inebilizumab (Rx)

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

AdultPediatric

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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Interactions

Interaction Checker

and inebilizumab

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • isavuconazonium sulfate

                  inebilizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Urinary tract infection (11%)

                  1-10%

                  Arthralgia (10%)

                  Infusion-related reaction, first dose (9.3%)

                  Headache (8%)

                  Back pain (7%)

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

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                  Warnings

                  Contraindications

                  History of life-threatening infusion reaction to inebilizumab

                  Active HBV infection

                  Active or untreated latent TB

                  Cautions

                  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

                  Infections

                  • 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
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                  Pregnancy & Lactation

                  Pregnancy

                  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

                  Contraception

                  • 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

                  Lactation

                  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.

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                  Pharmacology

                  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

                  Absorption

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

                  AUC: 2980 mcg⋅d/mL

                  Distribution

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

                  Metabolism

                  Degraded by proteolytic enzymes widely distributed in the body

                  Elimination

                  Half-life: 18 days

                  Clearance: 0.19 L/day

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                  Administration

                  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 (productsafety@vielabio.com)

                  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

                  Storage

                  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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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.