INDICATIONS AND USAGE

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TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a 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 fractures and nonvertebral fractures.

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Safety data

Adverse reactions were evaluated in 2460 postmenopausal women with osteoporosis1

This study was not designed to provide head-to-head comparative efficacy or safety data and cannot be interpreted as evidence of superiority or noninferiority to teriparatide.1

Safety information in postmenopausal women with osteoporosis1-3

 
TYMLOS
n=822 (%)
Most common
adverse reactions
(ARs)*
Hypercalciuria1,2
11
Dizziness1,2
10
Nausea1,2
8
Headache1,2
8
Palpitations1,2
5
Fatigue1,3
3
Abdominal pain, upper1,3
3
Vertigo1,3
2
Hypercalcemia
(prespecified
safety endpoint)1†
3.4
 
Placebo
n=820 (%)
Most common
adverse reactions
(ARs)*
Hypercalciuria1,2
9
Dizziness1,2
6
Nausea1,2
3
Headache1,2
6
Palpitations1,2
0.4
Fatigue1,3
2
Abdominal pain, upper1,3
2
Vertigo1,3
2
Hypercalcemia
(prespecified
safety endpoint)1†
0.4
 
Teriparatide
open-label, active
comparator
n=818 (%)
Most common
adverse reactions
(ARs)*
Hypercalciuria1,2
13
Dizziness1,2
7
Nausea1,2
4
Headache1,2
6
Palpitations1,2
2
Fatigue1,3
2
Abdominal pain, upper1,3
2
Vertigo1,3
2
Hypercalcemia
(prespecified
safety endpoint)1†
6.4
 
TYMLOS
n=822 (%)
Placebo
n=820 (%)
Teriparatide
open-label, active
comparator n=818 (%)
Most common adverse reactions (ARs)*
 
 
 
Hypercalciuria1,2
11
9
13
Dizziness1,2
10
6
7
Nausea1,2
8
3
4
Headache1,2
8
6
6
Palpitations1,2
5
0.4
2
Fatigue1,3
3
2
2
Abdominal pain, upper1,3
3
2
2
Vertigo1,3
2
2
2
Hypercalcemia
(prespecified safety endpoint)1†
3.4
0.4
6.4
*These data represent the most common ARs in the study; ARs were generally not present at baseline, occurred more commonly with TYMLOS than with placebo, and occurred in ≥2% of patients treated with TYMLOS.2
Hypercalcemia was a prespecified safety endpoint defined as albumin-corrected serum calcium level of at least 10.7 mg/dL (or ≥2.67 mmol/L) at any time point.1
  • This study compared TYMLOS vs placebo and teriparatide vs placebo. It did not compare TYMLOS vs teriparatide and cannot be interpreted as evidence of superiority or noninferiority to teriparatide1
  • The incidence of serious adverse events (SAEs) was 10% (TYMLOS), 11% (placebo), and 10% (teriparatide)1,2
    • There were no discernible differences in SAEs between treatment groups3
    • No single SAE occurred in >0.5% of patients in the TYMLOS or placebo groups3
    • None of the SAEs were classified by investigators as being related to the study medication in the TYMLOS or placebo groups3

Discontinuation rates1

  • Discontinuation rates due to adverse events were 10% (TYMLOS), 6% (placebo), and 7% (teriparatide)1,2
    • In the TYMLOS group, the most common ARs leading to drug discontinuation were nausea (2%), dizziness (1%), headache (1%), and palpitations (1%)2
References: 1. Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016;316(7):722-733 [published correction appears in JAMA. 2017;317(4):442]. 2. TYMLOS [package insert]. Boston, MA: Radius Health, Inc. 3. Data on file. Radius Health, Inc; Boston, MA.