Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Rayaldee

Descriptions


Calcifediol is a vitamin D3 analog that is used to treat 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. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone helps to control the concentrations of calcium and phosphorus in your blood.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of calcifediol in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcifediol in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Burosumab-twza

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Brivaracetam
  • Carbamazepine
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Conivaptan
  • Diazepam
  • Eslicarbazepine Acetate
  • Ethosuximide
  • Ethotoin
  • Ezogabine
  • Felbamate
  • Fosphenytoin
  • Gabapentin
  • Gabapentin Enacarbil
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lacosamide
  • Lamotrigine
  • Levetiracetam
  • Lopinavir
  • Lorazepam
  • Methsuximide
  • Midazolam
  • Nefazodone
  • Nelfinavir
  • Oxcarbazepine
  • Perampanel
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Pregabalin
  • Primidone
  • Ritonavir
  • Rufinamide
  • Saquinavir
  • Stiripentol
  • Telaprevir
  • Telithromycin
  • Tiagabine
  • Topiramate
  • Valproic Acid
  • Vigabatrin
  • Voriconazole
  • Zonisamide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone problems—Use with caution. May make these conditions worse.
  • Hypercalcemia (high calcium in the blood), or history of—Use with caution. May increase risk for cardiac arrhythmia and seizures.

Proper Use

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Swallow the extended-release capsule whole. Do not open, crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • For secondary hyperparathyroidism:
      • Adults—30 micrograms (mcg) (1 capsule) once a day, at bedtime. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and other laboratory tests may be needed to check for unwanted effects.

Hypercalcemia may occur while you are using this medicine. Tell your doctor right away if you are feeling tired, trouble thinking clearly, loss of appetite, nausea, vomiting, constipation, increase thirst, increased urination, or weight loss.

This medicine may cause adynamic bone disease (low bone turnover) with high risk of fractures. Tell your doctor right away if you have pain or swelling in the arms or legs without any injury.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Abdominal or stomach pain
  2. chest pain
  3. confusion
  4. cough
  5. cough producing mucus
  6. decreased urine output
  7. difficulty with breathing
  8. difficulty with moving
  9. dilated neck veins
  10. extreme fatigue
  11. fever or chills
  12. irregular breathing
  13. irregular heartbeat
  14. muscle pain or stiffness
  15. nausea or vomiting
  16. nervousness
  17. numbness or tingling in the hands, feet, or lips
  18. pain, swelling, or redness in the joints
  19. pale skin
  20. sneezing
  21. sore throat
  22. swelling of the face, fingers, feet, or lower legs
  23. tightness in the chest
  24. troubled breathing with exertion
  25. unusual bleeding or bruising
  26. unusual tiredness or weakness
  27. weakness or heaviness of the legs
  28. weight gain

Incidence not known

  1. Confusion
  2. constipation
  3. depression
  4. dry mouth
  5. headache
  6. incoherent speech
  7. increased urination
  8. loss of appetite
  9. metallic taste
  10. muscle weakness
  11. thirst
  12. weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Decreased appetite
  2. decreased urination
  3. dizziness
  4. dry mouth
  5. fainting
  6. high urine levels of calcium
  7. increase in heart rate
  8. irritability
  9. lightheadedness
  10. muscle weakness
  11. rapid breathing
  12. sunken eyes
  13. wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

  1. Bruise
  2. muscle aches
  3. stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: Feb. 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/calcifediol-oral-route/proper-use/drg-20312274