What Is Yorvipath?
Yorvipath is a medicine used to treat low parathyroid hormone levels, also called hypoparathyroidism. Hypoparathyroidism happens when your body does not make enough of the hormone called parathyroid hormone. Parathyroid hormone is made by glands in your neck and is important for balancing the levels of calcium and phosphorus in your blood.
How Does Yorvipath Work for Hypoparathyroidism?
Yorvipath works as a replacement for parathyroid hormone if your body does not make enough parathyroid hormone. This means that Yorvipath helps your body to:
- Keep the right amount of calcium in your blood by releasing it from your bones
- Move calcium from your kidneys to your blood
- Absorb calcium from your food through your gut
Your health care provider will monitor the amount of calcium in your blood before and during treatment with Yorvipath. You may need to adjust the amount of calcium or vitamin D you are taking during Yorvipath treatment to avoid having too much calcium in your blood (hypercalcemia) or too little calcium in your blood (hypocalcemia).
How Do I Use Yorvipath for Hypoparathyroidism?
Yorvipath is a shot given under your skin (subcutaneous) in your abdomen (stomach) or the front of your thigh. You should inject Yorvipath at the same time every day. Rotate the injection site each time you inject Yorvipath.
Yorvipath comes as a pre-filled injection pen that is ready to inject the medicine under your skin. Your health care provider will show you how to use the pen. You may feel dizzy or light-headed after injecting Yorvipath. You should give your first shots in a place where you can sit or lie down afterward in case you get these symptoms.
You should store the Yorvipath pen in the refrigerator until you use it for the first time. After the first use, you should store the injection pen at room temperature. Keep Yorvipath in the original package with the pen cap on. You should throw away the Yorvipath injection pen after 14 days, even if there is medicine left. Do not use your Yorvipath pen if you notice the liquid is cloudy, colored, or has particles in it.
Is Yorvipath Right for Me?
Your health care provider may consider treatment with Yorvipath if you have hypoparathyroidism and have been taking calcium and vitamin D treatment. Your health care provider will do a blood test to check the amount of calcium and vitamin D in your blood before you start Yorvipath.
How Was Yorvipath Studied for Hypoparathyroidism?
The effectiveness and safety of Yorvipath for hypoparathyroidism was studied in a clinical trial called the PaTHway Trial. The first part of the study compared Yorvipath to a placebo (inactive treatment) for 26 weeks. All people in the study also received treatment with a vitamin D analog (for example, calcitriol) and calcium when the study started, and the doses of vitamin D and calcium were adjusted by a health care provider based on blood calcium levels during the study. After 26 weeks, all people in the study received Yorvipath and the study continued for a total of 156 weeks.
Only adults at least 18 years old were included in the study. Other important things were necessary to be included in the study:
- Hypoparathyroidism for at least 26 weeks (chronic hypoparathyroidism)
- Treatment with a vitamin D analog (for example, calcitriol) and a calcium supplement for at least 12 weeks
- A normal or slightly low level of calcium in the blood
The study treated 61 people with Yorvipath and 21 people with a placebo. The average age of people in the study was 48.6 years. Most of the people were female (78%). A total of 93% of the people were White and 6% were Asian. The average length of their hypoparathyroidism was 11.7 years.
What Were the Benefits of Yorvipath?
The effectiveness of Yorvipath was determined by the percentage of people who achieved all the following by week 26:
- Normal amounts of calcium in the blood
- Independence from vitamin D and calcium treatment in the last four weeks (although calcium supplements in doses up to 600 mg per day were allowed)
- No increase in the dose of Yorvipath or the placebo in the last four weeks
- Maintained a dose of 30 mcg per day or less of Yorvipath or the placebo throughout the entire 26-week study
At 26 weeks, 79% of people treated with Yorvipath met all the criteria, compared with only 5% of people treated with a placebo. A total of 93% of people treated with Yorvipath no longer needed vitamin D or calcium treatment. A total of 78 people continued treatment to 52 weeks, and 81% met all the criteria for efficacy.
Your results may differ from what was seen in clinical studies.
Are There Other Benefits of Yorvipath?
In the PaTHway clinical trial, Yorvipath decreased the number of pills people needed to take each day from an average of 6.7 to 0.5 after 26 weeks of treatment.
What Can I Do to Prevent Side Effects?
Below are the most common side effects of Yorvipath, along with some tips to help lessen these effects.
- Pain, itching, swelling, or redness near where the needle went in. You should rotate injection sites each day to help avoid these side effects in the area where you inject Yorvipath.
- Dizziness when standing up. This is caused by low blood pressure (also called orthostatic hypotension). To help prevent this, you should be careful not to get up too quickly. When you give your first few doses of Yorvipath, make sure you have a place to sit or lie down in case you get dizzy. Contact your health care provider right away if you have dizziness that does not go away.
- High calcium levels (hypercalcemia). Your health care provider will monitor the amount of calcium in your blood to avoid hypercalcemia. You should adjust the dose of your calcium supplements as recommended by your health care provider.
Other common side effects of Yorvipath include headache, diarrhea, back pain, and sore throat. Contact your health care provider if these side effects are bothersome.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088).
What Happens if I Stop Taking Yorvipath?
You should not stop taking Yorvipath unless your health care provider says you should. You are at risk of serious hypocalcemia if you abruptly stop taking Yorvipath.
What Types of Drug Interactions Can Happen?
Because Yorvipath increases the calcium in your blood, it may increase the risk of toxicity when used with digoxin (Lanoxin). If you develop low blood calcium, digoxin may not work as well. Your health care provider will monitor both the amount of calcium and digoxin in your blood if you take both of these medicines.
Other medicines that affect the amount of calcium in your blood may affect how you respond to Yorvipath. Your health care provider will monitor your blood calcium more often if you are receiving these medicines with Yorvipath.
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have recently taken. This will help make sure your medicines work well together.
Is There Any Cost Assistance Available?
There may be cost assistance to help you afford Yorvipath. You may have options even if you do not have health insurance. With the Yorvipath copay assistance program, you may pay as little as a $5 copay. Your health care provider will help you get started. You can call 844-442-7236 or visit this website for more information.
