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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For postmenopausal women with osteoporosis
and a history of osteoporotic fracture,

Reduce the
risk of another
fracture with TYMLOS1

TYMLOS is an anabolic agent that helps build new bone1

86%

Relative Risk Reduction (RRR) in new
vertebral fractures vs placebo (P<0.0001)
and 3.6% Absolute Risk Reduction (ARR)
at 18 months.1

Primary endpoint: New vertebral fracture
incidence was 0.6% (n=690) vs 4.2% with
placebo (n=711) (P<0.001) at 18 months.1*

Relative Risk
Reduction
(RRR)

Relative Risk
Reduction (RRR)
in new
vertebral fractures vs placebo (P<0.0001)
and 3.6% Absolute Risk Reduction (ARR)
at 18 months.1

Primary endpoint: New vertebral fracture
incidence was 0.6% (n=690) vs 4.2% with
placebo (n=711) (P<0.001) at 18 months.1*

43%

Relative Risk Reduction (RRR) in
nonvertebral fractures vs placebo (P=0.049)
and 2.0% Absolute Risk Reduction (ARR)
at 19 months.1†

Relative Risk
Reduction
(RRR)


in nonvertebral fractures vs placebo (P=0.049)
and 2.0% Absolute Risk Reduction (ARR)
at 19 months.1†

Study Design: A randomized, multicenter, double-blind, placebo- and active-controlled clinical study in postmenopausal women with osteoporosis (N=1645) aged 49 to 86 years (mean age 69 years) who were randomized to receive TYMLOS 80 mcg (n=824) or placebo (n=821) subcutaneously once daily for 18 months.1,2 The primary endpoint was incidence of new vertebral fractures.1 Secondary endpoints were incidence of nonvertebral fractures and changes in bone mineral density (BMD) from baseline at the lumber spine, total hip, and femoral neck at 18 months.

*Modified ITT population, which includes patients who had both pre- and post-treatment spine radiographs.
Data included 18 months of treatment plus 1 month without treatment; P value based on the log-rank test.1
Excluded fractures of the sternum, patella, toes, fingers, skull, and face, and those associated with high trauma.3

ITT=intent to treat.

Efficacy
Efficacy

TYMLOS reduces the risk of vertebral
and nonvertebral fractures and increases BMD.1,2

Efficacy
Safety
Safety

See safety data for TYMLOS.

Safety
Resources
Resources

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about prescribing TYMLOS.

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Enrollment form
Enrollment Form

Use this form to enroll patients in the TYMLOS
support program.

Enrollment Form
BMD=bone mineral density.
References: 1. TYMLOS [prescribing information]. Boston, MA: Radius Health, Inc. 2. 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):22-33 [published correction appears in JAMA. 2017;317(4):442]. 3. Sornay-Rendu E, Boutroy S, Munoz F, Delmas PD. Alterations of cortical and trabecular architecture are associated with fractures in postmenopausal women, partially independent of decreased BMD measured by DXA: the OFELY study. J Bone Miner Res. 2007;22(3):425-433.