Orkedia (Evocalcet) | Secondary Hyperparathyroidism | DengYue

Evocalcet Application Scope

Secondary hyperparathyroidism (SHPT) in patients undergoing maintenance dialysis.

 

 Characteristics

• Ingredients:

  • Active Ingredient: Evocalcet

  • Excipients: Not specified in available sources.

• Properties:

  • Type: Small molecule

  • Mechanism of Action: Evocalcet is an orally available calcium-sensing receptor (CaSR) agonist. It binds to the CaSR on parathyroid cells, enhancing its activity and leading to decreased secretion of parathyroid hormone (PTH). This mechanism helps in managing SHPT by reducing elevated PTH levels.

• Packaging Specification:

  • Formulation: Oral tablets

  • Strengths: 1 mg and 2 mg tablets

  • Packaging: 10 g/bottle

• Storage:

  • Conditions: Store at room temperature, away from moisture and heat.

• Expiry Date: Refer to the expiration date printed on the packaging.

• Executive Standard: Approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) on March 23, 2018.

• Approval Number: Not specified in available sources.

• Date of Revision: Not specified in available sources.

• Manufacturer: Kyowa Kirin Co., Ltd.

Guidelines for the Use of Evocalcet

• Dosage and Administration:

  • Initial Dose: Start with 1 mg orally once daily.

  • Titration: Adjust the dose based on serum PTH and calcium levels. Increase the dose by 1 mg at intervals of at least two weeks.

  • Maximum Dose: Do not exceed 12 mg per day.

  • Administration: Take with or without food, as directed by a healthcare provider.

• Adverse Reactions:

  • Common Side Effects:

    • Gastrointestinal discomfort (e.g., nausea, diarrhea)

    • Headache

    • Dizziness

  • Serious Side Effects:

    • Hypocalcemia (low blood calcium levels)

    • Severe allergic reactions (e.g., rash, swelling, difficulty breathing)

    • Electrolyte imbalances

• Contraindications:

  • Hypocalcemia: Evocalcet is contraindicated in patients with serum calcium levels below the normal range

  • Hypersensitivity: Known hypersensitivity to evocalcet or any of its components

• Precautions:

  • Monitoring: Regular monitoring of serum calcium and PTH levels is recommended during treatment.

  • Adjustment: Adjust the dose if hypocalcemia occurs.

  • Pregnancy and Lactation: Use during pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus or infant.

Interactions

• Drug Interactions:​

• CYP2D6 Inhibitors: Use with caution when co-administered with strong CYP2D6 inhibitors, as they may increase evocalcet plasma concentrations.

• Calcium Supplements: Concurrent use with calcium supplements may increase the risk of hypercalcemia; monitor calcium levels closely.

• Phosphate Binders: Monitor for potential interactions that may affect calcium and phosphate balance.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.