Calcifediol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcifediol is used to treat secondary hyperparathyroidism (overactive parathyroid glands) in adults who have stage 3 or 4 chronic kidney failure and low vitamin D levels. Calcifediol is not for people who are receiving dialysis.

Calcifediol may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take calcifediol at bedtime each day.

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

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypocalcemia:

Initial dose: 50 mcg orally once a day or 100 mcg orally every other day.
Maintenance dose: May increase by 20 mcg/dose at 4 week intervals.

Usual Adult Dose for Renal Osteodystrophy:

Initial dose: 50 mcg orally once a day or 100 mcg orally every other day.
Maintenance dose: May increase by 20 mcg/dose at 4 week intervals.

Tell your doctor if you have ever had:

• heart problems; or

• high levels of calcium in your blood (hypercalcemia).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether calcifediol will harm an unborn baby. However, having chronic kidney disease during pregnancy may cause complications such as miscarriage, premature birth, low birth weight, stillbirth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating kidney disease may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice vomiting, constipation, weight loss, or seizures in the nursing baby.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, constipation, loss of appetite, feeling tired or irritable, muscle weakness, feeling very thirsty or hot, or urinating less than usual.

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 (http://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. http://www.upandaway.org

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

Ask a doctor or pharmacist before using any vitamins or mineral supplements. Many non-prescription dietary supplements contain calcium or vitamin D. Taking certain products together can cause you to get too much of these ingredients.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Calcifediol may cause serious side effects. Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of calcifediol may include:

• constipation; or

• runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• cholestyramine;

• digoxin, digitalis;

• phenobarbital or other seizure medications;

• an antibiotic or antifungal medicine;

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• a diuretic or "water pill";

• heart medication; or

• medications or mineral supplements that contain calcium or vitamin D.

This list is not complete and many other drugs may affect calcifediol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.