Yorvipath 294mcg/0.98ml Inj 1.96ml
It is used to treat poor parathyroid function.
Drug Class
Parathyroid hormone analog
Pharmacologic Class
Parathyroid hormone receptor agonist
Pregnancy Category
Not available
FDA Approved
Dec 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Yorvipath is a medicine that acts like a natural hormone in your body called parathyroid hormone (PTH). It helps your body control the levels of calcium and phosphate in your blood. It is used to treat adults with chronic hypoparathyroidism, a condition where your body doesn't make enough PTH, leading to low calcium levels.
How to Use This Medicine
Taking Your 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 cloudiness, leakage, or particles, and do not use if the solution has changed color or appears abnormal.
If you experience dizziness or lightheadedness after 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 your doctor. After use, replace the cap on the pen to protect it from light.
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 questions, consult your doctor or pharmacist.
Important Administration Guidelines
Do not administer more than one injection per day.
Storing and Disposing of Your Medication
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.
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.
Missing a Dose
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 cloudiness, leakage, or particles, and do not use if the solution has changed color or appears abnormal.
If you experience dizziness or lightheadedness after 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 your doctor. After use, replace the cap on the pen to protect it from light.
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 questions, consult your doctor or pharmacist.
Important Administration Guidelines
Do not administer more than one injection per day.
Storing and Disposing of Your Medication
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.
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.
Missing a Dose
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
- Follow your healthcare provider's instructions for diet, calcium, and vitamin D supplements.
- Do not stop taking Yorvipath or change your dose without talking to your doctor.
- Learn how to properly inject the medication subcutaneously.
- Store the medication as directed (refrigerated, protect from light).
- Do not share your pen with others.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 294 mcg (1.96 mL) subcutaneously once daily. Dose should be adjusted based on serum calcium and phosphate levels.
Dose Range:
294 - 588 mg
Condition-Specific Dosing:
Hypoparathyroidism:
Initial dose of 294 mcg subcutaneously once daily. Titrate dose based on serum calcium and phosphate levels, typically in increments of 147 mcg every 4 weeks, up to a maximum of 588 mcg once daily. Aim to maintain serum calcium in the lower half of the normal range (8.0-9.0 mg/dL) and serum phosphate in the normal range.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
Use with caution. Closely monitor serum calcium and phosphate. Consider lower initial doses and slower titration.
Dialysis:
Not studied. Use with caution and close monitoring.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Pharmacology
Mechanism of Action
Palopegteriparatide is a recombinant human parathyroid hormone (PTH) analog. It binds to the parathyroid hormone 1 receptor (PTH1R) in bone and kidney, mimicking the actions of endogenous PTH. In hypoparathyroidism, it helps to normalize serum calcium and phosphate levels by increasing renal tubular reabsorption of calcium, increasing urinary phosphate excretion, and stimulating the synthesis of 1,25-dihydroxyvitamin D (calcitriol), which in turn increases intestinal absorption of calcium and phosphate.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (subcutaneous administration)
Tmax:
Approximately 3-5 hours
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 1.1 L/kg
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 10-12 hours (terminal half-life)
Clearance:
Approximately 0.07 L/hr/kg
ExcretionRoute:
Renal (metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours for initial calcium effects
PeakEffect:
Within 24 hours for calcium and phosphate regulation
DurationOfAction:
Approximately 24 hours (once daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 pain that does not go away
A tender lump or swelling under your skin (note: there is a rare risk of bone cancer associated with this type of medication, although it 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 is not an exhaustive list of possible 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 attention 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 pain that does not go away
A tender lump or swelling under your skin (note: there is a rare risk of bone cancer associated with this type of medication, although it 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 is not an exhaustive list of possible 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:
- Symptoms of high calcium (hypercalcemia): feeling sick to your stomach, vomiting, constipation, feeling tired or weak, frequent urination, increased thirst, muscle weakness, confusion.
- Symptoms of low calcium (hypocalcemia): tingling or numbness around the mouth or in fingers/toes, muscle cramps, spasms, or twitching, seizures.
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 symptoms you experienced.
Certain health conditions, including:
+ High calcium levels in your blood
+ An overactive parathyroid gland
* If you are at 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ High calcium levels in your blood
+ An overactive parathyroid gland
* If you are at 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with 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.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.
Regular blood tests and other laboratory assessments are crucial, as directed by your doctor, to monitor your condition. Additionally, adhere to your doctor's recommendations regarding calcium and vitamin D supplementation.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if the needle has been replaced. Sharing these devices can spread infections, including those that may be asymptomatic.
Be aware that this medication can cause high calcium levels, which may be severe and require hospitalization. Conversely, stopping the medication abruptly can increase the risk of low calcium levels. If you have concerns, consult your doctor.
If you are taking digoxin, inform your doctor, as you may need more frequent blood tests to ensure safe treatment.
Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of the medication to both you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.
Regular blood tests and other laboratory assessments are crucial, as directed by your doctor, to monitor your condition. Additionally, adhere to your doctor's recommendations regarding calcium and vitamin D supplementation.
To prevent the transmission of infections, never share pen or cartridge devices with others, even if the needle has been replaced. Sharing these devices can spread infections, including those that may be asymptomatic.
Be aware that this medication can cause high calcium levels, which may be severe and require hospitalization. Conversely, stopping the medication abruptly can increase the risk of low calcium levels. If you have concerns, consult your doctor.
If you are taking digoxin, inform your doctor, as you may need more frequent blood tests to ensure safe treatment.
Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of the medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypercalcemia (e.g., nausea, vomiting, abdominal pain, muscle weakness, confusion, coma)
- Hypotension
- Bradycardia
What to Do:
Seek immediate medical attention. Management involves discontinuing the drug, hydration, and measures to lower serum calcium (e.g., loop diuretics, calcitonin, bisphosphonates). Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Digoxin (potential for hypercalcemia to increase digoxin toxicity)
- Vitamin D analogs (e.g., calcitriol, doxercalciferol, paricalcitol - may exacerbate hypercalcemia)
- Calcium supplements (may exacerbate hypercalcemia)
Monitoring
Baseline Monitoring
Serum Calcium (total and ionized)
Rationale: To establish baseline and guide initial dosing, and to assess severity of hypoparathyroidism.
Timing: Prior to initiation of therapy
Serum Phosphate
Rationale: To establish baseline and guide initial dosing, and to assess severity of hypoparathyroidism.
Timing: Prior to initiation of therapy
25-hydroxyvitamin D (25[OH]D)
Rationale: To ensure adequate vitamin D stores, as deficiency can impair response to therapy.
Timing: Prior to initiation of therapy
1,25-dihydroxyvitamin D (1,25[OH]2D)
Rationale: To assess baseline active vitamin D status.
Timing: Prior to initiation of therapy
Renal Function (e.g., eGFR, BUN, Creatinine)
Rationale: To assess kidney function, as renal impairment may affect drug clearance and calcium/phosphate homeostasis.
Timing: Prior to initiation of therapy
24-hour Urinary Calcium
Rationale: To assess baseline calcium excretion and risk of hypercalciuria.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum Calcium (total and ionized)
Frequency: Weekly during dose titration, then monthly once stable, or as clinically indicated.
Target: Lower half of normal range (e.g., 8.0-9.0 mg/dL)
Action Threshold: If calcium is consistently above target range or below 7.5 mg/dL, adjust dose of Yorvipath and/or concomitant calcium/vitamin D supplements.
Serum Phosphate
Frequency: Weekly during dose titration, then monthly once stable, or as clinically indicated.
Target: Normal range (e.g., 2.5-4.5 mg/dL)
Action Threshold: If phosphate is consistently outside normal range, adjust dose of Yorvipath and/or concomitant phosphate binders.
24-hour Urinary Calcium
Frequency: Periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Normal range or within acceptable limits to prevent nephrolithiasis/nephrocalcinosis.
Action Threshold: If elevated, consider dose reduction of Yorvipath or concomitant calcium/vitamin D supplements.
Renal Function (e.g., eGFR)
Frequency: Periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Stable
Action Threshold: Significant decline may require dose adjustment or re-evaluation of therapy.
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, cardiac arrhythmias)
Special Patient Groups
Pregnancy
There are no available data on Yorvipath use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown adverse effects on fetal development at doses higher than clinical exposure. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data.
Lactation
There are no data on the presence of palopegteriparatide in human milk, the effects on the breastfed infant, or the effects on milk production. 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:
Not available
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 patients (≥65 years) and younger patients. No dose adjustment is required based on age, but monitor renal function and calcium/phosphate levels closely.
Clinical Information
Clinical Pearls
- Yorvipath is a long-acting PTH analog, allowing for once-daily subcutaneous administration.
- It is crucial to monitor serum calcium and phosphate levels frequently, especially during dose titration, to prevent hypo- or hypercalcemia.
- Patients should be educated on the signs and symptoms of both hypo- and hypercalcemia and when to seek medical attention.
- Concomitant calcium and active vitamin D supplementation should be reduced or discontinued upon initiation of Yorvipath, and then adjusted based on calcium levels.
- The goal of therapy is to maintain serum calcium in the lower half of the normal range (8.0-9.0 mg/dL) and serum phosphate in the normal range, while minimizing the need for conventional therapy (oral calcium and active vitamin D).
Alternative Therapies
- Conventional therapy (oral calcium supplements and active vitamin D metabolites like calcitriol or alfacalcidol)
- Natpara (parathyroid hormone, recombinant) - currently unavailable in the US market due to manufacturing issues.
Cost & Coverage
Average Cost:
Not available per 1.96ml vial
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 consumed, and the time it occurred.