Uplizna

Treatment should be initiated under the supervision of a physician experienced in the treatment of NMOSD or IgG4-RD or gMG and with access to appropriate medical support to manage potential severe reactions such as serious infusion-related reactions.

4). 4). 1). Posology Initial doses The recommended loading dose is 300 mg (3 vials of 100 mg) intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion. Maintenance doses The recommended maintenance dose is 300 mg intravenous infusion every 6 months.

Inebilizumab is for chronic treatment. Based upon the chronic nature of IgG4-RD, treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice. Delayed or missed doses If an infusion of inebilizumab is missed, it should be administered as soon as possible and not delayed until the next planned dose.

Premedication for infusion-related reactions Infection assessment 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.

4). Special populations Elderly Inebilizumab has been administered to 72 elderly patients (≥ 65 years of age) in clinical studies. 2). Renal and hepatic impairment Inebilizumab has not been studied in patients with severe renal or hepatic impairment.

2). Paediatric population The safety and efficacy of inebilizumab in children and adolescents aged 0 to 18 years has not yet been established. No data are available. Method of administration For intravenous use. Vials should not be shaken.

Vials should be stored upright. 22 micron in-line filter according to the schedule in table 1. Table 1. 6.

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.

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.

1 • Severe active infection, including active chronic infection such as hepatitis B • Active or untreated latent tuberculosis • History of progressive multifocal leukoencephalopathy (PML) • Severely immunocompromised state • Active malignancies 5