Lepatagin 25mg (Cinacalcet Hydrochloride)

Adult dose

Do not divide the dose when taking this medicine orally. 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 serum calcium or parathyroid hormone (iPTH) to 25, 50, or 75 mg once daily, administered orally. 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 by 25mg at intervals of at least 3 weeks. 1. Since this medicine lowers blood calcium levels, confirm that the serum calcium level is not low (as a reference, 9.0 mg/dL or higher) before starting treatment. 2. Measure serum calcium once weekly when starting this medicine and when adjusting the dose, and at least once every 2 weeks during maintenance. If the serum calcium level falls below 8.4 mg/dL, respond as follows. Serum calcium level Response Management Monitoring Dose increase/restart Administration of this medicine Consider administering calcium or vitamin D preparations Below 8.4mg/dL As a rule, do not increase the dose of this medicine (reduce the dose if necessary) Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, do so only after confirming that the serum calcium level has recovered to 8.4mg/dL or higher Below 7.5mg/dL Discontinue treatment immediately If restarting treatment, resume at the previous dose or a lower dose only after confirming that the serum calcium level has recovered to 8.4mg/dL or higher Serum calcium should preferably be measured before taking this medicine 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 index. 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 maintain it within the target range. Measure parathyroid hormone (iPTH) twice monthly when starting this medicine and when adjusting the dose (as a guide, for approximately 3 months from the start of treatment); after confirming that parathyroid hormone (iPTH) has become relatively stable, monthly measurement is preferable. In addition, parathyroid hormone (iPTH) should preferably be measured before taking the medicine to appropriately assess its efficacy and safety. 4. Patients with hepatic impairment: Exposure to this medicine (based on AUC) was 2.4-fold and 4.2-fold higher, respectively, in patients with moderate and severe hepatic impairment (according to the Child-Pugh method) than in individuals with normal hepatic function. PTH and serum calcium levels should be closely monitored when this medicine is administered to patients with moderate or severe hepatic impairment.

Caution is required as this medication may cause seizures to recur in patients with a history of seizure disorder. It should be used carefully in patients with heart failure as there is a risk of worsening hypotension or heart failure symptoms. Patients with hypersensitivity to this medication or genetic issues such as lactose intolerance should not be administered this drug. Careful observation is needed for patients with hypocalcemia as this medication may exacerbate symptoms. In patients with impaired liver function, metabolism of this medication may slow down, potentially increasing drug concentration, warranting dosage adjustments. Patients with a history of gastrointestinal bleeding or ulcers should be administered cautiously as symptoms may worsen. During treatment with this medication, serum calcium levels should be regularly monitored to check for hypocalcemia, and calcium or vitamin D supplements should be considered if necessary. Severe side effects such as QT interval prolongation, paralysis, muscle cramps, arrhythmia, and hypotension may occur; hence attention to symptom changes is crucial. If gastrointestinal bleeding or ulcer symptoms occur, immediate discontinuation of the medication and appropriate treatment are required. If loss of consciousness or transient loss of consciousness occurs, the medication should be stopped immediately. Elderly patients are at higher risk for side effects such as QT prolongation; dosage adjustments may be necessary upon symptom onset. Pregnant or nursing women should use this medication cautiously as it may affect the fetus or newborn, only when necessary. The safety in children and adolescents under 19 years old has not been established, and there is insufficient experience with its use. Overdose may worsen hypocalcemia, requiring symptom observation and appropriate treatment; blood dialysis is not effective. This medication may interact with other drugs, so patients must discuss any concomitant medications with their healthcare provider. When removing the medication from the PTP package, care should be taken to avoid irritation or damage to the esophageal mucosa from the corners of the tablet.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

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

Package unit

100 tablets (10 tablets/PTP x 10)