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ULTOMIRIS is a brand name for Ravulizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paroxysmal Nocturnal Hemoglobinuria (PNH) ULTOMIRIS® (ravulizumab for injection) is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). Atypical Hemolytic Uremic Syndrome (aHUS) ULTOMIRIS® (ravulizumab for injection) is indicated for…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Ultomiris should be administered by a qualified healthcare professional. Vaccinate patients according to current NACI guidelines to reduce the risk of serious infection (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS, Other Systemic and Serious Infections).
Provide two 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. 2 Recommended Dose and Dosage Adjustment The recommended Ultomiris intravenous (IV) maintenance dosing in adult and pediatric patients with PNH or aHUS with a body weight greater than or equal to 5 kg or adult patients (≥ 18 years of age) with gMG or NMOSD with a body weight greater than or equal to 40 kg, is based on the patient’s body ULTOMIRIS® (ravulizumab) Product Monograph Page 6 of 60 weight, as shown in Table 1, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose.
Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of Ultomiris) but the subsequent dose should be administered according to the original schedule. For patients switching from Soliris to Ultomiris, the loading dose of Ultomiris should be administered at the time of the next scheduled Soliris infusion, and then Ultomiris maintenance doses are administered once every 4 to 8 weeks (depending on body weight), starting 2 weeks after loading dose administration as shown in .
Table 1 :
Ultomiris Weight-Based Dosing Regimen Indications Body weight range (kg) Loading dose (mg) Maintenance dose (mg) Dosing interval PNH or aHUS ≥ 5 to < 10 600 300 Every 4 weeks ≥ 10 to < 20 600 600 Every 4 weeks ≥ 20 to < 30 900 2,100 Every 8 weeks ≥ 30 to < 40 1,200 2,700 Every 8 weeks PNH, aHUS, gMG or NMOSD ≥ 40 to < 60 2,400 3,000 Every 8 weeks ≥ 60 to < 100 2,700 3,300 Every 8 weeks ≥ 100 3,000 3,600 Every 8 weeks Supplemental dosing following treatment with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg) Plasma exchange (PE), plasmapheresis (PP) and intravenous immunoglobulin (IVIg) have been shown to reduce Ultomiris serum levels.
A supplemental dose of Ultomiris is required in the setting of PE, PP or IVIg (Table 2).
1 Adverse Reaction Overview The most common adverse drug reactions reported in patients receiving ravulizumab were abdominal pain, arthralgia, back pain, diarrhea, dizziness, fatigue, nausea, pyrexia, nasopharyngitis, headache, upper respiratory tract infection and urinary tract infection.
Clinically significant serious adverse reactions reported in patients in clinical trials included meningococcal infection and meningococcal sepsis. Meningococcal infections were reported in the ravulizumab clinical development program.
These patients were treated with antibiotics and recovered while remaining on ravulizumab without treatment interruption. Patients should be informed of the signs and symptoms of meningococcal septicemia and advised to seek medical care immediately.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. PNH Adult patients with PNH (Primary Evaluation Period) 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 drug reactions (>10%) with Ultomiris were upper respiratory tract infection and headache. Table 10a describes adverse reactions that occurred at a rate of 5% or more among patients treated with Ultomiris. 8%) patients 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. 2) Notes: Phase 3 PNH Population = ALXN1210-PNH-301 and ALXN1210-PNH-302.
, Other Systemic and Serious Infections 2025-12 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 11 5 OVERDOSAGE............................................................................................................
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................ 16 8 ADVERSE REACTIONS ................................................................................................
24 9 DRUG INTERACTIONS ................................................................................................ 25 10 CLINICAL PHARMACOLOGY .......................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 29 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 29 PART II: SCIENTIFIC INFORMATION .......................................................................................
4 Administration, Home Infusion 2025-12 7 WARNINGS AND PRECAUTIONS, Other Systemic and Serious Infections 2025-12 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
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Table 2 :
Supplemental Dose of Ultomiris IV Dose after PE, PP, or IVIg Body Weight Group (kg) Most Recent Ultomiris Dose (mg) Supplemental Dose (mg) Following Each PP or PE Session Supplemental Dose (mg) following Completion of IVIg Cycle ≥ 40 to ≤ 60 2,400 1,200 600 3,000 1,500 ≥ 60 to < 100 2,700 1,500 600 3,300 1,800 ≥ 100 3,000 1,500 600 3,600 1,800 ULTOMIRIS® (ravulizumab) Product Monograph Page 7 of 60 Timing of Ultomiris Supplemental Dose Within 4 hours following each PE or PP intervention Within 4 hours following completion of an IVIg cycle Abbreviations: IVIg = intravenous immunoglobulin; PE = plasma exchange; PP = plasmapheresis Renal and Hepatic Impairment Studies have not been conducted to examine the effects of hepatic impairment; however, pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment.
No dose adjustment is required in patients with renal impairment. 2 Pharmacodynamics) The clinical trials of Ultomiris in patients with aHUS included patients with other complement-mediated TMA conditions (patients with renal impairment, some of whom were receiving dialysis).
No dose adjustment is required in this population. 3 Reconstitution Parenteral Products: Each vial of Ultomiris is intended for single use only. Ultomiris 100 mg/mL must be diluted to a final concentration of 50 mg/mL. Ultomiris 10 mg/mL must be diluted to a final concentration of 5 mg/mL.
Aseptic technique must be used. Prepare Ultomiris as follows: 1. 2 Recommended Dose and Dosage Adjustment. 2. Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation.
Do not use if there is evidence of particulate matter or precipitation. 3. 9%) solution for injection as diluent. Refer to the administration reference tables below. The product should be mixed gently. It should not be shaken. 4. After dilution, the final concentration of the solution to be infused is 50 mg/mL for Ultomiris 100 mg/mL and 5 mg/mL for Ultomiris 10 mg/mL.
5. The prepared solution should be administered immediately following preparation. Do not administer as an intravenous push or bolus injection. Refer to the administration reference tables below for minimum infusion duration. 2 micron filter.
6. If the medicinal product is not used immediately after reconstitution, storage times at 2°C to 8°C must not exceed 24 hours taking into account the expected infusion time. The loading, maintenance and supplemental dose administration reference tables for Ultomiris 100 mg/mL and 10 mg/mL are provided in Table 3 to Table 8.
8 60 ≥ 60 to < 100 […]
The data cut-off dates were the end of randomized treatment period for Study ALXN1210-PNH-301 and Study ALXN1210-PNH- 302. 1. 61) years. 8% of patients experienced at least 1 treatment- emergent adverse event. 5%) subjects died. The most frequently (≥5%) reported serious infections were upper respiratory tract infection, nasopharyngitis, COVID-19, influenza, urinary tract infection, gastroenteritis, and pneumonia.
Serious infections and sepsis were reported in 17% patients including 7 fatal cases. The fatal events included one case each of sepsis, pulmonary sepsis, septic shock, Escherichia sepsis, meningococcal sepsis, COVID-19, and intracranial infection.
Table 10b describes adverse reactions that occurred at a rate of 10% or more among patients treated with Ultomiris, throughout the treatment period of Ultomiris. 4) Notes: Phase 3 PNH Population in ALXN1210-PNH-301 and ALXN1210-PNH-302.
0. Pediatric patients with PNH In a study including 13 pediatric patients with PNH (aged 9 to 17 years), the safety profile appeared similar to that observed in adult PNH patients and in pediatric and adult aHUS patients. The most common adverse events (>20%) were upper respiratory tract infection, abdominal pain, abdominal pain upper, nasopharyngitis, COVID-19, nausea and headache (see Table 11 below).
ULTOMIRIS® (ravulizumab) Product Monograph Page 19 of 60 Table 11:
Adverse Reactions Reported in 10% or More of ULTOMIRIS-Treated Pediatric Patients with PNH in Study ALXN1210 PNH 304 System Organ Class Preferred Term Treatment Naïve (N=5) Eculizumab Experienced (N=8) Total […]
30 13 PHARMACEUTICAL INFORMATION ............................................................................ 30 14 CLINICAL TRIALS ........................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 51 PATIENT MEDICATION INFORMATION ..................................................................................
53 ULTOMIRIS® (ravulizumab) Product Monograph Page 4 of 60 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Paroxysmal Nocturnal Hemoglobinuria (PNH) ULTOMIRIS® (ravulizumab for injection) is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).
Atypical Hemolytic Uremic Syndrome (aHUS) ULTOMIRIS® (ravulizumab for injection) 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).
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