Label Changes for:
Stelara (Ustekinumab) Injection
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
- The safety data reflect exposure to STELARA in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 18521855 exposed for at least one year,16501653 exposed for at least two years, 11291569 exposed for at least three years, and 6191482 exposed for at least four years and 838 exposed for at least five years.
- In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 2.63.2 years), representing 67918998 subject-years of exposure, 7072.3% of STELARA-treated subjects reported infections (0.980.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).
- In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 2.63.2 years, representing 67918998 subject-years of exposure), 1.37% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.6260 per hundred subject-years of follow‑up). Non-melanoma skin cancer was reported in 1.35% of STELARA®-treated subjects (0.6152 per hundred subject-years of follow-up) [see Warnings and Precautions (5.4)]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, colorectal, melanoma in situ, colorectal and breast.
- Table 2 -- data updated
- The majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies.
- Skin reactions: Pustular psoriasis, erythrodermic psoriasis
5 WARNINGS AND PRECAUTIONS
- There have been post marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing nonmelanoma skin cancer. All patients receiving STELARA should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely [see Adverse Reactions (6.1)].
- added ..... Some people who are receiving STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your doctor if you develop any new skin growths.
- Clinically significant hypersensitivity to ustekinumab or to any of the excipients
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported post-marketing. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, discontinue Stelara and institute appropriate therapy
- Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria)