Calcepar Tablet 25mg (Cinacalcet Hydrochloride)

Adult dose

When this medicine is administered orally, do not divide the dose. The initial dose for adults is 25 mg of cinacalcet orally once daily. Thereafter, monitor the patient's parathyroid hormone (iPTH) and serum calcium levels, and adjust the dose to 25, 50, or 75 mg once daily based on the serum calcium or parathyroid hormone (iPTH) level. If improvement in parathyroid hormone (iPTH) is not confirmed, administer up to a maximum of 100 mg per dose. If increasing the dose, increase by 25 mg at intervals of at least 3 weeks. 1. Because this medicine lowers blood calcium levels, confirm that the serum calcium level is not low (as a general guideline, at least 9.0 mg/dL) before initiating treatment. 2. Measure serum calcium once weekly at initiation and during dose adjustment, and at least once every 2 weeks during maintenance. If the serum calcium level falls below 8.4 mg/dL, take the following actions. Serum calcium level Action Management Monitoring Dose increase/resumption Administration of this medicine Consider administering calcium or vitamin D preparations Below 8.4mg/dL As a general rule, do not increase the dose of this medicine (reduce the dose if necessary) Measure serum calcium at least once weekly. An electrocardiogram is recommended. If increasing the dose, do so after confirming recovery to 8.4mg/dL or higher Below 7.5mg/dL Discontinue treatment immediately If resuming treatment, do so at the previous dose or a lower dose after confirming recovery to 8.4mg/dL or higher Serum calcium should preferably be measured before taking this medicine to assess its efficacy and safety appropriately. In cases of hypoalbuminemia (serum albumin below 4.0 g/dL), the corrected value should preferably be used as the reference. 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. Parathyroid hormone (iPTH) should be measured twice monthly at initiation and during dose adjustment (generally for approximately 3 months from the start of treatment); after confirming that parathyroid hormone (iPTH) has become nearly stable, once monthly is recommended. Parathyroid hormone (iPTH) should preferably be measured before taking this medicine to assess its efficacy and safety appropriately. 4. 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, than in individuals with normal hepatic function. PTH and serum calcium concentrations should be closely monitored when this medicine is administered to patients with moderate or severe hepatic impairment.

This medication may cause seizures in patients with a history of seizure disorders, so caution is needed. In patients with heart failure, there is a possibility of worsening hypotension or heart failure symptoms, thus it should be used cautiously. Patients who are allergic to any ingredients of this medication or have genetic issues such as lactose intolerance should not take it. Patients with hypocalcemia should be careful, as this medication may worsen symptoms. Patients with poor liver function may experience side effects due to the metabolism of this medication, hence caution is necessary. Patients with a history of gastrointestinal bleeding or ulcers should consult their doctor before taking it, as symptoms may worsen. Gastrointestinal symptoms such as nausea, vomiting, loss of appetite, abdominal distension, low calcium level side effects, and heart-related adverse reactions like QT interval prolongation may occur during use. Serum calcium levels should be checked regularly to prevent hypocalcemia; calcium or vitamin D supplements may be necessary if needed. This medication can interact with other drugs, therefore it is important to inform the doctor especially if taking antifungal agents, antibiotics, antidepressants, or heart medications. Elderly patients aged 65 or older have a higher risk of side effects and should exercise extra caution while taking it. Pregnant or breastfeeding women are advised to avoid this medication, and if necessary, consult a doctor and make a careful decision. Safety in children and adolescents under 19 years has not been established, so use among this population is not recommended. Overdose may result in symptoms of hypocalcemia, so symptoms should be monitored and treatment should be administered as necessary. Patients are advised to take the tablet out of the PTP packaging for consumption, as incorrect administration may risk esophageal mucosal damage.

Seizures, hypotension, worsening heart failure, nausea, vomiting, stomach discomfort, loss of appetite, abdominal bloating, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle cramps, malaise, arrhythmia, blood pressure decrease, 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, gastritis and duodenitis, gastroesophageal reflux disease, indigestion, gastrointestinal disorders, stomatitis, gastroenteritis, fecal occult blood, hemorrhoids, epigastric discomfort, hiatal hernia, blood pressure increase, arrhythmia, myocardial infarction, myocardial ischemia, ventricular premature contractions, loss-of-excitability premature contractions, atrial fibrillation, palpitations, tachycardia, dizziness, headache, insomnia, limb pain, joint pain, muscle pain, numbness, CPK elevation, LDH elevation, increased blood sugar, hyperlipidemia, increased total cholesterol, taste disturbance, ALP elevation, liver function abnormalities, bilirubin elevation, γ-GTP elevation, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous hemorrhage, goiter, anemia, thrombocytopenia, lethargy, chest discomfort, chest pain, fatigue, edema, arteriovenous fistula occlusion, thirst, fever, erectile dysfunction, myalgia, weakness, infection, peritonitis, dyspnea, generalized weakness, nausea, colon polyps, enteritis, hematemesis, chest discomfort, fractures, Achilles tendon rupture, nosebleeds, pneumonia, pyelonephritis, bronchiolitis, seizures, worsening heart failure, blood pressure regulation failure, diabetic ulcers, procedural site reaction infection, cerebral infarction, surgical site reaction, laceration, upper respiratory infection, cold, neck/shoulder pain, fatigue, cold sensation, cough, bronchitis, procedural site reaction, shingles, side 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, leg trembling, peripheral neuropathy, carpal tunnel syndrome, restless legs syndrome, anxiety, sleep disorders, hypoglycemia, eye inflammation, eye redness, cataracts, venous stenosis, epididymal cyst, contusion

This medication should be stored in a sealed container to prevent air and moisture from entering, and at room temperature between 1°C and 30°C. Storing it this way will help preserve its effectiveness.

Appearance

Light green or light yellow-green round film-coated tablet

Package unit

100 tablets (10 tablets/ PTP packaging x 10)