Frequently Asked Questions About Rayaldee® (calcifediol) extended-release capsules and SHPT
Secondary hyperparathyroidism (SHPT) can develop as a complication of chronic kidney disease (CKD). In fact, of the people who have stage 3 CKD, 2 out of 5 develop SHPT. And of the people who have stage 4 CKD, 4 out of 5 develop SHPT. SHPT occurs when the parathyroid makes too much parathyroid hormone (PTH).
Left untreated, SHPT can cause health 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 SHPT.
Rayaldee is a prescription oral medicine that is indicated for treating adults with secondary hyperparathyroidism with stage 3 or 4 chronic kidney disease and low vitamin D levels. Rayaldee helps to increase the vitamin D levels and lower the parathyroid hormone levels found in the blood.
Your healthcare provider will keep track of how how your body responds to treatment with Rayaldee by monitoring levels of vitamin D, parathyroid hormone, calcium, and phosphorus. Your dose of Rayaldee may be adjusted based on these results.
In clinical trials, Rayaldee has been very well tolerated. In the group of people who were taking Rayaldee, only about 5 out of 100 people needed to stop their treatment because of treatment-emergent events. Of the people who were taking a placebo ("sugar" pill), 4 out of 100 people needed to stop their treatment because of treatment-emergent events.
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, increased levels of blood creatinine (a measure of kidney function), shortness of breath, cough, congestive heart failure, and constipation.
Calcium levels that are too high, also known as hypercalcemia, may occur during treatment with Rayaldee. Six people in the clinical trial needed to have their dose of Rayaldee adjusted because of increases in calcium. About 4 in 100 people in the clinical trial who were taking Rayaldee in the clinical trial had at least one elevation in calcium above normal limits, and none of those were found to be clinically significant. About 2 people in 100 who were taking the placebo ("sugar" pill) in the clinical trial experienced a similar elevation in calcium.
People who have secondary hyperparathyroidism (SHPT) have high levels of parathyroid hormone (PTH) and often also have low levels of vitamin D. Over-the-counter vitamin D addresses only the low levels of vitamin D and not the high PTH. Additionally, Over-the-counter vitamin D has not been FDA-approved to treat of SHPT. Learn about how Rayaldee works.
If you have questions about your health or why Rayaldee was prescribed for you, please speak with your healthcare provider.
Specialty pharmacies are pharmacies with extra training to work with medications that help treat rare or chronic diseases. Most specialty pharmacies have pharmacists, nurses, and support staff with extensive training about the diseases in which they concentrate and the medicines they provide.
Specialty pharmacies can deliver your medicine to your home, help with insurance reimbursement, and talk directly with your healthcare team. Many prescribers of Rayaldee use specialty pharmacies to help provide support to their patients.
Rayaldee is only available by prescription. Many healthcare providers use the support services offered by OPKO Connect. These services include help talking with your insurance company and pharmacy.
Many people receive their Rayaldee prescription through a specialty pharmacy that can deliver the medication directly to their door. A specialty pharmacy can provide additional support services as needed.
Rayaldee is taken by mouth at bedtime. Your healthcare provider may adjust the dose based on results of your lab work. You should take the dose of Rayaldee as exactly as prescribed by your healthcare provider. Learn about starting Rayaldee.