Calcifediol

Calcifediol is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood], ) in certain adults with chronic kidney disease (condition in which the kidneys stop working slowly and gradually). Calcifediol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements and by regulating the body's production of parathyroid hormone.

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take calcifediol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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.

Calcifediol is also sometimes used to treat osteomalacia (weakening and softening of the bones) due to liver disease. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking calcifediol,

• tell your doctor and pharmacist if you are allergic to calcifediol, any other medications, or any of the ingredients in calcifediol extended-release capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking calcifediol. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly) or if you have or have ever had high blood levels of calcium.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking calcifediol, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking calcifediol.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Calcifediol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, or weight loss
• shortness of breath
• pale skin
• fracture

Calcifediol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• constipation
• decreased appetite
• fatigue
• irritability
• muscle weakness
• vomiting

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response before you start taking calcifediol, at 3 months after the start of treatment or if your dose was changed, and then at least every 6 to 12 months.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Rayaldee^®