Tymlos (abaloparatide-SC) (BA058-SC, ITM-058) (formerly BA058 Injection)
FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
US Food and Drug Administration (FDA) has approved Tymlos (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
In postmenopausal women with osteoporosis, Tymlos reduces the risk of vertebral and nonvertebral fractures.
TYMLOS Rx
Generic Name and Formulations:
Abaloparatide 2000mcg/mL; soln for SC inj.
Company:
Radius Health, Inc.
RECENT UPDATES Monograph added.
Indications for TYMLOS:
Postmenopausal women with osteoporosis at high risk for fracture.
Limitations Of use:
Cumulative use >2yrs not recommended.
Adult:
80mcg SC once daily into periumbilical region of abdomen; rotate inj sites. Give supplemental calcium and vitamin D if dietary intake inadequate.
Children:
Not recommended.
Warnings/Precautions:
Increased baseline risk for osteosarcoma (eg, Paget's disease of bone, unexplained increased alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, prior external beam or skeletal implant radiation therapy), pre-existing hypercalcemia or underlying hypercalcemic disorder (eg, primary hyperparathyroidism): not recommended. Urolithiasis. Hypercalciuria. Severe renal impairment: monitor. Pregnancy, nursing mothers: not indicated.
Pharmacological Class:
Hormone (human parathyroid hormone related peptide analog).
Adverse Reactions:
Hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, vertigo; orthostatic hypotension, hypercalcemia, urolithiasis, inj site reactions.
Generic Availability:
NO
How Supplied:
Prefilled pen (1.56mL)—1
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8 |
