The Food and Drug Administration has approved ninte-danib (Ofev) to slow the rate of declining pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). A rare disease associated with systemic sclerosis or scleroderma, SSc-ILD is progressive, debilitating, and life threatening, as lung functions decline over time and the lungs are unable to supply the body with sufficient oxygen. In this chronic lung disease, scar tissue (fibrosis) and/or inflammation build up in the interstitial space, which includes the alveoli, and in the spaces around the blood vessels and small airways of the lungs. Scleroderma is an autoimmune disease. Only about half of people with scleroderma have SSc-ILD.

Nintedanib, a kinase inhibitor, was originally approved in 2014 to treat adults with idiopathic pulmonary fibrosis. The kinases blocked are believed to be important in creating the fibrotic tissue in this disease.

In a randomized, double-blind, placebo-controlled phase-3 trial of 576 patients with SSc-ILD, in which participants received nintedanib 150 mg twice daily or matching placebo for at least 52 weeks, those receiving nintedanib had less annual deterioration in their forced vital capacity (FVC) than those receiving placebo (a decline of 52 mL versus 93 mL).

Serious adverse effects can include hepatic impairment, gastrointestinal (GI) disorders severe enough to produce fluid and electrolyte imbalances, embryo-fetal harm, arterial thromboembolic events, bleeding events, and GI perforation. The most common adverse effects include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss, and hypertension.

Nurses caring for patients receiving nintedanib should confirm that liver function tests were performed prior to treatment. Patients should be taught the importance of regularly checking liver function. If levels are greatly elevated, the prescribing provider should be consulted about a dosage reduction or temporary discontinuation of the drug. If patients develop diarrhea, nausea, or vomiting, they should be provided with adequate hydration and antidiarrheal medication or antiemetics as soon as possible. Nintedanib should be discontinued if these GI disorders are severe. Nurses should instruct female patients of childbearing age to use a barrier method and hormonal contraceptives to prevent pregnancy because of the risk of embryo-fetal injury. The barrier method is added because the effect of nintedanib on hormonal contraceptives is not known. Patients with a known risk of arterial thromboembolic events, such as coronary artery disease, should be closely assessed for signs and symptoms of a clot. Patients should also be assessed for bleeding risk factors, as patients with such factors may be at higher risk for serious bleeding from nintedanib. Patients should be closely monitored if they have had recent abdominal surgery, a previous history of diverticular disease, or are receiving corticosteroids or nonsteroidal antiinflammatory drugs, as they may be at increased risk for GI perforation.

Nurses should instruct patients to swallow nintedanib whole with liquid and to take it with food. Chewing or crushing the capsules will produce a bitter taste.

For complete prescribing information, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf.