Yorvipath (palopegteriparatide)
Parathyroid Hormone Subcutaneous Pen Injector (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Palopegteriparatide, a prodrug of teriparatide, is a parathyroid hormone analog (PTH(1-34)).
Palopegteriparatide, a prodrug of teriparatide, is a parathyroid hormone analog (PTH(1-34)) conjugated to an inert methoxypolyethylene glycol carrier via a TransCon linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. When exposed to physiological temperature and pH, the linker of the drug molecule is cleaved releasing palopegteriparatide to maintain continuous systemic exposure; this modification to PTH(1-34) increases the half-life and provides a sustained release of active PTH.
The role of endogenous PTH is to maintain extracellular calcium and phosphate homeostasis by increasing serum calcium and decreasing serum phosphate. Similar to endogenous PTH, palopegteriparatide exerts its effects through parathyroid hormone 1 receptor (PTH1R), which is highly expressed on osteoblasts, osteocytes, renal tubular cells, and in several other tissues.
In healthy adults, serum PTH(1-34) and serum calcium increased in a dose-related manner. Steady state of PTH was achieved after 7 days of palopegteriparatide administration. At steady state, daily administration of palopegteriparatide resulted in a continuous exposure to released PTH throughout the dosing period.
The median time to reach maximum concentrations of PTH from palopegteriparatide administration is 4 hours. The apparent half life of PTH released is approximately 60 hours. PTH released from the administration of palopegteriparatide includes PTH(1-34) and the active metabolite PTH(1-33).
PTH(1-34) and PTH(1-33) have comparable affinity to and activation of PTH1R.
USES: Palopegteriparatide is a man-made form of parathyroid hormone, a certain natural substance made by the body. Parathyroid hormone helps maintain the balance of calcium and phosphorus in the body. This medication is used to treat low levels of parathyroid hormone.
Generic name: palopegteriparatide
Drug class: Parathyroid Hormone
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Yorvipath
Indications
The following indications are listed for Yorvipath:
- Hypoparathyroidism
Also known as: Condition Due To Low Levels Of Pth.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Severe hypersensitivity to palopegteriparatide or any components of palopegteriparatide.
There are no contraindication contraindications for this drug.
- Hypercalcemia
- Hypocalcemia
- Hypotension
Adverse reactions
The most common adverse reactions (>=5%) reported with palopegteriparatide in clinical studies were injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain.
Rare or Very Rare
- Anaphylaxis
- Angioedema
- Hypersensitivity drug reaction
More Frequent
- Dizziness
- Headache disorder
- Injection site erythema
- Injection site inflammation
- Injection site sequelae
- Orthostatic hypotension
- Palpitations
- Syncope
- Vertigo
Less Frequent
- Back pain
- Diarrhea
- Hypercalcemia
- Hypocalcemia
- Pain in oropharynx
Rare or Very Rare
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of palopegteriparatide have not been established in pediatric patients.
There are insufficient data on the use of palopegteriparatide in pregnant women to determine whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, no significant adverse effects were observed in pregnant rats and rabbits receiving palopegteriparatide doses of 16- and 13-fold the maximum recommended doses.
Hypocalcemia in pregnancy poses a risk to the mother and fetus. If palopegteriparatide is administered during pregnancy or if a patient becomes pregnant while on palopegteriparatide, report palopegteriparatide exposure by calling 844-442-7236.
It is not known whether palopegteriparatide is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Monitor for signs and symptoms of hypercalcemia or hypocalcemia in infants breastfed by females receiving palopegteriparatide; consider monitoring the infant's serum calcium levels.
No specific dosage adjustment is recommended in geriatric patients.
Safety and efficacy of palopegteriparatide have not been established in geriatric patients 65 years of age and older.
ICD codes
| Code | Type | Description |
|---|---|---|
| Hypoparathyroidism | ||
| E20 | ICD10CM | Hypoparathyroidism |
| E20.0 | ICD10CM | Idiopathic hypoparathyroidism |
| E20.1 | ICD10CM | Pseudohypoparathyroidism |
| E20.8 | ICD10CM | Other hypoparathyroidism |
| E20.81 | ICD10CM | Hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.810 | ICD10CM | Autosomal dominant hypocalcemia |
| E20.811 | ICD10CM | Secondary hypoparathyroidism in diseases classified elsewhere |
| E20.812 | ICD10CM | Autoimmune hypoparathyroidism |
| E20.818 | ICD10CM | Other specified hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.819 | ICD10CM | Hypoparathyroidism due to impaired parathyroid hormone secretion, unspecified |
| E20.89 | ICD10CM | Other specified hypoparathyroidism |
| E20.9 | ICD10CM | Hypoparathyroidism, unspecified |
| E89.2 | ICD10CM | Postprocedural hypoparathyroidism |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.