Ultomiris Dosage
Medically reviewed by Drugs.com. Last updated on May 3, 2022.
Generic name: ravulizumab 300mg in 30mL
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, 5.2)].
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)].
Recommended Weight-Based Dosage Regimen – PNH, aHUS, and gMG
The recommended dosing regimen in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH and aHUS, or in adult patients with gMG weighing 40 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The dosing is based on the patient's body weight, as shown in Table 1. Starting 2 weeks after the loading dose administration, begin maintenance doses once every 4 or 8 weeks, based on body weight.
The 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.
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 | |
60 to less than 100 | 2,700 | 3,300 | ||
100 or greater | 3,000 | 3,600 |
Dosing Considerations
Switch from Eculizumab to ULTOMIRIS
For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab maintenance infusion (or 1 week after the last eculizumab induction infusion), and then administer ULTOMIRIS maintenance doses once every 4 weeks or every 8 weeks depending on body weight, as shown in Table 1), starting 2 weeks after loading dose administration.
Supplemental Dose of ULTOMIRIS
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).
Body Weight Range (kg) | Most Recent ULTOMIRIS Dose (mg) | Supplemental Dose (mg) following each PE or PP Intervention | Supplemental Dose (mg) following Completion of an IVIg Cycle |
---|---|---|---|
Abbreviations: IVIg = intravenous immunoglobulin; PE = plasma exchange; PP = plasmapheresis | |||
|
|||
40 to less than 60 | 2,400 | 1,200 | 600 |
3,000 | 1,500 | ||
60 to less than 100 | 2,700 | 1,500 | 600 |
3,300 | 1,800 | ||
100 or greater | 3,000 | 1,500 | 600 |
3,600 | 1,800 | ||
Timing of ULTOMIRIS Supplemental Dose | Within 4 hours following each PE or PP intervention | Within 4 hours following completion of an IVIg cycle |
Preparation and Administration
Preparation of ULTOMIRIS
Dilute before use.
Each vial of ULTOMIRIS is intended for single-dose only.
Do not mix ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials) and 10 mg/mL (30 mL vial) concentrations together.
Use aseptic technique to prepare ULTOMIRIS as follows:
- 1.
- The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose [see Dosage and Administration (2.2)].
- 2.
- Prior to dilution, visually inspect the solution in the vials; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
- 3.
- Withdraw the calculated volume of ULTOMIRIS from the appropriate number of vials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a final concentration of:
- 50 mg/mL for the 3 mL and 11 mL vial sizes or
- 5 mg/mL for the 30 mL vial size.
The product should be mixed gently. Do not shake. Protect from light. Do not freeze.
Refer to the following reference tables for preparation and minimum infusion duration:
- ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials): see Table 3 (loading doses), Table 4 (maintenance doses), and Table 5 (supplemental doses)
- ULTOMIRIS 10 mg/mL (30 mL vial): see Table 6 (loading doses),Table 7 (maintenance doses), and Table 8 (supplemental doses)
- 4.
- Administer the prepared solution immediately following preparation.
- 5.
- If the diluted ULTOMIRIS infusion solution is not used immediately, storage under refrigeration at 2°C - 8°C (36°F - 46°F) must not exceed 24 hours taking into account the expected infusion time. Once removed from refrigeration, administer the diluted ULTOMIRIS infusion solution within 6 hours if prepared with ULTOMIRIS 30 mL vials or within 4 hours if prepared with ULTOMIRIS 3 mL or 11 mL vials.
Administration of ULTOMIRIS
Only administer as an intravenous infusion through a 0.2 or 0.22 micron filter.
Dilute ULTOMIRIS to a final concentration of:
- 50 mg/mL for the 3 mL and 11 mL vial sizes or
- 5 mg/mL for the 30 mL vial size.
Prior to administration, allow the admixture to adjust to room temperature (18°C - 25°C, 64°F - 77°F). Do not heat the admixture in a microwave or with any heat source other than ambient air temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Body Weight Range (kg)* | Loading Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) | Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
5 to less than 10‡ | 600 | 6 | 6 | 12 | 1.4 | 8 |
10 to less than 20‡ | 600 | 6 | 6 | 12 | 0.8 | 16 |
20 to less than 30‡ | 900 | 9 | 9 | 18 | 0.6 | 30 |
30 to less than 40‡ | 1,200 | 12 | 12 | 24 | 0.5 | 46 |
40 to less than 60 | 2,400 | 24 | 24 | 48 | 0.8 | 64 |
60 to less than 100 | 2,700 | 27 | 27 | 54 | 0.6 | 92 |
100 or greater | 3,000 | 30 | 30 | 60 | 0.4 | 144 |
Body Weight Range (kg)* | Maintenance Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) | Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
5 to less than 10‡ | 300 | 3 | 3 | 6 | 0.8 | 8 |
10 to less than 20‡ | 600 | 6 | 6 | 12 | 0.8 | 16 |
20 to less than 30‡ | 2,100 | 21 | 21 | 42 | 1.3 | 33 |
30 to less than 40‡ | 2,700 | 27 | 27 | 54 | 1.1 | 49 |
40 to less than 60 | 3,000 | 30 | 30 | 60 | 0.9 | 65 |
60 to less than 100 | 3,300 | 33 | 33 | 66 | 0.7 | 99 |
100 or greater | 3,600 | 36 | 36 | 72 | 0.5 | 144 |
Body Weight Range (kg)* | Supplemental Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) |
Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
Note: Refer to Table 2 for selection of ravulizumab supplemental dose | ||||||
40 to less than 60 | 600 | 6 | 6 | 12 | 0.25 | 48 |
1,200 | 12 | 12 | 24 | 0.42 | 57 | |
1,500 | 15 | 15 | 30 | 0.5 | 60 | |
60 to less than 100 | 600 | 6 | 6 | 12 | 0.20 | 60 |
1,500 | 15 | 15 | 30 | 0.36 | 83 | |
1,800 | 18 | 18 | 36 | 0.42 | 86 | |
100 or greater | 600 | 6 | 6 | 12 | 0.17 | 71 |
1,500 | 15 | 15 | 30 | 0.25 | 120 | |
1,800 | 18 | 18 | 36 | 0.28 | 129 |
Body Weight Range (kg)* | Loading Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) | Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
5 to less than 10‡ | 600 | 60 | 60 | 120 | 3.8 | 31 |
10 to less than 20‡ | 600 | 60 | 60 | 120 | 1.9 | 63 |
20 to less than 30‡ | 900 | 90 | 90 | 180 | 1.5 | 120 |
30 to less than 40‡ | 1,200 | 120 | 120 | 240 | 1.3 | 184 |
40 to less than 60 | 2,400 | 240 | 240 | 480 | 1.9 | 252 |
60 to less than 100 | 2,700 | 270 | 270 | 540 | 1.7 | 317 |
100 or greater | 3,000 | 300 | 300 | 600 | 1.8 | 333 |
Body Weight Range (kg)* | Maintenance Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) | Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
5 to less than 10‡ | 300 | 30 | 30 | 60 | 1.9 | 31 |
10 to less than 20‡ | 600 | 60 | 60 | 120 | 1.9 | 63 |
20 to less than 30‡ | 2,100 | 210 | 210 | 420 | 3.3 | 127 |
30 to less than 40‡ | 2,700 | 270 | 270 | 540 | 2.8 | 192 |
40 to less than 60 | 3,000 | 300 | 300 | 600 | 2.3 | 257 |
60 to less than 100 | 3,300 | 330 | 330 | 660 | 2 | 330 |
100 or greater | 3,600 | 360 | 360 | 720 | 2.2 | 327 |
Body Weight Range (kg)* | Supplemental Dose (mg) | ULTOMIRIS Volume (mL) | Volume of NaCl Diluent† (mL) | Total Volume (mL) | Minimum Infusion Time (hr) | Maximum Infusion Rate (mL/hr) |
---|---|---|---|---|---|---|
Note: Refer to Table 2 for selection of ravulizumab supplemental dose | ||||||
40 to less than 60 | 600 | 60 | 60 | 120 | 0.5 | 240 |
1,200 | 120 | 120 | 240 | 1.0 | 240 | |
1,500 | 150 | 150 | 300 | 1.2 | 250 | |
60 to less than 100 | 600 | 60 | 60 | 120 | 0.4 | 300 |
1,500 | 150 | 150 | 300 | 1.0 | 300 | |
1,800 | 180 | 180 | 360 | 1.1 | 327 | |
100 or greater | 600 | 60 | 60 | 120 | 0.4 | 300 |
1,500 | 150 | 150 | 300 | 1.0 | 300 | |
1,800 | 180 | 180 | 360 | 1.1 | 327 |
If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction.
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