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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 patients not up to date with meningococcal vaccines, and administer vaccines ASAP; comply with ACIP recommendations for meningococcal vaccination in patients 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 evaluate 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
- [drug name 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 patients; 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 patients; 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 patients; 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 patients; 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 patients; 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 patients; 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
- [drug name 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]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- N. meningitidis infection, active serious
- patients unvaccinated against N. meningitidis
- avoid: breastfeeding during tx and x8mo after D/C
- caution: patients unvaccinated against Streptococcus pneumoniae
- caution: patients unvaccinated against Haemophilus influenza type b
- caution: systemic infection, active
- caution: upon D/C
- caution: patients switching from crovalimab within 5.5 crovalimab half-lives (paroxysmal nocturnal hemoglobinuria use)
Drug Interactions .
Overview
ravulizumab
complement inhibitor
- immunomodulatory effects
Contraindicated
- BCG live intravesical
- talimogene laherparepvec
Avoid/Use Alternative
- abrocitinib
- anifrolumab
- cladribine oral
- crovalimab
- deuruxolitinib
- efgartigimod alfa
- etrasimod
- infliximab
- natalizumab
- nipocalimab
- pimecrolimus topical
- ritlecitinib
- rozanolixizumab
- ruxolitinib topical
- upadacitinib
Monitor/Modify Tx
- carfilzomib
- everolimus
- immune globulin
- mitomycin
- sipuleucel-T
Caution Advised
- abatacept
- abemaciclib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- carboplatin
- carmustine
- certolizumab pegol
- chlorambucil
- ciclesonide
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- coccidioides immitis skin test antigen
- copanlisib
- corticotropin
- cortisone
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- delgocitinib topical
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- etuvetidigene autotemcel
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loteprednol ophthalmic
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mirikizumab
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nadofaragene firadenovec intravesical
- narsoplimab
- nelarabine
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- regorafenib
- relacorilant
- rilonacept
- rilzabrutinib
- risankizumab
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- meningococcal infection
- Streptococcus pneumoniae infection
- Haemophilus influenzae infection
- Neisseria gonorrhoeae infection
- infection, serious
- sepsis
- hyperthermia
- intracranial hemorrhage
- HTN
- infusion reaction
- hypersensitivity reaction
- anaphylaxis
- hemolysis upon D/C (paroxysmal nocturnal hemoglobinuria use)
- thrombotic microangiopathy upon D/C (atypical hemolytic uremic syndrome use)
Common Reactions
- URI
- headache
- diarrhea
- fever
- nausea
- abdominal pain
- arthralgia
- extremity pain
- vomiting
- HTN
- constipation
- cough
- dyspnea
- gastroenteritis
- dizziness
- anemia
- peripheral edema
- UTI
- anxiety
- fatigue
- back pain
- viral infection
- infusion reaction
- myalgia
- lymphadenopathy
- ALT or AST incr. (atypical hemolytic uremic syndrome use)
- bilirubin incr. (atypical hemolytic uremic syndrome use)
Safety/Monitoring .
Monitoring Parameters
PNH: signs/symptoms of infusion reaction during and for at least 1h after infusion; signs/symptoms of meningococcal infection during tx and x8mo after D/C; Hgb, LDH, signs/symptoms of hemolysis for at least 16wk after D/C; signs/symptoms of type III hypersensitivity reaction x30 days after tx start if switching from crovalimab
aHUS: signs/symptoms of infusion reaction during and for at least 1h after infusion; signs/symptoms of meningococcal infection during tx and x8mo after D/C; Cr, LDH, Plt, signs/symptoms of thrombotic microangiopathy for at least 12mo after D/C
All Other Indications: signs/symptoms of infusion reaction during and for at least 1h after infusion; signs/symptoms of meningococcal infection during tx and x8mo after D/C
Pregnancy/Lactation .
Pregnancy
Clinical Summary
benefits outweigh risks during pregnancy; risk of fetal harm low based on limited human data with other complement inhibitors
Pregnancy Registry
encourage patients to enroll in Pregnancy Exposure Registry at 1-833-793-0563 or www.UltomirisPregnancyStudy.com
Lactation
Clinical Summary
avoid breastfeeding during tx and x8mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for ravulizumab: unknown; CYP450: unknown
Excretion: for ravulizumab: unknown; Half-life: 49.6-64.3 days
Subclass: Complement Inhibitors, Hematologic ; Complement Inhibitors, Neurologic ; Myasthenia Gravis ; Neuromyelitis Optica Spectrum Disorder
Mechanism of Action
for ravulizumab: selectively binds complement protein C5, inhibiting cleavage to C5a and C5b, preventing terminal complement complex C5b-9 generation (monoclonal antibody)
Formulary .
No Formulary Selected
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