Calcifediol Extended-Release Capsules

What is this medication?

CALCIFEDIOL (kal si fe DI ol) treats an overactive parathyroid gland (hyperparathyroidism) in people with kidney disease. It works by lowering parathyroid hormone levels in your body, which can support bone health. It is a form of vitamin D.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): RAYALDEE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• High levels of calcium, phosphorus, or vitamin D in the blood
• On hemodialysis
• An unusual or allergic reaction to calcifediol, vitamin D, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses

What may interact with this medication?

Do not take this medication with any of the following:

• Burosumab

This medication may also interact with the following:

• Calcium supplements
• Certain antibiotics like clarithromycin, telithromycin
• Certain medications for cholesterol like cholestyramine
• Certain medications for seizures like phenobarbital
• Digoxin
• Diuretics like hydrochlorothiazide
• Medications for fungal infections like ketoconazole, itraconazole, and voriconazole
• Medications for HIV called protease inhibitors
• Nefazodone
• Phosphate-binding agents
• Vitamin D

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checkups. It may be some time before you see the benefit from this medication. Do not stop taking your medication unless your care team tells you to. Your care team may order blood tests or other tests to see how you are doing.

You may need to follow a special diet. Talk to your care team. Do not take any non-prescription medications that have vitamin D, phosphorus, magnesium, or calcium including antacids, unless directed by your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain
• High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Cough
• Runny or stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.