What is Tymlos (abaloparatide) used for?

What is Tymlos Used For?

Tymlos (abaloparatide) is an anabolic bone-building medication used to treat osteoporosis in postmenopausal women and men who are at very high risk for fracture or who have failed or cannot tolerate other osteoporosis treatments. 1

FDA-Approved Indications

Tymlos is specifically indicated 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

Clinical Positioning in Treatment Algorithm

Tymlos should be reserved exclusively for patients at very high fracture risk—it is not a first-line treatment. 2, 3 The American College of Physicians recommends bisphosphonates as first-line therapy for osteoporosis, with Tymlos reserved only for females with primary osteoporosis at very high risk of fracture (conditional recommendation, low-certainty evidence for similar anabolic agents). 2, 3

Defining "Very High Risk" Patients

Very high risk typically includes patients with: 3, 4

• Prior vertebral fracture
• Multiple fractures
• Very low bone density (T-score ≤-3.0)
• Fracture occurring while on osteoporosis therapy
• Older age (typically >74 years) 4
• Recent fracture within the past 12 months 4

Mechanism and Efficacy

Tymlos is a synthetic peptide analogue of human parathyroid hormone-related protein that acts through selective activation of the parathyroid hormone type 1 receptor signaling pathway, producing anabolic (bone-building) effects. 5

Fracture Reduction

• Reduces new vertebral fractures by 86% compared to placebo in postmenopausal women 6
• Reduces nonvertebral fractures by 43% compared to placebo 6
• In men with osteoporosis, produces rapid and significant improvements in bone mineral density with a safety profile consistent with studies in women 7

Bone Density Improvements

• Increases lumbar spine BMD by 8.48% at 12 months in men 7
• Increases total hip BMD by 2.14% at 12 months in men 7
• Increases femoral neck BMD by 2.98% at 12 months in men 7
• Produces significantly greater BMD increases compared to antiresorptive agents in head-to-head studies 8

Critical Treatment Requirements

Mandatory Sequential Therapy

Patients must transition to an antiresorptive agent (bisphosphonate or denosumab) immediately after completing Tymlos therapy. 3, 4, 8 This is non-negotiable because:

• Discontinuing Tymlos without follow-on antiresorptive therapy causes rapid bone density loss 4
• There is serious risk of rebound and multiple vertebral fractures without transition therapy 3, 8
• Never discontinue anabolic therapy without immediately starting antiresorptive therapy 3

Treatment Duration

• Maximum lifetime use is 2 years 1
• Administered as 80 mcg subcutaneously once daily 1
• Each prefilled pen delivers 30 daily doses 1

Administration Protocol

• Inject subcutaneously into the periumbilical region of the abdomen (avoiding the 2-inch area around the navel) 1
• First several injections should be administered where the patient can sit or lie down due to risk of orthostatic hypotension 1
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate 1

Safety Profile and Contraindications

Black Box Warning

• Osteosarcoma risk: In animal studies, abaloparatide caused dose-dependent increase in osteosarcoma in rats 1
• Unknown if this occurs in humans, but avoid use in patients with increased osteosarcoma risk 1

Contraindications

Avoid Tymlos in patients with: 1

• Known hypersensitivity to abaloparatide
• Open epiphyses (children and young adults whose bones are still growing)
• Metabolic bone diseases including Paget's disease
• Bone metastases or history of skeletal malignancies
• Prior external beam or implant radiation therapy involving the skeleton
• Pre-existing hypercalcemia or underlying hypercalcemic disorders (such as primary hyperparathyroidism)

Common Adverse Effects

In postmenopausal women (≥2% incidence): 1

• Hypercalciuria
• Dizziness
• Nausea
• Headache
• Palpitations
• Fatigue
• Upper abdominal pain
• Vertigo

In men (≥2% incidence): 1

• Injection site reactions (erythema, swelling, pain)
• Dizziness
• Arthralgia
• Nausea
• Diarrhea
• Bone pain

Specific Safety Concerns

• Orthostatic hypotension: Instruct patients to sit or lie down if symptoms develop after dose administration 1
• Hypercalcemia: Lower incidence compared to teriparatide (3.4% vs 6.4%) 6
• Hypercalciuria: Monitor urine calcium if pre-existing hypercalciuria or active urolithiasis are suspected 1

Comparative Effectiveness

Real-world evidence demonstrates: 9

• Significantly lower rates of hip fractures with abaloparatide compared to teriparatide (1.1% vs 1.4%; HR 0.83, P=0.027)
• Significantly lower rates of nonvertebral fractures compared to teriparatide (4.4% vs 5.0%; HR 0.88, P=0.003)
• Lower incidence of hypercalcemia than teriparatide 10, 6
• Faster and more robust changes in BMD compared to teriparatide 10

Key Clinical Pitfalls to Avoid

• Do not use Tymlos as first-line therapy—bisphosphonates are first-line for most patients with osteoporosis 2, 3
• Do not use in patients who cannot commit to mandatory follow-on antiresorptive therapy 3
• Do not share the Tymlos pen or needles with other patients 1
• Do not transfer contents to a syringe—this can cause incorrect dosing 1
• Discard pen after 30 days even if unused solution remains 1