Paricalcitol is a synthetic (man-made) form of vitamin D. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Paricalcitol is used to help maintain healthy levels of parathyroid hormone in people with chronic kidney disease who are on dialysis.

Paricalcitol oral is for use in adults and children at least 10 years old.

Paricalcitol injection is for use in adults and children at least 5 years old.

Paricalcitol may also be used for purposes not listed in this medication guide.

You should not use paricalcitol if you have high levels of calcium or vitamin D in your blood.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Paricalcitol is usually given every other day or 3 times per week. Follow your doctor's instructions carefully.

Paricalcitol oral is taken by mouth.

You may take paricalcitol oral with or without food.

Paricalcitol injection is given as an infusion into a vein during dialysis. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling when paricalcitol is injected.

Your blood will need to be tested often. Your doses may be delayed based on the results.

Even if you have no symptoms, tests can help your doctor determine if paricalcitol is effective.

You may need to follow a special diet while using paricalcitol. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

Store paricalcitol oral at room temperature away from moisture, light, and heat.

Usual Adult Dose for Secondary Hyperparathyroidism:

Injectable:
Initial dose: 0.04 to 0.1 mcg/kg (2.8 to 7 mcg), injected as a bolus dose through a hemodialysis vascular access port at any time during dialysis

Maximum frequency: Every other day

Comments:
-Do not inject directly into a vein.

Use: Prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5.
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Oral:
Initial dose:
Stage 3 or 4 Chronic Kidney Disease (CKD):
Initial dosing is based on baseline intact parathyroid hormone (iPTH):
-500 pg/mL or less: 1 mcg orally daily OR 2 mcg orally 3 times a week
-Over 500 pg/mL: 2 mcg orally daily OR 4 mcg orally 3 times a week

Stage 5 CKD:
Starting dose (micrograms) = baseline iPTH level (pg/mL)/80
Starting dose is given orally 3 times a week; only start if baseline serum calcium has been adjusted to 9.5 mg/dL or lower.

Comments:
-If giving 3 times a week, do not give more often than every other day.

Use: Prevention and treatment of secondary hyperparathyroidism associated with:
-Chronic Kidney Disease (CKD) stages 3 and 4 (oral product only), or
-CKD stage 5 on hemodialysis or peritoneal dialysis (oral or injectable).

Usual Pediatric Dose for Secondary Hyperparathyroidism:

Safety and efficacy have not been established in pediatric patients.
The following is dosing used in a very small pediatric trial.
No data are available on children under 5 years old.

Initial dose, children 5 to 18 years:
0.04 mcg/kg three times per week if baseline intact parathyroid hormone (iPTH) is less than 500 pg/mL
0.08 mcg/kg three times per week if baseline iPTH is 500 pg/mL or higher
-Injected as a bolus dose through a hemodialysis vascular access port at any time during dialysis

Maximum frequency: Every other day

Comments:
-Do not inject directly into a vein.

Use: Prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5.

You should not use paricalcitol if you are allergic to it, or if you have high levels of vitamin D or calcium in your body.

You should not be treated with paricalcitol injection if you have ever had a severe allergic reaction to it.

Tell your doctor if you have ever had:

• high blood pressure;

• liver disease; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Tell your doctor if you are pregnant or breastfeeding.

If you breastfeed while receiving paricalcitol injection, watch for signs of hypercalcemia in your baby (such as feeding problems, vomiting, constipation, or seizure).

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Because you will receive paricalcitol injection in a clinical setting, you are not likely to miss a dose. Call your doctor for instructions if you miss a hemodialysis appointment.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid using any vitamin D or calcium supplements without your doctor's advice.

If you take paricalcitol oral: Ask your doctor before using an antacid, and use only the type your doctor recommends.

Grapefruit may interact with paricalcitol and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Paricalcitol may cause serious side effects. Call your doctor at once if you have:

• fast, slow, or pounding heartbeats;

• fever, flu symptoms, mouth and throat ulcers;

• new or worsening cough, fever, trouble breathing;

• a seizure; or

• high calcium levels--nausea, vomiting, loss of appetite, constipation, increased thirst or urination, confusion, weight loss, tiredness.

You may be more likely to have a broken bone if your parathyroid hormone levels get too low. Talk with your doctor about how to avoid the risk of fractures.

Common side effects of paricalcitol may include:

• nausea, vomiting;

• swelling in your hands or feet;

• dizziness or spinning sensation;

• joint pain; or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make paricalcitol much less effective when taken at the same time. If you take any of the following medicines, take your oral paricalcitol dose 1 hour before or 4 to 6 hours after you take the other medicine:

• cholestyramine; or

• mineral oil.

Tell your doctor about all your current medicines. Many drugs can affect paricalcitol, especially:

• digoxin (digitalis);

• a diuretic or "water pill";

• nefazodone;

• a phosphate binder--ferric citrate, sevelamer, lanthanum carbonate;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole; or

• antiviral medicine to treat HIV/AIDS--indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete and many other drugs may affect paricalcitol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.