Usymro

Usymro concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease. Usymro concentrate for solution for infusion should only be used for the intravenous induction dose.

3 Posology Adults Crohn’s disease Usymro treatment is to be initiated with a single intravenous dose based on body weight. 6 for preparation). Table 1 Initial intravenous dosing of Usymro Body weight of patient at the time of dosing Recommended dosea Number of 130 mg Usymro vials ≤ 55 kg 260 mg 2 > 55 kg to ≤ 85 kg 390 mg 3 > 85 kg 520 mg 4 a Approximately 6 mg/kg The first subcutaneous dose should be given at week 8 following the intravenous dose.

2 of the Usymro solution for injection (vial) and solution for injection in pre-filled syringe Summary of Product Characteristics (SmPC). 4). Renal and hepatic impairment Usymro has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population Paediatric Crohn’s disease (patients weighing at least 40 kg) Usymro treatment is to be initiated with a single intravenous dose based on body weight. 6 for preparation). Table 2 Initial intravenous dosing of Usymro Body weight of patient at the time of dosing Recommended dosea Number of 130 mg Usymro Vials ≥ 40 kg to ≤ 55 kg 260 mg 2 > 55 kg to ≤ 85 kg 390 mg 3 > 85 kg 520 mg 4 a Approximately 6 mg/kg The first subcutaneous dose should be given at week 8 following the intravenous dose.

2 of the Usymro solution for injection (vial) and solution for injection in prefilled syringe SmPC. The safety and efficacy of Usymro for the treatment of Crohn’s disease in paediatric patients weighing less than 40 kg have not yet been established.

No data are available. Method of administration Usymro 130 mg is for intravenous use only. It should be administered over at least one hour. 6.

Summary of the safety profile The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache.

Most were considered to be mild and did not necessitate discontinuation of study treatment. 4). The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Tabulated list of adverse reactions The safety data described below reflect exposure in adults to ustekinumab in 14 phase II and phase III studies in 6,710 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn’s disease and 826 patients with ulcerative colitis).

This includes exposure to ustekinumab in the controlled and non- 8 controlled periods of the clinical studies in patients with psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis for at least 6 months (4,577 patients) or at least 1 year (3,648 patients).

2,194 patients with psoriasis, Crohn’s disease or ulcerative colitis were exposed for at least 4 years while 1,148 patients with psoriasis or Crohn’s disease were exposed for at least 5 years. Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.

The adverse reactions are classified by System Organ Class and frequency, using the following convention: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4, Systemic and respiratory hypersensitivity reactions. Description of selected adverse reactions Infections In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.

Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Infections Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.

8). Opportunistic infections including reactivation of tuberculosis, other opportunistic bacterial infections (including atypical mycobacterial infection, listeria meningitis, pneumonia legionella, and nocardiosis), opportunistic fungal infections, opportunistic viral infections (including encephalitis caused by herpes simplex 2), and parasitic infections (including ocular toxoplasmosis) have been reported in patients treated with ustekinumab.

3). Prior to initiating treatment with Usymro, patients should be evaluated for tuberculosis infection. 3). Treatment of latent tuberculosis infection should be initiated prior to administering Usymro. Anti-tuberculosis therapy should also be considered prior to initiation of Usymro in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Patients receiving Usymro should be monitored closely for signs and symptoms of active tuberculosis during and after treatment. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.

If a patient develops a serious infection, the patient should be closely monitored and Usymro should not be administered until the infection resolves. Malignancies Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.

8). The risk of malignancy may be higher in psoriasis patients who have been treated with other biologics during the course of their disease. No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving ustekinumab.

1. g. 4). 4