inebilizumab (Rx)

Brand and Other Names:Uplizna, inebilizumab-cdon
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Dosing & Uses


Dosage Forms & Strengths

injection, solution

  • 100mg/10mL (10mg/mL) single-dose vials

Neuromyelitis Optica Spectrum Disorder

Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are antiaquaporin-4 (AQP4) antibody positive

Initial doses: 300 mg IV x 1 dose; follow 2 weeks later by a second 300-mg IV infusion

Subsequent doses (starting 6 months from first infusion): 300 mg IV q6Months

Premedication before each infusion

  • 30 minutes before
    • IV corticosteroid (eg, methylprednisolone 80-125 mg or equivalent)
  • 30-60 minutes before
    • PO antihistamine (eg, diphenhydramine 25-50 mg or equivalent)
    • PO antipyretic (eg, acetaminophen 500-650 mg)

Dosage Modifications

Renal or hepatic impairment

  • Clinical studies not conducted

Dosing Considerations

Assessments before first dose

  • Hepatitis B virus (HBV) screening
    • Contraindicated with active HBV infection confirmed by positive results for surface antigen (HBsAg) and anti-HBV tests
    • For patients who are negative for HBsAg and positive for HB core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult liver disease experts before initiating and during treatment
  • Serum immunoglobulins
    • Perform testing for quantitative serum immunoglobulins
    • For patients with low serum immunoglobulins, consult immunology experts before initiating
  • Tuberculosis (TB) screening
    • Evaluate for active TB and test for latent infection
    • For patients with active TB or positive TB screening without a history of appropriate treatment, consult infectious disease experts before initiating
  • Vaccinations
    • Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion
    • Administer all immunizations according to immunization guidelines at least 4 weeks before initiating inebilizumab for live or live-attenuated vaccines

Safety and efficacy not established



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            Adverse Effects


            Urinary tract infection (11%)


            Arthralgia (10%)

            Infusion-related reaction, first dose (9.3%)

            Headache (8%)

            Back pain (7%)

            Decreased neutrophils, 1-1.5 x109/L (6.9%)




            History of life-threatening infusion reaction to inebilizumab

            Active HBV infection

            Active or untreated latent TB


            Progressive and prolonged hypogammaglobulinemia may occur; monitor levels of quantitative serum immunoglobulins during treatment and until B-cell repletion after discontinuation of therapy, especially in patients with opportunistic or recurrent infections; consider discontinuing if low IgG or IgM develops or a serious infection

            Based on animal data, can cause fetal harm owing to B-cell lymphopenia

            Infusion reactions

            • Can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other signs or symptoms
            • Reactions are most common with initial infusion, but were also observed during subsequent infusions
            • Premedication with IV corticosteroid, antihistamine, and antipyretic required before every infusion
            • For life-threatening infusion reactions, immediately and permanently discontinue and administer appropriate supportive treatment
            • For less severe infusion reactions, management may involve temporarily stopping infusion, reducing infusion rate, and/or administering symptomatic treatment


            • Increased risk infections observed with other B-cell-depleting therapies
            • Risks include additive effects if coadministered with other immunosuppressants, HBV reactivation, progressive multifocal leukoencephalopathy, TB reactivation, or risk from live virus administration

            Drug interaction overview

            • Immunosuppressive drugs
              • Coadministration with immunosuppressant drugs, including systemic corticosteroids, may increase risk of infection
            • Vaccines
              • Administer all needed vaccines at least 4 weeks before initiating inebilizumab
              • Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion
            • Vaccination of infants born to mothers treated during pregnancy
              • Do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant
              • Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines
              • Nonlive vaccines, as indicated, may be administered before recovery from B-cell and immunoglobulin level depletion; consider consultation with a qualified specialist to assess whether a protective immune response was mounted

            Pregnancy & Lactation


            Humanized IgG1 monoclonal antibody and immunoglobulins are known to cross the placental barrier

            Data are not available on developmental risk associated with use in pregnant females; however, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy

            The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown


            • Females of childbearing potential should use contraception during therapy and for 6 months after the last infusion

            Animal data

            • Administration to mice q3days throughout organogenesis and lactation resulted in depletion of B cells and persistent reductions in immune function (even following repletion of B cells and lasting into adulthood) in offspring


            Data are not available on presence in human milk, effects on breastfed infants, or on milk production

            Human IgG is excreted in human milk, and the potential for absorption of inebilizumab to lead to B-cell depletion in the breastfed infant is unknown

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.



            Mechanism of Action

            Monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells; after binding to CD19, these cells are rapidly depleted from circulation

            In NMOSD, ~80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4); these AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system; binding of AQP4-IgG antibodies to CNS cells is believed to trigger attacks, which can damage the optic nerve, spinal cord, and brain


            Peak plasma concentration: 108 mcg/mL (second dose on Day 15)

            AUC: 2980 mcg⋅d/mL


            Vd: 2.95 L (central); 2.57 L (peripheral)


            Degraded by proteolytic enzymes widely distributed in the body


            Half-life: 18 days

            Clearance: 0.19 L/day



            IV Compatibilities

            0.9% NaCl

            IV Preparation

            Must be diluted before administration

            Before starting IV infusion, prepared infusion solution should be at room temperature

            Visually inspect solution for particulate matter and discoloration; solution should appear clear to slightly opalescent, colorless to slightly yellow

            If solution is cloudy, discolored, or contains discrete particulate matter, do not use and contact the manufacturer (

            Do not shake vial

            Withdraw 10 mL inebilizumab from each of the 3 vials contained in the carton and transfer a total of 30 mL into a 250-mL IV bag of 0.9% NaCl

            Do not use other diluents to dilute

            Mix diluted solution by gentle inversion; do not shake

            Discard unused portion remaining in vials

            IV Administration

            Assess for active infection; if present, delay inebilizumab infusion until infection resolves

            Administer premedications starting 30-60 minutes before inebilizumab infusion

            Administer prepared inebilizumab solution IV via infusion pump at an increasing rate to completion, ~90 minutes

            Close supervision by healthcare profession with access to appropriate emergency treatment is needed to manage potential reactions (eg, serious infusion reaction)

            Administer through an IV line containing a sterile, low-protein–binding (0.2 or 0.22 micron) in-line filter

            Monitor closely for infusion reactions during and for at least 1 hr after infusion completed

            Infusion rate recommendations

            • 0-30 minutes: 42 mL/hr
            • 31-60 minutes: 125 mL/hr
            • 61 minutes to completion: 333 mL/hr


            Contains no preservative

            Unopened vial

            • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
            • Do not freeze
            • Do not shake
            • Store vials upright

            Diluted solution for infusion

            • Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr or at room temperature at 20-25ºC (68-77ºF) for up to 4 hr prior to starting infusion


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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.