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FDA Labeling Changes
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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.
Limitations of Use:
- 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. [see Warnings and Precautions (5.1)]
- 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.
There is currently no drug history available for this drug.
The active ingredient in NATPARA, parathyroid hormone, is produced by recombinant DNA technology using a modified strain of Escherichia coli. Parathyroid hormone, has 84 amino acids and a molecular weight of 9425 daltons; The amino acid sequence for parathyroid hormone is shown below.
Figure 1: Amino Acid Sequence of Parathyroid Hormone
NATPARA (parathyroid hormone) for injection for subcutaneous use is supplied as a medication cartridge, which is comprised of a multiple dose, dual-chamber glass cartridge containing a sterile lyophilized powder and a sterile diluent, within a plastic cartridge holder. The sterile lyophilized powder contains either 0.40 mg or 0.80 mg or 1.21 mg or 1.61 mg of parathyroid hormone depending on dosage strength and 4.5 mg sodium chloride, 30 mg mannitol, and 1.26 mg citric acid monohydrate. The volume of the sterile diluent is 1.13 mL and the diluent contains a 3.2 mg/mL aqueous solution of m-cresol.
The disposable NATPARA medication cartridge is designed for use with a reusable mixing device for product reconstitution and a reusable Q-Cliq pen for drug delivery. The Q-Cliq pen delivers a fixed volumetric dose of 71.4 µL. Using the Q-Cliq pen, each NATPARA dual chamber cartridge delivers 14 doses of NATPARA [See Dosage Forms and Strengths (3)].