Select a medication above to begin.
Ultomiris (ravulizumab-cwvz)
ravulizumab
Black Box Warnings .
Appropriate Use
restricted distribution program (Ultomiris and Soliris REMS) due to meningococcal infection risk; prescribers, healthcare settings, pharmacies must enroll at 1-888-765-4747 or www.ultsolrems.com
Serious Meningococcal Infection
life-threatening and fatal cases have occurred; may become rapidly life-threatening or fatal if not recognized and treated early; complete or update vaccination for meningococcal bacteria serogroups A, C, W, Y, and B at least 2wk before tx start, unless tx delay risks outweigh infection risk; provide antibacterial prophylaxis if urgent tx indicated in pts not up to date w/ meningococcal vaccines, and admin. vaccines ASAP; comply w/ ACIP recommendations for meningococcal vaccination in pts receiving complement inhibitor; revaccinate per ACIP recommendations, considering tx duration; vaccination does not eliminate meningococcal infection risk despite antibodies developed after vaccination; monitor for early signs of meningococcal infection and eval. immediately if infection suspected
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-888-765-4747 or www.ultsolrems.com for more info]
Special Note
- [formulation clarification]
- Info: nonproprietary name = ravulizumab-cwvz
paroxysmal nocturnal hemoglobinuria
- [40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [>100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
atypical hemolytic uremic syndrome
- [40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [>100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
generalized myasthenia gravis
- [40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk; Info: for anti-acetylcholine receptor antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk; Info: for anti-acetylcholine receptor antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [>100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk; Info: for anti-acetylcholine receptor antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
neuromyelitis optica spectrum disorder
- [40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk; Info: for anti-aquaporin-4 antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk; Info: for anti-aquaporin-4 antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [>100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk; Info: for anti-aquaporin-4 antibody positive pts; if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-888-765-4747 or www.ultsolrems.com for more info]
Special Note
- [formulation clarification]
- Info: nonproprietary name = ravulizumab-cwvz
paroxysmal nocturnal hemoglobinuria
- [1 mo and older, 5-9 kg]
- Dose: 600 mg IV x1, then after 2wk, 300 mg IV q4wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 10-19 kg]
- Dose: 600 mg IV x1, then after 2wk, 600 mg IV q4wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 20-29 kg]
- Dose: 900 mg IV x1, then after 2wk, 2100 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 30-39 kg]
- Dose: 1200 mg IV x1, then after 2wk, 2700 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [1 mo and older, 60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [1 mo and older, >100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
atypical hemolytic uremic syndrome
- [1 mo and older, 5-9 kg]
- Dose: 600 mg IV x1, then after 2wk, 300 mg IV q4wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 10-19 kg]
- Dose: 600 mg IV x1, then after 2wk, 600 mg IV q4wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 20-29 kg]
- Dose: 900 mg IV x1, then after 2wk, 2100 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 30-39 kg]
- Dose: 1200 mg IV x1, then after 2wk, 2700 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose
- [1 mo and older, 40-59 kg]
- Dose: 2400 mg IV x1, then after 2wk, 3000 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [1 mo and older, 60-99 kg]
- Dose: 2700 mg IV x1, then after 2wk, 3300 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
- [1 mo and older, >100 kg]
- Dose: 3000 mg IV x1, then after 2wk, 3600 mg IV q8wk for at least 6mo; Info: if switching from eculizumab, give 1st dose at next scheduled eculizumab dose; see pkg insert for supplemental dose if plasma exchange, plasmapheresis, or IVIG
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]