About Rayaldee

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Get Back Into Balance With Rayaldee

Find Your Balance.

Rayaldee® (calcifediol) extended-release capsules is an oral medication 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 on dialysis.

Taking Rayaldee

Before you start treatment with Rayaldee, your healthcare provider will check certain hormones and minerals in your blood. After you get started with treatment, your healthcare provider will periodically check levels in your blood of PTH, vitamin D, calcium, and phosphorus. Based on the results, your healthcare provider may adjust or stop your dose of Rayaldee.

Rayaldee is taken by mouth one time per day at bedtime. You should take your dose of Rayaldee whole and 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 medicine.

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

Understanding How Rayaldee Works

Rayaldee contains medicine to address some of the imbalances going on inside the bodies of people with secondary hyperparathyroidism (SHPT). The active ingredients in Rayaldee work to help your body regain balance by gradually increasing vitamin D levels and decreasing parathyroid hormone in your blood.

Monitoring and dose adjustments

Your healthcare provider will keep track of your progress by regularly monitoring the levels of vitamin D, parathyroid hormone, calcium, and phosphorus. Your dose of Rayaldee may be adjusted based on these results.

Be sure to get your lab work as prescribed. Your healthcare provider uses this information to tell how well Rayaldee is working for you.

In clinical trials, Rayaldee has been very well tolerated, with only about 5% of people stopping their treatment due to treatment-emergent events (compared with around 4% of those on placebo).

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.

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.

Ready to get started? Need extra support? Talk with your healthcare provider or call OPKO Connect at 1-844-414-OPKO (6756).

Starting Rayaldee

Many healthcare providers choose to utilize support services available through OPKO Connect. The specialists at OPKO Connect can help you and your healthcare provider talk with your insurance company and pharmacy.

In addition to insurance specialists, OPKO Connect also has pharmacists who can answer general questions about Rayaldee and secondary hyperparathyroidism (SHPT). For specific questions about your health or diagnosis or why you were prescribed Rayaldee, you should talk with your healthcare provider.

Many people receive their Rayaldee prescription through a specialty pharmacy. This type of pharmacy can deliver medication directly to your door and provide additional support as needed.

Your Dose of Rayaldee

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

One Capsule

The starting dose of Rayaldee is 1 capsule and is taken once daily, by mouth, at bedtime. You should take your dose of Rayaldee whole and not chew or break the capsule. If you miss a dose of Rayaldee, do not take an extra dose. You should skip the missed dose and just take the next scheduled dose of medicine.

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

Two Capsules

If the level of parathyroid hormone or vitamin D levels are 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 to 2 capsules, you should take both capsules at bedtime.

You should take your dose of Rayaldee exactly as your healthcare provider has prescribed. If you have questions about your dose of Rayaldee, call your healthcare provider.

Staying on Track

Your healthcare provider will be monitoring certain blood levels before you start medicine, after approximately 3 months, and every 6 to 12 months thereafter. These tests help your healthcare provider tell how well Rayaldee is working for you. Based on the results from these tests, your healthcare provider may increase, decrease, stop, or restart your dose of Rayaldee. That means it is essential to get the tests your healthcare provider orders.

Because your dose of Rayaldee is based on the results of your lab work, be sure to take the dose your healthcare professional prescribes. You should let him or her know if there is anything that gets in the way of taking your dose as prescribed. That includes any side effects you may experience or if you are having trouble affording your medicine. Your healthcare provider may be able to help.

Rayaldee has not been proven to completely get rid of vitamin D insufficiency nor control secondary hyperparathyroidism. Remember, if untreated, secondary hyperparathyroidism (SHPT) can lead to serious health issues such as osteoporosis, bone fractures, kidney stones, heart disease, and high blood pressure. Over time, SHPT can progress and become more difficult to treat. Rayaldee is available to help treat SHPT.

If you have general questions about Rayaldee or SHPT, contact a Rayaldee Clinical Pharmacist at OPKO Connect at 1-844-414-OPKO (6756), option 1.

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.

We are Here to Help

  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).
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Important Safety Information