New Indication for Weight Loss Drug Semaglutide.

The weight loss drug semaglutide (Wegovy) is now approved for pediatric patients ages 12 and older whose body mass index categorizes them as obese.

New Combination Drug for Depression.

Auvelity, an extended-release fixed combination of dextromethorphan and bupropion, is approved for the treatment of major depressive disorder in adults.Like all antidepressants, dextromethorphan-bupropion carries a boxed warning that it may increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Seizures can also occur and are more likely at higher doses.The most common adverse effects of dextromethorphan-bupropion include dizziness, nausea, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, hyperhidrosis, anxiety, constipation, decreased appetite, and insomnia.

New Drug Treats Female Reproductive Cancers.

Mirvetuximab soravtansine-gynx (Elahere) has been granted accelerated approval to treat adult patients with folate receptor α-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.The drug's labeling includes a boxed warning for ocular toxicity. Other warnings include a risk of pneumonitis, peripheral neuropathy, and embryo-fetal toxicity.

Drug Approved to Prevent Cisplatin-Associated Ototoxicity in Children.

Sodium thiosulfate injection (Pedmark) has been approved to decrease the risk of ototoxicity associated with cisplatin use in children who are at least one month old and have localized nonmetastatic solid tumors.Nurses should regularly weigh children taking this drug, as the dose is based on weight. Patients should be premedicated with antiemetics to prevent nausea and vomiting and monitored closely for evidence of electrolyte imbalances.

Two New Drugs Approved for Non-Small Cell Lung Cancer.

The Food and Drug Administration (FDA) has approved capmatinib (Tabrecta) for the treatment of metastatic non-small cell lung cancer in adults whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping.Nurses should monitor patients for serious adverse effects such as interstitial lung disease/pneumonitis, hepatotoxicity, pancreatic toxicity, photosensitivity, and embryo-fetal toxicity.The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of unresectable or metastatic non-small cell lung cancer in adults whose tumors have activating human epidermal growth factor receptor 2 mutations and who have received a prior systemic therapy.Enhertu carries a boxed warning regarding the risk of interstitial lung disease and embryo-fetal toxicity.

Drug Receives New Indication for Pediatric Graft-Versus-Host Disease.

Ibrutinib (Imbruvica) has received a new indication for the treatment of graft-versus-host disease in pediatric patients at least one year of age when one or more systemic therapies have failed.The product's labeling warns of the risk of hemorrhage, infections, cardiac arrythmias, cardiac failure and sudden death, hypertension, cytopenia, secondary primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity.The most common adverse effects include laboratory abnormalities, musculoskeletal pain, pyrexia, pneumonia, abdominal pain, stomatitis, diarrhea, and headache. Nurses should carefully assess for these adverse effects and provide appropriate education regarding their prevention.

New Indication for Cancer Drug Crizotinib.

The Food and Drug Administration has approved crizotinib (Xalkori) to treat adult and pediatric patients ages one year and older who have recurrent or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors.The most common adverse effects in adults are vision disorders, nausea, and edema. The most common adverse effects in pediatric patients are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache.

Possible Increased Risk of Death from Blood Cancer Drug.

The Food and Drug Administration (FDA) is warning that an increased risk of death is possible with the use of duvelisib (Copiktra) compared with the monoclonal antibody ofatumumab in the treatment of chronic lymphocytic leukemia. Serious adverse effects also appear to be more likely with duvelisib use.Nurses should monitor for adverse effects and report them to the FDA's MedWatch program.

New Approval for Drug Treating Large B-Cell Lymphoma.

The Food and Drug Administration has approved lisocabtagene maraleucel (Breyanzi) to treat large B-cell lymphoma in adults who relapsed or were refractory after first-line treatment.Lisocabtagene maraleucel continues to be prescribed under the Risk Evaluation and Mitigation Strategy due to the risk of fatal or potentially fatal cytokine release syndrome and neurologic toxicities.Nurses need to closely monitor patients for these and for other serious adverse effects for at least seven days after infusion of the drug.

Drug Receives New Indication for Juvenile Myelomonocytic Leukemia.

Azacitidine (Vidaza) is now approved to treat juvenile myelomonocytic leukemia, a rare form of blood cancer mostly affecting children under four years of age.

New Second-Line Treatment for B-Cell Lymphoma.

Axicabtagene ciloleucel (Yescarta) has been approved for use as a second-line drug in patients with large B-cell lymphoma who are resistant to, or who relapse within 12 months of, first-line chemoimmunotherapy.Confirming the patient's identity and matching it to the drug are critical as this is an autologous infusion. Nurses should premedicate patients to minimize the risk of hypersensitivity reactions.

New Adjuvant Treatment for High-Risk Early Breast Cancer.

Olaparib (Lynparza) is now approved for the adjuvant treatment of adult patients who have, or are suspected to have, the germline variation of BRCA-mutated human epidermal growth factor receptor 2-negative high-risk early breast cancer and who were previously treated with neoadjuvant or adjuvant chemotherapy.

New Approved Use for Keytruda.

Pembrolizumab (Keytruda) is now approved as a single agent to treat advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient in those whose disease has progressed following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

New Drug for Metastatic Castration-Resistant Prostate Cancer.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has been approved for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have received androgen receptor pathway inhibition and taxane-based chemotherapy.

FDA Evaluating Possible Serious Risks From Umbralisib.

Initial clinical trial data for umbralisib (Ukoniq), a drug currently approved to treat relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma, indicate that umbralisib may increase the risk of death or serious adverse effects when given with a specific monoclonal antibody to treat chronic lymphocytic leukemia.Patients receiving umbralisib to treat lymphomas should be evaluated closely for adverse effects. Nurses and other health care providers should report any of these adverse effects to the Food and Drug Administration's MedWatch program.

New Drug Treats Pediatric Achondroplasia.

The Food and Drug Administration has granted accelerated approval to vosoritide (Voxzogo) to treat children ages five years and older with achondroplasia who still have open epiphyses.Children prescribed vosoritide should have a meal and 240 to 300 mL of fluid in the hour prior to drug administration to prevent hypotensive episodes.

New Treatment for Polycythemia Vera.

Ropeginterferon alfa-2b-njft (Besremi) is the first interferon for treating polycythemia vera and the first approved medication for this condition that can be taken regardless of the patient's treatment history. It is administered subcutaneously every two weeks.Like other interferon alfa products, ropeginterferon alfa-2b-njft has a boxed warning that it can cause or aggravate neuropsychiatric, autoimmune, ischemic, and infectious disorders, which can be life-threatening or fatal. Nurses should closely monitor patients for any persistently severe or worsening signs or symptoms of these adverse effects.

New Indication for Cabozantinib.

Cabozantinib (Cabometyx) is now approved to treat locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor-targeted therapy.

New Indication for Ruxolitinib.

The kinase inhibitor ruxolitinib (Jakafi) is now approved to treat chronic graft-vs-host disease.

New Drug Treats Cervical Cancer.

Tisotumab vedotin-tftv (Tivdak) has received accelerated approval to treat adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.Ocular adverse effects occurred in 60% of patients in clinical trials. To minimize this risk, nurses should follow the guidelines for premedication and required eye care.