Abaloparatide (Effective 12/2021, Box Warning has been removed)
Risk of Osteosarcoma (Effective 12/2021, Box Warning has been removed)
- Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma, a malignant bone tumor, in male and female rats. It is unknown whether TYMLOS will cause osteosarcoma in humans.
- Use of TYMLOS is not recommended in patients at increased risk for osteosarcoma.
- Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.
Patient Counseling Information
Updated January 2022