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Tymlos Approved for Osteoporosis in Postmenopausal Women

Radius Health news release; 2017 April 28

The FDA has approved Tymlos (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The drug is marketed by Radius Health, Inc., Waltham, MA. In postmenopausal women with osteoporosis, it reduced the risk of vertebral and nonvertebral fractures.

Indications: TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

Dosage/administration: Recommended dose is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Administer as a subcutaneous injection into periumbilical region of abdomen and initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur.

Adverse reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.

Citation:

FDA approves Radius Health’s TYMLOS (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture. [news release]. Waltham, MA: Radius Health, Inc.; April 28, 2017: http://ir.radiuspharm.com/releasedetail.cfm?ReleaseID=1023557. Accessed May 1, 2017.

Must Reads in Endocrinology

Labeling of Selective Androgen Receptor Modulators, JAMA; 2017 Nov 28; Van Wagoner, Eichner, et al

Vitamin D & Glycemic Control in Patients with T2D, J Clin Endocrinol Metab; 2017 Sep 1; Mirhosseini, et al

Continuous Glucose Monitoring in Patients with T2D, Ann Intern Med; ePub 2017 Aug 22; Beck, et al

Thyroid HT in Older Adults with Hypothyroidism, N Engl J Med; 2017 Jun 29; Stott, Rodondi, et al

Tymlos Approved for Osteoporosis in Postmenopausal Women, Radius Health news release; 2017 April 28