Pronunciation:

kal-sif-e-DYE-ol

Brand Names:

• Rayaldee

Dosage Forms:

• Capsule, Extended Release

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Vitamin D Analog

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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

Abdominal or stomach pain

chest pain

confusion

cough

cough producing mucus

decreased urine output

difficulty with breathing

difficulty with moving

dilated neck veins

extreme fatigue

fever or chills

irregular breathing

irregular heartbeat

muscle pain or stiffness

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pain, swelling, or redness in the joints

pale skin

sneezing

sore throat

swelling of the face, fingers, feet, or lower legs

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

weakness or heaviness of the legs

weight gain

Incidence not known

Confusion

constipation

depression

dry mouth

headache

incoherent speech

increased urination

loss of appetite

metallic taste

muscle weakness

thirst

weight loss

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

Symptoms of overdose

Decreased appetite

decreased urination

dizziness

dry mouth

fainting

high urine levels of calcium

increase in heart rate

irritability

lightheadedness

muscle weakness

rapid breathing

sunken eyes

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:

Bruise

muscle aches

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.