Paricalcitol is used to treat and prevent high levels of a certain natural substance made by the body (parathyroid hormone) in patients with long-term kidney disease. In these patients, the high level of parathyroid hormone is caused by a low level of calcium and a certain kind of vitamin D. Too much parathyroid hormone can cause serious problems such as bone disorders. Paricalcitol is a man-made form of vitamin D. It helps to reduce parathyroid hormone levels and may help your body absorb calcium and phosphorus.

Take this medication by mouth with or without food as directed by your doctor, usually once daily or 3 times a week. If you are taking this medication 3 times a week, do not take it more often than every other day.

The dosage is based on your medical condition, lab tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication on a schedule other than every day (such as 3 times a week), it may help to mark your calendar with a reminder.

It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (such as calcium, vitamin D) unless ordered by your doctor.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast/slow/irregular heartbeat
• seizures
• weakness
• loss of appetite
• back/bone/joint/muscle pain
• constipation
• dry mouth
• eye pain/redness/sensitivity to light
• headache
• nausea/vomiting
• drowsiness
• stomach/abdominal pain
• increased thirst
• signs of kidney problems (such as change in the amount of urine)
• mental/mood changes (such as psychosis)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking paricalcitol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high levels of calcium (hypercalcemia)
• high levels of vitamin D (hypervitaminosis D)
• heart disease (such as irregular heartbeat, coronary artery disease)
• seizures

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• burosumab
• other vitamin D products (such as ergocalciferol)
• products that contain aluminum (such as certain antacids, phosphate binders)
• corticosteroids (such as prednisone)

Check the labels on all your prescription and nonprescription/herbal products (such as antacids, vitamins) because they may contain aluminum, calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.

Certain medications can decrease the absorption of vitamin D (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat). Separate your doses of these medications as far as possible from your doses of vitamin D. It may be easiest to take vitamin D at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

This medication may interfere with certain lab tests (such as cholesterol tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: weakness, headache, loss of appetite, nausea, vomiting, stomach cramps, drowsiness.

Do not share this medication with others.

Lab and/or medical tests (such as calcium, phosphorus, parathyroid hormone levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.