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NATPARA® is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism.
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NATPARA® is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Because of the potential risk of osteosarcoma, NATPARA is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. NATPARA was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. NATPARA was not studied in patients with acute post-surgical hypoparathyroidism.
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How NATPARA Is Given
Patients and caregivers who will reconstitute and administer NATPARA should receive appropriate training and instruction prior to first use.
How NATPARA is supplied
NATPARA is supplied as a multiple dose, dual-chamber glass cartridge containing a sterile powder and diluent in 4 dosage strengths:
25 mcg per dose strength (0.4 mg for reconstitution with 1.13 mL)
50 mcg per dose strength (0.8 mg for reconstitution with 1.13 mL)
75 mcg per dose strength (1.21 mg for reconstitution with 1.13 mL)
100 mcg per dose strength (1.61 mg for reconstitution with 1.13 mL)
25 mcg per dose strength (0.4 mg for reconstitution with 1.13 mL)
50 mcg per dose strength (0.8 mg for reconstitution with 1.13 mL) – recommended starting dose
75 mcg per dose strength (1.21 mg for reconstitution with 1.13 mL)
100 mcg per dose strength (1.61 mg for reconstitution with 1.13 mL)
Reconstitution and Administration of NATPARA
NATPARA Medication Cartridges are reconstituted with the Mixing Device and administered with the Q-Cliq™ pen injector.
Prior to administration, the NATPARA Medication Cartridge should be visually inspected for particulate matter and discoloration.
Each NATPARA Medication Cartridge can be used for 14 subcutaneous injections. Patients should alternate between thighs each time they inject.
Following each administration, the disposable needles should be discarded in a puncture-resistant container.
NATPARA Medication Cartridges should be stored in the refrigerator (36°F to 46°F [2°C to 8°C]). Q-Cliq™ pens that still contain doses should be stored in a refrigerator. All reconstituted NATPARA Medication Cartridges older than 14 days must be discarded.
Severe hypercalcemia has been reported with NATPARA. The risk is highest when starting or increasing the dose of NATPARA.1
Reference: 1. NATPARA [package insert]. Shire-NPS Pharmaceuticals, Inc.
