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 indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria . the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy . ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria . the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy . Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome . Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome .
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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
1CONTRAINDICATIONS
ULTOMIRIS is contraindicated for initiation in patients with unresolved serious
2ADVERSE 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
2.1Clinical 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.
2.2Postmarketing 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.
3DESCRIPTION
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.
4PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide).
5PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton
NDC 25682-022-01
ULTOMIRIS
300 mg/30 mL
For Intravenous Infusion
Rx only
ATTENTION: Dispense the enclosed
6PRINCIPAL DISPLAY PANEL - 3 mL Vial Carton
Rx only
NDC 25682-025-01
ULTOMIRIS
300 mg/3 mL
For Intravenous Infusion
ATTENTION: Dispense the
7PRINCIPAL DISPLAY PANEL - 11 mL Vial Carton
Rx only
NDC 25682-028-01
ULTOMIRIS
1,100 mg/11mL
For Intravenous Infusion
ATTENTION: Dispense the
