Tymlos FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 27, 2022.
FDA Approved: Yes (First approved April 28, 2017)
Brand name: Tymlos
Generic name: abaloparatide
Dosage form: Injection
Company: Radius Health, Inc.
Treatment for: Osteoporosis
Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of osteoporosis.
- Tymlos is indicated for the:
- treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- Tymlos is administered by subcutaneous injection once daily into the periumbilical region of abdomen. Patients should not use Tymlos for more than 2 years over their lifetime.
- Warnings and precautions associated with Tymlos include risk of osteosarcoma, orthostatic hypotension, hypercalcemia, and hypercalciuria and urolithiasis.
- Common adverse reactions in postmenopausal women with osteoporosis include hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.
Common adverse reactions in men with osteoporosis include injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain.
Development timeline for Tymlos
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
