Yorvipath
Yorvipath (palopegteriparatide) is used to treat low parathyroid hormone (hypoparathyroidism) in adults. It works as a parathyroid hormone analog. This means it works like the parathyroid hormone that the body normally makes. You give Yorvipath as a once-daily injection under the skin using a prefilled pen. Common side effects include injection site reactions, dizziness when standing, and headache.
What is Yorvipath?
What is Yorvipath used for?
- Low parathyroid hormone (hypoparathyroidism)
How Yorvipath works
Yorvipath is a hormone replacement therapy. More specifically, it's a parathyroid hormone (PTH) analog.
Yorvipath slowly releases PTH over 24 hours to help raise PTH levels in your body. This helps balance calcium and phosphate levels in your body.
Drug facts
| Common Brands | Yorvipath |
|---|---|
| Drug Class | Parathyroid hormone analog |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Yorvipath
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Injection site reactions (e.g., bruising, redness; 39%)
- Drop in blood pressure (e.g., dizziness, racing heart; 28%)
- Headache (21%)
- Diarrhea (10%)
- Back pain (8%)
- High calcium levels (8%)
- Mouth or throat pain (7%)
Yorvipath serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: swelling of face, lips, or tongue; trouble breathing; fainting; rash; hives; fast heartbeat
- High calcium levels: nausea, vomiting, thirst, confusion, muscle weakness, irregular heartbeat
- Low calcium levels: tingling around the mouth or in the fingers or toes, muscle cramps or spasms, trouble thinking clearly, abnormal heart rhythms, seizures
- Drop in blood pressure when standing: dizziness, lightheadedness, palpitations, fainting
The following Yorvipath side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
- Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Yorvipath
Pros
- Only taken once a day
- Can reduce the need for high‑dose calcium and vitamin D analog medications
- Comes as prefilled, ready‑to‑use pens
Cons
- Need to get blood tests often during dose changes to check calcium levels
- Can cause high or low calcium, especially early in treatment
- Might cause dizziness or fainting from a drop in blood pressure
Pharmacist tips for Yorvipath
- Your healthcare team should show you how to use Yorvipath safely and properly before you can do it on your own. If you have questions, ask your care team.
- Inject Yorvipath at the same time every day. Following a steady schedule helps keep your calcium levels stable and lowers the chance of side effects.
- Only give one Yorvipath injection per day. Using two injections to get the full daily dose can cause big swings in your calcium, which can be dangerous.
- Make sure to keep your lab appointments during treatment. Your prescriber will check your calcium 7 to 10 days after you start Yorvipath or after any treatment changes. After that, they'll order blood work at least every 4 to 6 weeks.
- Yorvipath can lower your blood pressure when you stand up, especially early during treatment. This can make you dizzy or faint. To prevent this, you can inject when you can sit or lie down or inject before bed. Also keep hydrated and stand up slowly. If you feel dizzy or lightheaded, rest and tell your care team.
- Know the signs of high and low calcium while taking Yorvipath. High calcium can look like nausea, thirst, or confusion. Low calcium can cause tingling around the mouth or fingers or muscle cramps. Tell your care team if you notice any of these symptoms. They can check your calcium levels and manage any problems.
- Don’t make any changes on how you take calcium supplements or active vitamin D medications on your own while taking Yorvipath. This can cause large changes in your calcium levels. Your team can help adjust these safely.
- Tell your care team about all the medications and supplements you take or plan to take. They can make sure they're safe to take with Yorvipath. Some medications and supplements can raise calcium levels. This can include thiazide diuretics, lithium, and high‑dose vitamin D. Too much calcium can be very dangerous.
- Tell your prescriber if you take digoxin (Lanoxin). Also let your heart specialist know you're taking Yorvipath. Yorvipath can raise or lower calcium levels. High calcium can raise the risk of digoxin (Lanoxin) side effects. And low calcium can make digoxin work less well. Your prescribers might check your calcium and digoxin levels more often to keep you safe.
- If you miss your Yorvipath dose and your next dose is more than 12 hours away, inject it when you remember. If your next dose is less than 12 hours away, skip the missed dose and take your next dose at the usual time. Don't use two injections at once to make up for a missed dose. If you miss doses for 3 days or more, call your prescriber since they'll need to check for low calcium.
How to use the Yorvipath pen:
- How to store Yorvipath: Keep unused pens in the refrigerator (36°F to 46°F), but be careful not to let them freeze. After you use a new pen for the first time, you can store it at room temperature up to 86°F for 14 days. Throw away pens 14 days after first use. Keep the pen capped when stored and protect it from heat and light.
- Before using a new Yorvipath pen: Test the pen flow as directed by your care team. This helps make sure the pen works properly for each injection. Refer to the Instructions for Use or ask your care team for help.
- Check the Yorvipath pen before each injection: Check the pen to make sure it isn't expired and that the medication is clear and colorless. If it has particles, don't use it and use a new pen instead.
- Use a new needle for each Yorvipath injection: Use a new needle every time you use the medication. Pull the foil off of the new needle. Then, attach the needle straight on the pen and screw it onto the pen so it stays in place. Using a new needle each time helps lower the risk of infection.
- How to select the dose on the Yorvipath pen: Turn the dose selector to the right until you get to your prescribed dose. Don't press the push button on the pen while selecting your dose because the medication can come out.
- Where to inject Yorvipath: Choose an injection site on your stomach (2 inches away from the belly button) or the front of your thigh. Never inject into skin that's red, hard, or scarred. Choose a different spot each time you inject. This helps prevent skin irritation or skin damage. Clean the skin with an alcohol wipe before injecting.
- How to inject Yorvipath: Inject the medication under the skin as instructed by your care team. Make sure you can see the dose window when you insert the needle into the skin. Press the push button all the way and hold the button for 5 seconds. The injection is done when you see "•" in the dose window. Then, slowly remove the pen from the skin. Reattach the outer needle cover to remove the needle.
- After each Yorvipath injection: Place the used needle in a sharps container, then recap the Yorvipath pen. This helps keep you and others safe from needle sticks.
Risks and warnings for Yorvipath
Yorvipath can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
High calcium levels
- Risk factors: Conditions that can raise your calcium levels | History of high PTH levels in the blood | Taking calcium supplements | Taking vitamin D | Early in treatment
Yorvipath can cause high calcium levels. The risk is higher when you first start this medication or when your dose is raised. But it can also happen at any time during treatment. That's why your prescriber will check your calcium often while you're taking Yorvipath. Most cases of high calcium levels that caused symptoms happened within the first 3 months of treatment.
If you have nausea, vomiting, constipation, thirst, muscle weakness, a slow heartbeat, or confusion while taking Yorvipath, speak with your care team. These can be symptoms of high calcium levels. If it's too high, your prescriber can adjust your Yorvipath dose and your other medications or supplements.
Low calcium levels
- Risk factors: Missed doses | Dose is too low | Stopping calcium or vitamin D supplements too soon
Yorvipath can cause low calcium levels. The risk is greatest if you miss doses or stop taking it suddenly, but it can also happen at any time. Keep your lab appointments so your prescriber can check your calcium levels during treatment.
Also watch for symptoms of low calcium levels while taking Yorvipath. This can include tingling around the mouth, tingling in the fingers or toes, cramps, spasms, uneven heartbeat, confusion, or even seizures. If this happens, tell your care team. Get medical help right away for severe cramping, abnormal heartbeats, or seizures.
If you have low calcium, your prescriber can help treat it. They might also adjust your Yorvipath dose or temporarily add back active vitamin D or calcium supplements.
Possible risk of bone cancer (osteosarcoma)
- Risk factors: Paget's disease | History of bone cancer or cancer that has spread to the bones | Previous radiation therapy to the bones | Inherited conditions with higher risk of bone cancer
In animal studies, a rare bone cancer called osteosarcoma occurred in some rats given medications like Yorvipath. It's unclear if the risk of this bone cancer is higher in people who take Yorvipath.
To be safe, Yorvipath isn't recommended for people with certain bone problems or a higher risk of bone cancer. Your prescriber will weigh the risks and benefits, especially if you’ve had bone radiation or certain bone problems.
Watch for bone or joint pain that doesn't go away, unusual swelling, or broken bones while taking Yorvipath. If this happens, call your prescriber so they can check it out.
Low blood pressure when standing
- Risk factors: First doses | Dehydration | Standing quickly | Taking medications that lower blood pressure
Yorvipath can cause a brief drop in blood pressure when you stand, especially after your first few injections. This might make you feel dizzy, lightheaded, or faint.
To help prevent or lower the risk, sit or lie down when you inject Yorvipath. Injecting before bed can also help. Get up slowly when standing and drink fluids to help as well. Tell your care team if symptoms don't go away, if you faint, or if you have an abnormal heartbeat.
Higher risk of side effects from digoxin (Lanoxin)
- Risk factors: Taking digoxin (Lanoxin) at the same time as Yorvipath
Tell your prescriber and pharmacist if you need to take the heart medication digoxin (Lanoxin). Taking Yorvipath can possibly change how digoxin (Lanoxin) works in your body. This is because Yorvipath can affect your calcium levels and digoxin (Lanoxin) depends on calcium to work properly.
Yorvipath can raise your calcium levels. This can boost the effects of digoxin (Lanoxin) on the body. It can raise the risk of toxic effects, like stomach upset, vision changes, and irregular heart rhythm. Yorvipath can also lower your calcium levels. This can make digoxin (Lanoxin) not work as well.
If you need to take both, your prescribers will want to check your calcium and digoxin (Lanoxin) levels more often. Call your prescriber if you notice heart rhythm changes or other signs of digoxin toxicity at any time during treatment.
Yorvipath dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.56ml of 168mcg/0.56ml | 5 pens | $101,487.85 | $20,297.57 |
| 0.98ml of 294mcg/0.98ml | 5 pens | $57,995.45 | $11,599.09 |
| 1.4ml of 420mcg/1.4ml | 5 pens | $40,598.65 | $8,119.73 |
Typical dosage for Yorvipath
The typical starting dose is 18 mcg injected under the skin once daily.
Your prescriber will adjust your dose to keep your calcium levels normal without needing active vitamin D (e.g., calcitriol) or high‑dose calcium.
The usual dose of Yorvipath ranges from 6 mcg to 30 mcg once daily. The maximum dose is 30 mcg once daily.