TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea and urticaria.
Warnings and precautions1
Instruct patients to sit or lie down if symptoms develop after dose administration.
Avoid use in patients with pre-existing hypercalcemia and those known to have an underlying hypercalcemic disorder,such as primary hyperparathyroidism.
Hypercalciuria and Urolithiasis:
Monitor urine calcium if pre-existing hypercalciuria or active urolithiasis are suspected.
As with all therapeutic proteins, there is potential for immunogenicity. Antibody formation did not appear immune-related hypersensitivity or allergic reactions, or other adverse events.to have any clinically significant impact on safety or efficacy endpoints, including BMD response, fracture reduction,
Reference: 1. TYMLOS® [prescribing information]. Waltham, MA: Radius Health, Inc; 2020.