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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000407288.47749.4c
Drug Watch

Lymphoma Drug Receives Accelerated Approval

Aschenbrenner, Diane S. MS, RN

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Author Information

Diane S. Aschenbrenner is the course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: dianea@son.jhmi.edu.

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Abstract

* Brentuximab (Adcetris), an antibody–drug conjugate, has been given accelerated approval to treat Hodgkin's lymphoma and systemic anaplastic large cell lymphoma.

* The drug label warns of the following serious adverse effects: peripheral neuropathy, neutropenia, infusion reactions, tumor lysis syndrome, Stevens–Johnson syndrome, progressive multifocal leukoencephalopathy, and teratogenesis.

The Food and Drug Administration (FDA) has approved a new drug, brentuximab (Adcetris), for the treatment of Hodgkin's lymphoma and a rare non-Hodgkin's lymphoma called systemic anaplastic large cell lymphoma (ALCL). This is the first new drug approved for Hodgkin's lymphoma since 1977 and the first ever approved specifically for ALCL. The drug was approved on the basis of very small, single-arm, multicenter studies. The efficacy of brentuximab in Hodgkin's lymphoma was studied in 102 patients who'd relapsed after autologous stem cell transplantation. The drug's efficacy in ALCL was assessed in one phase 2, open label, single-arm, multicenter trial of 58 patients who'd relapsed after receiving therapy. Brentuximab was found to create a partial or full response in the majority of patients in the trials.

Brentuximab is called an antibody–drug conjugate and is considered a targeted therapy. It's a combination of a monoamine antibody and a drug that directs the antibody to a specific area or to target a lymphoma cell known as CD30. Binding to the target stops the cell cycle and triggers the intrinsic mechanisms that create cell death (apoptosis).

Brentuximab isn't used as primary therapy for either Hodgkin's lymphoma or ALCL. It's used in Hodgkin's lymphoma if the disease progresses after autologous stem cell transplantation or after two chemotherapy treatments have been given (usually in those who aren't eligible for transplantation). In ALCL it's used if the disease has progressed after one chemotherapy treatment.

Brentuximab is administered as an IV infusion every three weeks for a maximum of 16 cycles. The most common adverse effects (occurring in 20% or more of patients) are neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia. The drug can also cause severe neutropenia, infusion reactions (including anaphylaxis), tumor lysis syndrome, Stevens–Johnson syndrome, progressive multifocal leukoencephalopathy (PML), and teratogenesis.

Nurses administering intravenous brentuximab should follow the packaging instructions related to reconstitution and further dilution carefully and assess the patient throughout the course of treatment for evidence of peripheral neuropathy such as hypoesthesia, hyperesthesia, burning, or pain. If the nurse isn't the prescriber, she or he should contact the prescriber if the patient has new or worsening peripheral neuropathy because a delay in drug administration, a change of dosage, or discontinuation of the drug may be necessary. Patients should also be monitored for infusion reactions, and if one occurs the drug should be stopped and appropriate treatment should be begun. Patients who have a history of infusion reactions from previous infusions of brentuximab should be premedicated (with acetaminophen, an antihistamine, and a corticosteroid) before receiving additional doses. Patients who experience anaphylaxis shouldn't receive the drug again. Patients should be monitored for symptoms such as clumsiness; progressive weakness; and vision, speech, and personality changes because they may be indications of PML. Laboratory values should also be monitored for evidence of tumor lysis syndrome (hyperuricemia, the most common abnormality; hyperphosphatemia, the second most common abnormality and a warning sign of acute renal failure; hyperkalemia; and hypocalcemia). The white cell count should be watched for neutropenia. If grade 3 or 4 neutropenia develops, a dose delay, a dosage reduction, or discontinuation of the drug is warranted. The skin should be carefully assessed for rashes that may indicate Stevens–Johnson syndrome. For complete prescribing information, go to http://1.usa.gov/n7VnY7.

© 2011 Lippincott Williams & Wilkins, Inc.

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