SHPT Treatment With Rayaldee

Rayaldee^® (calcifediol) extended-release capsules is a medicine taken by mouth that is prescribed to treat adults with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD), and low vitamin D levels.

Rayaldee is not for children or for people who have stage 5 CKD or are on dialysis.

Taking Rayaldee

Before you start treatment with Rayaldee, your healthcare provider will check certain hormones and minerals in your blood. After you have taken Rayaldee for a few months, your healthcare provider will monitor the levels of

Vitamin D
Parathyroid hormone
Calcium
Phosphorus

Based on the results, your healthcare provider may adjust or stop your dose of Rayaldee.

Vitamin D
Parathyroid hormone
Calcium
Phosphorus

Based on the results, your healthcare provider may adjust or stop your dose of Rayaldee.

A cup of water and capsule of Rayaldee. Rayaldee is taken at bedtime.

Rayaldee is taken by mouth at bedtime. The starting dose of Rayaldee is one capsule daily. Your healthcare provider may increase the dose based on how your body responds. You should take Rayaldee whole. Do not chew or break the capsule. If you miss a dose of Rayaldee, do not take an extra dose. You should skip the dose that you missed and just take the next scheduled dose of Rayaldee.

Learn about how Rayaldee works

For help getting started or to speak with a pharmacist, call the OPKO Connect team at 1-844-414-OPKO (6756). Help is available Monday through Friday, 8 am to 8 pm ET.

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 the support programs offered by OPKO Connect, you can call 1-844-414-OPKO (1-844-414-6756), option 1.
3.	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 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 the support programs offered by OPKO Connect, you can call 1-844-414-OPKO (1-844-414-6756), option 1.
3.	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 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.