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Ultomiris Dosage

Generic name: ravulizumab 300mg in 30mL

Medically reviewed by Drugs.com. Last updated on Oct 19, 2020.

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

The recommended dosing regimen in adult patients with PNH weighing 40 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. Administer the doses based on the patient's body weight, as shown in Table 1. Starting 2 weeks after the loading dose administration, begin maintenance doses at a once every 8-week interval.

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 the subsequent doses should be administered according to the original schedule.

Table 1: ULTOMIRIS Weight-Based Dosing Regimen - PNH
Body Weight Range (kg) Loading Dose (mg) Maintenance Dose (mg) and Dosing Interval
greater than or equal to 40 to less than 60 2,400 3,000 Every 8 weeks
greater than or equal to 60 to less than 100 2,700 3,300
greater than or equal to 100 3,000 3,600

Recommended Weight-Based Dosage Regimen - aHUS

The recommended dosing regimen in adult and pediatric patients one month of age and older with aHUS weighing 5 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. Administer the doses based on the patient's body weight, as shown in Table 2. Starting 2 weeks after the loading dose administration, begin maintenance doses once every 8 weeks or every 4 weeks (depending 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 the subsequent doses should be administered according to the original schedule.

Table 2: ULTOMIRIS Weight-Based Dosing Regimen - aHUS
Body Weight Range (kg) Loading Dose (mg) Maintenance Dose (mg) and Dosing Interval
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
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

For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer maintenance doses once every 8 weeks or every 4 weeks (depending on body weight), starting 2 weeks after loading dose administration.

Administration of PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion) may reduce ULTOMIRIS serum levels. There is no experience with administration of supplemental doses of ULTOMIRIS.

Preparation and Administration

Preparation of ULTOMIRIS

Each vial of ULTOMIRIS is intended for single-dose only.

ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials) and 10 mg/mL (3o mL vials) should not be mixed 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, 2.3)].
  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: Table 3 (loading doses) and Table 4 (maintenance doses) for ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials) and Table 5 (loading doses) and Table 6 (maintenance doses) for ULTOMIRIS 10 mg/mL (30 mL vial).

  4. Administer the prepared solution immediately following preparation. Refer to Table 3 (loading doses) and Table 4 (Maintenance doses( for ULTOMIRIS 100 mg/mL (3 mL and 11mL vials) and Table 5 (loading doses) and Table 6 (maintenance doses) for ULTOMIRIS 10 mg/mL (30 mL vial) for minimum infusion duration. Infusion must be administered through a 0.2 or 0.22 micron filter.
  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.

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.

Administer ULTOMIRIS only through a 0.2 or 0.22 micron filter.

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.
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.
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: 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.
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 6: 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.
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

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.

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.

Further information

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