Legpara Tablet 25 mg (Cinacalcet Hydrochloride)

Adult dose

When taking this medicine orally, do not divide the dose. For the initial dose, adults should take 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 the serum calcium level or parathyroid hormone (iPTH) to 25, 50, or 75 mg once daily and administer orally. However, if improvement in parathyroid hormone (iPTH) is not confirmed, administer orally up to a maximum of 100mg per dose. When increasing the dose, increase it by 25mg at intervals of 3 weeks or longer. 1. This medicine lowers blood calcium levels. Begin 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 when starting this medicine and when adjusting the dose, and at least once every 2 weeks during maintenance therapy. If the serum calcium level falls below 8.4 mg/dL, respond as shown in the table below. Serum calcium level Response Action Monitoring Dose increase/resumption Treatment with this medicine Consider administering calcium or vitamin D preparations Below 8.4mg/dL As a rule, do not increase the dose of this medicine (reduce the dose of this medicine if necessary) 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 8.4mg/dL or higher Below 7.5mg/dL Temporarily discontinue immediately When resuming treatment, do so only after confirming that the level has recovered to 8.4mg/dL or higher, and resume at the dose used before discontinuation or a lower dose It is preferable to measure serum calcium before taking this medicine in order to appropriately 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 3. Measure parathyroid hormone (iPTH) regularly to maintain it within the target range. It is preferable to measure parathyroid hormone (iPTH) twice monthly when starting this medicine and when adjusting the dose (approximately 3 months from the start of treatment as a guideline), and once monthly after confirming that parathyroid hormone (iPTH) has become relatively stable. In addition, it is preferable to measure parathyroid hormone (iPTH) before taking this medicine in order to appropriately assess its efficacy and safety. 4. Patients with hepatic impairment: In patients with moderate and severe hepatic impairment (according to the Child-Pugh method), exposure to this medicine (based on AUC) was 2.4-fold and 4.2-fold higher, respectively, than in individuals with normal hepatic function. PTH and serum calcium levels 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 risk of hypotension or exacerbation of heart failure, so it should be used cautiously. This medication should not be used in patients with allergies to its ingredients or with genetic issues such as lactose intolerance. In patients with hypocalcemia, this medication may exacerbate the condition, so careful observation is required. Patients with impaired liver function may experience delayed metabolism of this medication, requiring dosage adjustment and monitoring. Patients with a history of gastrointestinal bleeding or ulcers should be careful as symptoms may worsen. Gastrointestinal symptoms such as nausea, vomiting, loss of appetite, and abdominal discomfort may occur during treatment. Regular blood tests are needed as low blood calcium levels may lead to muscle cramps, arrhythmias, hypotension, or seizures. QT prolongation may occur, so cardiac status should be regularly monitored. If gastrointestinal bleeding or ulcer symptoms occur, the medication should be stopped immediately and medical assistance sought. There may be a decrease in consciousness or temporary loss of consciousness; if unusual symptoms occur, the healthcare provider should be informed immediately. Overdose may worsen hypocalcemia, so strict adherence to the dosage is essential, and in case of an overdose, immediate medical attention is required. This medication may interact with other drugs, so caution is needed, especially when taken with antifungals, antibiotics, or antidepressants. Elderly individuals over 65 are at a higher risk of side effects, so careful monitoring is required. Pregnant or breastfeeding women are advised to avoid this medication and consult healthcare providers if use is necessary. The safety of this medication has not been established in children and adolescents under 19, so its use is preferable to be avoided. This medication should be taken properly from the packaging; improper use of the packaging may pose a risk of esophageal damage. Regularly checking serum calcium levels during treatment is essential to prevent and manage hypocalcemia. If parathyroid hormone levels drop too low, bone disorders may occur, so dosage adjustment may be required. Patients with severe liver impairment may experience increased plasma concentrations of this medication, requiring careful monitoring and adjustment.

Seizures, hypotension, worsening heart failure, nausea, vomiting, abdominal discomfort, loss of appetite, abdominal bloating, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle spasms, malaise, arrhythmia, decreased blood pressure, gastrointestinal bleeding, gastrointestinal ulcer, decreased level of consciousness, transient loss of consciousness, sudden death, epigastric pain, abdominal pain, abdominal discomfort, diarrhea, constipation, gastric ulcer, gastric and duodenal inflammation, gastroesophageal reflux disease, dyspepsia, gastrointestinal disorders, stomatitis, gastritis, fecal occult blood, hemorrhoids, discomfort in the precordial region, hiatal hernia, increased blood pressure, arrhythmia, myocardial infarction, myocardial ischemia, ventricular premature contractions, atrial premature contractions, atrial fibrillation, palpitations, tachycardia, paralysis, dizziness, headache, insomnia, limb pain, joint pain, muscle pain, numbness, elevated CPK, elevated LDH, increased blood sugar, hyperlipidemia, elevated total cholesterol, taste disturbances, elevated ALP, liver function abnormalities, increased bilirubin, elevated γ-GTP, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous hemorrhage, goiter, anemia, thrombocytopenia, fatigue, discomfort in the chest, chest pain, exhaustion, edema, arteriovenous fistula occlusion, thirst, fever, erectile dysfunction, myalgia, asthenia, infection, peritonitis, dyspnea, general weakness, nausea, colon polyps, enteritis, hematemesis, discomfort in the chest, fracture, Achilles tendon rupture, nosebleed, pneumonia, pyelonephritis, bronchiolitis, convulsions, worsening heart failure, failure to control blood pressure, diabetic ulcer, infection at the site of procedure reaction, cerebral infarction, reaction at the site of surgery, laceration, upper respiratory infection, cold, neck/shoulder pain, fatigue, cold sensation, cough, bronchitis, reaction at the site of procedure, shingles, 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, leg trembling, peripheral neuropathy, carpal tunnel syndrome, restless legs syndrome, anxiety, sleep disorders, hypoglycemia, eye inflammation, eye redness, cataract, venous stenosis, epididymal cyst, contusion, symptoms due to hypocalcemia (seizures, paralysis, muscle spasms, malaise, arrhythmia, decreased blood pressure)

This medication may be sensitive to air and humidity; it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's efficacy over time.

Appearance

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

Package unit

100 tablets (10 tablets/PTP x 10)