Doxercalciferol Oral capsule

What is this medicine?

DOXERCALCIFEROL (docks er kal SIF e role) is a man-made form of vitamin D. It helps the body have the right amount of calcium and phosphorus. This vitamin is needed for strong bones and teeth. It is used in patients with chronic renal failure.

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

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

• liver disease

• too much calcium, phosphorus, or vitamin D in your blood

• an unusual or allergic reaction to doxercalciferol, vitamin D, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine 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 medicine?

Do not take this medicine with any of the following medications:

• vitamin D

This medicine may also interact with the following medications:

• certain medicines for cholesterol like cholestyramine, colestipol

• certain medicines for seizures, like phenobarbital

• digoxin

• diuretics

• erythromycin

• glutethimide

• grapefruit juice

• ketoconazole

• mineral oil

• orlistat

• some over-the-counter products like antacids and vitamins

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need to have important lab work done while you are taking this medicine.

It is very important to follow any diet instructions your healthcare professional gives you. Do not take any non-prescription medicines that have vitamin D, phosphorus, magnesium, or calcium including antacids, unless directed by your doctor.

If you are taking cholestyramine, colestipol, or mineral oil, do not take these at the same time as this medicine. Separate the timing of the doses as much as possible.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone, muscle pain

• breathing problems

• chest pain, irregular heartbeat

• fever, infection

• hallucination, loss of contact with reality

• high blood pressure

• increased need to urinate, especially at night

• increased thirst

• numb, tingling pain

• seizures

• unexpected weight loss

• unusually weak or tired

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

• constipation

• dry mouth

• headache

• loss of appetite

• metallic taste

• stomach upset

• trouble sleeping

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Doxercalciferol Solution for injection

What is this medicine?

DOXERCALCIFEROL (docks er kal SIF e role) is a man-made form of vitamin D. It is used in patients with chronic renal failure. It helps your body keep the right amount of calcium and phosphorus for healthy bones and teeth.

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

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:

• liver disease

• too much calcium, phosphorus, or vitamin D in your blood

• an unusual or allergic reaction to doxercalciferol, vitamin D, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is injected into a muscle, or infused through a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine 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 medicine?

Do not take this medicine with any of the following medications:

• vitamin D

This medicine may also interact with the following medications:

• certain medicines for seizures like phenobarbital

• digoxin

• diuretics

• erythromycin

• glutethimide

• grapefruit juice

• ketoconazole

• certain medicines for cholesterol like cholestyramine, colestipol

• some over-the-counter products like antacids and vitamins

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 medicine?

Visit your doctor for regular check ups. You will need to have important lab work done while you are taking this medicine.

You will need to be on a special diet while you are taking this medicine. Do not take any non-prescription medicines that have vitamin D, phosphorus, magnesium, or calcium including antacids, unless your doctor instructs you to. Extra supplements can cause side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone, muscle pain

• breathing problems

• chest pain, irregular heartbeat

• fever, infection

• hallucination, loss of contact with reality

• high blood pressure

• increased thirst

• increased need to urinate, especially at night

• numb, tingling pain

• seizure

• unexpected weight loss

• unusually weak or tired

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

• constipation

• dry mouth

• headache

• loss of appetite

• metallic taste

• stomach upset

• trouble sleeping

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 medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.