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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.

Table 1: ULTOMIRIS Weight-Based Dosing Regimen – PNH, aHUS, and gMG*
Indications Body Weight Range (kg) Loading Dose (mg) Maintenance Dose (mg) and Dosing Interval
*
see Tables 3, 4, 6, and 7 for selection of the proper total volume and maximum infusion rate [see Dosage and Administration (2.4)]
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).

Table 2: Supplemental Dose of ULTOMIRIS after PE, PP, or IVIg*
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
*
see Table 5 and Table 8 for selection of the proper total volume and maximum infusion rate [see Dosage and Administration (2.4)]
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.

Table 3: Loading Dose Reference Table for ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials)
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)
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
For PNH and aHUS indications only.
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
Table 4: Maintenance Dose Reference Table for ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials)
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)
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
For PNH and aHUS indications only.
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
Table 5: Supplemental Dose Reference Table for ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials)
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
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
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
Table 6: Loading Dose Reference Table for ULTOMIRIS 10 mg/mL (30 mL vial)
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)
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
For PNH and aHUS indications only.
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
Table 7: Maintenance Dose Reference Table for ULTOMIRIS 10 mg/mL (30 mL vial)
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)
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
For PNH and aHUS indications only.
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
Table 8: Supplemental Dose Reference Table for ULTOMIRIS 10 mg/mL (30 mL vial)
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
*
Body weight at time of treatment.
Dilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.
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.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.