The US FDA has expanded the indications of abaloparatide to also include men with osteoporosis at high risk of fracture or intolerant to or in case of failure of other treatments. Abaloparatide is a parathyroid hormone related peptide [PTHrP(1-34)] analog and is available as Tymlos. The approval has been granted on the basis of the phase 3 ATOM (Abaloparatide Treatment of Men) study.^1-3

Abaloparatide is already FDA-approved (in 2017) for use in postmenopausal osteoporotic women at high risk of fracture/s or those in whom other anti-osteoporotic treatments have failed.

Dose and administration: 80ug subcutaneously once daily into the periumbilical region of abdomen. Ensure calcium and vitamin D supplementation in cases of insufficient dietary consumption.

Contraindications: Known hypersensitivity to abaloparatide

Adverse effects (in men): Local injection site reactions (such as erythema, swelling pain, contusion); nausea, diarrhea, abdominal distension, abdominal pain, dizziness, arthralgia, bone pain.

Warnings and precautions

• Abaloparatide should not be used in patients at high risk of osteosarcoma, patients with Paget’s disease, skeletal metastases/malignancies, radiation therapy involving the skeleton.
• Orthostatic hypotension may occur within 4 hours of administration specifically. Hence, it must be administered in sitting or lying down position.
• Hypercalciuria may occur. Urine calcium must be monitored especially in patients with pre-existing hypercalciuria or active urolithiasis.
• Use of Abaloparatide should be avoided in patients with pre-existing hypercalcemia, primary hyperparathyroidism because of concerns of worsening of hypercalcemia.

References

1. https://radiuspharm.com/radius-healths-tymlos-abaloparatide-receives-u-s-fda-approval-as-a-treatment-to-increase-bone-density-in-men-with-osteoporosis-at-high-risk-for-fracture/ December 20, 2022
2. Tymlos prescribing information. Available at: https://radiuspharm.com/wp-content/uploads/tymlos/tymlos-prescribing-information.pdf  
3. FDA Approves Abaloparatide (Tymlos) for osteoporosis in men - Medscape - Dec 22, 2022.