Information about Parsabiv (Etelcalcetide)
Parsabiv is a prescription medication that contains Etelcalcetide, a calcimimetic agent used primarily in the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis. Etelcalcetide works by mimicking the action of calcium on the parathyroid glands, helping to lower the levels of parathyroid hormone (PTH), which can become elevated in kidney disease and contribute to complications like bone disease and vascular calcification.
Product Highlights
- Parsabiv is primarily used to treat SHPT in patients with end-stage renal disease (ESRD) who are undergoing hemodialysis. SHPT often results from kidney dysfunction, where the kidneys can no longer regulate calcium and phosphate properly, leading to elevated PTH levels. This can cause bone mineral disorders and cardiovascular issues.
- Parsabiv may be used in specific situations where elevated calcium levels need to be controlled, although this is not its primary indication.
Key Ingredient
Key Benefits
- Parsabiv effectively lowers elevated PTH levels in patients with secondary hyperparathyroidism, which can reduce the risk of bone mineral disease and cardiovascular complications.
- By controlling PTH levels, Parsabiv helps maintain better calcium and phosphate balance, which is critical in preventing bone damage and soft tissue calcification.
- Lowering elevated PTH can help prevent renal osteodystrophy (bone disease associated with kidney failure) and improve overall bone mineralization.
- Parsabiv is given via intravenous injection during hemodialysis, which ensures consistent therapeutic delivery and reduces the need for oral medications.
- Unlike some other medications for SHPT, Parsabiv has a lower risk of causing hypercalcemia (high blood calcium levels) because of its mechanism of action, which balances calcium levels more effectively.
Direction of Use
- Parsabiv is administered intravenously at the end of hemodialysis sessions. It should be injected over a period of approximately 4 minutes.
- The typical initial dose of Parsabiv is 2.5 mg, 5 mg, or 7.5 mg given three times a week, based on the patient's PTH levels and clinical response. The dose may be adjusted by the healthcare provider, typically in increments of 2.5 mg to 5 mg per dialysis session, depending on how well the PTH levels are controlled.
- Doses can be adjusted based on the effectiveness and any side effects observed. Regular monitoring of PTH, calcium, and phosphate levels is recommended during treatment.
Safety Concerns
- The most common side effects of Parsabiv include nausea, muscle spasm, hypocalcemia (low blood calcium), and vomiting. These can be related to changes in calcium and phosphate metabolism.
- One of the most significant risks of Parsabiv is hypocalcemia. As PTH levels decrease, calcium levels may fall too low, leading to symptoms like muscle cramps, tetany, and severe bone pain. Blood calcium levels should be monitored regularly during treatment.
- In some cases, Etelcalcetide may cause bradycardia (slow heart rate) or affect other aspects of cardiovascular function. Monitoring for signs of heart problems is recommended, particularly in patients with pre-existing cardiovascular conditions.
- Nausea and vomiting are common side effects, especially in the early stages of treatment.
- Musculoskeletal pain or discomfort may occur, particularly if calcium levels drop too quickly or if there are significant changes in PTH and calcium balance.
- Rarely, patients may experience allergic reactions, including rash, itching, and swelling. Promptly seek medical help if these symptoms arise.
Avoid Parsabiv (Etelcalcetide) If
- Parsabiv should be avoided in patients who have severe hypocalcemia (low blood calcium levels) at the time of treatment. Treatment should not be initiated until calcium levels are normalized.
- If you have a known hypersensitivity to Etelcalcetide or any of the components in Parsabiv, it should not be used.
- In patients with severe bradycardia or other serious heart conditions, Parsabiv should be used with caution or avoided, as it may exacerbate these conditions.
- If phosphate levels are not adequately controlled, the use of Parsabiv may be contraindicated, as PTH control alone may not be sufficient for managing phosphorus imbalances in some cases.
- Parsabiv has not been studied extensively in pregnant women, and there is limited data on its safety during pregnancy. It should be used only if the potential benefit justifies the potential risk to the fetus. Women who are pregnant or planning to become pregnant should discuss the use of Parsabiv with their doctor.
- It is not known whether Etelcalcetide passes into breast milk, so it should be used with caution during breastfeeding or avoided unless absolutely necessary.
This product requires special packaging to maintain its integrity during the shipping process. DO NOT USE THIS MEDICATION if the attached temperature indicator shows that the medication was exposed to temperatures below 2 degrees or above 8 degrees Celsius, and contact the pharmacy immediately.
