Rayaldee
Rayaldee (calcifediol) is a vitamin D analog used to treat high parathyroid hormone levels (secondary hyperparathyroidism) in certain adults with kidney problems and low vitamin D levels. It comes as a 30 mcg extended-release capsule that's taken by mouth every night at bedtime. Common side effects include anemia, common cold symptoms, and shortness of breath.
What is Rayaldee (calcifediol)?
What is Rayaldee (calcifediol) used for?
- High parathyroid hormone levels (secondary hyperparathyroidism) in adults with stage 3 or 4 chronic kidney disease (CKD) and low vitamin D levels
How Rayaldee (calcifediol) works
Rayaldee (calcifediol) is a vitamin D analog, meaning it works like vitamin D. It binds to vitamin D receptors in your body, helping you absorb more calcium and phosphorus. When you absorb more calcium and phosphorus, your body makes less parathyroid hormone (PTH).
Drug facts
Side effects of Rayaldee (calcifediol)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Anemia (5%)
- High creatinine (5%)
- Common cold symptoms (5%)
- Heart failure (4%)
- Shortness of breath (4%)
- Cough (4%)
- Bronchitis (3%)
- Constipation (3%)
- High potassium level (3%)
Less Common Side Effects
- High uric acid
- Arthritis
- Bruising
- Pneumonia
- Chronic obstructive pulmonary disease (COPD)
Rayaldee (calcifediol) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- High blood phosphorus levels: muscle cramps, bone or joint pain, itchy skin, rash, tingling
- High blood calcium levels: fatigue, muscle weakness, loss of appetite, nausea, vomiting, constipation, bone pain, depression, confusion
The following Rayaldee (calcifediol) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
- High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Cough
- Runny or stuffy nose
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Pros and cons of Rayaldee (calcifediol)
Pros
- FDA approved specifically for people with stage 3 or 4 CKD
- Taken by mouth once per day
- Extended-release capsule provides consistent vitamin D levels
Cons
- Available by prescription only
- Requires regular blood tests
- Interacts with many commonly used medications
Pharmacist tips for Rayaldee (calcifediol)
- Write down your appointments to see your prescriber and to get blood tests while taking Rayaldee (calcifediol). These tests will check your calcium, vitamin D, and PTH levels to see how well the medication is working and if your dose needs to be adjusted.
- Take Rayaldee (calcifediol) with or without food. If it's hurting your stomach, try taking it with food to help.
- Take Rayaldee (calcifediol) at bedtime and swallow the capsules whole. Don't break, crush, or chew them. These capsules are extended-release, which means they release the medication slowly over time. Damaging the capsule can change how the medication works and raise your risk of side effects.
- If you miss a dose of Rayaldee (calcifediol), skip the missed dose and take your next dose at bedtime as scheduled. Don't take two doses to make up for a missed dose.
- Rayaldee (calcifediol) interacts with many medications like ketoconazole, clarithromycin, cholestyramine, and phenobarbital. Tell your health care team about all of the medications you're taking before and during treatment with Rayaldee (calcifediol).
- Rayaldee (calcifediol) can raise your calcium levels, causing symptoms like tiredness, trouble thinking, loss of appetite, nausea, vomiting, constipation, thirst, and frequent urination. Let your prescriber know right away if you notice any of these symptoms. Very high calcium levels might need emergency medical care.
- It’s not known if Rayaldee (calcifediol) passes into breast milk, affects milk production, or impacts a breastfed baby. So to be safe, watch your baby for signs of high calcium like vomiting, constipation, or seizures if you're breastfeeding. Discuss with your prescriber the benefits and risks of breastfeeding with this medication.
Common questions about Rayaldee (calcifediol)
Rayaldee (calcifediol) works gradually over time. In clinical studies, some people had lower PTH levels within a few weeks. By 6 months, about half of the people notice a bigger improvement, but it can take up to a year to see the full effects. Make sure to take Rayaldee (calcifediol) every day as directed, get your blood tests done, and follow up regularly with your prescriber to track how well this medication is working.
No, Rayaldee (calcifediol) is only available by prescription from a healthcare professional (HCP). While there's an over-the-counter (OTC) vitamin D3 analog called cholecalciferol, there are important differences between prescription and OTC forms of vitamin D. These differences include the amount of vitamin D per dose and what each type is approved to treat. Don't take cholecalciferol, or any other type of vitamin D, in place of Rayaldee (calcifediol) unless your HCP specifically says it's okay to do so.
Not exactly, but they are related. [Rayaldee (calcifediol) and vitamin D3 are different forms of vitamin D. Vitamin D3 or cholecalciferol is available OTC and is commonly used as a supplement to help raise vitamin D levels. On the other hand, Rayaldee (calcifediol) is a prescription medication specifically FDA approved to lower parathyroid hormone levels in people with secondary hyperparathyroidism. Always follow a healthcare professional's guidance when choosing the appropriate form of vitamin D for your needs.
Rayaldee (calcifediol) is made by OPKO Pharmaceuticals.
Some animal studies suggest that babies born to mothers exposed to Rayaldee (calcifediol) at doses much higher than what humans typically take experienced developmental problems. If you're pregnant or planning to get pregnant, tell your prescriber. They can talk to you about the risks and benefits of using this medication.
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Risks and warnings for Rayaldee (calcifediol)
Rayaldee (calcifediol) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
High blood calcium levels
- Risk factors: Taking too much vitamin D | Taking too much calcium | Taking thiazide diuretics
Rayaldee (calcifediol) can sometimes cause high calcium levels in the blood, which can be serious. High calcium can raise your risk of heart rhythm problems, blood vessel problems, and seizures. The risk is higher if you're also taking high doses of calcium-containing products (e.g., supplements), certain diuretics, or other vitamin D products. For this reason, don't take additional vitamin D- or calcium-containing supplements unless your prescriber says it's safe.
To check your calcium levels, you'll need regular blood tests, especially at the start of treatment or when your dose changes. Eventually these tests are done every 3 months. Your prescriber might adjust your Rayaldee (calcifediol) dose depending on these levels. Let them know if you notice symptoms of high calcium like tiredness, trouble thinking, loss of appetite, nausea, vomiting, constipation, and muscle weakness.
Risk of digoxin build up
- Risk factors: Taking digoxin
If you're taking Rayaldee (calcifediol) along with digoxin, high calcium levels in your blood can raise your risk of digitalis toxicity, a condition caused by the build-up of digoxin in your body. Your prescriber will monitor your calcium levels and watch for signs of this condition. Be sure to let them know if you experience symptoms like confusion, irregular heartbeat, nausea, or vision changes.
Bone problems
It's possible for Rayaldee (calcifediol) to lower your PTH levels too much. This can cause your bones to weaken, which raises your risk of fractures. Your prescriber will check your PTH levels closely through blood tests and adjust your dose to keep your levels in a healthy range.
Rayaldee (calcifediol) dosage
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 30mcg | 30 capsules | $1,245.48 | $41.52 |
Typical dosage for Rayaldee (calcifediol)
The typical starting dose is 30 mcg by mouth once a day at bedtime. Your prescriber will adjust your dose based on your vitamin D, calcium, phosphorus, and PTH levels in your blood.
How much does Rayaldee (calcifediol) cost?
$1,245.48
What are alternatives to Rayaldee (calcifediol)?
Rayaldee (calcifediol) images
