| Paroxysmal nocturnal hemoglobinuria
Ultomiris vs Fabhalta
Side-by-side clinical, coverage, and cost comparison for paroxysmal nocturnal hemoglobinuria.Deep comparison between: Ultomiris vs Fabhalta with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsFabhalta has a higher rate of injection site reactions vs Ultomiris based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Fabhalta but not Ultomiris, including UnitedHealthcare
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Category
Ultomiris
Fabhalta
At A Glance
IV infusion
Every 4-8 weeks
C5 complement inhibitor
Oral
Twice daily
Factor B inhibitor
Indications
- Paroxysmal nocturnal hemoglobinuria
- Atypical Hemolytic Uremic Syndrome
- Myasthenia Gravis, Generalized
- Neuromyelitis Optica
- Paroxysmal nocturnal hemoglobinuria
- IGA Glomerulonephritis
- Complement 3 Glomerulopathies
Dosing
Paroxysmal nocturnal hemoglobinuria, Atypical Hemolytic Uremic Syndrome (5 to <40 kg) Weight-based IV loading dose (600-1,200 mg), followed by weight-based maintenance dose every 4 weeks (5 to <20 kg) or every 8 weeks (20 to <40 kg), starting 2 weeks after loading dose.
Paroxysmal nocturnal hemoglobinuria, Atypical Hemolytic Uremic Syndrome, Myasthenia Gravis, Generalized, Neuromyelitis Optica (>=40 kg) Weight-based IV loading dose (2,400-3,000 mg), followed by weight-based maintenance dose (3,000-3,600 mg) every 8 weeks, starting 2 weeks after loading dose.
Paroxysmal nocturnal hemoglobinuria, IGA Glomerulonephritis, Complement 3 Glomerulopathies 200 mg orally twice daily without regard to food; swallow capsules whole.
PNH Patients Switching From Anti-C5 Initiate FABHALTA no later than 1 week after last eculizumab dose or no later than 6 weeks after last ravulizumab dose.
Contraindications
- Unresolved serious Neisseria meningitidis infection
- Serious hypersensitivity to iptacopan or any of the excipients
- Unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b (contraindicated for initiation)
Adverse Reactions
Most common (>=10%) Upper respiratory tract infection, headache, diarrhea, nausea, vomiting, hypertension, pyrexia, back pain, arthralgia, COVID-19
Serious Meningococcal infections, other infections (including fatal COVID-19 pneumonia and sepsis), infusion-related reactions
Postmarketing Anaphylaxis, cholestatic or mixed pattern liver injury with increased serum liver enzymes and bilirubin
Most common (>=10%) headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, rash
Serious serious infections caused by encapsulated bacteria, hyperlipidemia
Pharmacology
Ravulizumab-cwvz is a terminal complement inhibitor that specifically binds complement protein C5 with high affinity, preventing its cleavage to C5a (proinflammatory anaphylatoxin) and C5b (initiating subunit of the membrane attack complex), thereby inhibiting MAC formation and terminal complement-mediated tissue damage in PNH, aHUS, gMG, and NMOSD.
Factor B inhibitor; iptacopan binds to Factor B of the alternative complement pathway, regulating C3 cleavage and inhibiting downstream effectors to control both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis in PNH, and to inhibit complement-driven glomerular injury in IgAN and C3G.
Enter your patient's insuranceCheck specific coverage details for your patient.
Most Common Insurance
Anthem BCBS
Ultomiris
- Covered on 5 commercial plans
- PA (9/12) · Step Therapy (9/12) · Qty limit (0/12)
Fabhalta
- Covered on 5 commercial plans
- PA (9/12) · Step Therapy (9/12) · Qty limit (9/12)
UnitedHealthcare
Ultomiris
- Covered on 4 commercial plans
- PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
Fabhalta
- Covered on 4 commercial plans
- PA (5/8) · Step Therapy (4/8) · Qty limit (5/8)
Humana
Ultomiris
- Covered on 0 commercial plans
- PA (1/3) · Step Therapy (0/3) · Qty limit (0/3)
Fabhalta
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (2/3) · Qty limit (3/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
No savings programs available for Ultomiris.
Cost estimate not availableAssistance Fund: Immunoglobulin A Nephropathy (IgAN)
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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UltomirisView full Ultomiris profile
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.