Video Transcript: What are chronic kidney disease and secondary hyperparathyroidism, and how can Rayaldee help?

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Chronic Kidney Disease.

Chronic Kidney Disease, or CKD, is a condition characterized by a gradual loss of kidney function over time, resulting in lasting damage.

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Fifteen percent of the adult population. One in seven adults.

It affects approximately 30 million people in the U.S. - that’s 15% of the adult population or, one in seven adults!

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As a silent disease, approximately 90% of those with chronic kidney disease don’t even know they have it at the beginning. Once it starts progressing symptoms become noticeable.

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Kidney function in Stages One to Five.

CKD advances in five stages, beginning initially with very mild damage and no symptoms in the first two stages.

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But in stages three and four the kidneys begin to show damage and aren’t working at full capacity as they should.

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And at the final stage the kidneys are close to or at complete failure, requiring either dialysis or a kidney transplant.

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Patients in CKD stages 3 and 4 are at risk for, or may already have developed, Secondary Hyperparathyroidism (SHPT).

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So what is SHPT?

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Parathyroid hormone.

SHPT is a condition caused by changes in the parathyroid glands. These are four glands located in your neck which make sure that your blood has the right amount of calcium. When calcium levels become low, the parathyroid gland secretes a hormone called Parathyroid Hormone or PTH which acts to normalize the calcium levels in the blood.

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Too much PTH.

One function of PTH is to increase the release of calcium and phosphorus from your bones. As kidney disease progresses, the parathyroid glands may make too much PTH, which may remove too much calcium from bones. Over time, this can cause them to become brittle and painful and prone to fractures.

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Too much PTH.

Another issue is that correct levels of calcium and phosphorus in the blood are needed by many tissues in the body to function in a healthy way. That's why SHPT is not just about your bones.

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Too much PTH.

Excessive changes in calcium and phosphorus levels can damage your heart, blood vessels and other tissues.

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Decrease the level of active vitamin D.

Besides increases in PTH, as kidney disease progresses, production of Active Vitamin D hormone decreases, resulting in low levels of calcium absorption.

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Chronic kidney disease and SHPT can affect your vitamin D levels.

As a result, when your kidneys make less active vitamin D hormone, your body has less calcium to use. Because of these and other changes, people with later-stage CKD, SHPT, and low vitamin D levels have a greater risk of cardiovascular disease, bone disease and fractures.

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Understanding what is happening with your kidneys can be overwhelming.

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Your doctor will be able to explain how your kidneys are doing and guide you regarding treatment choices for your particular stage of CKD, SHPT and level of vitamin D insufficiency -

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Rayaldee (calcifediol) ER capsules, 30 micrograms.

including using Rayaldee!

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So, to treat your SHPT, it is recommended that you increase low vitamin D levels to help your parathyroid glands make less PTH. Rayaldee helps your body do both. It is an extended-release prohormone of the active form of vitamin D that works to gradually increase your vitamin D levels as it decreases your PTH levels.

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Rayaldee helps increase levels of vitamin D and lower your PTH levels.

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Works with your body to create an active form of vitamin D.

Rayaldee works with your body to create the active form of Vitamin D which your body can use.

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.

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Just as SHPT is a silent disorder, you may not feel Rayaldee working, but it is important to continue to take your dosage as directed by your doctor.

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.

Talk to your doctor if you have any of the following symptoms, including feeling tired, having difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, weight loss, or any other abnormal symptoms or side effects.

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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 for levels of calcium, phosphorus, 25-hydroxyvitamin D, and PTH.

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Results: PTH, calcium, phosphorus, 25(OH)D.

Based on your test results, your dose of Rayaldee may be changed or stopped until your lab results improve.

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In clinical trials, Rayaldee was found to be safe and generally well tolerated in most people who took it.

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So take a step forward -

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to managing SHPT with Rayaldee!

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Rayaldee (calcifediol) ER capsules, 30 micrograms.

WWW.RAYALDEE.COM

No voiceover.

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Rayaldee (calcifediol) ER capsules, 30 micrograms.

No voiceover.

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OP-US-0295-072019v.1

No voiceover.
See Indications and Limitations of Use, Important Safety Information, and Full Prescribing Information.

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.