ULTOMIRIS- ravulizumab solution, concentrate
Alexion Pharmaceuticals Inc.
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening meningococcal infections/sepsis have occurred in patients treated with ULTOMIRIS. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)].
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
- Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a meningococcal infection. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of meningococcal infection.
- Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS REMS [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
1.1 Paroxysmal Nocturnal Hemoglobinuria
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).
1.2 Atypical Hemolytic Uremic Syndrome
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Limitations of Use:
ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
1.3 Generalized Myasthenia Gravis
ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage Information
ULTOMIRIS may be administered as an intravenous infusion (ULTOMIRIS vial for intravenous administration) in adult or pediatric patients one month of age and older or as a subcutaneous injection for maintenance (ULTOMIRIS on-body delivery system for subcutaneous administration) in adult patients.
Vials are intended for intravenous use only, and on-body delivery systems (prefilled cartridge and on-body injector) are intended for subcutaneous maintenance use only.
2.2 Recommended Vaccination and Prophylaxis
Vaccinate patients for meningococcal disease according to current ACIP guidelines to reduce the risk of serious infection [see Warnings and Precautions (5.1, 5.3)].
Provide 2 weeks of antibacterial drug prophylaxis to patients if ULTOMIRIS must be initiated immediately and vaccines are administered less than 2 weeks before starting ULTOMIRIS therapy.
Healthcare professionals who prescribe ULTOMIRIS must enroll in the ULTOMIRIS REMS [see Warnings and Precautions (5.1)].
2.3 Intravenous Administration in Adult and Pediatric Patients with PNH, aHUS, or gMG
The recommended intravenous ULTOMIRIS loading and maintenance dosing in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH or aHUS, or in adult patients with gMG weighing 40 kg or greater, is based on the patient’s body weight, as shown in Table 1, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose.
The intravenous (IV) dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but subsequent doses should be administered according to the original schedule.
Following a missed intravenous ULTOMIRIS dose, the patient should contact their health care provider immediately.
| Indications||Body Weight Range (kg)||Loading Dose (mg)†||Maintenance Dose (mg) and Dosing Interval|
|PNH and aHUS||5 to less than 10||600||300||Every 4 weeks|
|10 to less than 20||600||600|
|20 to less than 30||900||2,100||Every 8 weeks|
|30 to less than 40||1,200||2,700|
|PNH, aHUS, and gMG||40 to less than 60||2,400||3,000||Every 8 weeks|
|60 to less than 100||2,700||3,300|
|100 or greater||3,000||3,600|
Refer to Table 2 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve, or switching treatment from subcutaneous (SUBQ) administration of ULTOMIRIS or eculizumab.
| Population||Weight-based ULTOMIRIS IV Loading Dose||Time of First ULTOMIRIS IV Weight-based Maintenance Dose|
|Not currently on ULTOMIRIS or eculizumab treatment||At treatment start||2 weeks after ULTOMIRIS IV loading dose|
|Currently treated with eculizumab||At time of next scheduled eculizumab dose||2 weeks after ULTOMIRIS IV loading dose|
| Currently treated with ULTOMIRIS on-body delivery system for subcutaneous administration (SUBQ)*||Not applicable||1 week after last ULTOMIRIS SUBQ maintenance dose|
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