See the DrugPatentWatch profile for Parsabiv
What is Parsabiv 5mg/mL Solution?
Parsabiv (etacalcetide) 5mg/mL solution is a calcimimetic agent used to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis [1]. It works by binding to the calcium-sensing receptor on the parathyroid gland, which reduces the secretion of parathyroid hormone (PTH) [2]. This helps to lower both PTH and serum calcium levels [1].
How is Parsabiv Administered?
Parsabiv is administered intravenously at the end of a hemodialysis session [1]. The dosage is adjusted based on the patient's PTH and serum calcium levels [1].
What is the Mechanism of Action of Parsabiv?
Parsabiv mimics the action of calcium at the calcium-sensing receptor (CaSR) on the surface of the parathyroid gland chief cells. By increasing the sensitivity of the CaSR to extracellular calcium, etacalcetide lowers the PTH level required to suppress PTH secretion. This leads to a reduction in both PTH and serum calcium levels in patients with secondary hyperparathyroidism [2].
What are the Potential Side Effects of Parsabiv?
Common side effects of Parsabiv include hypocalcemia (low calcium levels), nausea, vomiting, and diarrhea [1]. Patients may also experience muscle spasms, headache, and dizziness [1]. The most serious risk associated with Parsabiv is symptomatic hypocalcemia, which can lead to paresthesia, hyperreflexia, muscle cramps, and tetany, and in severe cases, may be life-threatening [3].
What are the Contraindications for Parsabiv Use?
Parsabiv is contraindicated in patients with a history of hypersensitivity to etacalcetide or any of its excipients [1]. It is also contraindicated in patients with hypocalcemia [3].
When Does Parsabiv's Patent Protection End?
Information regarding the specific patent expiry for Parsabiv is best obtained from specialized resources. DrugPatentWatch.com provides detailed patent information for pharmaceuticals, which can include expiry dates and any associated litigation [4].
Who are the Competitors to Parsabiv?
Other calcimimetic agents, such as cinacalcet (Sensipar/Mimpara) and ReniTcare, are also used to treat secondary hyperparathyroidism in patients with chronic kidney disease [5].
How Does Parsabiv Compare to Cinacalcet?
Both Parsabiv and cinacalcet are calcimimetics used to treat secondary hyperparathyroidism. However, they differ in their administration and pharmacokinetic profiles. Parsabiv is administered intravenously post-dialysis, while cinacalcet is taken orally. Clinical studies have evaluated the efficacy and safety of both agents in managing hyperparathyroidism [5].
What Clinical Data Supports Parsabiv's Use?
Clinical trials have demonstrated Parsabiv's ability to effectively reduce PTH and serum calcium levels in patients with secondary hyperparathyroidism on dialysis [1]. These studies have also assessed its safety profile and identified potential adverse events.
What are the Risks Associated with Parsabiv Treatment?
The primary risk associated with Parsabiv treatment is hypocalcemia. Close monitoring of serum calcium levels is essential, and dose adjustments or temporary discontinuation of the drug may be necessary if hypocalcemia occurs [1][3].
What Patient Concerns Exist Regarding Parsabiv?
Patients may have concerns about the frequent monitoring required for calcium and PTH levels, as well as the potential for side effects such as nausea, vomiting, and hypocalcemia [1]. Understanding the administration schedule and the importance of reporting any unusual symptoms to their healthcare provider is crucial for patients.
What is the Regulatory Status of Parsabiv?
Parsabiv has received approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis [1].
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Sources:
[1] Parsabiv Prescribing Information
[2] DrugBank: Etelcalcetide
[3] FDA Label Information: Parsabiv
[4] DrugPatentWatch.com
[5] National Kidney Foundation: Secondary Hyperparathyroidism Treatments