INDICATIONS AND USAGE

TYMLOS is indicated for the:

  • treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or 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.
  • treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
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Construction worker in orange safety gear climbing inside a massive, organic, bone-like architectural sculpture made of porous white material

FOUNDATION FIRST

TYMLOS rebuilds bone through rebalancing the natural remodeling process—out with the old, in with the strong.1,2*
See how it works

For men and postmenopausal women with osteoporosis at high risk for fracture

YOUR BLUEPRINT FOR BONE REBUILDING

TYMLOS works to address the architecture of bone—helping to improve bone strength.1*

*According to preclinical animal studies.1

REBALANCE

TYMLOS binds to and acts as an agonist on the parathyroid hormone 1 (PTH1) receptor to rebalance the body’s natural bone remodeling cycle.1

REMOVE

Osteocytes detect damage and signal osteoclasts to remove old bone.3

MODEST RESORPTION1

REBUILD

TYMLOS stimulates osteoblastic activity, rapidly shifting the balance towards formation over resorption.1

RAPID, SUSTAINED BONE FORMATION1

For illustrative purposes only. Not intended to imply clinical efficacy.
Please scroll down for bone marker data.

RAPID, SUSTAINED BONE FORMATION IN MEN AND POSTMENOPAUSAL WOMEN1

Greater increase of bone formation over bone resorption markers was sustained for the duration of therapy in men and postmenopausal women.1,4,5

Time course of serum bone turnover markers over 18 months post-baseline. Solid purple lines: s-P1NP (formation) in women peaks at 133% at 1 month, then declines to 45% at 18 months. Dashed purple: men peak at 93% and remain elevated at 84%. Solid orange: s-CTX (resorption) in women rises to 46% at 6 months. Dashed orange: men peak at 35%. Y-axis: % change from baseline.

Number of participants evaluated

Postmenopausal women: TYMLOS group: n=189; Placebo group: n=184.

Men: TYMLOS group: n=149; Placebo group: n=79.

s-CTX=serum carboxy-terminal cross-linked telopeptide of type 1 collagen; s-P1NP=serum procollagen type 1 N-terminal propeptide.

TYMLOS quickly shifts the balance during bone remodeling to favor bone formation.1

In preclinical animal studies,

TYMLOS HELPS BUILD BONE1

TYMLOS, a PTHrP(1-34) analog, affected both aspects of bone strength, including BMD and quality.1
Infographic stating that TYMLOS has an anabolic effect on bone, demonstrated by increases in bone strength correlated with BMD and bone mineral content, and increases in cortical and trabecular bone thickness
Infographic stating that TYMLOS has an anabolic effect on bone, demonstrated by increases in bone strength correlated with BMD and bone mineral content, and increases in cortical and trabececular bone thickness
*Bone microarchitecture can be understood in terms of trabecular architecture (thickness, orientation, spacing of the trabeculae, and the extent to which the trabeculae are interconnected) and cortical thickness and integrity.6
In animal models of postmenopausal osteoporosis, TYMLOS maintained or improved bone quality at all skeletal sites evaluated and did not cause any mineralization defects.1
Jump to bone formation on the surface

Watch how TYMLOS selectively binds to the PTH1 receptor to rebalance the body’s natural bone remodeling cycle.

TYMLOS QUICKLY SHIFTS THE BALANCE DURING BONE REMODELING TO FAVOR BONE FORMATION.1

Watch Dr. David Dempster discuss TYMLOS as a treatment option for both postmenopausal women and men that rebuilds bone.

BONE FORMATION ON THE SURFACE7

See study design

TYMLOS RAPIDLY INCREASED MINERALIZING SURFACE AT 3 MONTHS7*

Bar graph showing median mineralizing surface (MS/BS) in trabecular bone increasing from 4.5% at baseline to 24.7% after 3 months of abaloparatide treatment (over 500% increase, P
Bar graph showing median mineralizing surface (MS/BS) in trabecular bone increasing from 4.5% at baseline to 24.7% after 3 months of abaloparatide treatment (over 500% increase, P

Illustrates the increases in mineralizing surface in cancellous bone with abaloparatide (ABL) treatment.

No new safety signals were seen. Adverse events were similar to those seen in the ACTIVE trial.1,7

MS/BS=mineralizing surface per unit of bone surface.

*3 months is the amount of time it takes bones to form and mineralize in healthy adults.7-9

Should bone density and fracture history guide treatment sequence?

Find the answer
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IMPORTANT SAFETY INFORMATION

Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria.

Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential.

Adverse Reactions:

  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).
  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).
INDICATIONS AND USAGE TYMLOS is indicated for the:
  • treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or 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.
  • treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
Please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION

Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria.

Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget’s disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential.

Adverse Reactions:

  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).
  • The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).
INDICATIONS AND USAGE TYMLOS is indicated for the:
  • treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or 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.
  • treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
Please see full Prescribing Information.

References: 1. TYMLOS. Prescribing information. Radius Health, Inc. 2. Hattersley G, Dean T, Corbin BA, et al. Binding selectivity of abaloparatide for PTH-type-1 receptor conformations and effects on downstream signaling. Endocrinology. 2016;157(1):141-149. 3. Šromová V, Sobola D, Kaspar P. A brief review of bone cell function and importance. Cells. 2023;12(21):2576. doi: 10.3390/cells12212576. 4. 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. 5. Czerwinski E, Cardona J, Plebanski R, et al. The efficacy and safety of abaloparatide-SC in men with osteoporosis: A randomized clinical trial. J Bone Miner Res. 2022;37(12):2435-2442. doi:10.1002/jbmr.4719. 6. Felsenberg D, Boonen S. The bone quality framework: determinants of bone strength and their interrelationships, and implications for osteoporosis management. Clin Ther. 2005 Jan;27(1):1-11. doi: 10.1016/j.clinthera.2004.12.020. 7. Dempster DW, Zhou H, Rao SD, et al. Early effects of abaloparatide on bone formation and resorption indices in postmenopausal women with osteoporosis. J Bone Miner Res. 2021;36(4):644-653. 8. Baron R, Hesse E. Update on bone anabolics in osteoporosis treatment: rationale, current status, and perspectives. J Clin Endocrinol Metab. 2012;97(2):311-325. 9. Eriksen EF. Cellular mechanisms of bone remodeling. Rev Endocr Metab Disord. 2010;11(4):219-227.

Study design7

An open-label, single-arm study evaluated the effects of TYMLOS on indices of bone formation using transiliac bone biopsies in postmenopausal women with osteoporosis (n=19). 23 biopsy samples were included in the safety population; however, only 19 biopsy samples were evaluable.

PRIMARY ENDPOINT7

  • Change in the mineralizing surface per unit of bone surface (MS/BS) in trabecular bone, from baseline to 3 months

SECONDARY ENDPOINTS7

  • MS/BS (mineralizing surface per unit of bone surface) across cortical and periosteal surfaces
  • Remodeling- and modeling-based bone formation

INCLUSION CRITERIA7

  • Postmenopausal women with osteoporosis
  • 50–85 years of age
  • Bone mineral density (BMD) T-score -2.5 at the lumbar spine or hip (including femoral neck or total hip)
or
  • T-score -2.0 at the lumbar spine or hip with a recent (<5 years) low-trauma vertebral, forearm, humerus, sacral, pelvic, femoral, or tibial fracture

EXCLUSION CRITERIA7

Patients with unevaluable lumbar spine or hip BMD, a history of bone disorders, metabolic bone disease, malabsorption, cancer in the past 5 years, osteosarcoma at any time, or prior radiotherapy (besides radioiodine) were excluded. Patients with a known hypersensitivity to TYMLOS, those who received prior treatment with parathyroid hormone (PTH) or PTHrP, denosumab, or IV bisphosphonates, took medications that interfere with bone metabolism within 6 months, or received treatment with oral bisphosphonates within 3 years were not eligible for this study.

STUDY LIMITATIONS7

  • Consider open-label study limitations when interpreting results; this open-label study was not blinded; these results are not meant to imply fracture efficacy
  • Single-arm study with no placebo group comparison
  • Only included White female participants
  • Since the study included no control arm, a quadruple-labeling procedure was used to provide internal control, allowing for a baseline comparison of bone formation indices within the same sample
    • However, data generated from bone biopsies are variable, not only between subjects but also between biopsies taken from the same subject
  • While these parameters would not be expected to change significantly after only 3 months of treatment, this labeling procedure does limit the ability to evaluate the effect of treatment on bone microarchitectural endpoints
  • Transiliac bone biopsies may not precisely reflect changes in bone at weight-bearing sites