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Label Changes for:

Remicade (infliximab)

March 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

 

March 2013

WARNINGS AND PRECAUTIONS

Skin cancer
  • Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including REMICADE [see Adverse Reactions (6.2)]. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Concurrent Administration with other Biological Therapeutics
  • There is insufficient information regarding the concomitant use of REMICADE with other biological therapeutics used to treat the same conditions as REMICADE. The concomitant use of REMICADE with these biologics is not recommended because of the possibility of an increased risk of infection

ADVERSE REACTIONS

Postmarketing Experience
  • serious infections and malignancies, including melanoma and Merkel cell carcinoma

 

 

February 2011

 

WARNINGS AND PRECAUTIONS

Use with Abatacept
  • In clinical studies, concurrent administration of TNF-blocking agents and abatacept have been associated with an increased risk of infections including serious infections compared with TNF-blocking agents alone, without increased clinical benefit. Therefore, the combination of Remicade and abatacept is not recommended.
Switching between Biological Disease-Modifying Antirheumatic Drugs (DMARDs)
  • Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

DRUG INTERACTIONS

  • Abatacept

MEDICATION GUIDE

What should I avoid while receiving Remicade?
  • ‚Ķabatacept

 

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