What are the guidelines for prescribing Tymlos (abaloparatide) to a patient?

Prescribing Tymlos (Abaloparatide) for Osteoporosis

Tymlos (abaloparatide) 80 mcg subcutaneously once daily is FDA-approved for postmenopausal women and men with osteoporosis at high risk for fracture, defined as those with prior osteoporotic fracture, multiple fracture risk factors, or who have failed or are intolerant to other osteoporosis therapies. 1

Patient Selection Criteria

Approved Indications

• Postmenopausal women with osteoporosis at high risk for fracture 1
• Men with osteoporosis at high risk for fracture 1
• Patients who have failed or are intolerant to other available osteoporosis therapy 1

High-Risk Definition

High-risk patients include those with: 1

• History of osteoporotic fracture (particularly hip or vertebral)
• Multiple risk factors for fracture
• Treatment failure with antiresorptive agents

Absolute Contraindications

Do not prescribe Tymlos in patients with: 1

• Known hypersensitivity to abaloparatide
• Open epiphyses (pediatric/adolescent patients)
• Metabolic bone diseases including Paget's disease
• Bone metastases or history of skeletal malignancies
• Prior external beam or implant radiation therapy involving the skeleton
• Hereditary disorders predisposing to osteosarcoma
• Pre-existing hypercalcemia or underlying hypercalcemic disorders (such as primary hyperparathyroidism) 1

Special Populations Requiring Caution

Women of childbearing potential: Must use effective birth control during treatment, as safety data in pregnancy are lacking 2, 1

Patients with cardiovascular concerns: While the 2023 American College of Physicians guideline notes inconclusive evidence for abaloparatide, clinicians should be aware that some adverse cardiovascular effects (palpitations, increased heart rate) occur more frequently than with teriparatide 2, 3, 4

Patients with renal impairment or hypercalciuria: Monitor urine calcium if pre-existing hypercalciuria or active urolithiasis are suspected 1

Dosing and Administration

Standard Dosing

• 80 mcg subcutaneously once daily 1
• Administer into the periumbilical region of the abdomen 1
• Supplied as a prefilled pen delivering 30 daily doses 1

Supplementation Requirements

• Ensure adequate calcium and vitamin D supplementation if dietary intake is inadequate 1

Administration Precautions

Critical first-dose protocol: Administer the initial dose where the patient can sit or lie down, as orthostatic hypotension may occur 1. Instruct patients to sit or lie down if symptoms of dizziness or lightheadedness develop after any dose 1.

Treatment Duration and Sequential Therapy

Duration

• Maximum treatment duration: 18-24 months based on pivotal trial data 3, 4, 5
• The cumulative lifetime exposure should be limited, similar to other anabolic agents 1

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 rebound bone loss 2, 6. This is critical because anabolic agents produce gains that will be lost without subsequent antiresorptive therapy 2.

Monitoring Requirements

Baseline Assessment

• Serum calcium levels 1
• Renal function if concerns exist 1
• Urine calcium if hypercalciuria or urolithiasis suspected 1
• Cardiovascular assessment given palpitation risk 3, 4

During Treatment

• Monitor for symptoms of orthostatic hypotension, particularly after initial doses 1
• Assess for hypercalcemia symptoms 1
• Monitor urine calcium if pre-existing hypercalciuria or active urolithiasis 1
• Evaluate for adverse effects including palpitations, dizziness, nausea 1, 3

Common Adverse Effects

Postmenopausal Women (≥2% incidence): 1

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

Men (≥2% incidence): 1

• Injection site reactions (erythema, swelling, pain)
• Dizziness
• Arthralgia
• Nausea, diarrhea
• Abdominal distension and pain
• Bone pain

Clinical Efficacy Data

Abaloparatide demonstrated superior fracture reduction compared to placebo in the pivotal 18-month trial: 3, 5

• 86% reduction in new vertebral fractures
• 43% reduction in nonvertebral fractures
• Bone mineral density increases: lumbar spine 11.2%, total hip 4.2%, femoral neck 3.2% 4

Compared to teriparatide, abaloparatide showed greater BMD increases at the total hip (2.6% vs 0.5%) and significantly lower rates of hypercalcemia 4, 7.

Key Clinical Advantages Over Teriparatide

Abaloparatide has a more favorable profile than teriparatide due to: 7

• Lower hypercalcemia risk (faster receptor dissociation)
• Reduced bone resorption (less RANKL production)
• Maintained anabolic window without increased resorption over time
• Lower cost than teriparatide 3, 4

Common Prescribing Pitfalls

Failure to plan sequential therapy: Always discuss and arrange transition to antiresorptive therapy before completing abaloparatide treatment 2, 6

Inadequate first-dose precautions: Orthostatic hypotension can occur; ensure patients are seated or lying down for initial administration 1

Prescribing in contraindicated populations: Carefully screen for history of skeletal radiation, bone malignancies, or Paget's disease before prescribing 1

Ignoring cardiovascular symptoms: Palpitations and increased heart rate occur more frequently than with teriparatide; counsel patients accordingly 3, 4