Renatra Tablet 25 mg (Cinacalcet Hydrochloride)

Adult dose

When this drug is administered orally, do not divide the dose. The initial dose for adults is cinacalcet 25 mg orally once daily. Thereafter, monitor the patient's parathyroid hormone (iPTH) and serum calcium concentrations and adjust the dose to 25, 50, or 75 mg once daily based on the serum calcium level or parathyroid hormone (iPTH), for oral administration. However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum dose of 100mg per dose. If increasing the dose, increase it by 25mg at intervals of at least 3 weeks. 1. Because this drug lowers blood calcium, initiate treatment only after confirming that the serum calcium level is not low (as a guideline, 9.0 mg/dL or higher). 2. Measure serum calcium once weekly at initiation of treatment and during dose adjustment, and at least once every 2 weeks during maintenance. If the serum calcium level decreases to below 8.4 mg/dL, take the following measures as shown in the table below. Serum calcium level Response Treatment Testing Dose increase/restart Administration of this drug Consider administering a calcium supplement or vitamin D preparation Below 8.4mg/dL As a rule, do not increase the dose of this drug (reduce the dose of this drug if necessary) Measure serum calcium at least once weekly. An electrocardiogram is preferably performed. If increasing the dose, do so after confirming recovery to 8.4mg/dL or higher Below 7.5mg/dL Immediately discontinue treatment temporarily To restart treatment, confirm recovery to 8.4mg/dL or higher, then resume at the dose used before the interruption or a lower dose Serum calcium should preferably be measured before taking this drug in order 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 index. Method for calculating 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 at initiation of treatment and during dose adjustment (as a guideline, for approximately 3 months after starting treatment), and once monthly after confirming that parathyroid hormone (iPTH) has stabilized. Parathyroid hormone (iPTH) should preferably be measured before taking this drug in order to appropriately assess its efficacy and safety. 4. Patients with hepatic impairment: Exposure to this drug (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 classification, than in patients with normal hepatic function. PTH and serum calcium concentrations should be closely monitored when this drug is administered to patients with moderate or severe hepatic impairment.

This medication may cause seizures in patients with a history of seizures; caution is advised. Additionally, there is a risk of worsening hypotension or heart failure symptoms in patients with heart failure, so it should be used carefully. Patients allergic to any component of this medication should not take it. Patients with hypocalcemia should be cautious as this medication may further lower calcium levels. Patients with poor liver function may require dose adjustments, as the metabolism of this medication may be slower. Patients with a history of gastrointestinal bleeding or ulcers should be careful as symptoms may worsen. While taking this medication, gastrointestinal symptoms such as nausea, vomiting, appetite loss, and abdominal discomfort may occur. Regular blood tests are necessary as serum calcium levels may decrease, and calcium or vitamin D supplementation may be needed. Cardiac rhythm abnormalities (QT prolongation) may occur, so cardiac status should be monitored carefully. In case of serious side effects such as gastrointestinal bleeding, gastric ulcers, or decreased consciousness, immediate consultation with healthcare professionals is required. Elderly patients aged over 65 are at higher risk of side effects; thus, dose adjustment and monitoring are important. It is advisable for pregnant women or those who may become pregnant to avoid this medication, and if absolutely necessary, it should be administered cautiously under a physician's judgment. Nursing mothers should also discontinue breastfeeding while taking this medication. The safety in children and adolescents under 19 years has not been established, and it is therefore advisable not to use it. Overdosing can lead to symptoms of hypocalcemia; if symptoms occur, immediately inform healthcare professionals. When taking this medication, it should be swallowed whole without chewing or crushing the packaging, as doing so may risk esophageal injury. This medication may interact with various drugs, so patients should inform healthcare professionals if they are taking other medications.

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

This medication should be stored in a tightly sealed container to prevent air and moisture ingress and kept at a temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

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

Package unit

100 tablets/box [10 tablets/PTP x 10]