Osteosarcoma: Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. Avoid use in patients with increased baseline risk of osteosarcoma including patients with open epiphyses (pediatric and young adult patients), metabolic bone diseases including Paget’s disease of the bone, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. There is limited data assessing the risk of osteosarcoma beyond 2 years.
Hypercalcemia and Cutaneous Calcification: FORTEO may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia. Avoid FORTEO in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.
Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying autoimmune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue in patients developing calciphylaxis or worsening of previously stable cutaneous calcification.
Risk of Urolithiasis: Consider the risks and benefits in patients with active or recent urolithiasis because of risk of exacerbation. If FORTEO-treated patients have pre-existing hypercalciuria or suspected/known active urolithiasis, consider measuring urinary calcium excretion.
Orthostatic Hypotension: Transient orthostatic hypotension may occur with initial doses of FORTEO. FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. In short-term clinical pharmacology studies of FORTEO in healthy volunteers, transient episodes of symptomatic orthostatic hypotension were observed in 5% of volunteers.
Risk of Digoxin Toxicity: Hypercalcemia may predispose patients to digitalis toxicity because FORTEO transiently increases serum calcium. Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin.