Legcal Tablet 25 mg (Cinacalcet Hydrochloride)

Adult dose

When taken orally, this medicine must not be divided. 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 according to serum calcium 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 at least 3 weeks. 1. This medicine 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 when initiating this medicine and adjusting the dose, and at least once every 2 weeks during maintenance. If serum calcium falls below 8.4 mg/dL, respond as shown in the table below. Serum calcium level Response Management Testing Dose increase/restart Administration of this medicine Consider administering calcium or vitamin D preparations Below 8.4 mg/dL In principle, do not increase the dose of this medicine (reduce the dose of this medicine if necessary) Measure serum calcium at least once weekly. It is preferable to perform an electrocardiogram. If increasing the dose, do so after confirming recovery to 8.4mg/dL or higher. Below 7.5 mg/dL Discontinue immediately When restarting, do so at the pre-interruption dose or a lower dose after confirming recovery to 8.4mg/dL or higher. It is preferable to measure serum calcium before taking this medicine in order to appropriately assess its efficacy and safety. In addition, in cases of hypoalbuminemia (serum albumin 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. Parathyroid hormone (iPTH) should be measured twice monthly when initiating this medicine and adjusting the dose (as a guideline, for approximately 3 months after starting treatment); once it is confirmed that parathyroid hormone (iPTH) is generally stable, monthly measurement is preferable. In addition, measurement of parathyroid hormone (iPTH) before taking this medicine is preferable in order to appropriately assess its efficacy and safety. 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, according to the Child-Pugh method, than in patients 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 and should be used with caution. In patients with heart failure, careful monitoring is required due to the risk of worsening hypotension and heart failure. Patients allergic to any component of this medication should not take it. Caution should be exercised in patients with hypocalcemia as this drug may exacerbate symptoms. For patients with impaired liver function, dose adjustments and monitoring are necessary due to potential increases in drug concentration. Patients with gastrointestinal bleeding or ulcers should also be cautious as symptoms may worsen. Routine monitoring of serum calcium levels is recommended to prevent hypocalcemia during treatment. Adverse reactions may include gastrointestinal symptoms such as nausea, vomiting, loss of appetite, abdominal distension, etc. In severe cases, dangerous side effects such as hypocalcemia, QT interval prolongation, gastrointestinal bleeding, altered consciousness, and sudden death may occur, requiring immediate consultation with healthcare professionals. Interactions with other medications may occur; caution is advised when taken with antifungals, antibiotics, antidepressants, antipsychotics, calcitonin, corticosteroids, etc. Older adults may have a higher risk of side effects, so dose adjustments and monitoring are important. It is preferable for pregnant or breastfeeding women to avoid taking this medication, and if unavoidable, it should be used carefully under a physician's judgment. Safety in children and adolescents under 19 years of age has not been established, and use is not recommended. In case of overdose, hypocalcemia may worsen, requiring symptom monitoring and appropriate management. When taking the medication, it should be removed from the PTP packaging and swallowed whole to prevent esophageal damage. Chronic kidney disease patients or pre-dialysis patients must carefully monitor changes in serum calcium levels. This medication is used to treat bone disorders, but parathyroid hormone levels must be monitored to prevent bone formation disorders if levels drop too low.

Seizures, hypotension, worsening heart failure, nausea, vomiting, gastrointestinal discomfort, loss of appetite, abdominal bloating, hypocalcemia, decreased serum calcium, QT prolongation, paralysis, muscle spasms, 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, dyspepsia, gastrointestinal disturbances, stomatitis, gastritis, fecal occult blood, hemorrhoids, epigastric discomfort, hiatal hernia, blood pressure increase, arrhythmia, myocardial infarction, myocardial ischemia, ventricular ectopic beats, loss of ectopic beats, atrial fibrillation, palpitations, tachycardia, dizziness, headache, insomnia, limb pain, joint pain, muscle pain, numbness, increased CPK, increased LDH, increased blood sugar, hyperlipidemia, elevated total cholesterol, altered taste, increased ALP, liver dysfunction (increased AST and ALT), elevated bilirubin, increased γ-GTP, conjunctival hemorrhage, dry eyes, pruritus, rash, hair loss, subcutaneous bleeding, thyroid enlargement, anemia, thrombocytopenia, lethargy, chest discomfort, chest pain, exhaustion, edema, arteriovenous fistula occlusion, thirst, fever, erectile dysfunction, myalgia, hypertension, asthenia, infection, peritonitis, dyspnea, systemic weakness, nausea, colonic polyp, enteritis, hematemesis, chest discomfort, fracture, Achilles tendon rupture, nosebleed, pneumonia, pyelonephritis, bronchiolitis, seizures, worsening heart failure, blood pressure control failure, diabetic ulcer, procedural site reaction infection, cerebral infarction, surgical site reaction, laceration, upper respiratory tract infection, cold, neck/shoulder pain, fatigue, chills, cough, bronchitis, procedural site reaction, shingles, flank pain, tremors, falls, influenza-like symptoms, arthritis, bone pain, low back pain, bursitis, plantar fasciitis, increased sputum, orthopnea, throat pain, runny nose, worsening pneumonia, abscess, lower respiratory tract infection, leg tremors, peripheral neuropathy, carpal tunnel syndrome, restless legs syndrome, anxiety, sleep disorders, hypoglycemia, eye inflammation, eye congestion, cataracts, venous stenosis, epididymal cyst, bruise

Store this medication in a tightly sealed container to prevent air exposure, and it is best to keep it at a temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy of the drug.

Appearance

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

Package unit

100 tablets (10 tablets per PTP packaging x 10)