Rx Product News (January 2021)

Pharmacy TimesJanuary 2021
Volume 89
Issue 1

Four prescription products are featured in the January issue of Pharmacy Times®.

Marketed by AstraZeneca

The FDA has approved a new indication for ticagrelor to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack. Strokes are a leading cause of death and disability worldwide, and 1 in 4 patients who have had a stroke will experience a second one, according to a company statement. Ticagrelor is a well-established treatment for patients with coronary artery disease (CAD) and was approved in May 2020 to reduce the risk of a first heart attack or stroke in high-risk patients with CAD. Adverse effects can include bleeding more easily, bruising, cough, dizziness, headache, and nausea.


Sodium sulfate, magnesium sulfate, potassium chloride tablets (Sutab)

Marketed by Sebela

Pharmaceuticals Indicated for cleansing of the colon in preparation for colonoscopy in adults, Sutab tablets offer a new alternative to liquid-based colonoscopy solutions, which can be difficult and unpleasant to take. In 2 pivotal trials, 92% of patients achieved bowel cleansing with Sutab, and 92% to 95% of patients achieved successful cleansing in all segments of the colon, including the proximal colon. Most participants also said that it is easy to tolerate, and 78% said they would request Sutab again for a future colonoscopy. Adverse effects can include gastrointestinal issues, including nausea and vomiting.

FOR MORE INFORMATION: sebelapharma.com

Levonorgestrel, ethinyl estradiol patch (Twirla)

Marketed by Agile Therapeutics

Agile is launching the Twirla transdermal system, a nondaily, noninvasive contraceptive patch indicated for women of reproductive age with a body mass index of less than 30 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. The patch is worn weekly and delivers a 30-μg daily dose of ethinyl estradiol, the lowest exposure of estrogen in a transdermal contraceptive option, as well as a 120-μg daily dose of levonorgestrel. The patch uses Skinfusion technology and is made up of 5 layers for focused drug delivery and to help maintain adhesion, according to a company statement.

FOR MORE INFORMATION: agiletherapeutics.com

Marketed by Merck

The FDA has approved a new indication for Merck’s pembrolizumab, an anti—PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic

triple-negative breast cancer in patients whose tumors express PD-L1 as determined by an FDA approved test. The approval is based on results from the phase 3 KEYNOTE-355 trial (NCT02819518),

where the combination was shown to significantly reduce the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone. Fatal

adverse events occurred in 2.5% of patients, including cardiorespiratory arrest and septic shock. Serious adverse reactions occurred in 30% of patients receiving pembrolizumab.


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