Version May 2024
Note: Safety: Prior to initiating therapy, screen all patients for hepatitis B virus (hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [anti-HBc] tests), and screen for latent infections (eg, hepatitis, tuberculosis) in high-risk populations or in countries with a high tuberculosis burden. For patients who screen positive for latent infections, consult infectious disease or other appropriate specialists (eg, liver specialists) regarding treatment options before initiating therapy (Ref). Assess for infection prior to treatment initiation; delay treatment in patients with an active infection until the infection is resolved. Premedication: Premedicate with methylprednisolone 100 mg IV (or equivalent oral dosage or equivalent corticosteroid) 30 minutes prior to each infusion, and an antihistamine (eg, diphenhydramine) 30 to 60 minutes prior to each infusion to reduce frequency and severity of infusion reactions. May also consider premedication with an antipyretic (eg, acetaminophen).
Multiple sclerosis, relapsing: IV: 150 mg once on day 1, followed by 450 mg once 2 weeks later; subsequent doses of 450 mg are administered once every 24 weeks (beginning 24 weeks after the first dose of 150 mg) (Ref).
Missed doses: If a dose is missed, administer as soon as possible (do not wait until the next scheduled dose), then adjust the dose schedule to administer the next sequential dose 24 weeks after the missed infusion was administered. Doses must be separated by at least 5 months.
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.
There are no dosage adjustments provided in the manufacturer's labeling.
Hypogammaglobulinemia (prolonged, requiring IV immune globulin treatment or associated with severe opportunistic or recurrent infections): Consider discontinuation of therapy.
Infection, active: Delay administration until resolution of infection.
Infusion reactions:
Mild to moderate reactions: Reduce infusion rate to 50% of the rate at which the reaction occurred. If tolerated for at least 30 minutes, return to original infusion rate titration until completion of infusion.
Severe reactions: Immediately stop infusion and administer supportive treatment. Following complete symptom resolution, restart infusion rate at 50% the rate at which the onset of the infusion reaction occurred. If tolerated, may return to original infusion rate titration as appropriate until completion of infusion (see "Administration").
Life-threatening or disabling reactions: Immediately stop infusion and permanently discontinue therapy.
Progressive multifocal leukoencephalopathy:
Signs/symptoms suggestive of progressive multifocal leukoencephalopathy: Withhold therapy and perform diagnostic evaluation.
Confirmed progressive multifocal leukoencephalopathy: Discontinue therapy.
Refer to adult dosing.
Infection commonly occurs with ublituximab use. In clinical studies, most infections were upper respiratory tract infection and were mild to moderate in severity; serious infection was also reported. Viral infection, including herpes virus infection and reactivation of HBV, has also been rarely reported in clinical studies. Progressive multifocal leukoencephalopathy due to John Cunningham virus has been reported with other anti-CD20 antibodies.
Mechanism: Dose-related; anti-CD20 antibodies result in depletion of circulating B-cells and decreased immunoglobulin M, which can increase susceptibility to infection (Ref).
Risk factors:
• Treatment with immunosuppressive therapy before or after ublituximab
• Older age (potential risk factor) (Ref)
• Longer treatment duration (potential risk factor) (Ref)
• Comorbid conditions (potential risk factor) (Ref)
• Higher Expanded Disability Status Scale score (potential risk factor) (Ref)
Infusion-related reactions have been reported with ublituximab. Reactions may include fever, chills, headache, influenza-like illness, tachycardia, nausea, erythema, and anaphylactic reactions. Severe infusion-related reactions, including reactions requiring hospitalization, have also been rarely reported with ublituximab.
Mechanism: Not clearly established; possibly due to cytokine-release from B and NK cells (Ref)
Onset: Rapid; highest incidence within 24 hours following infusion
Risk factors:
• First infusion
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Hematologic & oncologic: Decreased neutrophils (15%), decreased serum immunoglobulins (IgA and IgG: 2% to 6%; IgM: 21%)
Hypersensitivity: Infusion-related reaction (48%; severe infusion-related reaction: <1%) (table 1)
|
Drug (Ublituximab) |
Comparator (Teriflunomide) |
Number of Patients (Ublituximab) |
Number of Patients (Teriflunomide) |
|---|---|---|---|
|
48% |
12% |
545 |
548 |
Infection: Infection (56%; serious infection: 5%) (table 2)
|
Drug (Ublituximab) |
Comparator (Teriflunomide) |
Number of Patients (Ublituximab) |
Number of Patients (Teriflunomide) |
|---|---|---|---|
|
56% |
54% |
545 |
548 |
|
Serious infection: 5% |
Serious infection: 3% |
545 |
548 |
Respiratory: Upper respiratory tract infection (45%) (table 3)
|
Drug (Ublituximab) |
Comparator (Teriflunomide) |
Number of Patients (Ublituximab) |
Number of Patients (Teriflunomide) |
|---|---|---|---|
|
45% |
41% |
545 |
548 |
1% to 10%:
Genitourinary: Urinary tract infection (10%)
Infection: Herpes virus infection (6%) (table 4)
|
Drug (Ublituximab) |
Comparator (Teriflunomide) |
Number of Patients (Ublituximab) |
Number of Patients (Teriflunomide) |
|---|---|---|---|
|
6% |
5% |
545 |
548 |
Nervous system: Fatigue (5%), insomnia (6%)
Neuromuscular & skeletal: Limb pain (6%)
Respiratory: Lower respiratory tract infection (9%)
Frequency not defined: Infection: Reactivation of HBV
Postmarketing: Infection: Bacterial infection, viral infection
History of life-threatening infusion reaction to ublituximab; active hepatitis B virus (HBV) infection.
Concerns related to adverse effects:
• Progressive multifocal leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the John Cunningham virus (JCV), typically only occurring in patients who are immunocompromised, and usually leads to death or severe disability. Although PML has not been reported in patients treated with ublituximab, JCV infection leading to PML has occurred in patients treated with other anti-CD20 antibodies and other therapies for multiple sclerosis. Symptoms of PML progress over days to weeks and may include progressive weakness on one side of the body or clumsiness of limbs, vision disturbances, and mental status changes. Cases of PML have been diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid without specific PML signs/symptoms.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Other warnings/precautions:
• Immunizations: Administer live-attenuated or live vaccines at least 4 weeks and non-live vaccines at least 2 weeks prior to treatment initiation. Avoid live-attenuated or live vaccines during treatment or after discontinuation until B-cell repletion; consider using live-attenuated vaccines only if risk of infection is high and non-live vaccines are unavailable (AAN [Farez 2019]). Ublituximab may interfere with the effectiveness of non-live vaccines. Prior to administration of live-attenuated or live vaccinations in infants exposed to ublituximab in utero, confirm recovery of B-cell counts. Administer inactivated or non-live vaccines as indicated, prior to B-cell recovery; consider assessment of vaccine immune response and consultation with qualified specialist to determine whether a protective immune response was mounted.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Briumvi: Ublituximab-xiiy 150 mg/6 mL (6 mL) [contains polysorbate 80]
No
Solution (Briumvi Intravenous)
150 mg/6 mL (per mL): $2,094.50
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IV: Premedicate with methylprednisolone 100 mg IV (or equivalent oral dosage or equivalent corticosteroid) 30 minutes prior to each infusion, and an antihistamine (eg, diphenhydramine) 30 to 60 minutes prior to each infusion to reduce frequency and severity of infusion reactions. May also consider premedication with an antipyretic (eg, acetaminophen). Infuse in an environment equipped to monitor for and manage severe infusion reactions.
Dose 1 (150 mg): Initiate infusion at 10 mL/hour for 30 minutes; if tolerated, increase to 20 mL/hour for 30 minutes; if tolerated, increase to 35 mL/hour for 60 minutes; if tolerated, increase to 100 mL/hour for the remainder of the infusion. Infusion duration: 4 hours.
Dose 2 and subsequent infusions (450 mg): Initiate infusion at 100 mL/hour for 30 minutes; if tolerated, increase to 400 mL/hour for the remainder of the infusion. Infusion duration: 1 hour.
Monitor for infusion reactions during infusion and observe for at least 1 hour after completion of first two infusions.
Multiple sclerosis, relapsing: Treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to 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: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 combination
Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Verify pregnancy status prior to treatment initiation. Pregnancy testing is recommended prior to each dose of ublituximab in patients who may become pregnant.
Patients who may become pregnant should use effective contraception during therapy and for 6 months after the last dose of ublituximab.
Ublituximab is a chimeric monoclonal antibody (IgG1) that may cross the placenta. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Based on data from animal reproduction studies, in utero exposure to ublituximab may cause fetal harm. Transient peripheral B-cell depletion and lymphocytopenia have been reported following in utero exposure to similar agents.
It is not known if ublituximab is present in breast milk.
Ublituximab is a chimeric monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
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.
Pregnancy testing (prior to each dose in patients who may become pregnant); infusion reaction (during infusion and for at least 1 hour after completion of first 2 infusions; additional monitoring as clinically appropriate), signs/symptoms of progressive multifocal leukoencephalopathy (PML), including progressive weakness on one side of the body or clumsiness of limbs, vision disturbances, and mental status changes; brain MRI (at first signs/symptoms suggestive of PML and as clinically indicated to monitor for early signs of PML).
Hepatitis B virus screening in all patients: Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) tests (prior to therapy initiation); do not administer to patients with active hepatitis B virus (HBV) confirmed by positive results for HBsAg and anti-HB tests; for patients who are negative for surface antigen (HBsAg) and positive for HB core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult a liver disease specialist prior to initiating and during therapy.
Active infection assessment (prior to each dose); latent infection screening (eg, hepatitis, tuberculosis) in high-risk populations or in countries with high tuberculosis burden (baseline) (AAN [Farez 2019]); quantitative serum immunoglobulins (at baseline and throughout treatment as clinically necessary, especially in patients with opportunistic or recurrent infections, after discontinuation of therapy until B-cell repletion).
Ublituximab is a chimeric IgG monoclonal antibody directed against the CD20 antigen on pre-B and mature B lymphocytes. Ublituximab binds to CD20 and results in cell lysis via complement-dependent cytolysis and antibody-dependent cellular cytolysis. B-cells are thought to affect the pathophysiology of multiple sclerosis through antigen presentation, pro-inflammatory cytokine production, soluble toxic factor production, contribution to formation of ectopic lymphoid aggregates in the meninges, and by providing an Epstein-Barr virus infection reservoir (Comi 2021).
Onset: Serum CD19+ B-cell counts (used as a marker for B-cell counts) are reduced within 24 hours after infusion.
Duration: Median time to CD19+ B-cell recovery (to baseline or the lower limit of normal): 70.3 weeks (range: 0.1 to 75.1 weeks).
Distribution: Central Vd: 3.18 L.
Metabolism: Expected pathway is degradation to small peptides and amino acids by proteolytic enzymes.
Half-life elimination: 22 days.
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