JAMTEKI I.V.

2 Breast-feeding 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ....................................................................................................................

2 Geriatrics..................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................

5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ................................................................................................

2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................ 5 Missed Dose ................................................................................................................

9 5 OVERDOSAGE ............................................................................................................... 9

). Carcinogenesis and Mutagenesis Malignancies Ustekinumab is a selective immunomodulator. Immunomodulating agents have the potential to increase the risk of malignancy. Some patients who received ustekinumab in clinical studies developed malignancies (see 8 ADVERSE REACTIONS, Malignancies).

Ustekinumab has not been studied in patients with a history of malignancy. V. in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. All patients, in particular those greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of skin cancer (see 8 ADVERSE REACTIONS).

Hepatic/Biliary/Pancreatic Specific studies have not been conducted in patients with hepatic insufficiency. Immune Concomitant immunosuppressive therapy In the Phase 3 psoriasis studies, the safety and efficacy of ustekinumab injection (ustekinumab) in combination with immunosuppressive agents or phototherapy have not been evaluated.

In the Phase 3 psoriatic arthritis studies, concomitant methotrexate did not appear to influence the safety of ustekinumab injection. In Crohn’s disease and ulcerative colitis studies, concomitant use of immunomodulators (6- mercaptopurine (6-MP), azathioprine (AZA), MTX) or corticosteroids did not appear to influence the overall safety of ustekinumab.

V. V. (Ustekinumab for injection) DRUG INTERACTIONS, Immunosuppressants). V. (ustekinumab). No data are available on the secondary transmission of infection by live vaccines in patients receiving ustekinumab. V. because of the potential risk for shedding from the household contact and transmission to the patient.

V. may receive concurrent inactivated or non-live vaccinations (see

2 Breast-feeding 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ....................................................................................................................

2 Geriatrics..................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................

5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ................................................................................................

2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................ 5 Missed Dose ................................................................................................................

9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS ..................................................................................

• Patients with known hypersensitivity to ustekinumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• Patients with severe infections such as sepsis, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, Infections).