Version July 2025
Dosage guidance:
Safety: Administer all vaccines at least 4 weeks prior to initiation of inebilizumab. Obtain quantitative serum immunoglobulins and screen for hepatitis B virus (hepatitis B surface antigen and anti-hepatitis B core antibody measurements) and tuberculosis (TB) disease (active TB) prior to inebilizumab initiation.
Clinical considerations: Premedicate with antihistamine (eg, diphenhydramine 25 to 50 mg orally or equivalent) 30 to 60 minutes prior to infusion, antipyretic (eg, acetaminophen 500 to 650 mg orally) 30 to 60 minutes prior to infusion, and corticosteroid (eg, methylprednisolone 80 to 125 mg IV or equivalent) 30 minutes prior to each infusion to prevent and/or reduce severity of infusion-related reactions.
Immunoglobulin G4-related disease: IV: 300 mg on day 1, followed by 300 mg 2 weeks later; subsequent doses of 300 mg are administered once every 6 months (beginning 6 months after the first 300 mg dose).
Neuromyelitis optica spectrum disorder: IV: 300 mg on day 1, followed by 300 mg 2 weeks later; subsequent doses of 300 mg are administered once every 6 months (beginning 6 months after the first 300 mg dose).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
B-cell-depleting antibodies, including inebilizumab, are associated with an increased risk for infection, including urinary tract infection, nasopharyngitis, upper respiratory tract infection, and influenza.
While hepatitis B virus (HBV) reactivation has been described with other B-cell-depleting antibodies, patients with chronic HBV infection were excluded from clinical trials and HBV reactivation was, therefore, not observed with inebilizumab. In addition, John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy, as well as reactivation of tuberculosis infection, has been described with other B-cell-depleting antibodies and is considered a theoretical concern with inebilizumab therapy.
Mechanism: Dose-related; related to the pharmacologic action (targets and depletes CD19-expressing B cells through antibody-dependent cellular cytolysis).
Risk factors:
• Active infection (including chronic HBV infection and tuberculosis infection)
Inebilizumab may cause infusion-related reactions, which are most often mild to moderate in severity (Ref); symptoms may include headache, nausea, somnolence, dyspnea, fever, myalgia, and rash.
Mechanism: Non–dose-related; exact mechanism has not been established.
Onset: Rapid. Most commonly occurs during first infusion; however, may occur with any dose.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Genitourinary: Urinary tract infection (11%)
|
Drug (Inebilizumab) |
Placebo |
Number of Patients (Inebilizumab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
11% |
10% |
161 |
52 |
Hematologic & oncologic: Decreased neutrophils (2% to 12%)
1% to 10%:
Hematologic & oncologic: Lymphocytopenia (5%)
Immunologic: Antibody development (6%)
Neuromuscular & skeletal: Arthralgia (10%), back pain (7%)
Frequency not defined: Hematologic & oncologic: Decreased serum immunoglobulins
History of a life-threatening infusion reaction to inebilizumab; active hepatitis B infection; tuberculosis (TB) disease (active TB) or untreated TB infection (latent TB).
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to inebilizumab or any component of the formulation; history of progressive multifocal leukoencephalopathy; severely immunocompromised; malignancy (active).
Concerns related to adverse effects:
• Hepatitis B reactivation: Consult liver disease specialist prior to starting and during treatment in patients who are chronic carriers of HBV (HBsAg+).
• Tuberculosis: Do not administer to patients with tuberculosis (TB) disease (active TB) or positive screening without appropriate treatment; consider infectious disease consult. Consider anti-TB therapy prior to treatment initiation in patients with a history of TB infection (latent TB) in whom an adequate course of TB treatment cannot be confirmed and for patients testing negative but having risk factors for TB.
Other warnings/precautions:
• Immunizations: Administer all immunizations at least 4 weeks prior to treatment initiation. Immunization with live-attenuated or live vaccines is not recommended during treatment or after discontinuation until B-cell repletion. Prior to administration of live-attenuated or live vaccinations in infants exposed to inebilizumab in utero, confirm recovery of B-cell counts. Non-live vaccines may be administered; however, consideration should be given to evaluating the immune response.
• Immunoglobulins: Progressive and prolonged hypogammaglobulinemia or declines in immunoglobulins (IgG, IgM) may occur with continued treatment. Prior to initiating therapy, assess quantitative serum immunoglobulin levels; consult immunology experts in patients with low levels. Monitor during therapy and after discontinuation of therapy until B-cell repletion, especially in patients with opportunistic or recurrent infections. Consider discontinuation if patients with low IgG or IgM develop severe opportunistic or recurrent infections or if prolonged hypogammaglobulinemia requires treatment with IV immunoglobulins.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Uplizna: Inebilizumab-cdon 100 mg/10 mL (10 mL) [contains polysorbate 80]
No
Solution (Uplizna Intravenous)
100 mg/10 mL (per mL): $5,609.94
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Uplizna: Inebilizumab-cdon 100 mg/10 mL (10 mL) [contains polysorbate 80]
IV: Administer by IV infusion via an infusion pump and using a low-protein binding 0.2 or 0.22 micron in-line filter. Prior to every infusion, assess for active infection; if present, delay infusion until infection resolves. Premedicate with antihistamine, antipyretic, and corticosteroid 30 to 60 minutes prior to infusion. Allow to reach room temperature prior to administration. Administer diluted infusion over ~90 minutes at an increasing rate: 42 mL/hour for first 30 minutes, followed by 125 mL/hour for the next 30 minutes, then 333 mL/hour until completion.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Uplizna: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf#page=17
Immunoglobulin G4-related disease: Treatment of immunoglobulin G4-related disease (IgG4-RD) in adults.
Neuromyelitis optica spectrum disorder: Treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Immunosuppressants (Cytotoxic Chemotherapy): May increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Immunosuppressants (Miscellaneous Oncologic Agents): May increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Immunosuppressants (Therapeutic Immunosuppressant Agents): May increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Methotrexate: May increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Females of reproductive potential should use effective contraception during therapy and for at least 6 months after the last inebilizumab dose.
Inebilizumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Based on data from animal reproduction studies, in utero exposure to inebilizumab may cause fetal harm. Transient B-cell depletion and lymphocytopenia may occur in infants following in utero exposure to inebilizumab.
Maternal neuromyelitis optica spectrum disorder (NMOSD) may be associated with adverse pregnancy outcomes. Information related to the treatment of NMOSD in pregnancy is limited; agents other than inebilizumab may be preferred (Borisow 2018; Chang 2020; Zhu 2020).
Data collection to monitor pregnancy and infant outcomes following exposure to inebilizumab is ongoing. Health care providers are encouraged to advise patients exposed to inebilizumab during pregnancy to register by contacting the UPLIZNA Pregnancy Registry (1-303-724-4644 or https://www.upliznapregnancyregistry.com).
It is not known if inebilizumab is present in breast milk. However, inebilizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Hepatitis B virus screening (HBsAg and anti-HBc measurements) prior to therapy initiation; quantitative serum immunoglobulins prior to therapy initiation, during therapy (especially in patients with severe opportunistic or recurrent infections), and after discontinuation of therapy until B-cell repletion; tuberculosis screening (disease [active] and infection [latent]) prior to initiation and signs/symptoms of TB disease during and after inebilizumab treatment; assess for active infection prior to each infusion; monitor infusion reactions during and for at least 1 hour following end of the infusion; monitor for signs/symptoms of infection and progressive multifocal leukoencephalopathy (eg, progressive weakness on one side of the body or clumsiness of limbs, vision disturbance, and changes in thinking, memory, and/or orientation leading to confusion and personality changes; MRI findings may be apparent prior to clinical signs/symptoms).
Inebilizumab is an anti-CD19 monoclonal antibody directed against pre-B and mature B-cell lymphocytes, which express the cell surface antigen CD19. Following binding to CD19, inebilizumab causes antibody-dependent cellular cytolysis.
Distribution: Vd: Central: 2.95 L; peripheral: 2.57 L.
Metabolism: Degraded by proteolytic enzymes widely distributed in the body.
Half-life elimination: Terminal: 18 days.
Excretion: Clearance: 0.19 L/day.
