Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders.

Most people get enough vitamin D from exposure to the sun and from fortified food products (such as dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. Vitamin D helps control parathyroid hormone and the levels of certain minerals (such as calcium, phosphorus) that are needed for building and keeping strong bones.

Read the Patient Information Leaflet if one is available from your pharmacist before you start using paricalcitol. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

This medication is given by injection into a vein during dialysis, usually by a health care professional. It is given as directed by your doctor, usually 3 times a week (every other day). The dosage is based on your condition, weight, lab tests, and response to treatment.

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

Headache, nausea, chills, or fever may occur. If any of these effects last or get worse, tell your doctor promptly.

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:

• constipation
• drowsiness
• dry mouth
• muscle/bone/joint pain
• metallic taste in mouth
• weakness
• vomiting
• loss of appetite
• unusual weight loss
• eye pain/redness/sensitivity to light
• severe runny nose
• stomach/abdominal pain
• dizziness
• fast/irregular/pounding heartbeat
• swelling hands/ankles/feet
• severe mental/mood changes (such as agitation, confusion)
• easy bleeding/bruising
• bloody/tarry stool
• vomit that looks like coffee grounds

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 using 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)
• regular use/abuse of alcohol
• brain problems (such as seizures, brain injury)
• heart problems (such as arrhythmias, coronary artery disease)
• liver disease

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

This medication contains alcohol. It may make you dizzy or drowsy. Marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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
• products that contain aluminum/magnesium (such as certain antacids, phosphate binders)
• corticosteroids (such as prednisone)
• calcium supplements
• other products that contain vitamin D or phosphate (such as ergocalciferol, sodium phosphate)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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

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.

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

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.