Yorvipath 168mcg/0.56ml Inj 1.12ml
It is used to treat poor parathyroid function.
Drug Class
Parathyroid hormone analog
Pharmacologic Class
Parathyroid hormone receptor agonist
Pregnancy Category
Risk Summary available, not assigned letter category (newer FDA format)
FDA Approved
Dec 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Yorvipath is an injectable medication used to treat chronic hypoparathyroidism, a condition where your body doesn't make enough parathyroid hormone (PTH). PTH helps control the levels of calcium and phosphate in your blood. By replacing this hormone, Yorvipath helps to normalize your calcium and phosphate levels, reducing the need for high doses of calcium and active vitamin D supplements.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
When giving yourself an injection, be sure to rotate the injection site as directed by your doctor. Before using the medication, inspect the solution for any signs of cloudiness, leakage, or particles, and do not use it if you notice any of these issues or if the solution has changed color.
If you experience dizziness or lightheadedness after administering the injection, you may need to sit or lie down immediately. Discuss this with your doctor to determine the best course of action.
Preparing for Injection
Before injecting a dose, remove all pen needle covers (there may be two). If you are unsure about the type of pen needle you have or how to use it, consult with your doctor. After administering the dose, replace the cap on the pen to protect the medication.
Disposing of Needles and Pens
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Important Administration Guidelines
Do not administer more than one injection per day.
Storage and Disposal
Store unopened pens in the refrigerator, but do not freeze. After the first use, store the pen at room temperature. The pen should be discarded after 14 days. Store the pen with the cap on to protect it from light. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it has been more than 12 hours since the missed dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you miss three consecutive days of medication, contact your doctor for guidance on how to proceed.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
When giving yourself an injection, be sure to rotate the injection site as directed by your doctor. Before using the medication, inspect the solution for any signs of cloudiness, leakage, or particles, and do not use it if you notice any of these issues or if the solution has changed color.
If you experience dizziness or lightheadedness after administering the injection, you may need to sit or lie down immediately. Discuss this with your doctor to determine the best course of action.
Preparing for Injection
Before injecting a dose, remove all pen needle covers (there may be two). If you are unsure about the type of pen needle you have or how to use it, consult with your doctor. After administering the dose, replace the cap on the pen to protect the medication.
Disposing of Needles and Pens
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with your doctor or pharmacist.
Important Administration Guidelines
Do not administer more than one injection per day.
Storage and Disposal
Store unopened pens in the refrigerator, but do not freeze. After the first use, store the pen at room temperature. The pen should be discarded after 14 days. Store the pen with the cap on to protect it from light. Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it has been more than 12 hours since the missed dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you miss three consecutive days of medication, contact your doctor for guidance on how to proceed.
Lifestyle & Tips
- Administer the injection subcutaneously (under the skin) once daily, preferably at the same time each day.
- Follow your healthcare provider's instructions regarding calcium and vitamin D supplementation, as these may need to be adjusted after starting Yorvipath.
- Store the medication properly as directed (refrigerated, protect from light).
- Do not share your pen or needles with others.
- Attend all scheduled blood tests to monitor calcium, phosphate, and other levels.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
168 mcg subcutaneously once daily
Dose Range:
168 - 168 mg
Condition-Specific Dosing:
initial:
168 mcg once daily. Adjust calcium and active vitamin D supplementation as needed to maintain serum calcium within the lower half of the normal range (8.0-9.0 mg/dL) and serum phosphate within the normal range.
maintenance:
Maintain serum calcium within the lower half of the normal range (8.0-9.0 mg/dL) and serum phosphate within the normal range.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution. Closely monitor serum calcium and phosphate.
Dialysis:
Not studied in patients on dialysis. Use with caution and close monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Palopegteriparatide is a long-acting parathyroid hormone (PTH) analog. It is a pegylated form of recombinant human PTH(1-34). It acts as an agonist at the PTH1 receptor, mimicking the continuous endocrine action of endogenous PTH to regulate calcium and phosphate homeostasis. In patients with chronic hypoparathyroidism, it replaces deficient endogenous PTH, thereby increasing serum calcium and decreasing serum phosphate.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified as a percentage, but well absorbed after subcutaneous administration.
Tmax:
Approximately 10-12 hours after subcutaneous administration.
FoodEffect:
Not applicable for subcutaneous injection.
Distribution:
Vd:
Not readily available in public domain, likely large due to pegylation.
ProteinBinding:
Not readily available.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 60-70 hours (due to pegylation, significantly longer than non-pegylated PTH analogs).
Clearance:
Not readily available.
ExcretionRoute:
Metabolites are likely excreted renally and hepatically.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Gradual, sustained effect on serum calcium and phosphate levels over 24 hours.
PeakEffect:
Not a sharp peak; sustained effect throughout the dosing interval.
DurationOfAction:
24 hours (supports once-daily dosing).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Dizziness or fainting
Fast or abnormal heartbeat
Bone pain, persistent pain, or a tender lump or swelling under the skin (note: although rare, bone cancer has occurred in humans taking similar medications, and animal studies have shown an increased risk of bone cancer)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Bruising, redness, or irritation at the injection site
Headache
Diarrhea
Back pain
* Mouth or throat pain or irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Dizziness or fainting
Fast or abnormal heartbeat
Bone pain, persistent pain, or a tender lump or swelling under the skin (note: although rare, bone cancer has occurred in humans taking similar medications, and animal studies have shown an increased risk of bone cancer)
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:
Bruising, redness, or irritation at the injection site
Headache
Diarrhea
Back pain
* Mouth or throat pain or irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Symptoms of low calcium (hypocalcemia): tingling or numbness in fingers, toes, or around the mouth; muscle cramps or spasms; twitching; seizures; fatigue; anxiety; depression.
- Symptoms of high calcium (hypercalcemia): nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, headache, bone pain.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ High calcium levels in your blood
+ An overactive parathyroid gland
If you are at increased risk for developing osteosarcoma, a type of bone cancer. This may include:
+ Having Paget's disease or other bone disorders
+ Having bones that have not yet stopped growing
+ A history of bone cancer
+ Previous radiation therapy to the bones
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ High calcium levels in your blood
+ An overactive parathyroid gland
If you are at increased risk for developing osteosarcoma, a type of bone cancer. This may include:
+ Having Paget's disease or other bone disorders
+ Having bones that have not yet stopped growing
+ A history of bone cancer
+ Previous radiation therapy to the bones
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Additionally, exercise caution when navigating stairs.
Regular blood tests and other laboratory assessments are crucial; adhere to the schedule recommended by your doctor. It is also important to take calcium and vitamin D supplements as directed by your healthcare provider.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if a new needle is used. Sharing these devices can spread infections, including those that may not be apparent.
Be aware that this medication can cause both high and low calcium levels in the blood. High calcium levels can be severe and may require hospitalization. The risk of low calcium levels is particularly elevated when the medication is stopped abruptly. If you have concerns, discuss them with your doctor.
If you are taking digoxin concurrently with this medication, your doctor may need to monitor your blood work more frequently.
It is crucial to notify your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your healthcare provider will need to discuss the potential benefits and risks of this medication to both you and your baby.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Additionally, exercise caution when navigating stairs.
Regular blood tests and other laboratory assessments are crucial; adhere to the schedule recommended by your doctor. It is also important to take calcium and vitamin D supplements as directed by your healthcare provider.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if a new needle is used. Sharing these devices can spread infections, including those that may not be apparent.
Be aware that this medication can cause both high and low calcium levels in the blood. High calcium levels can be severe and may require hospitalization. The risk of low calcium levels is particularly elevated when the medication is stopped abruptly. If you have concerns, discuss them with your doctor.
If you are taking digoxin concurrently with this medication, your doctor may need to monitor your blood work more frequently.
It is crucial to notify your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your healthcare provider will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (e.g., nausea, vomiting, weakness, confusion, stupor, coma)
- Hypotension
- Cardiac arrhythmias
What to Do:
Seek immediate medical attention. Discontinue Yorvipath. Hydrate with intravenous fluids. Monitor serum calcium and other electrolytes. Provide supportive care. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Digoxin (risk of digoxin toxicity due to hypercalcemia)
Moderate Interactions
- Thiazide diuretics (may increase risk of hypercalcemia)
- Vitamin D analogs (e.g., calcitriol, doxercalciferol, paricalcitol) and calcium supplements (may require dose reduction to avoid hypercalcemia)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation.
Serum Phosphate
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation.
Serum Magnesium
Rationale: To establish baseline, as hypomagnesemia can impair PTH action.
Timing: Prior to initiation.
25-hydroxyvitamin D
Rationale: To assess vitamin D status and guide supplementation.
Timing: Prior to initiation.
Renal Function (Creatinine, eGFR)
Rationale: To assess kidney health, as renal impairment may affect calcium/phosphate balance.
Timing: Prior to initiation.
Routine Monitoring
Serum Calcium
Frequency: Frequently (e.g., weekly) during dose titration, then periodically (e.g., monthly or every 3 months) once stable.
Target: Lower half of normal range (8.0-9.0 mg/dL)
Action Threshold: Above 9.0 mg/dL (consider reducing calcium/vitamin D supplements or Yorvipath dose); below 8.0 mg/dL (consider increasing calcium/vitamin D supplements or Yorvipath dose).
Serum Phosphate
Frequency: Frequently during dose titration, then periodically once stable.
Target: Normal range
Action Threshold: Outside normal range (adjust calcium/vitamin D supplements or Yorvipath dose).
Serum Magnesium
Frequency: Periodically, especially if symptoms of hypomagnesemia or poor response.
Target: Normal range
Action Threshold: Below normal range (consider supplementation).
Renal Function (Creatinine, eGFR)
Frequency: Periodically (e.g., every 6-12 months).
Target: Stable
Action Threshold: Significant decline (re-evaluate treatment).
Bone Mineral Density (BMD)
Frequency: Periodically (e.g., every 1-2 years) by DXA scan.
Target: Stable or improved
Action Threshold: Significant decline (re-evaluate treatment).
Symptom Monitoring
- Symptoms of hypocalcemia (e.g., paresthesias, muscle cramps, tetany, seizures, fatigue, anxiety, depression)
- Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, polyuria, polydipsia, fatigue, muscle weakness, confusion, headache)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of palopegteriparatide in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than clinical exposure.
Trimester-Specific Risks:
First Trimester:
Risk not specifically characterized by trimester; general risk summary applies.
Second Trimester:
Risk not specifically characterized by trimester; general risk summary applies.
Third Trimester:
Risk not specifically characterized by trimester; general risk summary applies.
Lactation
It is not known whether palopegteriparatide is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Yorvipath and any potential adverse effects on the breastfed infant from Yorvipath or from the underlying maternal condition.
Infant Risk:
Unknown
Pediatric Use
Safety and effectiveness in pediatric patients (less than 18 years of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (65 years and older) and younger patients in clinical trials. However, greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is generally not required based on age alone.
Clinical Information
Clinical Pearls
- Yorvipath is the first long-acting PTH analog approved for chronic hypoparathyroidism, offering a once-daily dosing regimen.
- Patients on Yorvipath will likely need to significantly reduce or discontinue their calcium and active vitamin D supplementation, requiring careful titration and monitoring.
- Close monitoring of serum calcium, phosphate, and magnesium is crucial, especially during the initial weeks of therapy and with any dose adjustments.
- Educate patients thoroughly on proper injection technique and the signs/symptoms of both hypocalcemia and hypercalcemia.
- Unlike teriparatide for osteoporosis, Yorvipath is not associated with an increased risk of osteosarcoma in its approved indication for hypoparathyroidism.
Alternative Therapies
- Conventional therapy (oral calcium and active vitamin D supplementation)
- Natpara (Parathyroid Hormone, currently unavailable in the US due to manufacturing issues)
Cost & Coverage
Average Cost:
Price range: $20,000 - $30,000+ per 28-day supply (1.12 mL vial)
Insurance Coverage:
Specialty Tier / Tier 4 or 5 (requires prior authorization and may have high co-pays/coinsurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.