Hypersensitivity: Hypersensitivity reactions (anaphylaxis, dyspnea, angioedema, urticaria, rash) have been reported.In patients using NATPARA concomitantly with digoxin, monitor serum calcium more frequently and increase monitoring when initiating or adjusting NATPARA dose. Digoxin Toxicity: Hypercalcemia increases the risk of digoxin toxicity.

Monitor serum calcium and replace calcium and vitamin D. Severe Hypocalcemia: Can occur with interruption or discontinuation of NATPARA treatment.Severe Hypercalcemia: Monitor serum calcium when starting or adjusting NATPARA dose and when making changes to co-administered drugs known to raise serum calcium.Avoid use of NATPARA in patients who are at increased risk for osteosarcoma. Potential Risk of Osteosarcoma: Prescribe NATPARA only to patients who cannot be well-controlled on calcium and active vitamin D.

NATPARA is available only through a restricted program called the NATPARA REMS Program ( 5.2).

Avoid use of NATPARA in patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, patients with hereditary disorders predisposing to osteosarcoma or patients with a history of prior external beam or implant radiation therapy involving the skeleton) ( 5.1).

Because of the potential risk of osteosarcoma, prescribe NATPARA only to patients who cannot be well-controlled on calcium and active forms of vitamin D and for whom the potential benefits are considered to outweigh the potential risk.

A risk to humans could not be excluded ( 5.1, 13.1)

In male and female rats, parathyroid hormone caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration.

WARNING: POTENTIAL RISK OF OSTEOSARCOMA See full prescribing information for complete boxed warning.

Sibelius 8.6 trial verifying hands