The Food and Drug Administration (FDA) is revising the label of rolapitant (Varubi) injectable emulsion to include a warning that the drug can cause anaphylaxis and serious hypersensitivity reactions.

Rolapitant is a substance P/neurokinin-1 receptor antagonist used to prevent delayed nausea and vomiting associated with chemotherapy.

The decision to include the safety warning is based on postmarketing reports received by the FDA of anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions during or soon after rolapitant administration.

Nurses administering rolapitant should assess patients carefully for hypersensitivity to any of the drug's components, including soybean oil. Because cross allergies are possible, nurses should also assess patients for known allergies to other legumes. Rolapitant should not be given to patients with a potential hypersensitivity. Nurses should assess patients closely during and after treatment for any indication of anaphylaxis and keep emergency equipment nearby. Any adverse effects should be reported to the FDA's MedWatch program: http://www.fda.gov/Safety/MedWatch/default.htm.

To view the "Dear Health Care Provider" letter regarding rolapitant, see http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor.