Medication Update

Mirena approved for 6 years of pregnancy prevention The FDA approved the levonorg- estrel-releasing intrauterine system (Mirena) for up to 6 years of pregnancy prevention. Previously, Gardasil 9 for prevention lesions caused by HPV types 6, 11, 16, the intrauterine device (IUD) was of head and neck cancer 18, 31, 33, 45, 52, and 58; and genital indicated for contracep- Gardasil 9 (Human Papillomavirus warts caused by HPV types 6 and 11. tion for up to 5 years. [HPV] 9-valent Vaccine, Recombi- The vaccine is a product of Merck. Approval was based on nant) was approved to prevent head data evaluating the and neck cancer. It is indicated in Canaglifl ozin boxed effi cacy of the IUD during females ages 9 through 45 for the warning for leg and foot extended use beyond 5 years. The prevention of cervical, vulvar, vaginal, amputations removed pregnancy rate, calculated as the anal, oropharyngeal, and other head Based on new data, the FDA Pearl Index, at the end of the 6th and neck cancers caused by HPV removed the boxed warning on the year of use was 0.35 with a 95% types 16, 18, 31, 33, 45, 52, and 58; prescribing information for the type upper confi dence limit of 1.95 cervical, vulvar, vaginal, and anal 2 diabetes mellitus (T2DM) drug based on the 1 pregnancy that precancerous or dysplastic lesions canaglifl ozin (Invokana, Invokamet, occurred during year 6 and within caused by HPV types 6, 11, 16, 18, 31, Invokamet XR) concerning amputa- 7 days after IUD removal or 33, 45, 52, and 58; and genital warts tion risk. The warning was added to expulsion. caused by HPV types 6 and 11. canaglifl ozin labeling in 2017 The vaccine is indicated in males because earlier data suggested the benefi ts, which led to additional ages 9 through 45 for the prevention risk of amputations was serious in approved uses for canaglifl ozin, of anal, oropharyngeal, and other relation to the potential benefi t of including reducing the risk of major head and neck cancers caused by taking the medication. However, adverse cardiovascular (CV) events HPV types 16, 18, 31, 33, 45, 52, and subsequent FDA reviews of new in patients with T2DM and known 58; anal precancerous or dysplastic clinical trial data showed additional CV disease, and reducing the risk of end-stage kidney disease, worsening Rapid-acting insulin approved for type 1 and type 2 of kidney function, CV death, and diabetes mellitus hospitalization for heart failure in The FDA approved Eli Lilly’s rapid-acting insulin lispro-aabc injection, certain patients with T2DM and 100 and 200 units/mL (Lyumjev) for the treatment of adults with type 1 diabetic kidney disease. (T1DM) and T2DM. The new formulation of insulin lispro was developed These heart- and kidney-related to speed insulin absorption into the bloodstream and reduce A1C levels. effects demonstrate signifi cantly The product is approved only for use as part of a multiple daily injection enhanced benefi ts of canaglifl ozin. regimen and is not indicated for use in insulin pumps. Data also suggest that the risk of Two phase 3 randomized controlled trials comparing amputation, while still increased, Lyumjev and Humalog in adults with T1DM and T2DM, is lower than previously described, respectively, met the primary end point of noninferior A1C especially when appropriately reduction from baseline compared with Humalog at 26 weeks. monitored. The FDA notes that the The product also demonstrated superior reduction in blood glucose amputation risk associated with spikes at both 1 hour and 2 hours after a test meal compared with canaglifl ozin remains and is still Humalog. Lyumjev and Humalog have similar safety and tolerability described in the warnings and pre- profi les. Hypoglycemia is the most common adverse reaction associ- cautions section of the labeling. ated with the drug. DOI-10.1097/01.NPR.0000718528.41559.d7

Medication Update alerts readers to new drug approvals and other timely drug information. Healthcare providers should not make clinical decisions from these announcements, as they are not comprehensive. Consult the manufacturer’s complete drug product label before prescribing any of the drugs discussed.

56 The Nurse Practitioner • Vol. 45, No. 11 www.tnpj.com