Recombinant human parathyroid hormone

[1][2][4][5] Recombinant human parathyroid hormone is used in the treatment of osteoporosis in postmenopausal women at high risk of osteoporotic fractures.

[3] Recombinant human parathyroid hormone (Natpara) was approved for medical use in the United States in January 2015, and in the European Union (as Natpar) in February 2017.

[1][2] Recombinant human parathyroid hormone (Natpar) is indicated as adjunctive treatment of adults with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

[4] Recombinant human parathyroid hormone (Preotact) is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures,[7] but the marketing authorization has been withdrawn at the manufacturer's request.

[3] Parathyroid hormone treatment should not be initiated in patients: The most common side effects include too high or too low blood calcium levels, which can lead to headache, diarrhea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch), and high calcium levels in the urine.

From the knowledge of the mechanism of action, combined use of Preotact and cardiac glycosides may predispose patients to digitalis toxicity if hypercalcemia develops.

Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney and the skeleton, and is therefore an expected undesirable effect.

In the same study mentioned above, Preotact increased bone mineral density in the lumbar spine after 18 months treatment by 6.5% compared with a reduction by 0.3% in the placebo group.

Under normal physiological conditions full-length parathyroid hormone H constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.

One chamber contains the active substance in the form of a white powder (with excipients: mannitol, citric acid monohydrate, NaCl, NaOH, HCl).