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Empaveli
pegcetacoplan
Black Box Warnings .
Appropriate Use
restricted distribution program (EMPAVELI REMS) due to risk of serious infections; prescribers must enroll at 1-888-343-7073 or at www.empavelirems.com
Serious Infections
may occur, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B; life-threatening and fatal cases have occurred with complement inhibitors; may become rapidly life-threatening or fatal if not recognized and treated early; complete or update vaccination for encapsulated bacteria at least 2wk before tx start, unless tx delay risks outweigh serious infection risk; give antibacterial prophylaxis if urgent tx indicated in patient not up to date with vaccines, and administer vaccines ASAP; comply with ACIP recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor; revaccinate per ACIP recommendations, considering tx duration; patients at incr. risk for invasive disease caused by encapsulated bacteria even if antibodies developed after vaccination; monitor for early signs of serious infection and evaluate immediately if infection suspected
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-888-343-7073 or www.empavelirems.com for more info]
paroxysmal nocturnal hemoglobinuria
- [1080 mg SC 2x/wk]
- Info: if switching from eculizumab, initiate 1st pegcetacoplan dose 4wk before last eculizumab dose; if switching from ravulizumab, initiate 1st pegcetacoplan dose within 4wk after last ravulizumab dose; incr. dose to 1080 mg SC q3 days if LDH >2x ULN
complement 3 glomerulopathy
- [1080 mg SC 2x/wk]
immune-complex membranoproliferative glomerulonephritis, primary
- [1080 mg SC 2x/wk]
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-888-343-7073 or www.empavelirems.com for more info]
complement 3 glomerulopathy
- [12 yo and older, <35 kg]
- Dose: 648 mg SC 2x/wk; Start: 540 mg SC 2x/wk x2 doses
- [12 yo and older, 35-49 kg]
- Dose: 810 mg SC 2x/wk; Start: 648 mg SC x1 dose
- [12 yo and older, >50 kg]
- Dose: 1080 mg SC 2x/wk
immune-complex membranoproliferative glomerulonephritis, primary
- [12 yo and older, <35 kg]
- Dose: 648 mg SC 2x/wk; Start: 540 mg SC 2x/wk x2 doses
- [12 yo and older, 35-49 kg]
- Dose: 810 mg SC 2x/wk; Start: 648 mg SC x1 dose
- [12 yo and older, >50 kg]
- Dose: 1080 mg SC 2x/wk
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- encapsulated bacterial infection, active serious
- N. meningitidis infection, active serious
- Streptococcus pneumoniae infection, active serious
- Haemophilus influenzae infection, active serious
- patients unvaccinated against N. meningitidis
- patients unvaccinated against Streptococcus pneumoniae
- avoid: breastfeeding during tx and x40 days after D/C
- caution: patients of childbearing potential
- caution: systemic infection, active
- caution: upon D/C (paroxysmal nocturnal hemoglobinuria use)
Drug Interactions .
Overview
pegcetacoplan
complement inhibitor
- immunomodulatory effects
Contraindicated
- BCG live intravesical
- talimogene laherparepvec
Avoid/Use Alternative
- cladribine oral
- etrasimod
- natalizumab
- pimecrolimus topical
Monitor/Modify Tx
- carfilzomib
- everolimus
- mitomycin
- sipuleucel-T
Caution Advised
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- 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
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- decitabine
- deflazacort
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- 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
- infliximab
- 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
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pentostatin
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- ravulizumab
- regorafenib
- relacorilant
- rilonacept
- rilzabrutinib
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- 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
- upadacitinib
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- meningococcal infection
- Streptococcus pneumoniae infection
- Haemophilus influenzae infection
- infection, serious
- septic shock
- biliary sepsis
- intestinal ischemia
- HTN
- infusion reaction
- hypersensitivity reaction
- anaphylaxis
- pneumonitis, hypersensitivity
- acute kidney injury
- thrombocytopenia
- hemolysis upon D/C (paroxysmal nocturnal hemoglobinuria use)
Common Reactions
- injection site reaction
- infection
- diarrhea
- abdominal pain
- nasopharyngitis
- respiratory infection
- hypokalemia
- viral infection
- extremity pain
- fatigue
- cough
- arthralgia
- dizziness
- rash
- headache
- nausea
- fever
- oropharyngeal pain
- chest pain
- back pain
- thrombocytopenia
- epistaxis
- ecchymosis
- erythema
- peripheral edema
- HTN
- somnolence
- Cr incr.
- abdominal distension
- acute kidney injury
- anxiety
- myalgia
Safety/Monitoring .
Monitoring Parameters
Paroxysmal Nocturnal Hemoglobinuria: pregnancy test at baseline; LDH at baseline, then periodically during tx or 2x/wk for at least 4wk if dose incr; signs/symptoms of serious infection during tx and x2mo after D/C; Hgb, LDH, signs/symptoms of hemolysis for at least 8wk after D/C
Complement 3 Glomerulopathy and Primary Immune-complex Membranoproliferative Glomerulonephritis: pregnancy test at baseline; signs/symptoms of serious infection during tx and x2mo after D/C
Pregnancy/Lactation .
Pregnancy
Clinical Summary
benefits outweigh risks during pregnancy; inadequate human data available; possible risk of embryo-fetal toxicity and death based on animal data at 2.9x systemic exposure
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x40 days after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x40 days after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for pegcetacoplan: catabolism; CYP450: unknown
Excretion: for pegcetacoplan: unknown; Half-life: 8.6-10.8 days
Subclass: Complement Inhibitors, Hematologic ; Complement Inhibitors, Nephrological
Mechanism of Action
for pegcetacoplan: in paroxysmal nocturnal hemoglobinuria, binds complement protein C3 and C3b, inhibiting C3 cleavage and its downstream complement activation cascade, preventing C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis; in C3 glomerulopathy or immune-complex membranoproliferative glomerulonephritis, binds complement protein C3 and C3b, inhibiting C3 activation, reducing C3 glomerular fragment deposition, and decreasing C5 convertase activity and C5b-9 assembly
Formulary .
No Formulary Selected
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