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U.S. Department of Health and Human Services

Safety

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Stelara (ustekinumab) injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

April 2013 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Skin reactions: Pustular psoriasis, erythrodermic psoriasis

 

January 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.4 Malignancies
  • 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)].

MEDICATION GUIDE

Cancers
  • 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.

 

June 2012 

Summary View

 

CONTRAINDICATIONS

  • Clinically significant hypersensitivity to ustekinumab or to any of the excipients

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • 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
Post-marketing Experience
  • Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria)

 

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