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Brand Name
Ultomiris
Generic Name
Ravulizumab
View Brand Information FDA approval date: December 21, 2018
Classification: Complement Inhibitor
Form: Solution
What is Ultomiris (Ravulizumab)?
ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria .
Approved To Treat
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Brand Information
Ultomiris (ravulizumab)
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by
- Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying therapy with ULTOMIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See
- Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by
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 and SOLIRIS REMS
1DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/3 mL or 1,100 mg/11 mL (100 mg/mL) as a translucent, clear to yellowish color solution in a single-dose vial.
2CONTRAINDICATIONS
ULTOMIRIS is contraindicated for initiation in patients with unresolved serious
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious Meningococcal Infections
- Other Infections
- Infusion-Related Reactions
3.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Adult Population with PNH Treated with ULTOMIRIS
The data described below reflect exposure of 441 adult patients with PNH in Phase 3 studies who received ULTOMIRIS (n = 222) or eculizumab (n = 219) at the recommended dosing regimens with median treatment duration of 6 months for ULTOMIRIS and 6 months for eculizumab. The most frequent adverse reactions (≥ 10%) with ULTOMIRIS were upper respiratory tract infection and headache. Table 7 describes adverse reactions that occurred at a rate of 5% or more among patients treated with ULTOMIRIS in PNH studies.
Serious adverse reactions were reported in 15 (6.8%) patients with PNH receiving ULTOMIRIS. The serious adverse reactions in patients treated with ULTOMIRIS included hyperthermia and pyrexia. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS.
One fatal case of sepsis was identified in a patient treated with ULTOMIRIS.
Clinically relevant adverse reactions in 1% of patients include infusion-related reactions.
Pediatric Population with PNH Treated with ULTOMIRIS
In pediatric patients with PNH (aged 9 to 17 years old) included in the pediatric PNH Phase 3 study, the safety profile appeared similar to that observed in adult patients with PNH and in pediatric and adult patients with aHUS. The most common adverse reactions (> 20%) were upper respiratory tract infection, anemia, abdominal pain, and headache. Table 8 describes the adverse reactions that occurred at a rate of 10% or more among pediatric patients treated with ULTOMIRIS in Study ALXN1210-PNH-304.
Atypical Hemolytic Uremic Syndrome (aHUS)
The data described below reflect exposure of 58 adult and 16 pediatric patients with aHUS in single-arm trials who received ULTOMIRIS at the recommended dose and schedule. The most frequent adverse reactions reported in ≥ 20% of patients treated with ULTOMIRIS were upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension, and pyrexia. Table 9, Table 10 and Table 11 describe adverse reactions that occurred at a rate of 10% or more among patients treated with ULTOMIRIS in aHUS studies. Serious adverse reactions were reported in 42 (57%) patients with aHUS receiving ULTOMIRIS. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia, and abdominal pain. Four patients died during the ALXN1210-aHUS-311 study. The cause of death was sepsis in 2 patients and intracranial hemorrhage in 1 patient. The fourth patient, who was excluded from the trial after a diagnosis of STEC-HUS, died due to pretreatment cerebral arterial thrombosis.
Clinically relevant adverse reactions include viral tonsilitis (in < 10% of patients) and infusion-related reactions (in 3% of patients).
Clinically relevant adverse reactions in < 10% of patients include viral infection.
Clinically relevant adverse reactions in < 10% of patients include viral infection.
Generalized Myasthenia Gravis (gMG)
The safety of ULTOMIRIS has been evaluated in 175 adult patients with gMG, including 169 patients who received at least one dose of ULTOMIRIS, 142 patients who were exposed for at least 6 months, and 95 who were exposed for at least 12 months
Neuromyelitis Optica Spectrum Disorder (NMOSD)
The safety of ULTOMIRIS has been evaluated in 58 adult patients with NMOSD who received at least one dose of ULTOMIRIS
Table 13 describes adverse reactions that occurred at a rate of 5% or more in patients treated with ULTOMIRIS. Serious adverse reactions were reported in 8 (13.8%) patients with NMOSD receiving ULTOMIRIS.
Immunoglobulin A Nephropathy (IgAN)
The safety of ULTOMIRIS has been evaluated in a randomized, double-blind, placebo-controlled Study ALXN1210-IgAN-320 in 483 adult patients with IgAN (eGFR ≥ 30 mL/min/1.73 m
Table 14 describes adverse reactions that occurred at a rate of ≥5% and at a greater frequency than placebo among patients treated with ULTOMIRIS in Study ALXN1210-IgAN-320. The most frequent adverse reaction (≥ 10%) with ULTOMIRIS was upper respiratory tract infection. Serious adverse reactions were reported in 11 (4.6%) patients receiving ULTOMIRIS and in 22 (9.0%) patients receiving placebo.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ULTOMIRIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ULTOMIRIS exposure.
Adverse Reactions from Postmarketing Spontaneous Reports
- Anaphylaxis
- Cases of cholestatic or mixed pattern liver injury with increased serum liver enzymes and bilirubin levels have been reported in adult and pediatric patients with aHUS who were treated with another C5 complement inhibitor. These events occurred within 3 to 27 days after starting treatment. The median time to resolution (or return to baseline) was approximately 3 weeks.
4DESCRIPTION
Ravulizumab-cwvz, a complement inhibitor, is a humanized monoclonal antibody (mAb) produced in Chinese hamster ovary (CHO) cells. Ravulizumab-cwvz consists of 2 identical 448 amino acid heavy chains and 2 identical 214 amino acid light chains and has a molecular weight of approximately 148 kDa. The constant regions of ravulizumab-cwvz include the human kappa light chain constant region, and the protein engineered "IgG2/4" heavy chain constant region.
The heavy chain CH1 domain, hinge region, and the first 5 amino acids of the CH2 domain match the human IgG2 amino acid sequence, residues 6 to 36 in the CH2 region (common to both human IgG2 and IgG4 amino acid sequences), while the remainder of the CH2 domain and the CH3 domain match the human IgG4 amino acid sequence. The heavy and light chain variable regions that form the human C5 binding site consist of human framework regions grafted to murine complementarity-determining regions.
ULTOMIRIS (ravulizumab-cwvz) injection is a sterile, translucent, clear to yellowish color, preservative-free solution for intravenous use. Each single-dose vial contains 300 mg or 1,100 mg ravulizumab-cwvz at a concentration of 100 mg/mL with a pH of 7.4. Each mL also contains L-arginine (4.33 mg), polysorbate 80 (0.5 mg) (vegetable origin), sodium phosphate dibasic (4.42 mg), sodium phosphate monobasic (4.57 mg), sucrose (50 mg), and Water for Injection, USP.
5PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide).
Serious Meningococcal Infections
Advise patients of the risk of serious meningococcal infection. Inform patients of the need to complete or update their meningococcal vaccinations at least 2 weeks prior to receiving the first dose of ULTOMIRIS or receive antibacterial drug prophylaxis if ULTOMIRIS treatment must be initiated immediately and they have not been previously vaccinated. Inform patients of the requirement to be revaccinated according to current ACIP recommendations for meningococcal infection while on ULTOMIRIS therapy
Inform patients that vaccination may not prevent serious meningococcal infection and to seek immediate medical attention if the following signs or symptoms occur
- fever
- fever and a rash
- headache with nausea or vomiting
- fever with high heart rate
- headache and a fever
- headache with a stiff neck or stiff back
- confusion
- muscle aches with flu-like symptoms
- eyes sensitive to light
Inform patients that they will be given a Patient Safety Card for ULTOMIRIS that they should carry with them at all times during and for 8 months following treatment with ULTOMIRIS. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation.
ULTOMIRIS and SOLIRIS REMS
ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS
Inform the patient of the following notable requirements:
- Patients must receive counseling about the risk of serious meningococcal infections.
- Patients must receive written educational materials about this risk.
- Patients must be instructed to carry the Patient Safety Card with them at all times during and for 8 months following treatment with ULTOMIRIS.
- Patients must be instructed to complete or update meningococcal vaccines for serogroups A, C, W, Y and B per ACIP recommendations as directed by the prescriber prior to treatment with ULTOMIRIS.
- Patients must receive antibiotics as directed by the prescriber if they are not up to date with meningococcal vaccines and have to start ULTOMIRIS right away.
Other Infections
Counsel patients of the increased risk of infections, particularly those due to encapsulated bacteria, especially
Discontinuation
Inform patients with PNH or aHUS that they may develop serious hemolysis or TMA, respectively, when ULTOMIRIS is discontinued and that they will be monitored by their healthcare professional for at least 16 weeks for PNH or at least 12 months for aHUS following ULTOMIRIS discontinuation
Inform patients who discontinue ULTOMIRIS to keep the Patient Safety Card with them for 8 months after the last ULTOMIRIS dose, because the increased risk of meningococcal infection persists for several months following discontinuation of ULTOMIRIS.
Infusion-Related Reactions
Advise patients that administration of ULTOMIRIS may result in infusion-related reactions
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ULTOMIRIS during pregnancy. Encourage participation and advise patients about how they may enroll in the registry
6PRINCIPAL DISPLAY PANEL - 3 mL Vial Carton
Rx only
NDC 25682-025-01
ULTOMIRIS
300 mg/3 mL
For Intravenous Infusion
ATTENTION: Dispense the enclosed
7PRINCIPAL DISPLAY PANEL - 11 mL Vial Carton
Rx only
NDC 25682-028-01
ULTOMIRIS
1,100 mg/11mL
For Intravenous Infusion
ATTENTION: Dispense the enclosed
