When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to vitamin D.

How to Use This Medicine:
Long Acting Capsule, Liquid Filled Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at bedtime.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how calcifediol works. Tell your doctor if you are using any of the following:
  
  • Atazanavir, cholestyramine, clarithromycin, digoxin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
  • Diuretic (water pill)
  • Medicine to treat seizures (including phenobarbital)
  • Other supplements containing calcium
  • Vitamin D supplements

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have bone problems or a history of hypercalcemia.
• This medicine may cause the following problems:
  
  • High calcium in the blood
  • Bone problems, including adynamic bone disease with high risk of fractures
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Feeling tired, trouble thinking clearly, loss of appetite, nausea, vomiting, constipation, increase thirst, weight loss
• Increase in how much or how often you urinate
• Bone pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088