Tymlos (abaloparatide)

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Tymlos (abaloparatide)

Tymlos (abaloparatide) is a medication used for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

How to buy Tymlos (abaloparatide): You can order Tymlos (abaloparatide) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

Rheumatology Osteoporosis
Marketing Authorisation Holder Radius Health, Inc.
Mode of Action Human parathyroid hormone related peptide [PTHrP(1-34)] analogue
Administration subcutaneous
Regulatory agency approval Food and Drug Administration (FDA), USA
Strength 2000 microgram / millilitre
Package 1 pre-filled pen with 30 doses (3120 mcg/1.56 mL) Syringes

What is Tymlos (abaloparatide) for?

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 fracture1.

How does Tymlos (abaloparatide) work?

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 osteoblasts2, the cells that synthesize bone3. 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.

Where has Tymlos (abaloparatide) been approved?

Tymlos (abaloparatide) was approved for the treatment of patients with osteoporosis at high risk for fracture by:

  • Food and Drug Administration (FDA), USA, April 28, 20171.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tymlos (abaloparatide) taken?

The standard dosage is:

  • 80 mcg subcutaneous injection once daily into periumbilical region of the abdomen.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Warning:

  • Use of Tymlos is not recommended in patients at increased risk for osteosarcoma.
  • Cumulative use of Tymlos and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

Complete information about Tymlos (abaloparatide) dosage and administration can be found in the official prescribing information listed in our resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Tymlos (abaloparatide)?

Common side effects

The most common side effects listed in the prescribing information include1:

  • hypercalciuria (elevated calcium in the urine)
  • dizziness
  • nausea
  • headache
  • palpitations
  • fatigue
  • upper abdominal pain
  • vertigo.

Serious side effects

The serious side effects listed in the prescribing information include1:

  • Orthostatic Hypotension
  • Hypercalcemia
  • Hypercalciuria and Urolithiasis.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.



More Information
Working ingredient abaloparatide
Shipping method Cold chain (temperature controlled)
Package 1 pre-filled pen with 30 doses (3120 mcg/1.56 mL)
Therapeutic Area Rheumatology
Rheumatology Osteoporosis
Indication Osteoporosis at high risk for fractures
Administration subcutaneous
Mode of Action Human parathyroid hormone related peptide [PTHrP(1-34)] analogue
Strength 2000
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Radius Health, Inc.

The Food and Drug Administration (FDA), USA, approval of Tymlos (abaloparatide) for osteoporosis in postmenopausal women at high risk for fracture were based on one study (NCT 01343004). The study lasted 18 months and involved 1,645 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 supplements1.

Results

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.

1. Summary of Product Characteristics [FDA]: Tymlos (abaloparatide) [PDF]
    Radius Health Inc., Apr. 2017.

2. Wikipedia. Parathyroid hormone 1 receptor
    cited June 2017 

3. Wikipedia. Osteoblast
    cited June 2016 

4. Drugs.com. FDA Approves Tymlos
    April 2017 

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.