Rayaldee

What is Rayaldee?

• Rayaldee (Calcifediol) is a vitamin D3 analog used for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease.

Calcidiol2

Calcifediol 3D skeletal

Calcifediol 3D ball

What are the uses of this medicine?

Rayaldee (Calcifediol) is used for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

Limitations of use:

• Rayaldee is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.

How does this medicine work?

• Calcifediol (25-hydroxyvitamin D3) is a prohormone of the active form of vitamin D3, calcitriol (1,25‑dihydroxyvitamin D3).
• Upon oral administration of the modified-release calcifediol capsule, calcifediol is slowly and gradually released in the gastrointestinal tract.
• Then it is taken up by the body and converted, in the kidneys, to the active form calcitriol (1,25-dihydroxyvitamin d or 1,25 d).
• Calcitriol binds to the vitamin D receptor in target tissues and activates vitamin D responsive pathways that result in increased intestinal absorption of calcium and phosphorus and reduced parathyroid hormone synthesis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• larithromycin (Biaxin, in Prevpac)
• cholestyramine
• digoxin (Lanoxin)
• itraconazole (Onmel, Sporanox)
• ketoconazole
• medications for HIV or AIDS including atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), and saquinavir (Invirase)
• nefazodone
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• telithromycin (Ketek)
• thiazide diuretics (water pills)
• voriconazole (Vfend)

Is this medicine FDA approved?

• In 2016, the FDA approved a formulation of calcifediol (Rayaldee) 60 microgram daily as a prescription medication to treat secondary hyperparathyroidism in patients with chronic kidney disease.

How should this medicine be used?

• Ensure serum calcium is below 9.8 mg/dL before initiating treatment.

Recommended dosage:

• The initial dose of Rayaldee is 30 mcg administered orally once daily at bedtime.
• Serum calcium should be below 9.8 mg/dL before initiating treatment.
• Monitor serum calcium, phosphorus, 25-hydroxyvitamin D and intact parathyroid hormone (PTH) 3 months after starting therapy or changing dose.
• Increase the dose to 60 mcg once daily after 3 months if intact PTH is above the treatment goal.
• Ensure serum calcium is below 9.8 mg/dL, phosphorus is below 5.5 mg/dL and 25-hydroxyvitamin D is below 100 ng/mL before increasing the dose.
• Suspend dosing if intact PTH is persistently abnormally low, serum calcium is consistently above the normal range or serum 25-hydroxyvitamin D is consistently above 100 ng/mL.

Administration:

• Calcifediol comes as an extended-release (long-acting) capsule to take by mouth.
• It is usually taken once a day at bedtime.
• Take calcifediol at around the same time(s) every day.
• Swallow the extended-release capsules whole; do not chew or crush them.
• Your doctor may increase or adjust your dose depending on your body's response to calcifediol.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release 30 mcg capsules

This medicine is available in fallowing brand namesː

• Rayaldee

What side effects can this medication cause?

The most common side effects of this medicine include:

• Anemia
• Nasopharyngitis
• Blood creatinine increased
• Dyspnea
• Cough
• Cardiac failure congestive
• Constipation
• Bronchitis
• Hyperkalemia
• Osteoarthritis
• Hyperuricemia
• Contusion
• Pneumonia
• Chronic obstructive pulmonary disease

What special precautions should I follow?

• Excessive administration of vitamin D compounds, including Rayaldee, can cause hypercalcemia and hypercalciuria. Severe hypercalcemia due to substantial overdosage of vitamin D and its metabolites may require emergency attention. Patients should be informed about the symptoms of elevated calcium.
• Hypercalcemia of any cause, including Rayaldee, increases the risk of digitalis toxicity. Monitor serum calcium and signs and symptoms of digitalis toxicity more frequently when initiating or adjusting the dose of Rayaldee.
• Adynamic bone disease with subsequent increased risk of fractures may develop if intact PTH levels are suppressed by Rayaldee to abnormally low levels. Monitor intact PTH levels and adjust Rayaldee dose, if needed.
• Tell patients to take Rayaldee at bedtime and to swallow the capsules whole.
• Inform patients if they miss a dose, to take Rayaldee at the next scheduled time. Do not take an extra dose to make up for the missed dose.
• Inform patients that they will need routine monitoring of laboratory parameters such as calcium, iPTH and total 25-hydroxyvitamin D while taking Rayaldee.
• Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g., feeling tired, having difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination or weight loss).
• Inform lactating women about the need to monitor infants exposed to Rayaldee through breast milk for signs of hypercalcemia to include seizures, vomiting, constipation and weight loss.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypercalciuria
• hypercalcemia
• hyperphosphatemia
• oversuppression of intact PTH
• constipation
• decreased appetite
• dehydration
• fatigue
• irritability
• muscle weakness
• vomiting

Management of overdosage:

• Treatment of acute accidental overdosage with Rayaldee should consist of general supportive measures.
• If the overdosage is discovered within a short time, induce emesis or perform gastric lavage to prevent further absorption.
• Obtain serial serum and urine calcium measurements, and assess any electrocardiographic abnormalities due to hypercalcemia.
• Discontinue supplemental calcium.
• Treat with standard medical care if persistent and markedly elevated serum calcium levels occur.
• Calcifediol is not significantly removed by dialysis.

Can this medicine be used in pregnancy?

• There are no human data with calcifediol use in pregnant women to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and efficacy of Rayaldee have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CALCIFEDIOL

Inactive ingredients:

• mineral oil, monoglycerides and diglycerides, paraffin, hypromellose, lauroyl polyoxylglycerides, dehydrated alcohol and butylated hydroxytoluene.
• The capsule shells contain modified starch, carrageenan, sodium phosphate, dibasic, sorbitol sorbitan solution, FD&C Blue #1, titanium dioxide and purified water.

Who manufactures and distributes this medicine?

• Rayaldee® is a registered trademark of EirGen Pharma Ltd.

Manufactured for:

• OPKO Pharmaceuticals, LLC
• Biscayne Blvd.
• Miami FL USA

What should I know about storage and disposal of this medication?

• Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).

• Dailymed label info on Rayaldee
• FDA Rayaldee

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