Understanding Rayaldee® (calcifediol) extended-release capsules

Rayaldee contains medicine to address some of the imbalances going on inside the bodies of people with secondary hyperparathyroidism (SHPT). The active ingredient in Rayaldee gradually increases vitamin D levels and decreases the levels of parathyroid hormone in your blood.

Monitoring and dose adjustments

Your healthcare provider will keep track of how your body responds to treatment with Rayaldee by regularly monitoring the levels of vitamin D, parathyroid hormone, calcium, and phosphorus.

 Be sure to get your lab work as prescribed.

Your healthcare provider may adjust the dose of Rayaldee based on the 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 are

  • Anemia (low levels of red blood cells or hemoglobin)
  • Infection in the nose and/or throat
  • Increased levels of blood creatinine (a test for measuring kidney function)
  • Shortness of breath
  • Cough
  • Congestive heart failure
  • Constipation
An island with a healthcare provider talking with a patient.

 Be sure to get your lab work as prescribed.

Your healthcare provider may adjust the dose of Rayaldee based on the 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 are

  • Anemia (low levels of red blood cells or hemoglobin)
  • Infection in the nose and/or throat
  • Increased levels of blood creatinine (a test for measuring kidney function)
  • Shortness of breath
  • Cough
  • Congestive heart failure
  • Constipation

Be sure to let your healthcare provider know how you feel or any issues you may have. He or she may have ideas for how to help.

Learn about getting started with Rayaldee  

Ready to get started? Need extra support?

Talk with your healthcare provider or call OPKO Connect at 1-844-414-OPKO (6756).

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.