Calcifediol, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat bone disease caused by kidney or parathyroid gland problems. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: vitamin D3 analog; nutritional supplement

Generic and brand names: calcifediol, oral; vitamin D, oral; Rayaldee

What is this medicine used for?

This medicine is taken by mouth to treat secondary hyperparathyroidism (increased production of hormone by the parathyroid glands). This problem may develop in people who have kidney problems and in people who need dialysis regularly.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to vitamin D
• Bone problems
• Heart disease or an irregular heartbeat
• High calcium levels in the blood (hypercalcemia)
• High vitamin D levels in the blood

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed. Do not take more of it or take it more often than directed by your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 18.

These are extended-release tablets. Do not break, crush, or chew them. Swallow them whole. Follow any special diet recommended by your healthcare provider. Take only the calcium supplements your healthcare provider prescribes.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, metallic taste, constipation, tiredness, weakness, muscle and bone pain, headache, dry skin, confusion, coma.

What should I watch out for?

You need to have lab tests regularly to see how the medicine affects you. Your healthcare provider may want to see you regularly to check your progress. Keep all appointments.

Check with your healthcare provider about taking other medicines, including nonprescription medicines and vitamin products that contain vitamin D.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Stomach pain, irregular heartbeat, seizures, unusual thirst, dry mouth, severe or continued headache, worsening constipation, extreme tiredness or weakness, unexplained muscle or bone pain, sudden or unexplained weight loss, severe dizziness or fainting, nausea, vomiting, unexplained loss of appetite, metallic taste, eye pain or sensitivity, confusion, unusual behavior or hallucinations, loss of balance, increased or decreased urination. These may be signs of too much vitamin D which may cause high calcium blood levels.

What products might interact with this medicine?

• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Do NOT take antacids while you are taking this medicine unless your healthcare provider approves.)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, primidone (Mysoline), and phenytoin (Dilantin, Phenytek)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Bosentan (Tracleer)
• Cancer medicines such as ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Conivaptan (Vaprisol)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• Corticosteroids such as cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)
• Danazol
• Diuretics (water pills) such as chlorothiazide (Diuril), chlorthalidone, indapamide, hydrochlorothiazide (Microzide), and metolazone (Zaroxolyn)
• Heart medicines such as digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines and vitamin products that contain vitamin D such as calcitriol (Rocaltrol), cholecalciferol, ergocalciferol (Calciferol, Drisdol), and paricalcitol (Zemplar)
• Medicines to treat high phosphate levels such as lanthanum (Fosrenol) and sevelamer (Renagel, Renvela)
• Mifepristone (Korlym, Mifeprex)
• Mineral oil
• Modafinil (Provigil)
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• Nefazodone
• Orlistat (alli, Xenical)
• St. John’s Wort
• Sucralfate (Carafate)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.