Starting Rayaldee® (calcifediol) extended-release capsules

Before you start treatment with Rayaldee, your healthcare provider will check the levels of certain vitamins and minerals in your blood, including vitamin D, calcium, and PTH.

Person holding a capsule of Rayaldee near their mouth. Words read: x1 daily.

The starting dose of Rayaldee is 1 capsule, by mouth, at bedtime.

An outline of a person swallowing a capsule of Rayaldee. Words read: Swallow whole.

Take your dose of Rayaldee whole. Do not chew or break the capsule.

A capsule of Rayaldee crossed out with an x. Words read: Skip missed dose.

If you miss a dose of Rayaldee, do not take an extra dose. Skip the missed dose and just take the next scheduled dose of Rayaldee.

After you have taken Rayaldee for about 3 months, your healthcare provider will check lab work again. Your dose of Rayaldee may be adjusted based on these results.

If the parathyroid hormone level or vitamin D level is outside the desired range, your healthcare provider may increase the dose of Rayaldee to 60 mcg (2 capsules) by mouth daily. If your healthcare provider increases your dose of Rayaldee, you should take both capsules at bedtime.

 You should take your dose of Rayaldee exactly as prescribed.

If you have questions about your dose of Rayaldee, call your healthcare provider.

Learn about how to stay on track  

Support when you need it

It can feel overwhelming to talk with insurance companies or navigate copayments. The specialists at OPKO Connect may be able to help.

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.