Tymlos (abaloparatide)

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Tymlos (abaloparatide)

How to buy Tymlos: You can order Tymlos (abaloparatide) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Radius Health Inc.
Disease Osteoporosis
Indication Osteoporosis at high risk for fracture
Mode of Action Human parathyroid hormone related peptide [PTHrP(1-34)] analogue
Approval Status FDA approved (USA)
Strength 2000 mcg / mL

Who is abaloparatide for?

Tymlos (abaloparatide) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture [1].

Recommended dose

Complete information about Tymlos (abaloparatide) dosage and administration can be found here: [1].
The standard dosage is:
  • 80 mcg subcutaneous injection once daily  into periumbilical region of abdomen
  • Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Consult your treating doctor for personalised dosing.

What is abaloparatide and how does it work?

Tymlos (abaloparatide) 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 [1].

Abaloparatide is a PTHrP(1-34) analogue which acts as an agonist at the PTH1 receptor (PTH1R) [1]. In bone, the PTH1R is expressed on the surface of osteoblasts [2], the cells that synthesize bone [3]. By attaching to these receptors abaloparatide activates important processes in target cells, which are expected to stimulate the increase of bone’s density and strength.

What is abaloparatide's approval status?

Tymlos (abaloparatide) was approved by:
  • FDA (USA) on April 28, 2017
for postmenopausal women with osteoporosis at high risk for fracture [4].

The approval was based on a study (NCT 01343004) that lasted 18 months and involved 1645 in postmenopausal women aged 49 to 86 years who received either Tymlos (abaloparatide) (N = 824) or placebo (N = 821). The majority of women that completed the first study were involved in a 6 months-maintenance study (N = 1139) during which they received 70 mg alendronate weekly, with calcium and vitamin D supplements [1].

The percentage of women new vertebral fractures at 18 months was 0.6 % with Tymlos (abaloparatide) and 4.2 % with placebo, which corresponds to an absolute risk reduction of 3.6 % (95 % CI: 2.1, 5.4)  with Tymlos (abaloparatide) and the relative risk reduction was 86 % (95 % CI: 61, 95). The relative risk reduction after 25 months was 87 % (95 % CI: 59, 96) in the patients treated with Tymlos (abaloparatide) [1].

For what concerns nonvertebral fractures at 18 months the relative risk reduction in nonvertebral fractures for Tymlos (abaloparatide) compared to placebo was 43 % and the absolute risk reduction was 2.0 %. At 25 months, the relative risk reduction in nonvertebral fractures was 52 % and the absolute risk reduction was 2.9 % [1].

The most common adverse reactions are hypercalciuria (elevated calcium in the urine), dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo [1].

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