Understanding SHPT

Understanding SHPT

Chronic kidney disease (CKD) is a common cause of SHPT.

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Inside your neck, behind your thyroid, are 4 glands called parathyroid glands. They are each about the size of a grain of rice. These little glands have very important jobs. The parathyroid glands produce a hormone called parathyroid hormone (PTH), which is responsible for balancing several hormones and minerals within your body.

When the parathyroid glands make too much PTH, this condition is called hyperparathyroidism. Too much PTH means your body does not balance minerals and hormones correctly. Secondary hyperparathyroidism (SHPT) is a type of hyperparathyroidism. The word secondary means that the problem is caused by something outside of the parathyroid glands.

SHPT causes imbalances in PTH, calcium, and phosphorus, and are frequently accompanied by low levels of vitamin D.

Causes of SHPT

People with chronic kidney disease (CKD) are at risk for developing SHPT. In fact, 40% of people with stage 3 CKD and 82% with stage 4 CKD develop SHPT.

When someone has a diagnosis of SHPT and stage 3 or 4 CKD and low vitamin D levels, effective treatment for SHPT can help him or her get back in balance. Left untreated, SHPT can get worse and more difficult to treat and can cause issues such as osteoporosis, bone fractures, kidney stones, heart disease, and high blood pressure. Rayaldee has not been proven to completely get rid of vitamin D insufficiency nor control secondary hyperparathyroidism.

Learn more about a treatment called Rayaldee® (calcifediol) extended-release capsules that can help you manage the ups and downs of SHPT. Talk to your healthcare provider to see if Rayaldee could help you get back in balance.

Living With SHPT

If your healthcare provider has said that you have secondary hyperparathyroidism (SHPT), you may have questions. Many people who receive this diagnosis have not had any symptoms or didn’t realize there was a problem with their parathyroid glands.

Chronic kidney disease (CKD) is a common cause of SHPT. When someone has SHPT related to CKD stage 3 or 4 and has low levels of vitamin D, there is treatment available. Rayaldee® (calcifediol) extended-release capsules is an oral medicine approved to treat the imbalances noted in SHPT.

Your healthcare provider will check levels of vitamin D, parathyroid hormone, calcium, and phosphorus in your blood. You may also have other tests to monitor for other changes that may occur with SHPT, such as x-rays to monitor your bones.

Be sure to let your healthcare provider know about how you feel. The symptoms of SHPT can be mild. Some people don’t have any symptoms at all. Your healthcare provider will be better equipped to help if he or she understands your experience.

Treating SHPT is Important

The symptoms of secondary hyperparathyroidism (SHPT) are often mild. Many people don’t experience symptoms at all. Symptoms may include depression, excessive urination, abdominal pain, bone and joint pain, and fatigue.

Without treatment, secondary hyperparathyroidism (SHPT) can lead to serious health issues, including osteoporosis, bone fractures, kidney stones, heart disease, and high blood pressure. Over time, SHPT can progress and get more difficult to treat. Rayaldee has not been proven to completely get rid of vitamin D insufficiency nor control secondary hyperparathyroidism.

Talk with your healthcare provider about your risks for SHPT and whether treatment with Rayaldee could be right for you.

Indication and Limitations of Use

Rayaldee is a treatment for secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and low vitamin D levels (25-hydroxyvitamin D less than 30 ng/mL). It is not for patients with stage 5 CKD or end-stage kidney disease on dialysis.

Important Safety Information

  • Before starting Rayaldee, the level of calcium in your blood should be in the normal range (below 9.8 mg/dL). Your doctor can tell you if your calcium level is right for starting Rayaldee.
  • Rayaldee can cause hypercalcemia and hypercalciuria (high levels of calcium in your blood and urine, respectively). You should tell your doctor if you are taking any other medications, including other vitamin D medications (prescription or over-the-counter vitamin D supplements). Your doctor may tell you to stop taking them while you are taking Rayaldee, as very high calcium levels due to high vitamin D levels could cause severe changes to your heart rhythm or seizures and require emergency treatment.
  • Tell your doctor about any and all medication you may be taking. While you are taking Rayaldee, tell your doctor if you receive any new prescriptions or start any new over-the-counter medications.
  • Tell your doctor immediately if you experience any of the following symptoms of very high calcium: feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, weight loss, or any other abnormal symptoms or side effects.
  • While you are taking Rayaldee, your doctor will order laboratory tests to see how your SHPT is doing. These lab tests will also examine your blood levels of calcium, phosphorus, 25-hydroxyvitamin D, and PTH. Based on your test results, your dose of Rayaldee may be changed or stopped until your lab results improve.
  • The most common side effects of Rayaldee reported by patients in clinical trials were anemia (low levels of red blood cells or hemoglobin), infection in the nose and/or throat, high levels of blood creatinine (a lab test for measuring kidney function), shortness of breath, cough, congestive heart failure, and constipation.
  • Take your Rayaldee at bedtime and swallow your capsules whole; do not bite or chew them.
  • If you miss a dose, take Rayaldee at your next scheduled time. Do not take an extra dose to make up for the dose you missed.
  • Be sure to follow your doctor’s orders, including getting your laboratory tests done on time.

We are Here to Help

  1. If you have questions regarding why you were prescribed Rayaldee, please speak with your doctor.
  2. If you have questions regarding Rayaldee or the disease state it is designated to treat, you may contact a Rayaldee Clinical Pharmacist at OPKO Connect at 1-844-414-OPKO (1-844-414-6756), option 1.
  3. If you have questions regarding the support programs offered by OPKO Connect, you can call 1-844-414-OPKO (1-844-414-6756), option 2.
  4. You are encouraged to report negative side effects to the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch or via phone at 1-800-FDA-1088 (1-800-332-1088).
  5. For more information about Rayaldee, please contact OPKO Medical Information at 1-844-729-2539 or medicalinformation@opko.com.
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Important Safety Information