Ravulizumab: Drug information

For additional information see "Ravulizumab: Patient drug information" and "Ravulizumab: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Serious meningococcal infection:

Ravulizumab, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ravulizumab, unless the risks of delaying therapy with ravulizumab outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor.

Patients receiving ravulizumab are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, ravulizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS.

Brand Names: US

Ultomiris

Brand Names: Canada

Ultomiris

Pharmacologic Category

Complement C5 Inhibitor;
Complement Inhibitor;
Monoclonal Antibody;
Monoclonal Antibody, Complement Inhibitor

Dosing: Adult

Dosage guidance:

Safety: Vaccinate patients against meningococcal infection (serogroups A, C, W, Y and B) according to current guidelines at least 2 weeks prior to treatment initiation; revaccinate according to current guidelines. If urgent ravulizumab initiation is necessary in a patient not up to date with meningococcal vaccines according to current guidelines, provide antibacterial prophylaxis and administer vaccines as soon as possible. Following the first maintenance dose, the ravulizumab dosing schedule is allowed to occasionally vary within 1 day (SUBQ) or 7 days (IV) of the scheduled infusion day, although the subsequent dose should be administered according to the original schedule.

Clinical considerations: To reduce the risk for meningococcal disease, consider antimicrobial prophylaxis with oral antibiotics (penicillin, or macrolides if penicillin-allergic) for the duration of ravulizumab therapy (Ref).

Atypical hemolytic uremic syndrome

Atypical hemolytic uremic syndrome:

Note: A minimum treatment duration of 6 months is recommended. Dose is based on weight at time of treatment.

IV:

Weight 20 kg to <30 kg:

Loading dose: IV: 900 mg as a single dose.

Maintenance dose: IV: 2,100 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 30 kg to <40 kg:

Loading dose: IV: 1,200 mg as a single dose.

Maintenance dose: IV: 2,700 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 40 kg to <60 kg:

Loading dose: IV: 2,400 mg as a single dose.

Maintenance dose: IV: 3,000 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 60 kg to <100 kg:

Loading dose: IV: 2,700 mg as a single dose.

Maintenance dose: IV: 3,300 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight ≥100 kg:

Loading dose: IV: 3,000 mg as a single dose.

Maintenance dose: IV: 3,600 mg once every 8 weeks starting 2 weeks after the loading dose.

SUBQ: Weight ≥40 kg: Maintenance dose: 490 mg once weekly starting 2 weeks after weight-based IV loading dose.

Myasthenia gravis, generalized, chronic immunosuppression

Myasthenia gravis, generalized, chronic immunosuppression:

Note: Dose is based on weight at time of treatment. Use in patients with anti-acetylcholine receptor antibody-positive (AChR+) myasthenia gravis.

Weight 40 kg to <60 kg:

Loading dose: IV: 2,400 mg as a single dose.

Maintenance dose: IV: 3,000 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 60 kg to <100 kg:

Loading dose: IV: 2,700 mg as a single dose.

Maintenance dose: IV: 3,300 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight ≥100 kg:

Loading dose: IV: 3,000 mg as a single dose.

Maintenance dose: IV: 3,600 mg once every 8 weeks starting 2 weeks after the loading dose.

Neuromyelitis optica spectrum disorder

Neuromyelitis optica spectrum disorder:

Note: Dose is based on weight at time of treatment. Use in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.

Weight 40 kg to <60 kg:

Loading dose: IV: 2,400 mg as a single dose.

Maintenance dose: IV: 3,000 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 60 kg to <100 kg:

Loading dose: IV: 2,700 mg as a single dose.

Maintenance dose: IV: 3,300 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight ≥100 kg:

Loading dose: IV: 3,000 mg as a single dose.

Maintenance dose: IV: 3,600 mg once every 8 weeks starting 2 weeks after the loading dose.

Paroxysmal nocturnal hemoglobinuria

Paroxysmal nocturnal hemoglobinuria: Dose is based on weight at time of treatment:

IV:

Weight 20 kg to <30 kg:

Loading dose: IV: 900 mg as a single dose.

Maintenance dose: IV: 2,100 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 30 kg to <40 kg:

Loading dose: IV: 1,200 mg as a single dose.

Maintenance dose: IV: 2,700 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 40 kg to <60 kg:

Loading dose: IV: 2,400 mg as a single dose.

Maintenance dose: IV: 3,000 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight 60 kg to <100 kg:

Loading dose: IV: 2,700 mg as a single dose.

Maintenance dose: IV: 3,300 mg once every 8 weeks starting 2 weeks after the loading dose.

Weight ≥100 kg:

Loading dose: IV: 3,000 mg as a single dose.

Maintenance dose: IV: 3,600 mg once every 8 weeks starting 2 weeks after the loading dose.

SUBQ: Weight ≥40 kg: Maintenance dose: 490 mg once weekly starting 2 weeks after weight-based IV loading dose.

Conversion from eculizumab to IV ravulizumab: When converting from eculizumab to IV ravulizumab, administer the ravulizumab loading dose at the time of the next scheduled eculizumab dose and then administer ravulizumab maintenance doses once every 4 or 8 weeks (depending on body weight) beginning 2 weeks after the ravulizumab loading dose.

Conversion from eculizumab to SUBQ ravulizumab: When converting from eculizumab to SUBQ ravulizumab, administer IV ravulizumab as the loading dose at the time of the next scheduled eculizumab dose and then administer SUBQ ravulizumab maintenance doses weekly beginning 2 weeks after the ravulizumab IV loading dose.

Conversion from ravulizumab IV to SUBQ: When converting from IV ravulizumab to SUBQ ravulizumab, begin SUBQ maintenance dose 8 weeks after last IV maintenance dose.

Conversion from ravulizumab SUBQ to IV: When converting from SUBQ ravulizumab to IV ravulizumab, begin IV maintenance dose 1 week after last SUBQ maintenance dose.

Supplemental dose following plasma exchange, plasmapheresis, or IV immune globulin (IVIG):

**Supplemental Ravulizumab Doses Following PE, PP, or IVIG^a**
Weight (kg)^b	Most recent ravulizumab dose (mg)	Supplemental ravulizumab dose (mg) following each PE or PP intervention	Supplemental ravulizumab dose (mg) following completion of an IVIG cycle
^a PE = plasma exchange; PP = plasmapheresis; IVIG = IV immune globulin.
^bWeight at time of treatment.
40 to <60 kg	2,400 mg	1,200 mg	600 mg
40 to <60 kg	3,000 mg	1,500 mg	600 mg
60 to <100 kg	2,700 mg	1,500 mg	600 mg
60 to <100 kg	3,300 mg	1,800 mg	600 mg
≥100 kg	3,000 mg	1,500 mg	600 mg
≥100 kg	3,600 mg	1,800 mg	600 mg
Timing of ravulizumab supplemental dose		Within 4 hours following each PE or PP intervention	Within 4 hours following completion of an IVIG cycle

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, renal impairment had no clinically important effect on ravulizumab pharmacokinetics.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, hepatic impairment had no clinically important effect on ravulizumab pharmacokinetics.

Dosing: Adjustment for Toxicity: Adult

Adverse reaction during infusion: May slow or stop infusion (at discretion of health care provider). Interrupt infusion and begin appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Meningococcal infection: Consider interrupting ravulizumab therapy in patients being treated for serious infections, depending on the risks of interrupting treatment in the disease being treated.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ravulizumab: Pediatric drug information")

Dosage guidance:

Safety: Vaccinate with meningococcal vaccine at least 2 weeks prior to treatment initiation; revaccinate according to current guidelines. If urgent ravulizumab initiation is necessary and patient is not up to date with meningococcal vaccines (based on Advisory Committee on Immunization Practices [ACIP] recommendations), administer vaccination as soon as possible and provide antibacterial drug prophylaxis. To reduce the risk for meningococcal disease, consider antimicrobial prophylaxis with oral antibiotics (penicillin, or macrolides if penicillin-allergic) for the duration of therapy (Ref).

Dosage form information: Multiple concentrations of solution in vials are available (10 mg/mL and 100 mg/mL) for intravenous administration; only a single concentration should be used to prepare a dose for infusion; the on-body delivery system is only for subcutaneous administration in adults.

Clinical considerations: Following the first maintenance dose, the ravulizumab dosing schedule is allowed to occasionally vary within 7 days (IV infusion) of the scheduled infusion day, although the subsequent dose should be administered according to the original schedule.

Atypical hemolytic uremic syndrome

Atypical hemolytic uremic syndrome (aHUS):

Infants, Children, and Adolescents: IV infusion: Administer the first maintenance dose 2 weeks after loading dose; for subsequent maintenance doses, the interval varies with weight; use precaution to ensure appropriate interval. Dose is based on weight at time of treatment for that dose. Following the first maintenance dose, the ravulizumab dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day; subsequent doses should be administered according to the original schedule. For aHUS, treatment should continue for a minimum of 6 months.

**Ravulizumab Dosing for Atypical Hemolytic Uremic Syndrome in Infants, Children, and Adolescents**
Weight (at time of treatment)	Loading dose (fixed, mg/dose)	Maintenance dose (fixed, mg/dose)	Maintenance interval
5 to <10 kg	600 mg	300 mg	Every 4 weeks
10 to <20 kg	600 mg	600 mg	Every 4 weeks
20 to <30 kg	900 mg	2,100 mg	Every 8 weeks
30 to <40 kg	1,200 mg	2,700 mg
40 to <60 kg	2,400 mg	3,000 mg
60 to <100 kg	2,700 mg	3,300 mg
≥100 kg	3,000 mg	3,600 mg

Paroxysmal nocturnal hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH):

**Ravulizumab Dosing for Paroxysmal Nocturnal Hemoglobinuria in Infants, Children, and Adolescents**
Weight (at time of treatment)	Loading dose (fixed, mg/dose)	Maintenance dose (fixed, mg/dose)	Maintenance interval
5 to <10 kg	600 mg	300 mg	Every 4 weeks
10 to <20 kg	600 mg	600 mg	Every 4 weeks
20 to <30 kg	900 mg	2,100 mg	Every 8 weeks
30 to <40 kg	1,200 mg	2,700 mg
40 to <60 kg	2,400 mg	3,000 mg
60 to <100 kg	2,700 mg	3,300 mg
≥100 kg	3,000 mg	3,600 mg

Conversion from eculizumab: When converting from eculizumab to ravulizumab, administer the ravulizumab loading dose 2 weeks after the last eculizumab dose and then administer subsequent ravulizumab maintenance doses according to weight-based schedule, beginning 2 weeks after the ravulizumab loading dose.

Supplemental dose following plasma exchange (PE), plasmapheresis (PP), or IV immune globulin (IVIG):

Note: Serum levels of ravulizumab are decreased by PE, PP, or IVIG; supplemental ravulizumab dosing is necessary; the supplemental dose varies with intervention used. Dosing in patients weighing <40 kg has not been determined; use caution. Dose should be administered within 4 hours following PE or PP intervention or following completion of an IVIG cycle.

Children and Adolescents weighing ≥40 kg: IV infusion:

**Supplemental Ravulizumab Doses in Children and Adolescents Weighing ≥40 kg**
Weight (kg) at time of treatment	Most recent ravulizumab dose (mg)	Supplemental ravulizumab dose (mg) following each PE or PP intervention	Supplemental ravulizumab dose (mg) following completion of an IVIG cycle
40 to <60 kg	2,400 mg	1,200 mg	600 mg
40 to <60 kg	3,000 mg	1,500 mg	600 mg
60 to <100 kg	2,700 mg	1,500 mg	600 mg
60 to <100 kg	3,300 mg	1,800 mg	600 mg
≥100 kg	3,000 mg	1,500 mg	600 mg
≥100 kg	3,600 mg	1,800 mg	600 mg

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: May slow or stop infusion at the discretion of the health care provider if adverse reaction occurs.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, renal impairment had no clinically important effect on ravulizumab pharmacokinetics.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, hepatic impairment had no clinically important effect on ravulizumab pharmacokinetics.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults with paroxysmal nocturnal hemoglobinuria (PNH) unless otherwise indicated for generalized myasthenia gravis (gMG).

>10%:

Gastrointestinal: Diarrhea (gMG, PNH: 4% to 15%)

Local: Injection-site reaction (SUBQ: 27%)

Nervous system: Headache (9% to 32%)

Respiratory: Upper respiratory tract infection (gMG, PNH: 8% to 39%)

1% to 10%:

Gastrointestinal: Abdominal pain (gMG, PNH: 6%), nausea (9%)

Genitourinary: Urinary tract infection (gMG: 6%)

Hypersensitivity: Infusion-related reaction (1%; including hypersensitivity reaction)

Nervous system: Dizziness (gMG, PNH: 5% to 9%)

Neuromuscular & skeletal: Arthralgia (5%), back pain (gMG: 8%), limb pain (6%)

Miscellaneous: Fever (7%)

<1%: Immunologic: Antibody development

Frequency not defined:

Infection: Meningococcal infection (including meningitis, septicemia)

Nervous system: Hyperthermia

Postmarketing:

Hypersensitivity: Anaphylaxis

Infection: Serious infection (including disseminated gonococcal infection)

Contraindications

Initiation in patients with unresolved serious N. meningitidis infection.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to ravulizumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Infection: Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. Ravulizumab blocks terminal complement activation and therefore may increase the risk for susceptibility to bacterial infections, especially encapsulated bacteria, such as infections caused by N. meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and, to a lesser extent, Neisseria gonorrhoeae. Pediatric patients receiving ravulizumab may be at increased risk for serious S. pneumoniae and H. influenzae type b (Hib) infections; vaccinate for S. pneumoniae and Hib according to the Advisory Committee on Immunization Practices (ACIP) recommendations. Patients may be at increased risk for infection despite developing antibodies after vaccination.

• Infusion reactions: Administration of ravulizumab may result in infusion reactions, including anaphylaxis and hypersensitivity. In clinical trials, a small number of patients experienced infusion reactions (lower back pain, abdominal pain, muscle spasms, BP changes, rigors, limb discomfort, allergic reaction, bad taste, and drowsiness) during administration. Infusion reactions did not require ravulizumab discontinuation.

• Meningococcal infection: The use of ravulizumab increases susceptibility to serious life-threatening or fatal meningococcal infections (septicemia and/or meningitis) in some patients despite vaccination. ACIP vaccination recommendations differ from the administration schedule in the vaccine prescribing information. Meningococcal disease due to any serogroup, including nongroupable strains, may occur. If urgent ravulizumab therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide at least 2 weeks of antibacterial prophylaxis. Educate patients on signs/symptoms of meningitis and steps necessary to seek immediate medical care. Consider interruption of ravulizumab therapy in patients who are undergoing treatment for serious meningococcal infection.

Concurrent drug therapy issues:

• Anticoagulation: Treatment with ravulizumab should not alter anticoagulation management; the effect of anticoagulant therapy withdrawal is unknown.

Dosage form specific issues:

• Acrylic adhesive: On-body injector uses acrylic adhesive; allergic reactions may occur in patients with an allergy to acrylic adhesive. Consider premedication and supportive therapy if allergic reaction occurs.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: Vials are intended for IV use only. Prefilled cartridge and on-body injector are intended for SUBQ maintenance use only.

• Discontinuation in atypical hemolytic uremic syndrome: If thrombotic microangiopathy complications occur after discontinuation, consider restarting ravulizumab treatment or appropriate organ-specific supportive measures.

• Discontinuation in paroxysmal nocturnal hemoglobinuria: If hemolysis signs/symptoms (including elevated lactate dehydrogenase) occur after discontinuation, consider restarting ravulizumab treatment.

• Plasmapheresis/plasma exchange: Plasmapheresis and plasma exchange may reduce ravulizumab levels; supplemental ravulizumab doses are recommended.

• REMS program: Counsel patients about the risk of meningococcal infection/sepsis; provide REMS educational materials to patients, and ensure patients are vaccinated with meningococcal vaccines. Additional information is available at https://www.UltSolREMS.com or 1-888-765-4747.

Product Availability

Ultomiris 245 mg/3.5 mL single-dose prefilled cartridge: FDA approved July 2022; anticipated availability currently unknown.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Ultomiris: Ravulizumab-cwvz 300 mg/3 mL (3 mL); Ravulizumab-cwvz 300 mg/30 mL (30 mL [DSC]); Ravulizumab-cwvz 1100 mg/11 mL (11 mL) [contains polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (Ultomiris Intravenous)

300 mg/3 mL (per mL): $2,561.60

1100MG/11ML (per mL): $2,561.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Ultomiris: 300 mg/30 mL (30 mL); Ravulizumab-cwvz 300 mg/3 mL (3 mL); Ravulizumab-cwvz 1100 mg/11 mL (11 mL) [contains polysorbate 80]

Administration: Adult

IV: Infuse through a 0.2- or 0.22-micron filter. Allow solution to adjust to room temperature (do not use a heat source) prior to infusion. Flush line with NS after administration. Infusion rate for loading, maintenance, and supplemental doses is based on patient weight.

3 mL or 11 mL vial (100 mg/mL):

Loading dose:

**Loading Dose** Infusion Recommendations Using **100 mg/mL (3 mL and 11 mL)** Vials
Weight (kg)^a	Loading dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Weight at time of treatment.
20 to <30 kg	900 mg	18 mL	0.6 hours	30 mL/hour
30 to <40 kg	1,200 mg	24 mL	0.5 hours	48 mL/hour
40 to <60 kg	2,400 mg	48 mL	0.8 hours	60 mL/hour
60 to <100 kg	2,700 mg	54 mL	0.6 hours	90 mL/hour
≥100 kg	3,000 mg	60 mL	0.4 hours	150 mL/hour

Maintenance dose:

**Maintenance Dose** Infusion Recommendations Using **100 mg/mL (3 mL and 11 mL)** Vials
Weight (kg)^a	Maintenance dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Weight at time of treatment.
20 to <30 kg	2,100 mg	42 mL	1.3 hours	33 mL/hour
30 to <40 kg	2,700 mg	54 mL	1.1 hours	50 mL/hour
40 to <60 kg	3,000 mg	60 mL	0.9 hours	67 mL/hour
60 to <100 kg	3,300 mg	66 mL	0.7 hours	95 mL/hour
≥100 kg	3,600 mg	72 mL	0.5 hours	144 mL/hour

Supplemental dose:

**Supplemental Dose** Infusion Recommendations Using **100 mg/mL (3 mL and 11 mL)** Vials^a
Weight (kg)^b	Supplemental dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Supplemental doses are only indicated following plasma exchange, plasmapheresis, or IV immune globulin (IVIG) therapy.
^b Weight at time of treatment.
40 to <60 kg	600 mg	12 mL	0.25 hours	48 mL/hour
	1,200 mg	24 mL	0.42 hours	57 mL/hour
	1,500 mg	30 mL	0.5 hours	60 mL/hour
60 to <100 kg	600 mg	12 mL	0.2 hours	60 mL/hour
	1,500 mg	30 mL	0.36 hours	83 mL/hour
	1,800 mg	36 mL	0.42 hours	86 mL/hour
≥100 kg	600 mg	12 mL	0.17 hours	71 mL/hour
	1,500 mg	30 mL	0.25 hours	120 mL/hour
	1,800 mg	36 mL	0.28 hours	129 mL/hour

30 mL vial (10 mg/mL):

Loading dose:

**Loading Dose** Infusion Recommendations Using *10 mg/mL (30 mL)* Vials
Weight (kg)^a	Loading dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Weight at time of treatment.
20 to <30 kg	900 mg	180 mL	1.5 hours	120 mL/hour
30 to <40 kg	1,200 mg	240 mL	1.3 hours	185 mL/hour
40 to <60 kg	2,400 mg	480 mL	1.9 hours	253 mL/hour
60 to <100 kg	2,700 mg	540 mL	1.7 hours	318 mL/hour
≥100 kg	3,000 mg	600 mL	1.8 hours	334 mL/hour

Maintenance dose:

**Maintenance Dose** Infusion Recommendations Using **10 mg/mL (30 mL)** Vials
Weight (kg)^a	Maintenance dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Weight at time of treatment.
20 to <30 kg	2,100 mg	420 mL	3.3 hours	128 mL/hour
30 to <40 kg	2,700 mg	540 mL	2.8 hours	193 mL/hour
40 to <60 kg	3,000 mg	600 mL	2.3 hours	261 mL/hour
60 to <100 kg	3,300 mg	660 mL	2 hours	330 mL/hour
≥100 kg	3,600 mg	720 mL	2.2 hours	328 mL/hour

Supplemental dose:

**Supplemental Dose** Infusion Recommendations Using **10 mg/mL (30 mL)** Vials^a
Weight (kg)^b	Supplemental dose (mg)	Total volume to be administered (mL)	Minimum infusion time (hours)	Maximum infusion rate (mL/hour)
^a Supplemental doses are only indicated following plasma exchange, plasmapheresis, or IV immune globulin (IVIG) therapy.
^b Weight at time of treatment.
40 to <60 kg	600 mg	120 mL	0.5 hours	240 mL/hour
	1,200 mg	240 mL	1 hour	240 mL/hour
	1,500 mg	300 mL	1.2 hours	250 mL/hour
60 to <100 kg	600 mg	120 mL	0.4 hours	300 mL/hour
	1,500 mg	300 mL	1 hour	300 mL/hour
	1,800 mg	360 mL	1.1 hours	327 mL/hour
≥100 kg	600 mg	120 mL	0.4 hours	300 mL/hour
	1,500 mg	300 mL	1 hour	300 mL/hour
	1,800 mg	360 mL	1.1 hours	327 mL/hour

SUBQ: For use with the on-body delivery system; see manufacturer's labeling for detailed administration instructions. Self-administration may occur after proper training from a health care provider. Administer SUBQ into abdomen, thigh, or upper arm; do not administer into tender, bruised, red, or hard skin; avoid injecting into areas with scars, stretch marks, wrinkles, skin folds, tattoos, moles, or excessive hair. Rotate injection sites. The 2 on-body delivery systems may be administered concurrently or sequentially; each injection is administered over ~10 minutes.

Administration: Pediatric

Note: Assess immunization status prior to initiation.

Parenteral:

IV: Infuse through a 0.2 or 0.22 micron filter. If previous refrigeration, allow solution to adjust to room temperature at ambient air temperature (do not use a heat source) prior to infusion. Infusion rate for loading and maintenance dose is highly variable as it is based on concentration of ravulizumab used to prepare the infusion and patient weight; use extra precaution. Decrease infusion rate or discontinue for infusion reactions. Flush line with NS after administration.

Note: Multiple final concentrations for infusion exist (5 mg/mL or 50 mg/mL) and each concentration has different infusion rates; use extra precaution verifying concentration of infusion solution.

Loading and maintenance doses:

**5 mg/mL Solution Administration Rates and Infusion Times For Loading and Maintenance Doses**: Final Concentration of Infusion *5 mg/mL* ^a
Weight	Dose type	Total dose/Total volume (5 mg/mL)	Maximum infusion rate (mL/hour)	Minimum infusion time (hours)
^aSolutions prepared from the 10 mg/mL (30 mL) vial and further diluted in NS.
5 to <10 kg	Loading	600 mg/120 mL	31 mL/hour	3.8 hours
5 to <10 kg	Maintenance	300 mg/60 mL	31 mL/hour	1.9 hours
10 to <20 kg	Loading	600 mg/120 mL	63 mL/hour	1.9 hours
10 to <20 kg	Maintenance	600 mg/120 mL	63 mL/hour	1.9 hours
20 to <30 kg	Loading	900 mg/180 mL	120 mL/hour	1.5 hours
20 to <30 kg	Maintenance	2,100 mg/420 mL	127 mL/hour	3.3 hours
30 to <40 kg	Loading	1,200 mg/240 mL	184 mL/hour	1.3 hours
30 to <40 kg	Maintenance	2,700 mg/540 mL	192 mL/hour	2.8 hours
40 to <60 kg	Loading	2,400 mg/480 mL	252 mL/hour	1.9 hours
40 to <60 kg	Maintenance	3,000 mg/600 mL	257 mL/hour	2.3 hours
60 to <100 kg	Loading	2,700 mg/540 mL	317 mL/hour	1.7 hours
60 to <100 kg	Maintenance	3,300 mg/660 mL	330 mL/hour	2 hours
≥100 kg	Loading	3,000 mg/600 mL	333 mL/hour	1.8 hours
≥100 kg	Maintenance	3,600 mg/720 mL	327 mL/hour	2.2 hours

**50 mg/mL Solution Administration Rates and Infusion Times For Loading and Maintenance Doses**: Final Concentration of Infusion *50 mg/mL* ^a
Weight	Dose type	Total dose/Total volume (50 mg/mL)	Maximum infusion rate (mL/hour)	Minimum infusion time (hours)
^aSolutions prepared from the 100 mg/mL (3 mL or 11 mL) vial and further diluted in NS.
5 to <10 kg	Loading	600 mg/12 mL	8 mL/hour	1.4 hours
5 to <10 kg	Maintenance	300 mg/6 mL	8 mL/hour	0.8 hours
10 to <20 kg	Loading	600 mg/12 mL	16 mL/hour	0.8 hours
10 to <20 kg	Maintenance	600 mg/12 mL	16 mL/hour	0.8 hours
20 to <30 kg	Loading	900 mg/18 mL	30 mL/hour	0.6 hours
20 to <30 kg	Maintenance	2,100 mg/42 mL	33 mL/hour	1.3 hours
30 to <40 kg	Loading	1,200 mg/24 mL	46 mL/hour	0.5 hours
30 to <40 kg	Maintenance	2,700 mg/54 mL	49 mL/hour	1.1 hours
40 to <60 kg	Loading	2,400 mg/48 mL	64 mL/hour	0.8 hours
40 to <60 kg	Maintenance	3,000 mg/60 mL	65 mL/hour	0.9 hours
60 to <100 kg	Loading	2,700 mg/54 mL	92 mL/hour	0.6 hours
60 to <100 kg	Maintenance	3,300 mg/66 mL	99 mL/hour	0.7 hours
≥100 kg	Loading	3,000 mg/60 mL	144 mL/hour	0.4 hours
≥100 kg	Maintenance	3,600 mg/72 mL	144 mL/hour	0.5 hours

Supplemental dose:

**Supplemental Dose 5 mg/mL Solution Infusion Administration Recommendations** : Final Concentration of Infusion *5 mg/mL* ^a
Weight (kg)^b	Supplemental dose (mg)	Total volume to be administered (mL)	Maximum infusion rate (mL/hour)	Minimum infusion time (hours)
^a Solutions prepared from the 10 mg/mL (30 mL) vial and further diluted in NS.
^b Weight at time of treatment.
40 to <60 kg	600 mg	120 mL	240 mL/hour	0.5 hours
	1,200 mg	240 mL	240 mL/hour	1 hour
	1,500 mg	300 mL	250 mL/hour	1.2 hours
60 to <100 kg	600 mg	120 mL	300 mL/hour	0.4 hours
	1,500 mg	300 mL	300 mL/hour	1 hour
	1,800 mg	360 mL	327 mL/hour	1.1 hours
≥100 kg	600 mg	120 mL	300 mL/hour	0.4 hours
	1,500 mg	300 mL	300 mL/hour	1 hour
	1,800 mg	360 mL	327 mL/hour	1.1 hours

**Supplemental Dose 50 mg/mL Solution Infusion Administration Recommendations** : Final Concentration of Infusion *50 mg/mL* ^a
Weight (kg)^b	Supplemental dose (mg)	Total volume to be administered (mL)	Maximum infusion rate (mL/hour)	Minimum infusion time (hours)
^a Solutions prepared from the 100 mg/mL (3 mL or 11 mL) vial and further diluted in NS.
^b Weight at time of treatment.
40 to <60 kg	600 mg	12 mL	48 mL/hour	0.25 hours
	1,200 mg	24 mL	57 mL/hour	0.42 hours
	1,500 mg	30 mL	60 mL/hour	0.5 hours
60 to <100 kg	600 mg	12 mL	60 mL/hour	0.2 hours
	1,500 mg	30 mL	83 mL/hour	0.36 hours
	1,800 mg	36 mL	86 mL/hour	0.42 hours
≥100 kg	600 mg	12 mL	71 mL/hour	0.17 hours
	1,500 mg	30 mL	120 mL/hour	0.25 hours
	1,800 mg	36 mL	129 mL/hour	0.28 hours

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Ultomiris: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s026s031lbl.pdf#page=53

Use: Labeled Indications

Atypical hemolytic uremic syndrome: Treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy in adult and pediatric patients ≥1 month of age.

Limitations of use: Not indicated for the treatment of Shiga toxin Escherichia coli-related hemolytic uremic syndrome.

Myasthenia gravis, generalized, chronic immunosuppression (IV only): Treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody-positive (AChR+).

Neuromyelitis optica spectrum disorder (IV only): Treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin 4 antibody-positive.

Paroxysmal nocturnal hemoglobinuria: Treatment of paroxysmal nocturnal hemoglobinuria in adults and pediatric patients ≥1 month of age.

Medication Safety Issues

Sound-alike/look-alike issues:

Ravulizumab may be confused with eculizumab, ramucirumab, ranibizumab, raxibacumab, reslizumab.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination

Immune Globulin: May decrease the serum concentration of Ravulizumab. Management: Administer a supplemental dose of ravulizumab (600 mg) within 4 hours of completion of the immune globulin cycle. Risk D: Consider therapy modification

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Pregnancy Considerations

Ravulizumab is a humanized monoclonal antibody (IgG₂). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Data related to maternal use of ravulizumab during pregnancy (Tomazos 2020) or immediately postpartum (Gäckler 2021) are limited.

Adverse pregnancy outcomes are associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Adverse maternal outcomes associated with PNH may include worsening cytopenias, thrombotic events, infections, bleeding, fetal loss, and increased maternal mortality; increased fetal death and premature delivery is also reported. Patients with aHUS may have an increased risk of preeclampsia and preterm delivery; intrauterine growth restriction/low birth weight and fetal death may also occur.

Breastfeeding Considerations

It is not known if ravulizumab is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 8 months after the last ravulizumab dose.

Monitoring Parameters

Assess immunization status (prior to treatment). Monitor for early signs of meningococcal infection (N. meningitidis); evaluate immediately if infection is suspected. Monitor closely for signs/symptoms of worsening infection (if administering ravulizumab to patients with active systemic infections). Monitor for signs/symptoms of an infusion reaction; monitor patients during and for at least 1 hour after administration.

After ravulizumab discontinuation for paroxysmal nocturnal hemoglobinuria: Monitor closely for ≥16 weeks (after discontinuation) to detect hemolysis and other reactions; monitor for signs/symptoms of hemolysis (eg, elevated lactate dehydrogenase [LDH] along with sudden decrease in paroxysmal nocturnal hemoglobinuria clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], major adverse vascular event [including thrombosis], dysphagia, or erectile dysfunction) after discontinuation of ravulizumab treatment.

After ravulizumab discontinuation for atypical hemolytic uremic syndrome: Monitor closely for ≥12 months (after discontinuation) for signs/symptoms of thrombotic microangiopathy (TMA) complications. TMA complications may be identified by clinical symptoms (changes in mental status, seizures, angina, dyspnea, thrombosis, or increasing blood pressure) in addition to ≥2 of the following laboratory values observed concurrently (and confirmed by a second measurement 28 days apart with no interruption): platelet count decreased ≥25% compared to baseline or peak count during ravulizumab treatment; serum creatinine increased ≥25% compared to baseline or to nadir during ravulizumab treatment; or LDH increased ≥25% compared to baseline or to nadir during ravulizumab treatment.

Mechanism of Action

Ravulizumab is a humanized monoclonal antibody which is a terminal complement inhibitor that specifically binds to the complement protein C5 (with high affinity), inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing generation of the terminal complement complex C5b9. Ravulizumab inhibits terminal complement-mediated intravascular hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome. The C5 inhibition of complement-mediated hemolysis achieved by ravulizumab in patients with PNH is immediate, thorough, and sustained (Lee 2019). The mechanism in generalized myasthenia gravis has not been fully elucidated but is presumed to involve reduction of terminal complement complex C5b-9 at the neuromuscular junction. The mechanism in neuromyelitis optica spectrum disorder has not been fully elucidated but is presumed to involve inhibition of aquaporin-4 antibody induced terminal complement complex C5b-9 deposition.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Lactate dehydrogenase (LDH) reduction: Rapid and sustained, beginning as early as day 8 (Roth 2018). LDH normalization: By week 4 (in complement-inhibitor naive patients with paroxysmal nocturnal hemoglobinuria [PNH]).

Bioavailability: SUBQ: ~79%.

Distribution: V_d: IV: 5.22 L (atypical hemolytic uremic syndrome [aHUS] patients); 5.3 L (PNH patients); 5.74 L (generalized myasthenia gravis patients [gMG]); 4.77 L (neuromyelitis optica spectrum disorder [NMOSD]); SUBQ: 5.3 L (PNH patients).

Half-life elimination: Terminal: IV: 51.8 days (aHUS patients); 49.6 days (PNH patients); 56.6 days (gMG patients); 64.3 days (NMOSD patients); SUBQ: 52.4 days (PNH patients).

Excretion: Clearance: IV: 0.05 to 0.08 L/day; SUBQ: 0.07 L/day.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Ultomiris;
(AT) Austria: Ultomiris;
(AU) Australia: Ultomiris;
(BE) Belgium: Ultomiris;
(BG) Bulgaria: Ultomiris;
(CH) Switzerland: Ultomiris;
(CZ) Czech Republic: Ultomiris;
(DE) Germany: Ultomiris;
(EC) Ecuador: Ultomiris;
(EE) Estonia: Ultomiris;
(ES) Spain: Ultomiris;
(FI) Finland: Ultomiris;
(FR) France: Ultomiris;
(GB) United Kingdom: Ultomiris;
(HU) Hungary: Ultomiris;
(IT) Italy: Ultomiris;
(JP) Japan: Ultomiris;
(KR) Korea, Republic of: Ultomiris;
(NL) Netherlands: Ultomiris;
(NO) Norway: Ultomiris;
(PL) Poland: Ultomiris;
(PR) Puerto Rico: Ultomiris;
(QA) Qatar: Ultomiris;
(RO) Romania: Ultomiris;
(SE) Sweden: Ultomiris;
(SI) Slovenia: Ultomiris;
(SK) Slovakia: Ultomiris

Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
Centers for Disease Control and Prevention (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
Gäckler A, Schönermarck U, Dobronravov V, et al. Efficacy and safety of the long-acting C5 inhibitor ravulizumab in patients with atypical hemolytic uremic syndrome triggered by pregnancy: a subgroup analysis. BMC Nephrol. 2021;22(1):5. doi:10.1186/s12882-020-02190-0 [PubMed 33407224]
Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
Lee JW, Sicre de Fontbrune F, Wong Lee Lee L, et al. Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. Blood. 2019;133(6):530-539. doi:10.1182/blood-2018-09-876136 [PubMed 30510080]
Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil JR. High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab (Soliris) Despite Receipt of Meningococcal Vaccine. MMWR Morb Mortal Wkly Rep. 2017;66(27):734-737. doi:10.15585/mmwr.mm6627e1 [PubMed 28704351]
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
Röth A, Rottinghaus ST, Hill A, et al. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018;2(17):2176-2185. doi:10.1182/bloodadvances.2018020644 [PubMed 30171081]
Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. [PubMed 7746084]
Tomazos I, Sierra JR, Johnston KM, Cheung A, Brodsky RA, Weitz IC. Cost burden of breakthrough hemolysis in patients with paroxysmal nocturnal hemoglobinuria receiving ravulizumab versus eculizumab. Hematology. 2020;25(1):327-334. doi:10.1080/16078454.2020.1807226 [PubMed 32856539]
Ultomiris (ravulizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals; March 2024.
Ultomiris (ravulizumab) [product monograph]. Bear, Switzerland: Alexion Pharma GmbH; October 2023.

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