Ultomiris Dosage

Generic name: ravulizumab 300mg in 30mL
Dosage form: intravenous solution, concentrate
Drug class: Selective immunosuppressants

Medically reviewed by drugclasses.com. Last updated on Jul 5, 2024.

Important Dosage Information

ULTOMIRIS is intended to be administered only as an intravenous infusion in adult or pediatric patients one month of age and older.

Recommended Vaccination and Prophylaxis for Meningococcal Infection

Vaccinate patients against meningococcal infection (serogroups A, C, W, Y and B) according to current ACIP recommendations at least 2 weeks prior to initiation of ULTOMIRIS [see Warnings and Precautions (5.1)].

If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible.

Healthcare providers who prescribe ULTOMIRIS must enroll in the ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].

Recommended Dosage for Intravenous Administration in Adult and Pediatric Patients with PNH or aHUS, and in Adult Patients with gMG or NMOSD

The recommended intravenous (IV) ULTOMIRIS loading and maintenance dosing in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH or aHUS, or in adult patients with gMG or NMOSD weighing 40 kg or greater, is based on the patient's body weight, as shown in Table 1, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose.

The IV 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.

Following a missed IV ULTOMIRIS dose, the patient should contact their health care provider immediately.

Table 1: IV Administration of ULTOMIRIS Weight-Based Dosing Regimen – PNH, aHUS, gMG, or NMOSD*
Indications	Body Weight Range (kg)	Loading Dose (mg)†	Maintenance Dose (mg) and Dosing Interval
* See Table 4, Table 5, Table 7, and Table 8 for selection of the proper total volume and maximum infusion rate [see Dosage and Administration (2.5)] † See Table 2 for ULTOMIRIS treatment initiation instruction and timing of loading dose and maintenance dose
PNH or aHUS	5 to less than 10	600	300	Every 4 weeks
	10 to less than 20	600	600	Every 4 weeks
	20 to less than 30	900	2,100	Every 8 weeks
	30 to less than 40	1,200	2,700	Every 8 weeks
PNH, aHUS, gMG, or NMOSD	40 to less than 60	2,400	3,000	Every 8 weeks
	60 to less than 100	2,700	3,300
	100 or greater	3,000	3,600

Refer to Table 2 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve or switching treatment from eculizumab.

Table 2: IV Administration of ULTOMIRIS Treatment Initiation Instructions – PNH, aHUS, gMG, or NMOSD
Population	Weight-based ULTOMIRIS Loading Dose	Time of First ULTOMIRIS Weight-based Maintenance Dose
Not currently on ULTOMIRIS or eculizumab treatment	At treatment start	2 weeks after ULTOMIRIS loading dose
Currently treated with eculizumab	At time of next scheduled eculizumab dose	2 weeks after ULTOMIRIS loading dose

Dosing Considerations

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 3).

Table 3: 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 6 and Table 9 for selection of the proper total volume and maximum infusion rate [see Dosage and Administration (2.5)]
40 to less than 60	2,400	1,200	600
40 to less than 60	3,000	1,500	600
60 to less than 100	2,700	1,500	600
60 to less than 100	3,300	1,800	600
100 or greater	3,000	1,500	600
100 or greater	3,600	1,800	600
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 Vials for Intravenous Administration

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

ULTOMIRIS vials are for intravenous administration by a healthcare provider and are intended for intravenous administration only.

Dilute before use.

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 (2.3)].

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 for IV preparation and minimum infusion duration:

ULTOMIRIS 100 mg/mL (3 mL and 11 mL vials): see Table 4 (loading doses), Table 5 (maintenance doses), and Table 6 (supplemental doses)
ULTOMIRIS 10 mg/mL (30 mL vial): see Table 7 (loading doses), Table 8 (maintenance doses), and Table 9 (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.

Intravenous Administration of ULTOMIRIS (Healthcare Providers)

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.

After administration of ULTOMIRIS, flush the entire line with 0.9% Sodium Chloride Injection, USP.

Table 4: 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	9
10 to less than 20‡	600	6	6	12	0.8	15
20 to less than 30‡	900	9	9	18	0.6	30
30 to less than 40‡	1,200	12	12	24	0.5	48
40 to less than 60	2,400	24	24	48	0.8	60
60 to less than 100	2,700	27	27	54	0.6	90
100 or greater	3,000	30	30	60	0.4	150

Table 5: 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	15
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	50
40 to less than 60	3,000	30	30	60	0.9	67
60 to less than 100	3,300	33	33	66	0.7	95
100 or greater	3,600	36	36	72	0.5	144

Table 6: 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 3 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 7: 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	32
10 to less than 20‡	600	60	60	120	1.9	64
20 to less than 30‡	900	90	90	180	1.5	120
30 to less than 40‡	1,200	120	120	240	1.3	185
40 to less than 60	2,400	240	240	480	1.9	253
60 to less than 100	2,700	270	270	540	1.7	318
100 or greater	3,000	300	300	600	1.8	334

Table 8: 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	32
10 to less than 20‡	600	60	60	120	1.9	64
20 to less than 30‡	2,100	210	210	420	3.3	128
30 to less than 40‡	2,700	270	270	540	2.8	193
40 to less than 60	3,000	300	300	600	2.3	261
60 to less than 100	3,300	330	330	660	2	330
100 or greater	3,600	360	360	720	2.2	328

Table 9: 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 3 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	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	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	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 1 hour following completion of the infusion for signs or symptoms of an infusion-related reaction.

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