Yorvipath
Pronunciation: YOR-vih-path
Generic name: palopegteriparatide
Dosage form: prefilled pen for subcutaneous use
What is Yorvipath?
Yorvipath (palopegteriparatide) is an injectable parathyroid hormone replacement therapy that can be used to treat adults with low parathyroid hormone levels (hypoparathyroidism). Yorvipath is self-administered subcutaneously (under the skin) using a prefilled pen once a day.
Yorvipath (palopegteriparatide) is a long-acting parathyroid hormone analog that releases PTH (1-34) throughout the day, which temporarily restores physiologic levels of parathyroid hormone, maintaining the balance of calcium and phosphate in the body. This addresses both the short-term symptoms and long-term complications of hypoparathyroidism.
Yorvipath gained FDA approval on August 9, 2024.
Yorvipath side effects
The most common side effects of Yorvipath include:
- injection site reactions
- blood pressure drops or lightheadedness when standing up (vasodilatory signs or symptoms)
- headache
- diarrhea
- back pain
- high calcium levels
- sore throat.
Serious side effects and warnings
Yorvipath may cause the following serious side effects.
High levels of calcium in the blood (hypercalcemia). Yorvipath can cause some people to have higher blood calcium levels than normal. Your healthcare provider should check your blood calcium before you start and during your treatment. Tell your healthcare provider if you have nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, and irregular heartbeat. Hypercalcemia is more likely to occur within the first 3 months of starting Yorvipath, but it may occur at any time.
Low levels of calcium in the blood (hypocalcemia). People who stop using, miss, or change a dose of Yorvipath may have an increased risk of low blood calcium levels, but hypocalcemia may occur at any time. Tell your healthcare provider if you have tingling in your fingertips, toes, lips, or tongue, muscle spasms or cramps, oral numbness, depression, problems thinking or remembering, abnormal heart rhythms, or seizures.
Possible bone cancer (osteosarcoma). Tell your health care provider right away if you have pain in any areas of your body that do not go away or any new or unusual lumps or swelling under your skin that is tender to touch. These are some of the signs and symptoms of osteosarcoma and your health care provider may need further tests. Tell your health care provider right away if you have any of these signs and symptoms of osteosarcoma, or high or low blood calcium levels.
Allergic (hypersensitivity) reaction, including anaphylaxis. Stop taking Yorvipath and tell your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:
- swelling of your face, lips, mouth, or tongue
- fast heartbeat
- breathing problems
- itching
- fainting, dizziness, feeling lightheaded (low blood pressure)
- rash
- hives
Decrease in blood pressure when you change positions (orthostatic hypotension). Some people may feel dizzy, have a fast heartbeat, or feel light-headed right after injecting Yorvipath. For the first few doses, give your injection of Yorvipath in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, contact your healthcare provider before you continue using Yorvipath.
Digoxin toxicity if you are using digoxin and Yorvipath at the same time. Tell your healthcare provider if you experience irregular heart rhythm, heart palpitations, confusion, loss of appetite, nausea, vomiting, diarrhea, or vision problems.
It is not known if Yorvipath is safe and effective in:
- People who have been recently diagnosed with hypoparathyroidism after surgery.
- People with low levels of calcium in the blood.
- In children.
These are not all of the possible side effects of Yorvipath. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking
Do not use Yorvipath if you are allergic to palopegteriparatide, Yorvipath, or any of the inactive ingredients in the injection.
Yorvipath should not be used in children and young adults whose bones are still growing.
Before using Yorvipath, tell your healthcare provider about all of your medical conditions, including if you:
- are at higher risk of a type of bone cancer called osteosarcoma. This is especially important:
- if you have a bone disease that increases your risk of developing osteosarcoma (including if you have Paget’s disease).
- if a blood test shows that you have unexplained increases in bone alkaline phosphatase.
- if you have cancer of the bones or other cancer that has spread to your bones
- if you are having or have had radiation therapy to the skeleton
- if you are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones.
- take medicines that contain digoxin
- take medicines used to treat osteoporosis
- take medicines that can affect calcium levels in your blood.
- are pregnant or plan to become pregnant
- are breastfeeding.
Pregnancy
It is not known if Yorvipath will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Yorvipath. If you become pregnant while being treated with Yorvipath, you are encouraged to enroll in the Pregnancy Safety Study. The purpose of the pregnancy safety study is to collect information about the health of you and your baby. Contact Ascendis Pharma at 1-844-442-7236 as soon as you learn that you are pregnant or ask your health care provider to contact them for you.
Breastfeeding
Monitor breastfed infants for symptoms of high or low calcium. Consider monitoring serum calcium in the breastfed infant.
How should I use Yorvipath?
Read the detailed Instructions for Use that come with Yorvipath Package Insert. Use Yorvipath exactly as your healthcare provider tells you to take it.
- Do not stop taking or change your dose of Yorvipath unless your healthcare provider tells you to. The levels of calcium in your blood may change, and you may develop symptoms
Before you use Yorvipath for the first time, a healthcare provider should show you how to use the pen the right way.
- Yorvipath is injected once a day.
- You can inject just under the skin in your belly (abdomen) or the front of the thigh just under your skin (subcutaneous).
- Inject into a different area each day to help avoid damaging your skin.
Some people may feel dizzy, have a fast heartbeat, or feel light-headed right after injecting Yorvipath. For the first few doses, give your injection in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, contact your healthcare provider before you continue using Yorvipath.
- Throw away each pen 14 days after first use.
- Yorvipath is colorless. Do not use it if the solution is cloudy, colored, or has visible particles in it.
- Your health care provider should check your blood calcium level when you start and while you are using Yorvipath. After you start Yorvipath, your healthcare provider may change your doses of calcium and active vitamin D.
Yorvipath dosage
Use only one injection to achieve the once-daily recommended dosage.
- Using two injections to achieve the recommended once-daily dosage increases the risk of unintended changes in serum calcium levels, including hypocalcemia and hypercalcemia.
The recommended starting dosage Is 18 mcg once daily.
- This is titled in 3 mcg increments or decrements to maintain serum calcium within the normal range without the need for active vitamin D (e.g., calcitriol) or therapeutic calcium doses (elemental calcium >600 mg/day). Calcium supplementation sufficient to meet daily dietary requirements may be continued.
- The maximum recommended dosage is 30 mcg under the skin (subcutaneously) once daily.
If an adequate response is not achieved with a maximum Yorvipath dosage of 30 mcg, consider adding or restarting calcium and/or active vitamin D therapy and/or seek other treatment options
What happens if I miss a dose of Yorvipath?
If you miss a day or forget to inject your daily dose of Yorvipath, you can inject the dose as soon as you remember if less than 12 hours have passed. If the dose has been missed by more than 12 hours, skip the missed dose and continue injecting your next dose as you normally would.
What other drugs will affect Yorvipath?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. YORVIPATH and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:
- Digoxin
- Medicines that can affect calcium levels in your blood, such as diuretics, lithium, or phenytoin
- Medicines that are used to treat osteoporosis, such as denosumab, alendronate, or risedronate.
This is not a complete list of interactions. See the Yorvipath Prescribing Information for a full list.
Storage
Do not freeze. Store away from heat. Keep Yorvipath in the packaging to protect from light.
- Until first use, store Yorvipath in the refrigerator between 2°C to 8°C (36°F to 46°F).
- After first use, store Yorvipath for 14 days at room temperature below 30°C (86°F).
- After each use, remove the needle and put the pen cap on to protect it from light.
- Discard the prefilled pen 14 days after first use.
Yorvipath ingredients
Active ingredient: palopegteriparatide
Inactive ingredients: mannitol, metacresol, sodium hydroxide, succinic acid, and water for injection.
Yorvipath is supplied in 3 prefilled pen strengths, each is identified by a different colored push button, and each one contains multiple doses. How long the pen lasts depends on the dose you are prescribed:
- Yorvipath 168 mcg/0.56 mL – blue push button
- Labeled doses: 6, 9 and 12 mcg
- Yorvipath 294 mcg/0.98 mL – orange push button
- Labeled doses: 15, 18 and 21 mcg
- Yorvipath 420 mcg/1.4 mL – burgandy push button
- Labeled doses: 24, 27 and 30 mcg
Who makes Yorvipath?
Ascendis Pharma Bone Diseases A/S manufactures Yorvipath.
References
More about Yorvipath (palopegteriparatide)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
