Section 04 · Monograph
Inebilizumab
Reviewed Nov 2026FDA label
UpliznaAnti-CD19 mAb
- Forms
- IV: 100mg/10mL
- Dose
- 300mg IV, repeat in 2 weeks, then 300mg every 6 months
- MOA
- Depletes CD19+ B-cells
Indications
- Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positiveFDA-labeled
- Immunoglobulin G4-related disease (IgG4-RD) in adultsFDA-labeled
- Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positiveFDA-labeled
Mechanism of Action
- Humanized afucosylated IgG1 kappa monoclonal antibody directed against CD19, a cell-surface antigen expressed on pre-B and mature B lymphocytes, including plasmablasts and some plasma cells
- Binding to CD19 results in antibody-dependent cellular cytolysis and depletion of CD19-positive B cells
- Depletion of pathogenic AQP4-antibody-producing B-lineage cells is presumed to underlie efficacy in NMOSD
- Targets a broader range of B-lineage cells (including some antibody-secreting plasmablasts) than anti-CD20 agents, since CD19 is expressed later into plasma cell differentiation than CD20
Full Dosing
Adult / usual
- NMOSD: 300 mg IV infusion on Day 1, followed by a second 300 mg IV infusion 2 weeks later (Day 15)
- NMOSD maintenance: 300 mg IV every 6 months, starting 6 months after the first infusion of the initial dosing series
- Dilute in 250 mL normal saline and infuse over approximately 90 minutes using a stepped/escalating infusion rate
- Premedicate with a corticosteroid, antihistamine, and antipyretic prior to each infusion to reduce infusion-reaction risk
- Monitor patients during infusion and for at least 1 hour after completion
- Pretreatment screening for hepatitis B, tuberculosis, and immunoglobulin levels is required before initiation
Contraindications
- History of a life-threatening infusion reaction to inebilizumab-cdon
- Active hepatitis B infection
- Active or untreated latent tuberculosis
Drug Interactions
- Concomitant immunosuppressive or immune-modulating therapies may increase the risk of additive immunosuppression and infection
- Live-attenuated or live vaccines are not recommended during treatment and until B-cell repletion; complete all immunizations at least 4 weeks before starting inebilizumab
- No formal cytochrome P450 drug-drug interaction studies conducted; not expected given monoclonal antibody pharmacology
Adverse Effects
- Urinary tract infection (~20% vs ~10% placebo)
- Arthralgia (~11% vs ~4% placebo)
- Nasopharyngitis (~13%)
- Infusion reactions (~12%)
- Headache (~10%)
- Back pain
- Nausea
Monitoring Parameters
- Screen for hepatitis B (HBsAg, anti-HBc) and tuberculosis before initiating therapy
- Screen serum immunoglobulin levels before, during, and after treatment; monitor for hypogammaglobulinemia
- Monitor closely during and for at least 1 hour after each infusion for infusion reactions/anaphylaxis
- Monitor for signs/symptoms of infection, including progressive multifocal leukoencephalopathy (new/worsening weakness, vision changes, cognitive or personality changes)
- Delay dosing in patients with active infection
Pregnancy & Lactation
- No adequate human pregnancy data are available; may cause fetal B-cell lymphocytopenia based on animal data
- Animal (monkey) studies demonstrated transient peripheral B-cell depletion and lymphocytopenia in offspring, with marked reduction of B cells in fetal blood and lymphoid tissue
- Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the final dose
- A pregnancy exposure registry is available (1-303-724-4644 or www.upliznapregnancyregistry.com)
- No data on presence of inebilizumab-cdon in human milk or effects on the breastfed infant or milk production; weigh developmental/health benefits of breastfeeding against the mother's clinical need for therapy and potential infant B-cell depletion