Rx Products January 2019
MANUFACTURED BY: Janssen Pharmaceuticals, Inc
INDICATION: The FDA has approved Janssen’s Xarelto (rivaroxaban) to reduce major cardiovascular (CV) events including death, myocardial infarction, and stroke in individuals with chronic coronary or peripheral artery disease (CAD/ PAD). The FDA approved Xarelto as an anticoagulant in 2011. The new indica- tion follows clinical trials that showed a 24% reduction of major CV events in patients with chronic CAD/PAD.
DOSAGE FORM: Tablet
FOR MORE INFORMATION: xarelto-us.com
HEMLIBRA
MANUFACTURED BY: Genentech
INDICATION: The FDA has approved Hemlibra (emicizumab-kxwh) to prevent and reduce the frequency of bleeding in patients with hemophilia A and no factor VIII inhibitors. The subcutaneous treatment is safe for patients of all ages and has multiple dosing options. The treatment promotes blood clotting by connecting clotting factors, proteins in the blood that control bleeding.
DOSAGE FORM: Subcutaneous injection
FOR MORE INFORMATION: hemlibra.com
TALZENNA
MANUFACTURED BY: Pfizer
INDICATION: The FDA has approved Talzenna (talazoparib) for the treatment of HER2-negative locally advanced or metastatic breast cancer with germline BRCA mutations. Talzenna is a dual-mechanism poly—(adenosine diphosphate–ribose) polymerase (PARP) inhibitor that promotes cancer cell death by trapping the PARP enzyme. The tablets are recommended in 1-mg doses taken by mouth daily.
DOSAGE FORM: Tablet
FOR MORE INFORMATION: pfizer.com
TEGSEDI
MANUFACTURED BY: Akcea Therapeutics
INDICATION: FDA officials have approved Tegsedi (inotersen) for the treatment of polyneuropathy of the hereditary transthyretin-mediated amyloidosis (hATTR) in adults.
The newly approved drug is an antisense oligonucleotide and works by inhibiting the production of the transthyretin (TTR) protein. Tegsedi is the second approved drug to treat hATTR, a rare disease in which TTR proteins misfold and gather as amyloid deposits throughout the body and interfere with normal functions.
DOSAGE FORM: Subcutaneous injection
FOR MORE INFORMATION: akceatx.com
