Drug Safety Warnings and Updates: April-June 2018

Beth F. Fritsch, PharmD, MBA, BCPS; Steve Morin, RN

Disclosures

September 10, 2018

Editorial Collaboration

Medscape &

In This Article

Cetuximab (Erbitux)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

Updated Boxed Warning

WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST

Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions (5.1), Adverse Reactions (6)]. Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration (2.4)].

Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions (5.2, 5.6)].

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