What is the recommended dosage and usage of teriparatide (injection) for osteoporosis treatment?

Teriparatide Dosing and Administration

The FDA-approved dosage of teriparatide is 20 mcg administered subcutaneously once daily into the thigh or abdominal region, with treatment duration limited to 2 years during a patient's lifetime unless high fracture risk persists. 1

Dosing Specifications

• Standard dose: 20 mcg subcutaneously once daily 1
• No dose adjustment needed for age or gender 2
• Administer via subcutaneous injection into the thigh or abdominal wall 1
• Not approved for intravenous or intramuscular administration 1

Treatment Duration

• Maximum recommended duration: 2 years during a patient's lifetime 1
• Typical treatment courses range from 14-24 months, with 18 months being common 3, 2
• Use beyond 2 years should only be considered if the patient remains at or has returned to very high fracture risk 1

Administration Precautions

• Initial doses should be given under circumstances where the patient can sit or lie down due to risk of transient orthostatic hypotension 1
• Inspect solution visually before administration - should be clear and colorless with no particulate matter 1
• Do not use if solid particles appear or if solution is cloudy or colored 1
• Requires refrigeration of prefilled delivery devices 4
• Patients/caregivers require proper training from qualified healthcare professionals on pen device use 1

Required Supplementation

• Ensure adequate calcium and vitamin D supplementation based on dietary intake 1
• The American Academy of Family Physicians recommends 1,000-1,200 mg calcium and 600-800 IU vitamin D daily for adults with osteoporosis 5

Patient Selection Criteria

Teriparatide is FDA-approved for three specific populations 1:

• Postmenopausal women with osteoporosis at high risk for fracture (history of osteoporotic fracture, multiple risk factors, or failed/intolerant to other therapies) 1
• Men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed/are intolerant to other therapies 1
• Men and women with glucocorticoid-induced osteoporosis (≥5 mg prednisone equivalent daily) at high risk for fracture 1

Critical Contraindications and Warnings

Absolute contraindications 1:

• Hypersensitivity to teriparatide or excipients (including angioedema/anaphylaxis risk) 1

Avoid use in patients with increased osteosarcoma risk 1:

• Open epiphyses (pediatric/young adults) 1
• Metabolic bone diseases other than osteoporosis, including Paget's disease 1
• Bone metastases or history of skeletal malignancies 1
• Prior external beam or implant radiation therapy involving skeleton 1
• Hereditary disorders predisposing to osteosarcoma 1

Additional cautions 6, 1:

• Avoid in patients with underlying hypercalcemic disorders (e.g., primary hyperparathyroidism) 1
• Discontinue if calciphylaxis or worsening cutaneous calcification develops 1
• Use caution in patients with cardiovascular disease, especially pre-existing arrhythmias 6
• Consider risks/benefits in active or recent urolithiasis 1
• Avoid in cancer patients with tendency to metastasize to bone 5, 6

Common Pitfalls

• Do not use teriparatide as first-line therapy - it is reserved for very high fracture risk patients or those who have failed bisphosphonates 5, 3
• The American College of Rheumatology conditionally recommends teriparatide over anti-resorptives only in patients at very high fracture risk 5
• Rat studies showed increased osteosarcoma risk, though this has not been definitively observed in human observational studies; nonetheless, the 2-year lifetime limit exists due to limited safety data beyond this duration 1, 4