Zemplar (paricalcitol) is a 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.
Zemplar is used to treat or prevent overactive parathyroid gland (hyperparathyroidism) in people with chronic kidney failure.
Zemplar may also be used for purposes not listed in this medication guide.
Important information
You should not use Zemplar if you have high levels of calcium or vitamin D in your blood.
Before taking Zemplar, tell your doctor if you have high blood pressure, liver disease, or an electrolyte imbalance.
Do not take other vitamin or mineral supplements unless your doctor has told you to.
Avoid using calcium supplements or antacids without your doctor"s advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
While using Zemplar, you may need blood tests at your doctor"s office. Visit your doctor regularly.
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.
Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.
Before taking this medicine
You should not use Zemplar if you have ever had an allergic reaction to vitamin D, or if you have:
To make sure Zemplar is safe for you, tell your doctor if you have:
FDA pregnancy category C. It is not known whether Zemplar will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Zemplar.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether paricalcitol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take Zemplar?
Take Zemplar exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Zemplar is sometimes taken daily, and sometimes taken every other day or 3 times per week. Follow your doctor"s instructions carefully.
You may take this medication with or without food.
While using Zemplar, you may need frequent blood tests.
Zemplar is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.
Store at room temperature away from moisture, light, and heat.
Zemplar dosing information
Usual Adult Dose for Secondary Hyperparathyroidism:
Chronic kidney disease (CKD) stage 3 and 4:
Initial: dosage based on baseline intact parathyroid hormone level (iPTH):
iPTH <= 500 pg/mL: 1 mcg orally once a day or 2 mcg orally three times a week.
iPTH >500 pg/mL: 2 mcg orally once a day or 4 mcg orally three times a week.
Maintenance: dose may be adjusted at 2 to 4 week intervals based on relation of subsequent iPTH levels to baseline iPTH level:
If iPTH levels remain the same, increase, or decrease by less than 30%: increase daily dose by 1 mcg or increase 3 times a week dose by 2 mcg.
If iPTH levels decrease by >= 30% and <= 60 %: maintain current dose.
If iPTH levels decrease by > 60% or iPTH level < 60 pg/mL: decrease daily dose by 1 mcg or decrease 3 times a week dose by 2 mcg.
If patient is on lowest dose on the daily regimen and a dose reduction is necessary, decrease dose to 1 mcg 3 times a week. If a further dose reduction is necessary, withhold the drug as needed and restart at a lower dose when feasible.
Chronic kidney disease (CKD) Stage 5 with dialysis:
Initial: 0.04 to 0.1 mcg/kg administered as an IV bolus dose no more frequently than every other day at any time during dialysis.
Maintenance:
If parathyroid hormone (PTH) levels remain the same or increase, an additional increase in Zemplar dosage is necessary.
If PTH levels have decreased <30%, increase the Zemplar dose.
If PTH levels have decreased by >30% but <60%, maintain the current dose.
If PTH levels have decreased more than 60%, decrease the Zemplar dose.
If PTH levels are 1.5 to 3 times the upper limit of normal, maintain the current dose.
When using Zemplar injection, the dosage may be increased by 2 to 4 mcg at 2- to 4-week intervals as necessary to produce the desired results. In clinical studies, doses as high as 0.24 mcg/kg (16.8 mcg) have been safely administered.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.
Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.
What should I avoid while taking Zemplar?
Do not take other vitamin or mineral supplements (including mineral oil), unless your doctor has told you to.
Avoid using calcium supplements or antacids without your doctor"s advice. Use only the specific type of supplement or antacid your doctor recommends.
Zemplar side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Zemplar: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Zemplar and call your doctor at once if you have:
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fever, chills, body aches, flu symptoms;
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pain or burning when you urinate;
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early signs of vitamin D overdose - weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting; or
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signs of too much calcium in the blood - nausea, vomiting, loss of appetite, weight loss, constipation, increased thirst or urination, confusion, and feeling tired or restless.
Common Zemplar side effects may include:
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.
See also: Side effects (in more detail)
What other drugs will affect Zemplar?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zemplar, especially:
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cholestyramine;
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digoxin (digitalis, Lanoxin);
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nefazodone;
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antifungal medicine - ketoconazole, itraconazole, voriconazole;
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an antibiotic - clarithromycin, telithromycin; or
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HIV or AIDS medications - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir.
This list is not complete. Other drugs may interact with paricalcitol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
