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Drug overview for YORVIPATH (palopegteriparatide):
Generic name: PALOPEGTERIPARATIDE
Drug class: Parathyroid Hormone
Therapeutic class: Endocrine
Palopegteriparatide, a prodrug of teriparatide, is a parathyroid hormone analog (PTH(1-34)).
No enhanced Uses information available for this drug.
Generic name: PALOPEGTERIPARATIDE
Drug class: Parathyroid Hormone
Therapeutic class: Endocrine
Palopegteriparatide, a prodrug of teriparatide, is a parathyroid hormone analog (PTH(1-34)).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for YORVIPATH (palopegteriparatide) have been approved by the FDA:
Indications:
Hypoparathyroidism
Professional Synonyms:
Condition due to low levels of PTH
Indications:
Hypoparathyroidism
Professional Synonyms:
Condition due to low levels of PTH
The following dosing information is available for YORVIPATH (palopegteriparatide):
On the day of initiation or up-titration of palopegteriparatide, adjust the dose of active vitamin D and calcium based on albumin-corrected serum calcium and current active vitamin D (see Table 1).
Table 1: Dosage Adjustments to Active Vitamin D (calcitriol) and Calcium Supplements upon Initiation or Up-titration of Palopegteriparatide Treatment
Albumin Corrected Current Adjust Active Adjust Calcium Serum Calcium Calcitriol Intake Calcitriol Intake Supplements >=8.3 mg/dL >1 mcg/day Reduce calcitriol Maintain current dosage by >=50% dosage >=8.3 mg/dL <=1 mcg/day Discontinue Maintain current calcitriol dosage >=7.8
to <8.3 Any amount Reduce calcitriol Maintain current mg/dL dosage >=50% dosage >=7.8 mg/dL Not currently on Not applicable Reduce calcium active vitamin D daily dosage by >=1500 mg or discontinue if current calcium dosage is <=1500 mg/day (if calcium supplements are needed to meet dietary requirements, can continue supplemental calcium at elemental dosages <=600 mg/day instead of discontinuing c alcium entirely)
Table 1: Dosage Adjustments to Active Vitamin D (calcitriol) and Calcium Supplements upon Initiation or Up-titration of Palopegteriparatide Treatment
Albumin Corrected Current Adjust Active Adjust Calcium Serum Calcium Calcitriol Intake Calcitriol Intake Supplements >=8.3 mg/dL >1 mcg/day Reduce calcitriol Maintain current dosage by >=50% dosage >=8.3 mg/dL <=1 mcg/day Discontinue Maintain current calcitriol dosage >=7.8
to <8.3 Any amount Reduce calcitriol Maintain current mg/dL dosage >=50% dosage >=7.8 mg/dL Not currently on Not applicable Reduce calcium active vitamin D daily dosage by >=1500 mg or discontinue if current calcium dosage is <=1500 mg/day (if calcium supplements are needed to meet dietary requirements, can continue supplemental calcium at elemental dosages <=600 mg/day instead of discontinuing c alcium entirely)
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for YORVIPATH (palopegteriparatide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for YORVIPATH (palopegteriparatide):
Drug contraindication overview.
*Severe hypersensitivity to palopegteriparatide or any components of palopegteriparatide.
*Severe hypersensitivity to palopegteriparatide or any components of palopegteriparatide.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypercalcemia |
| Hypocalcemia |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypotension |
The following adverse reaction information is available for YORVIPATH (palopegteriparatide):
Adverse reaction overview.
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.
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.
There are 0 severe adverse reactions.
There are 12 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Injection site erythema Injection site inflammation Injection site sequelae Orthostatic hypotension Palpitations Syncope Vertigo |
Back pain Diarrhea Hypercalcemia Pain in oropharynx |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for YORVIPATH (palopegteriparatide):
Safety and efficacy of palopegteriparatide have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
Safety and efficacy of palopegteriparatide have not been established in geriatric patients 65 years of age and older.
The following prioritized warning is available for YORVIPATH (palopegteriparatide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for YORVIPATH (palopegteriparatide)'s list of indications:
| Hypoparathyroidism | |
| E20 | Hypoparathyroidism |
| E20.0 | Idiopathic hypoparathyroidism |
| E20.1 | Pseudohypoparathyroidism |
| E20.8 | Other hypoparathyroidism |
| E20.81 | Hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.810 | Autosomal dominant hypocalcemia |
| E20.811 | Secondary hypoparathyroidism in diseases classified elsewhere |
| E20.812 | Autoimmune hypoparathyroidism |
| E20.818 | Other specified hypoparathyroidism due to impaired parathyroid hormone secretion |
| E20.819 | Hypoparathyroidism due to impaired parathyroid hormone secretion, unspecified |
| E20.89 | Other specified hypoparathyroidism |
| E20.9 | Hypoparathyroidism, unspecified |
| E89.2 | Postprocedural hypoparathyroidism |
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