Calegna Tablet 25 mg (Cinacalcet Hydrochloride)

Adult dose

When administering this drug orally, do not divide the dose. As the starting dose, administer cinacalcet 25 mg orally once daily to adults. Thereafter, adjust the dose to 25, 50, or 75 mg once daily and administer orally, based on the serum calcium level or parathyroid hormone (iPTH), while monitoring the patient's parathyroid hormone (iPTH) and serum calcium levels. However, if no improvement in parathyroid hormone (iPTH) is observed, 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. As this drug lowers blood calcium, confirm that the serum calcium level is not low (as a guideline, at least 9.0 mg/dL) before starting treatment. 2. Measure serum calcium once weekly when starting this drug and 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. Serum calcium level Response Action Monitoring Dose increase/resumption 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 that the level has recovered to at least 8.4mg/dL Below 7.5mg/dL Discontinue this drug immediately To resume treatment, confirm that the level has recovered to at least 8.4mg/dL, then resume at the pre-discontinuation dose or a lower dose Serum calcium should preferably be measured before taking this drug to appropriately assess its efficacy and safety. In cases of hypoalbuminemia (serum albumin level 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 3. Measure parathyroid hormone (iPTH) regularly to maintain it within the target range. As a guideline, measure parathyroid hormone (iPTH) twice monthly when starting this drug and adjusting the dose (for approximately 3 months after starting treatment); after confirming that parathyroid hormone (iPTH) has stabilized, it is preferable to measure it once monthly. In addition, parathyroid hormone (iPTH) should preferably be measured before taking this drug to appropriately assess its efficacy and safety. 4. 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 induce seizures in patients with a history of seizures, so caution is needed. In patients with heart failure, there is a risk of lower blood pressure or worsening heart failure, thus it should be used carefully. This medication should not be used in patients who have an allergy to its ingredients or have a genetic disorder that prevents lactose digestion. Patients with hypocalcemia require special attention as this medication may lower calcium levels further. Patients with poor liver function may experience slowed drug metabolism, necessitating dose adjustments and monitoring. Patients with a history of gastrointestinal bleeding or ulcers should be cautious as symptoms may worsen. During treatment, serum calcium levels should be checked regularly to detect and manage symptoms related to hypocalcemia early. Cardiac-related adverse reactions such as QT interval prolongation may appear, so heart conditions should be closely monitored. Common gastrointestinal symptoms may include nausea, vomiting, abdominal discomfort, appetite loss, abdominal bloating, upper abdominal pain, abdominal pain, diarrhea, constipation, gastric ulcer, gastro-duodenitis, gastroesophageal reflux disease, dyspepsia, gastrointestinal disorders, stomatitis, gastroenteritis, fecal occult blood, hemorrhoids, upper abdominal discomfort, hiatal hernia, blood pressure increase, arrhythmia, blood pressure drop, myocardial infarction, myocardial ischemia, ventricular extrasystole, atrial fibrillation, palpitations, tachycardia, paralysis. In case of overdose, symptoms of hypocalcemia should be closely monitored, and calcium supplementation should be administered if necessary. Elderly patients aged 65 and over have a higher risk of adverse effects, hence dose adjustment and careful observation are necessary. Use in pregnant or nursing women is not recommended, and if absolutely necessary, it should be used cautiously under medical supervision. Safety has not been established in children and adolescents under 19 years, and use is not recommended. When combined with other medications, consultation with healthcare providers is necessary as interactions may alter the concentrations of this medication or others. This medication should be taken out of the PTP pack and caution is required as taking it directly from the packaging may pose a risk of esophageal injury.

Convulsions, seizures, worsening of heart failure, nausea, vomiting, upper abdominal discomfort, loss of appetite, abdominal distension, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle cramps, malaise, arrhythmia, hypotension, gastrointestinal bleeding, gastrointestinal ulcer, decreased level of consciousness, transient loss of consciousness, sudden death, upper abdominal pain, abdominal pain, abdominal discomfort, diarrhea, constipation, gastric ulcer, gastritis and duodenitis, gastroesophageal reflux disease, dyspepsia, gastrointestinal disturbance, stomatitis, gastroenteritis, fecal occult blood, hemorrhoids, precordial discomfort, hiatal hernia, hypertension, arrhythmia, myocardial infarction, myocardial ischemia, ventricular ectopy, loss of ectopy, atrial fibrillation, palpitations, tachycardia, dizziness, headache, insomnia, limb pain, joint pain, myalgia, numbness, elevated CPK, elevated LDH, increased blood sugar, hyperlipidemia, elevated total cholesterol, taste disturbance, elevated ALP, liver dysfunction (increased AST and ALT), elevated bilirubin, elevated γ-GTP, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous hemorrhage, goiter, anemia, thrombocytopenia, fatigue, chest discomfort, chest pain, exhaustion, edema, arterial-venous fistula occlusion, thirst, fever, erectile dysfunction, myalgia, lethargy, infection, peritonitis, dyspnea, systemic weakness, nausea, colonic polyps, enteritis, hematemesis, chest discomfort, fracture, Achilles tendon rupture, nosebleed, pneumonia, pyelonephritis, bronchitis, seizures, worsening heart failure, inadequate blood pressure control, diabetic ulcer, infection at procedure site, cerebral infarction, reaction at surgical site, laceration, upper respiratory infection, cold, neck/shoulder pain, fatigue, cold sensation, cough, bronchitis, reaction at procedure site, shingles, flank pain, tremor, 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 shaking, peripheral neuropathy, carpal tunnel syndrome, restless legs, anxiety, sleep disturbances, hypoglycemia, eye inflammation, eye redness, cataract, venous stenosis, epididymal cyst, bruises

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. Additionally, it should be stored at room temperature, between 1 and 30 degrees Celsius, avoiding extreme heat or cold.

Appearance

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

Package unit

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