Legcal Tablet 25 mg (Sinacalcet Hydrochloride)

Adult dose

When this drug is administered orally, do not divide the dose. The initial dose for adults is 25 mg of cinacalcet orally once daily. Thereafter, while monitoring the patient's parathyroid hormone (iPTH) and serum calcium levels, adjust the dose based on the serum calcium level or parathyroid hormone (iPTH) to 25, 50, or 75 mg once daily, and administer orally. However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum dose of 100mg per dose. When increasing the dose, increase it by 25mg at intervals of at least 3 weeks. Because this drug lowers blood calcium levels, confirm that the serum calcium level is not low (9.0 mg/dL or higher as a reference) before starting treatment. Measure serum calcium once weekly at the start of treatment and when adjusting the dose, and at least once every 2 weeks during the maintenance phase. If the serum calcium level falls below 8.4 mg/dL, take the following measures as shown in the table below. Below 8.4 mg/dL: In principle, do not increase the dose of this drug (reduce the dose if necessary). Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, confirm that the level has recovered to 8.4mg/dL or higher before increasing the dose. Consider administering calcium or vitamin D preparations. Below 7.5 mg/dL: Immediately suspend treatment. If resuming treatment, confirm that the level has recovered to 8.4mg/dL or higher, then resume at the dose used before suspension or a lower dose. It is preferable to measure serum calcium before taking this drug in order to appropriately assess its efficacy and safety. In cases of hypoalbuminemia (serum albumin below 4.0 g/dL), it is preferable to use the corrected value as an indicator. Method for calculating corrected calcium: Corrected calcium (mg/dL)=serum calcium (mg/dL)－serum albumin (g/dL)＋4.0 Measure parathyroid hormone (iPTH) regularly to ensure it remains within the target range. Parathyroid hormone (iPTH) should be measured twice monthly when starting this drug and when adjusting the dose (as a guideline, for approximately 3 months after starting treatment); after confirming that parathyroid hormone (iPTH) is almost stable, once monthly is preferable. In addition, it is preferable to measure parathyroid hormone (iPTH) before taking this drug in order to appropriately assess its efficacy and safety. Patients with hepatic impairment: Drug exposure in patients with moderate and severe hepatic impairment (according to the Child-Pugh method) was 2.4-fold and 4.2-fold higher, respectively, than in individuals with normal hepatic function, based on AUC. When administering this drug 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 seizure disorders, so caution is needed. Additionally, there is a risk of hypotension and worsening heart failure in patients with heart failure, so their condition should be closely monitored. This drug should not be used in patients who are allergic to its components. Caution should also be exercised in patients with hypocalcemia, impaired liver function, heart failure, gastrointestinal bleeding, or ulcers. During the use of this medication, blood calcium levels should be regularly checked to prevent the occurrence of hypocalcemia, and if symptoms arise, consideration should be given to administering calcium supplements or vitamin D preparations, and if necessary, adjusting or discontinuing the dosage. The QT interval may be prolonged, so regular heart condition checks are needed. Gastrointestinal bleeding or ulcers may occur, so gastrointestinal symptoms should be monitored closely and if any abnormalities arise, consult a physician immediately. Decreased consciousness or transient loss of consciousness may occur, so the patient's consciousness state should be carefully observed. In the case of overdose, hypocalcemia may worsen, so dosage must be strictly adhered to, and blood dialysis is not an effective treatment for overdose. This medication can interact with certain antifungals, antibiotics, antidepressants, etc., leading to increased blood concentration, so patients must inform their doctor about other medications they are taking. Elderly patients over 65 years of age have a higher risk of side effects, requiring additional caution. Pregnant or breastfeeding women should avoid use whenever possible, and if necessary, should be administered cautiously under a physician's judgment. Safety in patients under 19 years of age has not been established, so use should be avoided. Patients should be instructed to take the medication directly from the PTP packaging. Possible side effects include gastrointestinal symptoms, decreased serum calcium, cardiac arrhythmias, liver dysfunction, skin rashes, etc.; in case of any unusual symptoms, immediate consultation with medical personnel is advised.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and safety.

Appearance

Light green or light yellow green round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)