This medication is used to treat people with serious kidney disease who have high levels of a certain natural substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may result in weak bones. Doxercalciferol is a man-made form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.

Take this medication by mouth with or without food as directed by your doctor, usually 3 times a week on dialysis days (such as Monday, Wednesday, Friday).

The dosage is based on your medical condition, lab tests, and response to treatment. Do not increase your dose, take it more often, or stop taking this medication without your doctor's approval.

It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take more than 2 grams of calcium a day while you are taking this medication. Sources of calcium include your diet, phosphate binders, or calcium supplements. If you have any questions about how much calcium you take in a day, ask your doctor or pharmacist. Do not take other supplements/vitamins (such as vitamin D) unless otherwise directed by your doctor. (See also Drug Interactions section.)

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day that you have a prescribed dose.

Headache, upset stomach, constipation, nausea, vomiting, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• bone/joint/muscle pain
• loss of appetite
• increased thirst
• increased urination
• fast/slow/irregular heartbeat
• mental/mood changes (such as drowsiness, disturbed/irrational thoughts or beliefs)
• metallic taste in mouth
• weakness
• unexplained weight gain or loss

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking doxercalciferol, tell your doctor or pharmacist if you are allergic to it; or to vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as irregular heartbeat)
• liver disease
• high calcium blood levels (hypercalcemia)
• high phosphate blood levels (hyperphosphatemia)
• seizure

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• burosumab

Certain medications (such as bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the effect of doxercalciferol if taken at the same time. Avoid taking these medications within 2 hours before or after this medication.

Check the labels on all your prescription and nonprescription/herbal products (such as antacids, laxatives, vitamins/nutritional supplements) because they may contain calcium, magnesium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: metallic taste in the mouth, irregular heartbeat, severe mental/mood changes.

Do not share this medication with others.

Lab and/or medical tests (such as PTH levels, calcium/magnesium/phosphorus levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. Ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.