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The TYMLOS pen is
thoughtfully designed.1

TYMLOS is a self-administered
daily injection pen1

Rebuild bone with TYMLOSRebuild bone with TYMLOS

5- to 8-mm
31 gauge needle,
the size of an eyelash.2

The self-administered TYMLOS daily injection pen

Pen needles are not included and may require a separate prescription in some states.

Recommended dosage and administration1

Subcutaneous injection should be administered in the periumbilical region of the abdomen

Administer the first several doses where the patient can sit or lie down, if necessary, in case symptoms of orthostatic hypotension occur

Rotate injection site every day and administer at approximately the same time every day

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

No dosage adjustment is required for patients with mild, moderate, or severe renal impairment.1

The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient’s lifetime is not recommended.1

Simple storage and handling.1,2

Before first use

  • TYMLOS can be stored in a refrigerator (until expiration date) between 36 °F and 46 °F (2 °C and 8 °C) at all times
  • Do not freeze or subject to heat

After first use

  • TYMLOS can be stored for up to 30 days without refrigeration at a temperature between 68 °F and 77 °F (20 °C and 25 °C)
  • Do not freeze or subject to heat
  • Store with pen cap on
  • Do not store with needle attached

TYMLOS support—resources available to you and your patients.

Support to help patients start and stay on treatment.

TYMLOS Clinical Educator Network provides 1-on-1 help for patients.

A TYMLOS Clinical Educator is ready to help your patients.

Following prescription, a Clinical Educator can help your patients learn about their injection and train them on how to use the pen.

The TYMLOS Clinical Educators are available to provide training for you and your staff on using the TYMLOS pen.

Both you and your patients can reach the Clinical Educator Network Monday through Friday from 8 AM to 7 PM ET at 1-855-730-8591.

NEED SUPPORT OR SAMPLES?

Let us know if you want to request samples or a visit from a TYMLOS representative or Field reimbursement manager.

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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. (opens in a new tab)

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 (opens in a new tab).

References: 1. TYMLOS. Prescribing information. Radius Health, Inc. 2. 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. 3. 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. 4. Eriksen EF. Cellular mechanisms of bone remodeling. Rev Endocr Metab Disord. 2010;11(4):219-227. 5. 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. 6. Tay D, Cremers S, Bilezikian JP. Optimal dosing and delivery of parathyroid hormone and its analogues for osteoporosis and hypoparathyroidism—translating the pharmacology. Br J Clin Pharmacol. 2018;84(2):252-267. 7. Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding selectivity of abaloparatide for PTH-type-1-receptor conformations and effects on downstream signaling. Endocrinology. 2016;157(1):141-149. 8. Siddiqui JA, Partridge NC. Physiological bone remodeling: systemic regulation and growth factor involvement. Physiology (Bethesda). 2016;31(3):233-245. 9. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis–2020 update. Endocr Pract. 2020;26(suppl 1):1-46.