Renapara Tablets (Cinacalcet Hydrochloride)

Adult dose

Do not divide the dose when administering 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 at a maximum dose of 100 mg per dose. When increasing the dose, increase by 25 mg at intervals of at least 3 weeks. This medicine lowers blood calcium levels. Initiate treatment only after confirming that the serum calcium level is not low (as a guideline, 9.0 mg/dL or higher). Measure serum calcium once weekly when initiating this medicine and adjusting the dose, and at least once every 2 weeks during maintenance therapy. If serum calcium falls below 8.4 mg/dL, take the following action as shown below. Below 8.4mg/dL: Consider administering calcium supplements or vitamin D preparations. As a rule, do not increase the dose of this medicine (reduce the dose if necessary). Measure serum calcium at least once weekly. An ECG is advisable. If increasing the dose, do so only after confirming that serum calcium has recovered to 8.4mg/dL or higher. Below 7.5mg/dL: Discontinue treatment immediately. If treatment is resumed, restart at the pre-interruption dose or lower only after confirming that serum calcium has recovered to 8.4mg/dL or higher. Serum calcium should preferably be measured before taking this medicine to adequately 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 initiating this medicine and during dose adjustment (as a guideline, for approximately 3 months after starting treatment); after confirming that parathyroid hormone (iPTH) has stabilized, once monthly measurement is preferable. Parathyroid hormone (iPTH) should preferably be measured before taking this medicine to adequately 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 classification), than in healthy subjects. In patients with moderate or severe hepatic impairment, PTH and serum calcium concentrations must be closely monitored during treatment with this medicine.

This drug may cause seizures in patients with a history of seizures, so caution is advised. Care should be taken in patients with heart failure, as there is a possibility of worsening hypotension or heart failure symptoms. Patients with allergies to any ingredients in this drug or those with genetic issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Special caution is needed when administering to patients with hypocalcemia, impaired liver function, heart failure, or a history of gastrointestinal bleeding or ulcer. While taking this medication, gastrointestinal symptoms such as nausea, vomiting, decreased appetite, abdominal distension, as well as heart-related adverse reactions like hypocalcemia and QT interval prolongation may occur. Regularly monitor serum calcium levels to manage hypocalcemia, and consider calcium or vitamin D supplementation if abnormalities are found. Since this drug is metabolized in the liver, caution is required in patients with liver dysfunction as drug concentrations may increase. There is a potential for interaction with other medications; therefore, consult a professional when used concurrently with antifungals, antibiotics, antidepressants, or antipsychotics. Elderly patients may experience side effects more frequently, so caution is advised during administration. It is generally advised that pregnant or lactating women do not use this medication, and if necessary, should consult a specialist. Safety for use in pediatric and adolescent patients under 19 years of age has not been established, so use is not recommended. In cases of overdose, hypocalcemia may worsen, so symptoms should be carefully monitored, and appropriate treatment should be provided if necessary. When taking the medication, instructions should be provided to remove the pill from the packaging and avoid chewing or swallowing the packaging.

Seizures, hypotension, worsening of heart failure, nausea, vomiting, upper abdominal discomfort, decreased appetite, abdominal bloating, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle cramps, malaise, arrhythmia, decreased blood pressure, gastrointestinal bleeding, gastrointestinal ulcers, decreased level of consciousness, transient loss of consciousness, sudden death, upper abdominal pain, abdominal pain, abdominal discomfort, diarrhea, constipation, gastric ulcer, gastro-duodenitis, gastroesophageal reflux disease, dyspepsia, gastrointestinal disorder, stomatitis, gastroenteritis, fecal occult blood, hemorrhoids, epigastric discomfort, hiatal hernia, increased blood pressure, arrhythmia, myocardial infarction, myocardial ischemia, ventricular ectopy, atrial ectopy, atrial fibrillation, palpitations, tachycardia, dizziness, headache, insomnia, limb pain, joint pain, muscle pain, numbness, increased CPK, increased LDH, elevated blood sugar, hyperlipidemia, elevated total cholesterol, altered taste, increased ALP, liver dysfunction, elevated bilirubin, increased γ-GTP, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous hemorrhage, goiter, anemia, thrombocytopenia, fatigue, chest discomfort, chest pain, exhaustion, edema, arteriovenous fistula occlusion, dry mouth, fever, erectile dysfunction, myalgia, hypertension, lethargy, infection, peritonitis, shortness of breath, systemic weakness, nausea, colonic polyps, enteritis, hematemesis, chest discomfort, fracture, Achilles tendon rupture, nosebleed, pneumonia, pyelonephritis, bronchitis, seizures, worsening heart failure, failure to control blood pressure, diabetic ulcers, procedural site reaction infection, cerebral infarction, procedural site reaction, lacerations, upper respiratory infection, cold, neck/shoulder pain, fatigue, cold sensation, cough, bronchitis, procedural site reaction, herpes zoster, flank pain, tremors, falls, influenza-like symptoms, arthritis, bone pain, low back pain, bursitis, plantar fasciitis, increased sputum, orthopnea, sore throat, runny nose, worsening pneumonia, abscess, lower respiratory infection, leg tremors, peripheral neuropathy, carpal tunnel syndrome, restless legs, anxiety, sleep disorders, hypoglycemia, eye inflammation, eye redness, cataract, venous stenosis, epididymal cyst, bruising, symptoms due to hypocalcemia (paralysis, muscle cramps, malaise, arrhythmia, decreased blood pressure, seizures)

This drug may be sensitive to air and moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

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

Package unit

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