Several medications approved by the US Food and Drug Administration (FDA) in January 2021 impact the practice of nurse practitioners (NPs) and physician assistants (PAs), including new treatments for HIV, heart failure, dry eye disease, and light chain amyloidosis.
Cabenuva for HIV
Cabenuva (cabotegravir and rilpivirine) is the first FDA-approved long-acting injectable medication available for patients with HIV.1 This agent combines 2 antiviral agents: cabotegavir, an HIV-1 integrase strand inhibitor, and rilpivirine, and HIV-1 non-nucleoside reverse transcriptase inhibitor.
The medication is meant to replace existing antiretroviral regimens for patients with HIV-1 who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Hepatotoxicity and depressive disorders have been reported in patients using cabotegravir and rilpivirine; monitoring liver chemistries and immediate mental health evaluation is recommended.
Verquvo for Heart Failure
For adults with symptomatic chronic heart failure and ejection fraction less than 45%, Verquvo® (vericiguat) has been approved to reduce the risk for cardiovascular mortality and heart failure hospitalization.2
The recommended starting dose of oral vericiguat tablets is 2.5 mg; the dose should be doubled approximately every 2 weeks, as tolerated, until the target daily maintenance dose of 10 mg is achieved. Pregnant women should not take vericiguat, as it is known to cause fetal harm.
Eysuvis for Dry Eye Disease
EysuvisTM (loteprednol etabonate ophthalmic suspension 0.25%) is a topical corticosteroid approved for the management of dry eye disease. The medication is approved for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye. One to 2 drops should be inserted into each eye 4 times daily for symptom relief.3
Similar to other ophthalmic corticosteroids, this medication is contraindicated in patients who have viral or bacterial infections of the eye. Long-term use of ophthalmic corticosteroids may increase the risk of developing cataracts, fungal infections, or an increase in intraocular pressure.
Eysuvis is the fourth FDA-approved drug for dry eye disease, joining Restasis®, Xiidra®, and Cequa™.
Darzalex Faspro for Amyloidosis
Darzalex FasproTM (daratumumab and hyaluronidase-fihj) was granted accelerated approval by the FDA to treat patients with newly diagnosed light chain amyloidosis. The agent is designed to be used in combination with bortezomib, cyclophosphamide, and dexamethasone.4
The medication is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase. This agent was previously approved in 2020 to treat adult patients with multiple myeloma when combined with other medications.
There is a risk for both cardiac and embryo-fetal toxicity; the medication is not recommended for pregnant women or patients with light chain amyloidosis who have class 3 heart failure, class 4 heart disease, or Mayo Stage IIIb cardiac amyloidosis.
- Cabenuva [package insert]. Research Triangle Park, NJ: ViiV Healthcare; 2021.
- Verquvo [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2021.
- Eysuvis [package insert]. Watertown, MA: Kala Pharmaceuticals; 2021.
- Darzalex Faspro [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2021.