The Food and Drug Administration has approved a new indication for dupilumab (Dupixent), an interleukin-4 receptor alpha antagonist previously approved to treat asthma and moderate to severe atopic dermatitis. The drug is now approved as an add-on maintenance treatment for adults with chronic rhinosinusitis with nasal polyps that hasn't been adequately controlled with intranasal steroids.

The use of dupilumab for this indication was studied in two randomized, double-blind, parallel-group, placebo-controlled studies of 724 adults. Treatment with dupilumab significantly decreased nasal congestion, polyp size, loss of smell, and sinonasal symptoms. Dupilumab also significantly reduced the use of and need for oral corticosteroids and the need for surgery compared with placebo. The most common adverse effects of dupilumab for this indication (seen in at least 1% of patients) are injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Nurses should confirm that the proper dose of dupilumab has been ordered for the patient, because it is different for the drug's three approved clinical indications. For chronic rhinosinusitis with nasal polyps the dose is 300 mg administered subcutaneously every other week. Injection sites should be rotated, so it's helpful if the patient keeps a log of where the medication has been administered. The syringes are stable at room temperature for up to 14 days; longer storage requires refrigeration. If refrigerated, the drug should be left to naturally warm to room temperature at least 30 minutes prior to injection. Patients should avoid placing the syringes in direct sunlight. The medication is normally clear to pale yellow, and the air bubble in the syringe should be injected along with the medication to ensure that no medication is left in the syringe or needle itself. Specific directions for drug administration, with illustrations, can be found in the drug's labeling.

Because it compromises the immune system, dupilumab should not be administered with live vaccines (which, according to the Centers for Disease Control and Prevention, include measles, mumps, rubella, vaccinia, varicella, zoster, yellow fever, rotavirus, and intranasal influenza) or if the patient has an untreated helminth infection. Although using dupilumab may permit a reduction in corticosteroid dose, patients should be told not to suddenly stop the use of corticosteroids. Tapering of steroids, if clinically appropriate, should be under the direction of the patient's health care provider.

For complete prescribing information for dupilumab, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf.