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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (7)
- axicabtagene ciloleucel
inebilizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
inebilizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
inebilizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
inebilizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
inebilizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
inebilizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- upadacitinib
inebilizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Monitor Closely (5)
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of inebilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of inebilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- isavuconazonium sulfate
inebilizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of inebilizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- ublituximab
ublituximab and inebilizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
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%)
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
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.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
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
Images
Formulary
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