Uses

This medication is used to treat people with serious kidney disease whose bodies make too much of a certain natural substance (parathyroid hormone-PTH). High amounts of PTH can affect other minerals in the body (such as calcium, phosphorus) that are needed for strong bones. Calcifediol belongs to a class of drugs known as vitamin D analogs. It works by decreasing PTH and increasing calcium and phosphorus in the body.

How to use Calcifediol Capsule, Extended Release 24 Hr (Capsule, ER Hr)

Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If your doctor has told you to follow a special diet (such as a diet high in calcium), it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other vitamins/supplements unless directed by your doctor.

Side Effects

Calcifediol usually has very few side effects. If you have any unusual side effects, contact 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, nausea/vomiting, constipation, increased thirst, increased urination, fast/slow/irregular heartbeat, mental/mood changes (such as difficulty thinking clearly), weakness.

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.

Precautions

Before taking calcifediol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products (such as calcitriol); 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.

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. Consult your doctor before breast-feeding.

Interactions

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.

Calcifediol is very similar to other forms of vitamin D. Do not use medications containing other forms of vitamin D while using calcifediol.

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Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes Notes

Do not share this medication with others.

Lab and/or medical tests (such as PTH, calcium/phosphorus, vitamin D levels) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage Storage

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.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.