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.

OPKO Connect is a support program that can provide comprehensive support for people who have been prescribed Rayaldee.

OPKO Connect offers support to people who have been prescribed Rayaldee. Services include help finding financial assistance and support talking with insurance companies. Learn more about what OPKO Connect can offer.

If you have questions about your health or why Rayaldee was prescribed for you, please speak with your healthcare provider.

If you have general questions about Rayaldee or secondary hyperparathyroidism, you can speak with a Rayaldee Clinical Pharmacist at OPKO Connect by calling 1-844-414-OPKO (6756).

If you have questions about OPKO Connect or want to talk about financial support that may be available, call 1-844-414-OPKO (6756).

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.

OPKO Connect may be able to help you and your healthcare provider talk with your insurance company. Call 1-844-414-OPKO (6756) to learn more. Support services are available Monday through Friday, 8 am to 8 pm ET.

Financial assistance may be available to those who qualify. To learn more, call OPKO Connect Monday through Friday, 8 am to 8 pm ET, at 1-844-414-OPKO (6756).

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.

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.

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.

Please see Full Prescribing Information.

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.

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.

Please see Full Prescribing Information.