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OPKO Connect Can Help

Get the Support You Need. 1-844-414-OPKO (6756)

OPKO Connect, a program developed by the makers of Rayaldee® (calcifediol) extended-release capsules, offers comprehensive support. People who have been prescribed Rayaldee can speak with a pharmacist, get help with finding financial assistance for those who qualify, or receive support when talking with insurance companies.

OPKO Connect services are available Monday through Friday, 8 am to 8 pm ET by calling 1-844-414-OPKO (6756).

Affording Your Medicine

The makers of Rayaldee, OPKO Renal, are committed to making sure that every person who is eligible for Rayaldee and has a prescription, has access to treatment. With this commitment in mind, OPKO Connect was formed.

After you receive a prescription for Rayaldee, your healthcare provider can help you enroll in OPKO Connect for comprehensive support. The team at OPKO Connect is available to help identify people who may be eligible for copayment assistance, can assist with talking with insurance companies, and provide support in case of insurance issues or delays.

For help with your prescription for Rayaldee, call 1-844-414-OPKO (6756), option 2, to speak with a support specialist at OPKO Connect. Support specialists are available Monday through Friday from 8 am to 8 pm ET. Or download a form to get started.

Para obtener ayuda con su prescripción para Rayaldee, llame a 1-844-414-OPKO (6756) o descargue este formulario.

Frequently Asked Questions About Rayaldee and SHPT

Secondary hyperparathyroidism (SHPT) can develop as a complication of chronic kidney disease (CKD). SHPT occurs when the parathyroid makes too much of a type of hormone, called parathyroid hormone, or PTH.

People with stage 3 or 4 CKD are at risk for developing SHPT. It’s important for people with a diagnosis of SHPT and low vitamin D levels to receive effective treatment.

Left untreated, SHPT can cause health issues including osteoporosis, bone fractures, kidney stones, heart disease, and high blood pressure. Rayaldee has not been proven to completely get rid of vitamin D insufficiency nor control secondary hyperparathyroidism.

Rayaldee is a prescription oral medicine that is indicated for treating adults with secondary hyperparathyroidism with stage 3 or 4 chronic kidney disease and low vitamin D levels. Rayaldee helps to increase the levels of vitamin D and lowers the amount of parathyroid hormone found in the blood.

Your healthcare provider will keep track of how you are doing by monitoring certain levels in your blood. Vitamin D, parathyroid hormone, calcium, and phosphorus will be checked regularly. This will help your healthcare provider tell how well Rayaldee is working for you. Your dose of Rayaldee may be adjusted based on these results.

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

The most common side effects (those occurring in more than 2% of people taking Rayaldee) were anemia (low levels of red blood cells or hemoglobin), infection in the nose or throat, increased blood creatinine (a lab test for measuring kidney function), difficulty breathing, cough, congestive heart failure, constipation, bronchitis, high potassium levels, and osteoarthritis.

Elevations in calcium, also known as hypercalcemia, may occur during treatment with Rayaldee. Six people in the clinical trial needed to have their dose of Rayaldee adjusted due to increases in calcium. A total of 4.2% of patients taking Rayaldee (vs 2.1% of patients taking placebo) in the clinical trials experienced at least one elevation in calcium above normal limits, and none of those were found to be clinically significant.

Secondary hyperparathyroidism (SHPT) is often accompanied by low levels of vitamin D and is characterized by high levels of parathyroid hormone (PTH). Over-the-counter vitamin D addresses only the low levels of vitamin D and not the high PTH and has not been FDA-approved for the treatment of SHPT. Ready to learn more about how Rayaldee works?

OPKO Connect is a support program that can provide comprehensive support for people who have been prescribed Rayaldee. To learn more about OPKO Connect, click here.

OPKO Connect can provide comprehensive support for people who have been prescribed Rayaldee. Ready to learn more about OPKO Connect?

If you have questions about why you were prescribed Rayaldee, your health, or diagnosis, please speak with your healthcare provider.

If you have general questions about Rayaldee or secondary hyperparathyroidism, you can speak with a Rayaldee Clinical Pharmacist at OPKO Connect at 1-844-414-OPKO (6756), option 1.

If you have questions about OPKO Connect or want to talk about the financial support that may be available, call 1-844-414-OPKO (6756), option 2.

Specialty pharmacies are pharmacies with extra training to work with medications that help treat rare or chronic diseases. Most specialty pharmacies have pharmacists, nurses, and support staff with extensive training about the diseases in which they concentrate and the medicines they provide.

Specialty pharmacies can deliver your medicine to your home, help with insurance reimbursement, and talk directly with your healthcare team. Many prescribers of Rayaldee use specialty pharmacies to help provide support to their patients.

Many healthcare providers choose to utilize the support services available through OPKO Connect, which can be a hub to help talk with your insurance company and pharmacy. Many people receive their Rayaldee prescription through a specialty pharmacy that can deliver the medication directly to their door and provide additional support as needed.

OPKO Connect may be able to help you and your healthcare provider talk with your insurance company. Call 1-844-414-OPKO (6756), option 2, to learn more. Support specialists are available Monday through Friday, 8 am to 8 pm ET at 1-844-414-OPKO (6756).

Financial assistance may be available to those who qualify. To learn more, call OPKO Connect Monday through Friday, 8 am to 8 pm ET at 1-844-414-OPKO (6756).

Rayaldee is taken by mouth, once daily at bedtime. Your healthcare provider may adjust the dose based on results of your lab work.

Ready to learn more? Download the brochure for Rayaldee. Rayaldee Brochure Icon

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).
  5. For more information about Rayaldee, please contact OPKO Medical Information at 1-844-729-2539 or medicalinformation@opko.com.
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Important Safety Information