Yorvipath 420mcg/1.4ml Inj, 2.8ml
It is used to treat poor parathyroid function.
Drug Class
Parathyroid hormone replacement
Pharmacologic Class
Parathyroid hormone analog
Pregnancy Category
Not available
FDA Approved
Dec 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Yorvipath is a man-made version of a hormone called parathyroid hormone (PTH). It helps your body control calcium and phosphate levels in your blood. It's used to treat adults with chronic hypoparathyroidism, a condition where your body doesn't make enough PTH, leading to low calcium levels. Yorvipath is given as a shot under the skin once a week.
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 injecting the medication, be sure to rotate the injection site as directed by your doctor. Before use, 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 injection, you may need to sit or lie down immediately. Discuss this with your doctor. 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 your doctor.
After use, replace the cap on the pen and dispose of the needle in a designated sharps disposal container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it is full. If you have any questions, consult your doctor or pharmacist.
Important Dosage Information
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 and discard it after 14 days. Keep the pen cap on to protect the medication from light. Store all medications in a safe location, 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 it 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 injecting the medication, be sure to rotate the injection site as directed by your doctor. Before use, 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 injection, you may need to sit or lie down immediately. Discuss this with your doctor. 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 your doctor.
After use, replace the cap on the pen and dispose of the needle in a designated sharps disposal container. Do not reuse needles or other items, and follow local regulations for disposing of the container when it is full. If you have any questions, consult your doctor or pharmacist.
Important Dosage Information
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 and discard it after 14 days. Keep the pen cap on to protect the medication from light. Store all medications in a safe location, 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 it 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
- Maintain adequate hydration to prevent kidney stones.
- Follow dietary recommendations regarding calcium and vitamin D intake as advised by your doctor.
- Report any new or worsening symptoms promptly to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 420 mcg (1.4 mL) subcutaneously once weekly. Dose may be adjusted based on serum calcium and 24-hour urinary calcium excretion.
Dose Range:
420 - 840 mg
Condition-Specific Dosing:
hypoparathyroidism:
Initial 420 mcg (1.4 mL) SC once weekly. Titrate in 140 mcg increments every 4 weeks based on serum calcium and 24-hour urinary calcium. Max dose 840 mcg (2.8 mL) once weekly.
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; monitor serum calcium and 24-hour urinary calcium closely. Consider lower initial dose and slower titration.
Dialysis:
Not studied. Use with caution; monitor serum calcium and 24-hour urinary calcium closely.
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 binds to the PTH1 receptor, activating adenylyl cyclase and phospholipase C, leading to increased serum calcium and decreased serum phosphate. Its pegylated formulation provides an extended half-life, allowing for once-weekly administration.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but well absorbed after subcutaneous administration.
Tmax:
Approximately 12-24 hours
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 70-80 hours (terminal half-life)
Clearance:
Not available
ExcretionRoute:
Primarily renal, with some hepatic involvement.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours, with sustained effect over the week.
PeakEffect:
Approximately 1-2 days after administration.
DurationOfAction:
Up to 7 days (once weekly dosing).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 or any persistent pain
A tender lump or swelling under your skin (note: there is a rare association between drugs like this one and bone cancer in animal studies, although a higher risk has not been seen in human studies)
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 do not go away, 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, contact 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 medical help right away:
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 or any persistent pain
A tender lump or swelling under your skin (note: there is a rare association between drugs like this one and bone cancer in animal studies, although a higher risk has not been seen in human studies)
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 do not go away, 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, contact 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:
- Signs of too much calcium (hypercalcemia): feeling sick to your stomach, throwing up, constipation, feeling very tired, urinating a lot, feeling very thirsty, muscle weakness, confusion.
- Signs of too little calcium (hypocalcemia): tingling or numbness around your mouth or in your fingers and toes, muscle cramps or spasms, seizures, feeling tired, anxious, or depressed.
- Signs of an allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing.
- Signs of kidney stones: severe pain in your side or back, blood in your urine.
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ 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
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ 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
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Additionally, take calcium and vitamin D supplements as instructed by your doctor to maintain optimal levels.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if you change the needle. Sharing these devices can spread infections, including those that may not be apparent.
Be aware that this medication can cause high calcium levels, which may be severe and require hospitalization. Conversely, it can also lead to low calcium levels, particularly if the medication is stopped abruptly. If you have concerns, consult your doctor.
If you are taking digoxin, inform your doctor, as you may need more frequent blood tests to monitor your condition.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. Additionally, take calcium and vitamin D supplements as instructed by your doctor to maintain optimal levels.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if you change the needle. Sharing these devices can spread infections, including those that may not be apparent.
Be aware that this medication can cause high calcium levels, which may be severe and require hospitalization. Conversely, it can also lead to low calcium levels, particularly if the medication is stopped abruptly. If you have concerns, consult your doctor.
If you are taking digoxin, inform your doctor, as you may need more frequent blood tests to monitor your condition.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (e.g., nausea, vomiting, abdominal pain, muscle weakness, confusion, coma)
- Hypotension
- Cardiac arrhythmias
What to Do:
Discontinue Yorvipath. Manage hypercalcemia with hydration, loop diuretics, and other calcium-lowering agents as needed. Monitor serum calcium and other electrolytes. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Digoxin (increased risk of digoxin toxicity due to hypercalcemia)
- Calcium supplements and active vitamin D analogs (increased risk of hypercalcemia)
Moderate Interactions
- Thiazide diuretics (may increase serum calcium, requiring dose adjustment of palopegteriparatide)
- Lithium (may affect calcium homeostasis, monitor closely)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
24-hour Urinary Calcium
Rationale: To establish baseline and guide initial dosing, assess risk of hypercalciuria.
Timing: Prior to initiation
Serum Phosphate
Rationale: To establish baseline and monitor treatment effect.
Timing: Prior to initiation
Serum Magnesium
Rationale: To establish baseline and monitor for potential imbalances.
Timing: Prior to initiation
Renal Function (e.g., eGFR, BUN, Creatinine)
Rationale: To assess kidney health, as renal impairment may affect calcium homeostasis and drug elimination.
Timing: Prior to initiation
Routine Monitoring
Serum Calcium
Frequency: Weekly for the first 4 weeks, then every 4 weeks during titration, and periodically (e.g., monthly to quarterly) once stable.
Target: Low-normal to normal range (e.g., 8.0-9.5 mg/dL), individualized to minimize symptoms and avoid hypercalciuria.
Action Threshold: If >9.5 mg/dL or symptomatic hypercalcemia, reduce dose or temporarily discontinue. If <8.0 mg/dL and symptomatic hypocalcemia, increase dose.
24-hour Urinary Calcium
Frequency: Every 4 weeks during titration, and periodically (e.g., every 3-6 months) once stable.
Target: <250 mg/24 hours (women), <300 mg/24 hours (men), or individualized to minimize risk of nephrolithiasis.
Action Threshold: If persistently elevated, consider dose reduction or discontinuation, and evaluate for nephrolithiasis.
Serum Phosphate
Frequency: Periodically (e.g., every 3-6 months) once stable.
Target: Normal range.
Action Threshold: Significant deviations may indicate need for dose adjustment or evaluation of other factors.
Serum Magnesium
Frequency: Periodically (e.g., every 3-6 months) once stable.
Target: Normal range.
Action Threshold: Significant deviations may indicate need for dose adjustment or evaluation of other factors.
Symptom Monitoring
- Symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, polyuria, polydipsia, muscle weakness, confusion)
- Symptoms of hypocalcemia (e.g., paresthesias, muscle cramps, tetany, seizures, fatigue, anxiety, depression)
- Symptoms of hypersensitivity reactions (e.g., rash, urticaria, angioedema, dyspnea)
- Symptoms of nephrolithiasis (e.g., flank pain, hematuria)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Yorvipath in pregnant women. Based on animal studies, it may cause fetal harm. Use is generally not recommended unless the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies.
Lactation
It is not known whether palopegteriparatide is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with Yorvipath.
Infant Risk:
Unknown, but potential for serious adverse reactions.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients under 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Clinical Information
Clinical Pearls
- Yorvipath is a long-acting PTH analog, administered once weekly, which may improve patient adherence compared to daily injections of other PTH therapies.
- Careful monitoring of serum calcium and 24-hour urinary calcium is crucial, especially during dose titration, to prevent hypercalcemia and hypercalciuria.
- Unlike other PTH analogs, Yorvipath does not carry a Black Box Warning for osteosarcoma, which may be a consideration for long-term use.
- Patients should be educated on the signs and symptoms of both hypercalcemia and hypocalcemia, and when to seek medical attention.
- Calcium and active vitamin D supplementation should be reduced or discontinued upon initiation of Yorvipath and adjusted based on calcium levels.
Alternative Therapies
- Natpara (recombinant human parathyroid hormone, rhPTH(1-84)) - currently unavailable in the US market due to manufacturing issues.
- Conventional therapy: Oral calcium supplements and active vitamin D analogs (e.g., calcitriol, doxercalciferol, paricalcitol).
Cost & Coverage
Average Cost:
Very high (e.g., >$20,000) per 2.8 mL vial (840 mcg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.