Cinabi M Tablets 25 mg (Cinacalcet Hydrochloride)

Adult dose

For oral administration, 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 concentrations, adjust the dose based on the serum calcium or parathyroid hormone (iPTH) level to 25, 50, or 75 mg once daily for oral administration. However, if improvement in parathyroid hormone (iPTH) is not observed, administer orally up to a maximum single dose of 100mg. When increasing the dose, increase by 25mg at intervals of at least 3 weeks. Because this medicine lowers blood calcium, confirm that the serum calcium level is not low (as a guideline, at least 9.0 mg/dL) before initiating treatment. 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, take the following actions as indicated in the table below. Below 8.4 mg/dL: In principle, 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 that the level has recovered to at least 8.4mg/dL. Below 7.5 mg/dL: Discontinue the medicine immediately. If restarting treatment, resume at the previous dose or a lower dose only after confirming that the level has recovered to at least 8.4mg/dL. Serum calcium should preferably be measured before taking this medicine to appropriately assess its efficacy and safety. In patients with hypoalbuminemia (serum albumin below 4.0 g/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 Measure parathyroid hormone (iPTH) regularly to maintain it within the target range. As a guideline, measure parathyroid hormone (iPTH) twice monthly when starting this medicine and during dose adjustment (for approximately 3 months after initiation); after confirming that parathyroid hormone (iPTH) has become generally stable, once monthly is preferable. In addition, measurement of parathyroid hormone (iPTH) is preferably performed before taking the medicine to appropriately assess its efficacy and safety. Patients with hepatic impairment: Exposure to this medicine (based on AUC) was 2.4-fold and 4.2-fold higher in patients with moderate and severe hepatic impairment, respectively (according to the Child-Pugh method), than in normal subjects. When administering this medicine to patients with moderate or severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored.

This medication may cause seizures in patients with a history of seizure disorders; therefore, caution is required. In patients with heart failure, hypotension or symptoms of heart failure may worsen, so it should be used with care. Patients with hypersensitivity to any ingredient should not use this medication. Caution is also warranted in hypocalcemia patients as there is a risk of lowering serum calcium levels further. For patients with impaired liver function, dose adjustments and monitoring are necessary due to the potential for increased drug concentrations. Patients with a history of gastrointestinal bleeding or ulcers should exercise caution as symptoms may worsen. During treatment, gastrointestinal symptoms such as nausea, vomiting, loss of appetite, and abdominal discomfort may occur. Regular blood tests are needed due to possible symptoms such as muscle cramps, paralysis, arrhythmias, and hypotension from decreased serum calcium levels. QT interval prolongation may occur, necessitating periodic heart checks. Neurological abnormalities such as decreased consciousness or transient loss of consciousness can happen, so monitoring symptoms is important. In cases of overdose, hypocalcemia may worsen, requiring immediate medical attention. Elderly patients over 65 years have a higher risk of side effects and require careful monitoring. Pregnant or breastfeeding individuals should consult a healthcare professional as this medication may affect the fetus or newborn. Safety in children and adolescents under 19 years has not been confirmed, so use is not recommended. This medication may interact with other medicines; therefore, it is important to inform your healthcare provider of any concurrent medications. When taking, the tablet should be removed from the PTP packaging before swallowing, as taking it in the packaging can cause esophageal damage. Serum calcium levels should be monitored regularly, and calcium supplements or vitamin D supplements can be taken if necessary. This medication is metabolized in the liver, so periodic monitoring of liver function status is required.

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

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the medication's effectiveness over time.

Appearance

Round film-coated tablets of light green or light yellow-green color

Package unit

100 tablets/box [(10 tablets/PTP packaging x 10)]