1. Aschenbrenner, Diane S. MS, RN


* Imfinzi (durvalumab), a drug previously approved to treat locally advanced or metastatic bladder cancer, is now also approved to treat stage III non-small cell lung cancer with tumors that are unresectable and have not progressed after chemoradiation.


* New warnings for durvalumab include risk of infusion reactions and embryo-fetal toxicity.



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Imfinzi (durvalumab) is a human immunoglobulin G1 kappa monoclonal antibody that targets specific proteins found on immune cells and some cancer cells. Blocking the action of these proteins appears to help the body's immune system attack cancer cells. The drug was approved in 2017 for the treatment of locally advanced or metastatic bladder cancer. It is now also approved to treat stage III non-small cell lung cancer whose tumors are unresectable and have not progressed after chemoradiation.


Approval was granted for this indication based on a randomized trial of 713 patients whose cancer had not progressed after completing chemoradiation. The median length of time before tumors showed significant growth was 16.8 months for those receiving durvalumab versus 5.6 months for those receiving placebo.


Common adverse effects of durvalumab, which are different depending on the cancer treated, include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. The most serious adverse effects of durvalumab are immune mediated, occurring when the immune system attacks healthy cells or organs in addition to cancer cells. These include pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis. Warnings related to these effects were included in the original durvalumab label. Additional warnings now added to the label include the risk of infusion-related reactions and embryo-fetal toxicity.


When nurses administer durvalumab as an iv infusion they should assess for infusion-related reactions. The rate of infusion should be slowed or the infusion should be temporarily stopped if the patient has a mild or moderate reaction to the drug. Durvalumab should be discontinued permanently if the patient experiences a severe or life-threatening infusion-related reaction. Nurses should review durvalumab's label for the recommended action if the patient experiences immune-mediated adverse effects, as the action varies depending on the adverse effect.


Nurses should educate patients receiving durvalumab on the signs and symptoms of possible immune-mediated adverse effects and instruct patients to immediately contact the prescriber if they experience any of these. Patients should be advised of the risk to an embryo or fetus of durvalumab use and told to use effective contraception during treatment and for at least three months afterward. Although there are no known data on the effects of durvalumab on a breastfeeding infant, breastfeeding is not recommended during therapy and for three months after treatment stops.


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