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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RESOURCES For YOUR PATIENTS

The resources below include information to help patients understand treatment with TYMLOS.

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

Not actual patients.

FOR YOUR PATIENTS

Tymlos_CEN_Logo

TYMLOS Clinical Educator Network

The TYMLOS Clinical Educators are registered nurses who are available to provide training for you and your staff on using the TYMLOS pen. Following prescription, a Clinical Educator can help your patients learn about their injection and train them on how to use the pen.

Connect to a Clinical Educator Monday through Friday, 8 AM to 7 PM ET at 1-855-730-8591

Encourage your patients to register for virtual training at www.TYMLOSsignup.com

Empower patients with 1-on-1 virtual injection training from a Clinical Educator—plus a TYMLOS Welcome Kit.

Brochure spread for TYMLOS (abaloparatide) injection: left page with dark blue background, headline "Add To The Bone", slogan "TYMLOS can help stand up to osteoporosis by rebuilding bone", group photo of four smiling seniors (two men, two women) labeled "Not actual patients", indications for postmenopausal women at high risk of fracture and men with osteoporosis; right page titled "TYMLOS has a well established safety profile", features 86% reduced risk of vertebral fractures and 43% reduced risk of non-vertebral fractures vs placebo, BMD increases (spine 9.2% vs 0.5%, hip 3.4% vs -0.1%, femoral neck 2.9% vs -0.4%), most common side effects table comparing TYMLOS to placebo (e.g., increased urine calcium 11% vs 9%, dizziness 10% vs 6%), photo of mature woman in orange top labeled "Not actual patient", safety notes and "Please read Important Safety Information"

Patient Brochure

This brochure will help your patients understand osteoporosis as a disease, its associated risk factors, and the role TYMLOS plays in treating it.

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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.