Maintenance
Dose (mg)
greater 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
See Full Prescribing Information for important preparation and administrationinstructions (2.2, 2.3).
DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial (3).
CONTRAINDICATIONS
ULTOMIRIS is contraindicated in patients with unresolved NeisseriaMeningitidis infection (4).
WARNINGS AND PRECAUTIONS
Use caution when administering ULTOMIRIS to patients with any othersystemic infection (5.2).
ADVERSE REACTIONS
The most frequent adverse drug reactions (>10%) were upper respiratoryinfection and headache (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact AlexionPharmaceuticals, Inc. at) 1-844-259-6783- or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 12/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Vaccination and Prophylaxis
2.2 Recommended Weight-Based Dosage Regimen
2.3 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Meningococcal Infections
5.2 Other Infections
5.3 Monitoring Disease Manifestations after ULTOMIRIS
Discontinuation
5.4 Thromboembolic Event Management
5.5 Infusion Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Study in Complement-Inhibitor Naïve Patients with PNH
14.2 Study in Eculizumab-Experienced Patients with PNH
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed
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FULL PRESCRIBING INFORMATION
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening meningococcal infections/sepsis have occurred in patients treatedwith 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 withcomplement deficiencies.
•Immunize patients with meningococcal vaccines at least 2 weeks prior toadministering the first dose of ULTOMIRIS, unless the risks of delayingULTOMIRIS therapy outweigh the risk of developing a meningococcal infection[see Warnings and Precautions (5.1) for additional guidance on the managementof the risk of meningococcal infection].
•Vaccinatio |
