What is Tymlos (abaloparatide) used for?

What is Tymlos (Abaloparatide) Used For?

Tymlos (abaloparatide) is an anabolic bone-building medication used to treat osteoporosis in postmenopausal women and men who are at high risk for fracture, including those with a history of osteoporotic fractures, multiple fracture risk factors, or who have failed or cannot tolerate other osteoporosis therapies. 1

FDA-Approved Indications

Abaloparatide is specifically approved for:

• Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy 1
• Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy 1

Mechanism and Clinical Advantages

Abaloparatide is a synthetic peptide analogue of human parathyroid hormone-related protein (PTHrP 1-34) that works through selective activation of the parathyroid hormone type 1 receptor signaling pathway. 2, 3

The key advantage of abaloparatide over teriparatide is its maintained anabolic window without increased bone resorption over time, making it a more favorable anabolic agent. 4

Patient Selection Criteria

Very High-Risk Patients Who Should Be Considered

• Patients with prior osteoporotic fractures, particularly hip or vertebral fractures 5, 4
• Patients with multiple risk factors for fracture 5, 4
• Patients who have failed bisphosphonate therapy or experienced fractures despite antiresorptive treatment 5
• Patients who are intolerant to other osteoporosis medications 1

Evidence Quality Consideration

The American College of Physicians (2023) notes that evidence on benefits and harms was inconclusive to recommend for or against abaloparatide, though it may be considered as first-line treatment for men with osteoporosis at very high risk based on bone mineral density data. 5

Clinical Efficacy

Abaloparatide demonstrates significant benefits:

• Reduces vertebral fracture risk (0.6% vs 4.2% with placebo) 6, 7
• Reduces nonvertebral fracture risk (2.7% vs 4.7% with placebo) 6
• Increases bone mineral density at lumbar spine (6.7%-11.2%), femoral neck (3.1%-3.2%), and total hip (2.6%-4.2%) 6, 8, 7

Critical Treatment Requirements

Mandatory Sequential Therapy

After completing abaloparatide treatment, patients MUST transition to an antiresorptive agent (bisphosphonate or denosumab) to maintain bone mineral density gains and prevent serious rebound bone loss and multiple vertebral fractures. 5, 4, 9

This is not optional—failure to follow with antiresorptive therapy can result in rapid bone loss and vertebral fractures occurring as soon as 7-9 months after discontinuation. 5

Supplementation Requirements

Patients should receive supplemental calcium (1,000-1,200 mg daily) and vitamin D (600-800 IU daily) if dietary intake is inadequate. 1, 9

Administration Details

• Dosage: 80 mcg subcutaneously once daily 1
• Route: Subcutaneous injection into the periumbilical region of abdomen 1
• Initial administration: Should occur where the patient can sit or lie down due to risk of orthostatic hypotension 1, 4
• Duration: Delivered via prefilled pen containing 30 daily doses 1

Common Adverse Effects

In Postmenopausal Women

• Hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo (incidence ≥2%) 1, 4

In Men

• Bone pain, injection site reactions (erythema, swelling, pain), dizziness, arthralgia, nausea, diarrhea, and abdominal pain (incidence ≥2%) 1, 4

Cardiovascular Considerations

Clinicians should be aware that palpitations and increased heart rate occur more frequently with abaloparatide than with teriparatide. 4

Important Contraindications and Warnings

Absolute Contraindication

• Known hypersensitivity to abaloparatide 1

Avoid Use In (Osteosarcoma Risk)

• Patients with open epiphyses 1
• Metabolic bone diseases including Paget's disease 1
• Bone metastases or history of skeletal malignancies 1
• Prior external beam or implant radiation therapy involving the skeleton 1
• Hereditary disorders predisposing to osteosarcoma 1

Other Precautions

• Pre-existing hypercalcemia or underlying hypercalcemic disorders (e.g., primary hyperparathyroidism) 1
• Pre-existing hypercalciuria or active urolithiasis—monitor urine calcium if suspected 1
• Women of childbearing potential must use effective birth control due to lacking safety data in pregnancy 4

Positioning in Treatment Algorithm

While the 2023 American College of Physicians guideline found evidence inconclusive for definitive recommendation 5, abaloparatide is positioned as:

• An option for very high-risk patients as initial anabolic therapy based on BMD data 5, 4
• An alternative when bisphosphonates have failed or are not tolerated 5, 1
• A choice that should be made based on clinician and patient preferences, comorbidities, and specific risk factors rather than rigid rank ordering 5

The decision to use abaloparatide should prioritize patients at very high fracture risk where rapid bone formation is critical, always followed by antiresorptive therapy to maintain gains. 4, 9