Paricalcitol Solution for injection

What is this medicine?

PARICALCITOL (par i KAL si trole) is a man made form of vitamin D. It is used in patients with chronic renal failure. It helps your body maintain 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 paricalcitol, 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 for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

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?

This does not apply.

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 antibiotics like clarithromycin, telithromycin
• certain medicines for seizures like phenobarbital
• digoxin
• diuretics
• grapefruit juice
• medicines for cholesterol like cholestyramine, colestipol
• medicines for fungal infections like ketoconazole and itraconazole
• medicines for HIV called protease inhibitors
• nefazodone
• some 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.

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 directed by your doctor. Taking extra supplements can cause side effects, take only as directed.

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
• hallucinations
• increased need to urinate
• increased thirst
• metallic taste
• numb, tingling pain
• unexpected weight loss
• unusual blood pressure
• 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, diarrhea
• dry mouth
• headache
• loss of appetite
• nausea, vomiting
• 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?

This drug is given in a hospital or clinic and will not be stored at home.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.