FAQs About PTH Replacement Therapy for Hypoparathyroidism
Hypoparathyroidism is a rare disease in which patients have low levels of a hormone called PTH. Normally, the parathyroid glands produce this hormone, which controls the levels of calcium and phosphate in the blood. A loss of the parathyroid glands (either due to genetics or surgery) or an autoimmune disease can cause hypoparathyroidism. When PTH levels are too low, bones become fragile, among other complications.
Doctors normally treat patients with hypoparathyroidism with high doses of calcium and vitamin D. However, for many patients, this does not completely resolve symptoms. Researchers have been working on PTH replacement therapies for many years.
Here are some frequently asked questions about PTH replacement therapy:
What is PTH replacement therapy?
PTH replacement therapy is a treatment that replaces the hormone that patients with hypoparathyroidism cannot make themselves.
Is there an approved PTH replacement?
Several experimental PTH replacement therapies are under development. The U.S. Food and Drug Administration (FDA) approved one, Natpara, but the medication was recalled in the U.S. in 2019. (It is still available outside the U.S.). The recall occurred as a result of concerns that small rubber particulates from the cartridge of the medication were contaminating it. Takeda Pharmaceuticals, the manufacturer of Natpara is working with the FDA to address the issue and make the medication available again in the U.S.
How to administer it?
PTH replacement therapies must be infusions or injections. Because PTH is a hormone, it cannot reach the bloodstream from digestion and you cannot take it orally.
Researchers are testing several infusion and injection types, including a pump system (similar to an insulin pump) that delivers PTH to the bloodstream. Other companies are working to make a long-lasting PTH replacement therapy. This way, patients would not need to take the medication as frequently.
To receive the treatment, patients will have to go to their doctor’s office, hospital, or clinic. If an under-the-skin (subcutaneous) formulation becomes available, some patients could learn to administer their own treatment at home. For a continuous infusion (as with a pump) a small surgery would be necessary to install a port for the pump.
What are the side effects?
Some PTH replacement therapies like Natpara may cause side effects, including tingling feeling in the skin, low or high blood calcium, headache, nausea, diarrhea, vomiting, pain in the joints, and high calcium in the urine. Some patients may develop an allergic reaction to the medication, which can be severe.
Last updated: Aug. 7, 2020
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