Calcifediol

Calcifediol is a vitamin D3. Vitamin D is important for helping the body absorb calcium from the stomach and for how calcium works 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 reasons not mentioned in this medication guide.

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.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and any medicines you take.

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.

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 immediately 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.

Usual Adult Dose for Secondary Hyperparathyroidism:

Initial dose: 30 mcg orally once a day at bedtimeMaintenance dose should target:-Serum total 25-hydroxyvitamin D levels between 30 and 100 ng/mL-Intact parathyroid hormone (PTH) levels within the desired therapeutic range-Serum calcium (corrected for low albumin) within the normal range-Serum phosphorus below 5.5 mg/dLComments:-Limitations of Use: This drug is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic renal disease or in patients with ESRD on dialysis.Use: For the treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic renal disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

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.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change your blood levels of other drugs you take, 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.