ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Inebilizumab

Monoclonal Antibodies

Sold as UPLIZNA

GB MHRAEU EMACA Health Canada

Drug class: Monoclonal Antibodies
Availability: See label
Routes: Intravenous
Markets covered: 3
Products on record: 4

L04AGMonoclonal Antibodies

Overview

Inebilizumab is an active pharmaceutical ingredient in the Monoclonal Antibodies group (L04AG). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	February 20, 2026
EU European Union	EMA	1	May 22, 2026
CA Canada	Health Canada	1	May 21, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised February 20, 2026[1]

1). 1).

How to take

GBOfficial regulatory label· revised February 20, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 22, 2026[2]

1). 1). 1). 3

How to take

EUOfficial regulatory label· revised May 22, 2026

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

UPLIZNAAMGEN CANADA INC

Drug interactions

Known interactions involving Inebilizumab. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB138320099 · revised February 20, 2026
[2]European Medicines Agency · EMEA/H/C/005818 · revised May 22, 2026
[3]Health Canada (DPD) · 02543931 · revised May 21, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]

7%) across both the randomised controlled period (RCP) and open-label period (OLP). 8%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials and post-marketing experience following treatment with inebilizumab are listed in table 2 according to the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Table 2. Adverse reactions reported in inebilizumab clinical trials, including patients with NMOSD and IgG4-RD as well as from post-marketing experience MedDRA system organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Infections and infestations Urinary tract infection, respiratory tract infection, nasopharingitis, influenza Pneumonia, cellulitis, herpes zoster, sinusitis Sepsis, subcutaneous abscess, bronchiolitis Blood and lymphatic system disorders Lymphopenia* Neutropenia, Late-on-set neutropenia Musculoskeletal and connective tissue disorders Arthralgia, back pain Myalgia General disorders and administration site conditions Pyrexia Investigations Immunoglobulins decreased Injury, poisoning and procedural complications Infusion-related reaction * Lymphopenia includes lymphocyte count decreased Description of selected adverse reactions Infusion-related reactions Inebilizumab can cause infusion-related reactions, which can include headache, nausea, somnolence, dyspnoea, fever, myalgia, rash, palpitations or other symptoms.
All patients were given premedication. 7% of placebo-treated patients. 9% of placebo-treated patients during the RCP. Infusion-related reactions were most common with the first infusion but were observed during subsequent infusions. The majority of infusion-related reactions reported in inebilizumab-treated patients were either mild or moderate in severity.
5% of IgG4-RD patients treated with inebilizumab across the RCP and OLP. 7%). 8%). 3%). 8%). 4 for action to be taken in case of infection. Opportunistic and serious infections In NMOSD study during the RCP, no opportunistic infections occurred in either treatment group, and a single Grade 4 infectious adverse reaction (atypical pneumonia) occurred in a patient treated with inebilizumab.
4%) experienced a grade 4 infectious adverse reaction. 4 for action to be taken in case of infection. 7%) experienced an opportunistic infection (all non-serious herpes zoster) across the RCP and OLP. Laboratory abnormalities Decreased immunoglobulins Consistent with its mechanism of action, average immunoglobulin levels decreased with inebilizumab use.
6% placebo. A single adverse reaction of IgG decreased was reported (grade 2, during the OLP). 9%. 6%. In IgG4-RD study at the end of the 12-month RCP, the total immunoglobulin level was reduced by approximately 12% from baseline for patients treated with inebilizumab as compared to an increase of 21% in patients treated with placebo.
The mean decreases from baseline in immunoglobulin G (IgG) and immunoglobulin M (IgM) were approximately 9% and 32%, respectively, in patients treated with inebilizumab, whereas IgG was increased by 26% and IgM was increased by approximately 3% in placebo-treated patients.
8% of placebo-treated patients. 7% of inebilizumab-treated patients versus 0% of placebo-treated patients. 5% of […]

GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]

Instructions for patients at the time of prescribing Patients treated with Uplizna should be given a patient card which includes information that inebilizumab treatment may increase the risk of infections, including serious infections, viral reactivation, opportunistic infections, and progressive multifocal leukoencephalopathy (PML), and how to seek early medical care in case of signs and symptoms of infection and PML.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions and hypersensitivity Inebilizumab can cause infusion-related reactions and hypersensitivity reactions, which can include headache, nausea, somnolence, dyspnoea, fever, myalgia, rash, palpitations or other symptoms.
Infusion-related reactions were most common with the first infusion but were also observed during subsequent infusions. 8). 2). During the infusion The patient should be monitored for infusion-related reactions. Management recommendations for infusion reactions depend on the type and severity of the reaction.
For life-threatening infusion reactions, treatment should be stopped immediately and permanently, and appropriate supportive treatment should be administered. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
After the infusion The patient should be monitored for infusion reactions for at least one hour after the completion of the infusion. Infections Inebilizumab causes reduction in peripheral blood lymphocyte count and Ig levels consistent with the mechanism of action of B-cell depletion.
Reduction of neutrophil counts were also reported. 8). e. within 6 months) complete blood cell count (CBC) including differentials and immunoglobulins should be obtained before initiation of inebilizumab. Assessments of CBC including differentials and immunoglobulins are also recommended periodically during treatment and after discontinuation of treatment until B-cell repletion.
Prior to every infusion of inebilizumab, it should be determined whether there is a clinically significant infection. In case of infection, infusion of inebilizumab should be delayed until the infection resolves. Patients should be instructed to promptly report symptoms of infection to their physician.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 22, 2026[2]

3%) across both the randomised controlled period (RCP) and open-label period (OLP). 8%). 10 Tabulated list of adverse reactions Adverse reactions reported in clinical trials and post-marketing experience following treatment with inebilizumab are listed in table 2 according to the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Table 2. Adverse reactions reported in inebilizumab clinical trials, including patients with NMOSD, gMG and IgG4-RD as well as from post-marketing experience MedDRA system organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Infections and infestations Urinary tract infection, respiratory tract infection, nasopharingitis, influenza Pneumonia, cellulitis, herpes zoster, sinusitis Sepsis, subcutaneous abscess, bronchiolitis Blood and lymphatic system disorders Lymphopenia* Neutropenia, Late-on-set neutropenia Musculoskeletal and connective tissue disorders Arthralgia, back pain Myalgia General disorders and administration site conditions Pyrexia Nervous system disorder Headache Investigations Immunoglobulins decreased Injury, poisoning and procedural complications Infusion-related reaction Respiratory, thoracic and mediastinal disorders Cough * Lymphopenia includes lymphocyte count decreased Description of selected adverse reactions Infusion-related reactions Inebilizumab can cause infusion-related reactions, which can include headache, nausea, somnolence, dyspnoea, fever, myalgia, rash, palpitations or other symptoms.
All patients were given premedication. 7% of placebo-treated patients. 9% of placebo-treated patients during the RCP. 9% of placebo-treated patients during the RCP. Infusion-related reactions were most common with the first infusion but were observed during subsequent infusions.
The majority of infusion-related reactions reported in inebilizumab-treated patients were either mild or moderate in severity. 9% of gMG patients treated with inebilizumab across the RCP and OLP. 7%). 8%). 3%). 8%). 9%). 5%). 4 for action to be taken in case of infection.
Opportunistic and serious infections In NMOSD study during the RCP, no opportunistic infections occurred in either treatment group, and a single grade 4 infectious adverse reaction (atypical pneumonia) occurred in a patient treated with inebilizumab.
4%) experienced a grade 4 infectious adverse reaction. 4 for action to be taken in case of infection. 7%) experienced an opportunistic infection (all non-serious herpes zoster) across the RCP and OLP. 8%) experienced a grade 3 serious event (herpes zoster disseminated) during the RCP.
Laboratory abnormalities Decreased immunoglobulins Consistent with its mechanism of action, average immunoglobulin levels decreased with inebilizumab use. 6% placebo. A single adverse reaction of IgG decreased was reported (grade 2, during the OLP).
9%. 6%. In IgG4-RD study at the end of the 12-month RCP, the total immunoglobulin level was reduced by approximately 12% from baseline for patients treated with inebilizumab as compared to an increase of 21% in patients treated with placebo.
The mean decreases from baseline in immunoglobulin G […]

EUOfficial regulatory label· Warnings and precautions· revised May 22, 2026[2]

Instructions for patients at the time of prescribing Patients treated with Uplizna should be given a patient card which includes information that inebilizumab treatment may increase the risk of infections, including serious infections, viral reactivation, opportunistic infections, and progressive multifocal leukoencephalopathy (PML), and how to seek early medical care in case of signs and symptoms of infection and PML.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions and hypersensitivity Inebilizumab can cause infusion-related reactions and hypersensitivity reactions, which can include headache, nausea, somnolence, dyspnoea, fever, myalgia, rash, palpitations or other symptoms.
Infusion-related reactions were most common with the first infusion but were also observed during subsequent infusions. 8). 2). During the infusion The patient should be monitored for infusion-related reactions. Management recommendations for infusion reactions depend on the type and severity of the reaction.
For life-threatening infusion reactions, treatment should be stopped immediately and permanently, and appropriate supportive treatment should be administered. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
After the infusion The patient should be monitored for infusion reactions for at least one hour after the completion of the infusion. Infections Inebilizumab causes reduction in peripheral blood lymphocyte count and Ig levels consistent with the mechanism of action of B-cell depletion.
Reduction of neutrophil counts were also reported. 8). e. within 6 months) complete blood cell count (CBC) including differentials and immunoglobulins should be obtained before initiation of inebilizumab. Assessments of CBC including differentials and immunoglobulins are also recommended periodically during treatment and after discontinuation of treatment until B-cell repletion.
Prior to every infusion of inebilizumab, it should be determined whether there is a clinically significant infection. In case of infection, infusion of inebilizumab should be delayed until the infection resolves. Patients should be instructed to promptly report symptoms of infection to their physician.

This is not medical advice. Consult a qualified healthcare professional.

Inebilizumab: Uses, Side Effects, Dosage - Drugvu