-week interval. The dosing schedule is allowed to occasionally vary within7 days of the scheduled infusion day (except for the first maintenance dose ofULTOMIRIS) but the subsequent dose should be administered according to the original
schedule.
For patients switching from eculizumab to ULTOMIRIS, administer the loading dose ofULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer
maintenance doses once every 8 weeks, starting 2 weeks after loading doseadministration, as shown in Table 1.
Table 1: ULTOMIRIS Weight-Based Dosing Regimen
Body Weight Range (kg) Loading Dose (mg) Maintenance Dose (mg)
greater than or equal to 40 to
less than 60
2,400 3,000
greater than or equal to 60 to
less than 100
2,700 3,300
greater than or equal to 100 3,000 3,600
2.3 Preparation and Administration
Preparation of ULTOMIRIS
Each vial of ULTOMIRIS is intended for single-dose only.
ULTOMIRIS requires dilution to a final concentration of 5 mg/mL.
Use aseptic technique to prepare ULTOMIRIS as follows:
1.The number of vials to be diluted is determined based on the individual patient’sweight and the prescribed dose [see Dosage and Administration (2.2)].
2.Prior to dilution, visually inspect the solution in the vials; the solution should be freeof any particulate matter or precipitation. Do not use if there is evidence of particulatematter or precipitation.
3.Withdraw the calculated volume of ULTOMIRIS from the appropriate number ofvials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a
final concentration of 5 mg/mL. Refer to the administration reference tables below.
The product should be mixed gently. Do not shake. Protect from light. Do not freeze.
4.Administer the prepared solution immediately foll |
