Doxercalciferol, Oral/Injection

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KEY POINTS

• This medicine is taken by mouth or given by injection to treat high levels of parathyroid hormone in people with chronic kidney disease. 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.
• Do not start or stop any medicine or supplement unless you check with your healthcare provider first. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: synthetic vitamin D

Generic and brand names: doxercalciferol, injection; doxercalciferol, oral; Hectorol

What is this medicine used for?

This medicine is taken by mouth or given by injection (shot) to treat high levels of parathyroid hormone in people with chronic kidney disease.

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 dyes
• High levels of calcium or phosphate in your blood
• Heart disease or an irregular heartbeat
• Liver disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. 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. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Take capsules exactly as your healthcare provider prescribes. Your healthcare provider will carefully adjust your dose based upon your lab tests.

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

Injections of this medicine will be given by a healthcare provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, 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, weakness, confusion, constant headache, severe nausea and vomiting, loss of appetite, tiredness, metallic taste, dry mouth, severe bone or muscle pain, coma.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Follow your healthcare provider's advice about diet and calcium supplements while taking this medicine. Do not start or stop any medicine or supplement unless you check with your healthcare provider first. Having too much calcium in your body can be very dangerous.

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.): Irregular heartbeat; seizures; constipation, dry mouth, constant headache, thirst, increased urination, metallic taste, unusual weakness, tiredness, loss of appetite, sudden weight loss, muscle pain, bone pain, irritability, eye pain or sensitivity, confusion, severe nausea and vomiting.

Other: Headache, slow heartbeat, nausea, vomiting, gas, swelling of the ankles and feet, dizziness, shortness of breath, itching, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS
• Antibiotics such as clarithromycin (Biaxin) and erythromycin (E.E.S., Ery-Tab, Erythrocin)
• 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, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Calcium supplements
• Cholesterol-lowering medicines such as cholestyramine (Prevalite) 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
• Digoxin (Lanoxin)
• Diuretics (water pills) such as chlorothiazide (Diuril), chlorthalidone, hydrochlorothiazide (Microzide), methyclothiazide (Enduron), and metolazone (Zaroxolyn)
• Mineral oil
• Orlistat (alli, Xenical)
• Other vitamin D medicines such as calcitriol (Rocaltrol), cholecalciferol, ergocalciferol (Calciferol, Drisdol), and paricalcitol (Zemplar)
• Rifabutin (Mycobutin) and rifampin (Rifadin)
• Sucralfate (Carafate)

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

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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 medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.