How YORVIPATH Works | YORVIPATH® (palopegteriparatide) Patient Site

How YORVIPATH Works

YORVIPATH delivers continuous PTH over 24 hours to help keep calcium levels normal

YORVIPATH is a ready-to-use, once-daily injection and comes in a convenient, prefilled pen.
YORVIPATH Pen

YORVIPATH is designed to help provide your body with the PTH it needs

Helps maintain normal movement of calcium through your bones, blood, and vital organs
Activates vitamin D to help with calcium absorption
YORVIPATH uses innovative TransCon® technology to help keep PTH in your body throughout the day.

YORVIPATH provided continuous PTH to keep calcium levels normal over 24 hours*

Blood calcium on Yorvipath chart
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*This study measured the effect of PTH on calcium levels over 24 hours following the administration of YORVIPATH in 7 participants with hypoparathyroidism. Participants achieved continuous exposure to PTH after 7 days of taking YORVIPATH. The mean dose of YORVIPATH was 22.3 mcg, ranging from 12 mcg to 33 mcg.
With PTH delivered over 24 hours, YORVIPATH helps to maintain normal calcium levels throughout the day.
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“I feel like we’re treating the root cause of [my hypopara], and I like that.”

– Joanna, a real YORVIPATH patient

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Results With YORVIPATH

Explore results from a comprehensive clinical study on the effectiveness and safety of YORVIPATH.

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Important Safety Information and use

What is the most important information I should know about YORVIPATH?

YORVIPATH may cause serious side effects, including:

  • Allergic (hypersensivity) reactions, including anaphylaxis. Stop taking YORVIPATH and get medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, lips, mouth or tongue, breathing problems, fainting, dizziness, feeling lightheaded (low blood pressure), fast heartbeat, itching, rash or hives.
  • 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 with YORVIPATH. Tell your healthcare provider right away if you have nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, or irregular heartbeat. Hypercalcemia is more likely to occur within the first 3 months of starting YORVIPATH, but it may occur at any time.

INDICATION AND LIMITATIONS OF USE

What is YORVIPATH® used for?

YORVIPATH is a prescription medicine used to treat adults with low parathyroid hormone (PTH) (hypoparathyroidism).

It is not known if YORVIPATH is safe and effective in people who have been recently diagnosed with hypoparathyroidism after surgery; if it is started in people with low levels of blood calcium; or in children. Do not use YORVIPATH in children and young adults whose bones are still growing.

  • 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 right away if you have tingling in your fingertips, toes, lips or tongue, muscle spasms or cramps, oral numbness, depression, have problems thinking or remembering, abnormal heart rhythms, or seizures.
  • Possible bone cancer (osteosarcoma). Tell your healthcare provider right away if you have pain in any areas of your body that does 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 healthcare provider may need to do further tests.

Who should not take YORVIPATH?

Do not use YORVIPATH if you have had a severe allergic reaction to palopegteriparatide or any of the other ingredients in YORVIPATH.

What should I tell my healthcare provider before taking YORVIPATH?

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, are used to treat osteoporosis, or can affect calcium levels in your blood.
  • are pregnant or plan to become pregnant. It is not known if YORVIPATH will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with YORVIPATH.
  • are breastfeeding or plan to breastfeed. It is not known if YORVIPATH passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with 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.

What are the possible side effects of YORVIPATH?

YORVIPATH may cause serious side effects:

  • Decrease in blood pressure when you change positions (orthostatic hypotension). Some people may feel dizzy, get 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.

The most common side effects of YORVIPATH include injection site reactions, vasodilatory signs or symptoms such as a drop in blood pressure or lightheadedness when standing up, headache, diarrhea, back pain, high calcium levels, and sore throat.

These are not all of the possible side effects of YORVIPATH. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please see the full Prescribing Information for YORVIPATH and the Medication Guide.

INDICATION AND LIMITATIONS OF USE

close isi icon open isi icon

What is YORVIPATH® used for?

YORVIPATH is a prescription medicine used to treat adults with low parathyroid hormone (PTH) (hypoparathyroidism).

It is not known if YORVIPATH is safe and effective in people who have been recently diagnosed with hypoparathyroidism after surgery; if it is started in people with low levels of blood calcium; or in children. Do not use YORVIPATH in children and young adults whose bones are still growing.

Important Safety Information and use

close isi icon open isi icon

What is the most important information I should know about YORVIPATH?

YORVIPATH may cause serious side effects, including:

  • Allergic (hypersensivity) reactions, including anaphylaxis. Stop taking YORVIPATH and get medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, lips, mouth or tongue, breathing problems, fainting, dizziness, feeling lightheaded (low blood pressure), fast heartbeat, itching, rash or hives.
  • 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 with YORVIPATH. Tell your healthcare provider right away if you have nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, or 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 right away if you have tingling in your fingertips, toes, lips or tongue, muscle spasms or cramps, oral numbness, depression, have problems thinking or remembering, abnormal heart rhythms, or seizures.
  • Possible bone cancer (osteosarcoma). Tell your healthcare provider right away if you have pain in any areas of your body that does 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 healthcare provider may need to do further tests.

Who should not take YORVIPATH?

Do not use YORVIPATH if you have had a severe allergic reaction to palopegteriparatide or any of the other ingredients in YORVIPATH.

What should I tell my healthcare provider before taking YORVIPATH?

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, are used to treat osteoporosis, or can affect calcium levels in your blood.
  • are pregnant or plan to become pregnant. It is not known if YORVIPATH will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with YORVIPATH.
  • are breastfeeding or plan to breastfeed. It is not known if YORVIPATH passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with 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.

What are the possible side effects of YORVIPATH?

YORVIPATH may cause serious side effects:

  • Decrease in blood pressure when you change positions (orthostatic hypotension). Some people may feel dizzy, get 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.

The most common side effects of YORVIPATH include injection site reactions, vasodilatory signs or symptoms such as a drop in blood pressure or lightheadedness when standing up, headache, diarrhea, back pain, high calcium levels, and sore throat.

These are not all of the possible side effects of YORVIPATH. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please see the full Prescribing Information for YORVIPATH and the Medication Guide.

Hypopara = hypoparathyroidism; PTH = parathyroid hormone.

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