Zemplar Injection Indication and Important Safety Information

• ZEMPLAR^® (paricalcitol) Injection is an activated vitamin D therapy and is used for the prevention and treatment of elevated parathyroid hormone levels (secondary hyperparathyroidism) in patients with kidney failure (chronic kidney disease Stage 5).
• ZEMPLAR Injection should not be taken if there are symptoms of abnormally elevated vitamin D or calcium levels or if the person is allergic to any product ingredient. Early symptoms of elevated vitamin D or calcium include weakness, headache, nausea, vomiting, constipation, muscle or bone pain, and metallic taste. Talk with your doctor if you think you might be experiencing any of these symptoms.
• Taking too much vitamin D or taking vitamin D for a long period of time can cause high calcium levels, which can trigger serious health problems and the need for immediate medical attention.
• Certain medication can interact with ZEMPLAR Injection. Dosage adjustments of ZEMPLAR Injection may be required if other medications are initiated or discontinued. Do not take any medications or vitamin/mineral supplements without your physician's knowledge.
• You should have blood tests to measure the parathyroid hormone (PTH), calcium, and phosphorus levels in the blood every 3 months and more often when starting ZEMPLAR Injection or when the dose is changed. Your doctor may adjust your dose based on the results of the blood tests.
• It is important for anyone taking ZEMPLAR Injection to take their medications as prescribed, to adhere to a diet low in phosphorus and to take phosphate binders as prescribed.
• Potential side effects of ZEMPLAR Injection are, in general, similar to effects of taking too much vitamin D. Nausea, vomiting, and excess fluid in the body were common side effects in patients taking ZEMPLAR Injection. For more information about possible side effects of ZEMPLAR Injection, ask your doctor or healthcare provider.

Zemplar Capsule Indication and Important Safety Information

• Zemplar^® (paricalcitol) Capsules are indicated for the prevention and treatment of elevated parathyroid hormone levels (secondary hyperparathyroidism) associated with moderate to severe (Stages 3 & 4) chronic kidney disease.
• Zemplar should not be taken if there are symptoms of abnormally elevated vitamin D or calcium levels or if the person is allergic to any product ingredient.
• Taking too much vitamin D can cause high calcium levels, which could require immediate medical attention.
• Do not take any medications or vitamin/mineral supplements without your physician's knowledge.
• High levels of calcium can trigger serious health problems. Dosage adjustments of Zemplar may be required if other medications are initiated or discontinued; do not stop taking other medications without your physician's knowledge.
• Laboratory tests should be done routinely every 3 months and more frequently when Zemplar is initiated and with dose changes, to measure the parathyroid hormone (PTH), calcium, and phosphorus levels in the blood. Zemplar doses will be adjusted accordingly to maintain blood levels of minerals within targeted levels and to ensure optimum PTH reduction/levels.
• It is important for anyone taking Zemplar to take their medications as prescribed, to adhere to a diet low in phosphorus and to take phosphate binders as prescribed. Early symptoms of elevated vitamin D or calcium include weakness, headache, nausea, vomiting, constipation, muscle or bone pain, and metallic taste.
• Potential side effects of Zemplar are, in general, similar to effects of taking too much vitamin D. Vertigo (dizziness), allergic reaction, arthritis and rash were common side effects that were experienced at least twice as often by Zemplar CKD Stages 3&4 patients as patients taking placebo (sugar pill).
• For more information about possible side effects of Zemplar, ask your doctor or pharmacist. Talk with your doctor if you think you might be experiencing a side effect of Zemplar.

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