Enaroi Tablets 4mg (Erythropoietin)

Adult dose

Treatment with this medicine should be initiated by a physician experienced in the diagnosis and treatment of anemia. Before deciding to initiate treatment with this medicine or increase the dose, first evaluate other causes of anemia. When initiating treatment with this medicine, ensure that iron stores are adequate and check transferrin saturation (TSAT) and ferritin levels. For patients not previously treated with an erythropoiesis-stimulating agent (ESA), the criterion for initiating this medicine is a hemoglobin (Hb) concentration below 10 g/dL. Patients receiving an erythropoiesis-stimulating agent (ESA) may be switched to this medicine. However, switching patients receiving a stable ESA regimen to this medicine should be considered only when there is a valid clinical reason. Individualize the dose according to the patient's condition to achieve and maintain a hemoglobin (Hb) concentration of 11 ± 1 g/dL. This medicine is administered orally once daily on an empty stomach, before a meal or at bedtime. 1. Initial dose The initial dose is 4 mg of enarodustat per dose. 2. Dose adjustment and maintenance dose Adjust the dose appropriately according to the patient's condition; the maximum dose is 8 mg per dose. Monitor hemoglobin (Hb) concentration every 2 weeks until the target is reached and maintained, and thereafter every 4 weeks or as clinically indicated. If dose adjustment is needed, increase or decrease the dose by 1 step, referring to Tables 1 and 2. When increasing the dose of this medicine, allow at least 4 weeks between dose adjustments. Do not adjust the dose of this medicine more frequently than every 4 weeks. As an exception, if Hb concentration increases by more than 2g/dL during 4 weeks of treatment, take action immediately at any time, such as reducing the dose or temporarily discontinuing treatment. If treatment is resumed after a temporary interruption, restart at a dose at least 1 step lower than the dose used before the interruption. Table 1. Dose adjustment steps and sequence Step 1: Dose of this medicine 1 mg Step 2: Dose of this medicine 2 mg Step 3: Dose of this medicine 4 mg Step 4: Dose of this medicine 6 mg Step 5: Dose of this medicine 8 mg Table 2. Dose adjustment algorithm Hb value (g/dL): 13.0 or higher Change in Hb value over 4 weeks is +2.0g/dL or less: Temporarily discontinue treatmenta), b) Change in Hb value over 4 weeks is greater than +2.0g/dL: Temporarily discontinue treatmenta) However, discontinue treatment if the minimum dose is being administered Hb value (g/dL): 12.0 or higher and below 13.0 Change in Hb value over 4 weeks is +2.0g/dL or less: Decrease the dose by 1 step. However, maintain the dose if the minimum dose is being administered. The dose may be maintained if the change in Hb value over 4 weeks is -0.5g/dL or less. Change in Hb value over 4 weeks is greater than +2.0g/dL: Decrease the dose by 1 step. However, discontinue treatment if the minimum dose is being administered. Hb value (g/dL): 10.0 or higher and below 12.0 (target range) Change in Hb value over 4 weeks is +2.0g/dL or less: Maintain the dose. However, the dose may be increased or decreased by 1 step, taking the Hb trend into account. Change in Hb value over 4 weeks is greater than +2.0g/dL: Maintain the dose. However, the dose may be increased or decreased by 1 step, taking the Hb trend into account. Hb value (g/dL): below 10.0 Change in Hb value over 4 weeks is +2.0g/dL or less: Increase the dose by 1 step. However, maintain the dose if the change in Hb value over 4 weeks is +0.5g/dL or greater. Change in Hb value over 4 weeks is greater than +2.0g/dL: Increase the dose by 1 step. However, maintain the dose if the change in Hb value over 4 weeks is +0.5g/dL or greater. *Discontinue treatment if the Hb value falls below 8.0g/dL despite administration of the maximum dose a) If treatment is resumed after a temporary interruption, confirm that the Hb value is below 12.0g/dL, then resume treatment at a dose reduced by 1 step. b) If the minimum dose was being administered when treatment was temporarily interrupted, resume treatment at the minimum dose.

This medication should be administered at the minimum dose necessary to maintain hemoglobin levels below the recommended target. Regular monitoring of hemoglobin levels should be conducted to prevent excessive red blood cell production during administration. This medication presents serious risks of thrombosis, including stroke, myocardial infarction, and thrombosis, so a careful assessment of the patient's medical history and risk factors must be conducted before administration. During treatment, thrombosis symptoms should be closely monitored. This medication should not be used in patients with hypersensitivity to any ingredient, uncontrolled hypertension, pregnant or breastfeeding women. Administer with caution to patients with a history of thrombosis or patients with hypertension, malignant tumors, diabetic retinopathy, severe infections, liver dysfunction, polycystic kidney disease, or heart failure. Common side effects include rhinitis, diarrhea, bruising, constipation, hypertension, vomiting, and serious adverse reactions such as pneumonia, heart failure, and thrombosis have also been reported. Regular checks of blood pressure and blood condition during treatment are essential, and appropriate iron supplementation may be required. Be cautious of increases in blood pressure and the possibility of shunt (hemodialysis device) occlusion or stenosis, and it is advisable not to use with other erythropoiesis-stimulating agents. When taken with other medications, particularly phosphate binders or multi-cation drugs, an interval should be maintained between doses and interactions may occur with certain medications. Women who are pregnant or may become pregnant should not use this medication and effective contraception should be practiced for a certain period after treatment. Breastfeeding women should also avoid using this medication for safety. Safety and efficacy in pediatric patients have not been established. In case of overdose, hemoglobin levels may increase excessively, so if overdose is suspected, consult a healthcare professional immediately for appropriate measures. This medication should be stored out of reach of children and should not be transferred to another container.

nasopharyngitis, diarrhea, contusion, constipation, hypertension, vomiting, pneumonia, occlusive blockage, chronic kidney disease, peritonitis, colonic polyp, congestive heart failure, coronary artery stenosis, cholangitis, occlusive stenosis, peripheral artery occlusive disease, increased fibrin D dimer, increased blood pressure, retinal hemorrhage, coronary artery stenosis, edema, anti-neutrophil cytoplasmic antibody positive vasculitis, fluid retention, hyperkalemia, osteosarcoma, brainstem infarction, renal impairment, deep vein thrombosis, peripheral artery occlusive disease, retinal hemorrhage, macular edema, diabetic retinopathy, vitreous hemorrhage, chorioretinopathy, neovascular age-related macular degeneration, retinal aneurysm, osteosarcoma, renal impairment, anti-neutrophil cytoplasmic antibody positive vasculitis, presence of urinary protein, conjunctival hemorrhage, dry eyes, cavities, gastroesophageal reflux disease, influenza, bronchitis, cystitis, gastroenteritis, periodontitis, pharyngitis, upper respiratory infection, skin abrasion, procedure-related hypotension, wounds, hyperphosphatemia, low back pain, muscle cramping, myalgia, limb pain, dizziness, cough, oropharyngeal pain, contact dermatitis, eczema, subcutaneous hemorrhage, pruritus, skin desquamation, internal bleeding, generalized edema, angina, abnormal uterine bleeding

This medication should be stored in a tightly closed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging x3]