Person Sinacalcet Tablet 25 mg (Sinacalcet Hydrochloride)

Adult dose

Do not divide the dose when taking this medicine orally. The initial dose for adults is cinacalcet 25mg orally once daily. Thereafter, while monitoring the patient's parathyroid hormone (iPTH) and serum calcium levels, adjust the dose to 25, 50, or 75mg orally once daily based on the serum calcium level or parathyroid hormone (iPTH). However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum of 100mg per dose. If increasing the dose, increase it by 25mg at intervals of at least 3 weeks. 1. This medicine lowers blood calcium levels. Initiate treatment only after confirming that the serum calcium level is not low (as a guideline, at least 9.0mg/dL). 2. Measure serum calcium once weekly when initiating this medicine and adjusting the dose, and at least once every 2 weeks during maintenance. If the serum calcium level falls below 8.4mg/dL, respond as shown in the table below. Serum calcium level Response Management Monitoring Dose increase/resumption Administration of this medicine Below 8.4mg/dL As a rule, do not increase the dose of this medicine. (Reduce the dose if necessary.) Consider administering calcium or vitamin D preparations. Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, do so only after confirming recovery to at least 8.4mg/dL. Below 7.5mg/dL Immediately discontinue temporarily. If resuming treatment, resume at the dose used before discontinuation or a lower dose, only after confirming recovery to at least 8.4mg/dL. It is preferable to measure serum calcium before taking this medicine to appropriately assess its efficacy and safety. In cases of hypoalbuminemia (serum albumin below 4.0g/dL), it is preferable to use the corrected value as an indicator. * Calculation of corrected calcium: Corrected calcium (mg/dL) = serum calcium (mg/dL) - serum albumin (g/dL) + 4.0 3. Measure parathyroid hormone (iPTH) regularly to ensure it remains within the target range. It is preferable to measure parathyroid hormone (iPTH) twice monthly when initiating this medicine and adjusting the dose (as a guideline, for approximately 3 months after starting treatment), and once monthly after confirming that parathyroid hormone (iPTH) has stabilized. In addition, it is preferable to measure parathyroid hormone (iPTH) before taking this medicine to appropriately assess its efficacy and safety. 4. Patients with hepatic impairment: Exposure to this medicine (based on AUC) was 2.4 times and 4.2 times higher, respectively, in patients with moderate and severe hepatic impairment (according to the Child-Pugh method) than in healthy individuals. When administering this medicine to patients with moderate or severe hepatic impairment, PTH and serum calcium levels should be closely monitored.

This medication may cause seizures in patients with a history of convulsions, thus caution is required. Additionally, there is a possibility of exacerbation of hypotension or symptoms of heart failure in patients with heart failure, so it should be used carefully. Patients allergic to any component of this medication or with lactose intolerance should not take it. Patients with hypocalcemia, poor liver function, heart failure, gastrointestinal bleeding, or a history of ulcers should use this medication with extra caution. During use, regular monitoring of blood calcium levels is important to prevent hypocalcemia; if hypocalcemia is suspected, calcium supplements or vitamin D supplements may need to be taken together or the medication dosage adjusted. This medication may cause gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, and loss of appetite, and may rarely cause severe side effects such as QT interval prolongation, gastrointestinal bleeding, decreased consciousness, or sudden death, thus if any symptoms occur, immediate consultation with a physician is necessary. There may be drug interactions, thus caution is needed when taking this medication alongside specific antibiotics, antifungals, antidepressants, antipsychotics, calcitonin, adrenal corticosteroids, etc. Elderly patients over 65 years of age may have a higher risk of side effects, so dosage adjustments may be necessary if side effects occur. Pregnant or breastfeeding women are advised to avoid taking this medication, and if it is unavoidable, careful consideration regarding its effects on the fetus and newborn should be made. Safety in pediatric and adolescent patients under 19 years has not been established. In case of overdose, hypocalcemia may worsen, so symptoms should be closely monitored, and appropriate treatment should be sought if necessary. This medication should be taken out from the PTP packaging, and caution should be taken to avoid swallowing the packaging as it may pose a risk of esophageal damage. For chronic kidney disease patients starting dialysis, special caution is needed as blood calcium levels may drop. During treatment, regular examinations are important to prevent excessive decreases in parathyroid hormone levels.

• Convulsions
• hypotension
• worsening of heart failure
• nausea
• vomiting
• abdominal discomfort
• loss of appetite
• abdominal distension
• hypocalcemia
• decreased serum calcium

This medication should be stored in a tightly sealed container to protect it from air and moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and prevents deterioration.

Appearance

Pale green or pale yellow-green round film-coated tablet

Package unit

100 tablets (10 tablets/PTP X 10)