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Brand Name :
TransCon PTH
Synonyms :
palopegteriparatide
Class :
Calcium regulators agent, Parathyroid hormone analog
Dosage Forms & Strengths
N/A
Palopegteriparatide (FDA approval pending) is an investigational drug, and the new drug application (NDA) is submitted to FDA
Now waiting for approval of Prescription Drug User Fee Act (PDUFA)
Not suggested
Refer to adult dosing
Actions and Spectrum
Palopegteriparatide is helps to regulate calcium levels in the blood by mimicking the effects of endogenous parathyroid hormone. This involves promoting the release of calcium from bone and enhancing the reabsorption of calcium in the kidneys.
Frequency not defined
None
Black Box Warning
None
Contraindication/Caution:
None
Pregnancy consideration:
Pregnancy category: N/A
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
parathyroid hormone (PTH) has an impact on renal function, particularly in terms of calcium reabsorption in the kidneys.
It influences these processes to maintain appropriate calcium levels.
Pharmacodynamics
parathyroid hormone stimulates the release of calcium from bones into the bloodstream.
parathyroid hormone also enhances the reabsorption of calcium in the kidneys, reducing calcium excretion in the urine.
Pharmacokinetics
Information not available on ADME.
Administration
Not known as the drug is under investigational phase.
Patient information leaflet
Generic Name: palopegteriparatide
Why do we use palopegteriparatide?
Palopegteriparatide (FDA approval pending) is an investigational medication indicated for the treatment of chronic hypoparathyroidism.
It is a transiently pegylated parathyroid hormone.
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