Monoclonal antibodies are types of laboratory-made proteins that copy the immune system's ability to repel harmful antigens and can bind to specific sites or cells in the body. They have a wide range of uses, among them to treat various cancers, autoimmune disorders, hypercholesterolemia, asthma, osteoporosis, inflammatory bowel disease, allograft rejection, infectious organisms, and drug reversal. The uses for monoclonal antibodies continue to expand. Here are the latest new drugs and indications.

Alirocumab (Praluent) is now approved as an adjunct for the treatment of homozygous familial hypercholesterolemia, a rare, life-threatening genetic condition in which extremely high circulating levels of low-density lipoprotein (LDL) cholesterol can occur, leading to premature cardiovascular disease-including myocardial infarction-in patients in their teens or early 20s. Alirocumab is not intended to be used alone, but instead to be added to other treatments for homozygous familial hypercholesterolemia.

Alirocumab inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) protein. PCSK9 binds to LDL receptors on the surface of hepatocytes to promote the breakdown of these receptors in the liver. Blocking PCSK9 ensures more LDL receptors. Alirocumab thus promotes faster removal of LDL cholesterol from the blood. Alirocumab is administered subcutaneously every other week. Common adverse effects include nasopharyngitis, injection site reactions, and influenza.

For full prescribing information for alirocumab, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125559s029s030lbl.pdf.

Sacituzumab govitecan-hziy (Trodelvy) is now approved to treat adults diagnosed with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more systemic therapies, at least one of which was for advanced-stage disease. Sacituzumab govitecan-hziy is also newly approved to treat advanced urothelial cancer.

An immune targeted therapy, sacituzumab govitecan-hziy is composed of a monoclonal antibody that targets the Trop-2 (trophoblast cell-surface antigen 2) protein in the majority of triple-negative breast cancers, a topoisomerase inhibitor that interferes with the cancer cells' ability to replicate, and a compound that links the other two components. It is administered by intravenous infusion, not a push or bolus.

Sacituzumab govitecan-hziy carries a boxed warning for severe or life-threatening neutropenia as well as severe diarrhea. The most common adverse effects are neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain. Hypersensitivity and infusion-related reactions are possible, including anaphylaxis. Premedication will help to prevent infusion reactions and chemotherapy-induced nausea and vomiting. Nurses should monitor patients during the infusion and for at least 30 minutes afterward for infusion reactions.

For full prescribing information for sacituzumab govitecan-hziy, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf.

Loncastuximab tesirine-lpyl (Zynlonta) is a newly approved drug for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The drug is administered as an intravenous infusion.

Loncastuximab tesirine-lpyl is a CD19-directed antibody and alkylating agent conjugate. Its most common adverse effects are laboratory abnormalities (thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, and hypoalbuminemia), fatigue, rash, edema, nausea, and musculoskeletal pain. The label also warns of effusion and edema, myelosuppression, infections, and cutaneous reactions, including photosensitivity reactions. Nurses should educate patients on the importance of ongoing blood tests to check for the presence of these adverse effects.

For full prescribing information for loncastuximab tesirine-lpyl, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761196s000lbl.pdf.

Amivantamab-vmjw (Rybrevant) is the first treatment for non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. A diagnostic test, Guardant360 CDx, was also approved as a companion to the drug.

Amivantamab-vmjw is a bispecific antibody directed against EGFRs and MET receptors. The recommended dose is 1,050 mg for patients who weigh less than 80 kg and 1,400 mg for those who weigh 80 kg or more. It is administered weekly for four weeks, then every two weeks thereafter until disease progression or unacceptable toxicity occurs.

The most common adverse effects of treatment are rash (including acneiform dermatitis and toxic epidermal necrolysis), infusion-related reactions, skin infections around the fingernails or toenails (paronychia), musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. Common laboratory abnormalities include decreased lymphocytes, albumin, phosphate, potassium, and sodium, and increased alkaline phosphatase, glucose, and gamma-glutamyl transferase. In addition to these common adverse effects, amivantamab-vmjw carries warnings of interstitial lung disease/pneumonitis, ocular toxicity, and embryo-fetal toxicity.

Nurses should administer premedication prior to infusion of amivantamab-vmjw to minimize the risk of infusion-related reactions. Even with premedication, however, infusion-related reactions (such as dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting) are possible and nurses should monitor patients carefully for these adverse effects. If they occur, the infusion should be paused, then resumed at a slower rate. For severe reactions, the drug needs to be permanently discontinued.

For complete prescribing information for amivantamab-vmjw, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf.