Enalo Tablets 2mg (Enarodustat)

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 2 3 4 5 Dose of this medicine 1 mg 2 mg 4 mg 6 mg 8 mg Table 2. Dose adjustment algorithm Hb value (g/dL) Adjustment method Change in Hb value over 4 weeks is +2.0g/dL or less Change in Hb value over 4 weeks is greater than +2.0g/dL 13.0 or higher Temporarily discontinue treatmenta), b) Temporarily discontinue treatmenta) However, discontinue treatment if the minimum dose is being administered 12.0 or higher and below 13.0 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 Decrease the dose by 1 step However, discontinue treatment if the minimum dose is being administered 10.0 or higher and below 12.0 (target range) Maintain the dose However, the dose may be increased or decreased by 1 step, taking the Hb trend into account Below 10.0 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 that can maintain hemoglobin levels within the recommended target range. During administration, regular monitoring of hemoglobin levels is necessary to prevent excessive erythropoiesis. There is a risk of serious thromboembolism such as stroke, myocardial infarction, and thrombosis, hence a careful evaluation of the patient’s history or risk factors for these conditions is necessary before administration. If symptoms suggestive of thromboembolism appear, inform medical personnel immediately. Individuals allergic to the active ingredient or excipients of this medication, uncontrolled hypertensive patients, pregnant women, and nursing mothers should not take this medication. Patients with a history of thromboembolism or conditions such as hypertension, malignant tumors, diabetic retinopathy, severe infections, liver dysfunction, polycystic kidney disease, or congestive heart failure should use this medication with caution. Common side effects associated with this medication include nasopharyngitis, diarrhea, bruising, constipation, hypertension, vomiting, etc., and in rare cases, serious side effects such as pneumonia, chronic kidney disease, peritonitis, and congestive heart failure may occur. Excessively elevated hemoglobin levels can increase the risk of mortality and cardiovascular diseases, requiring careful monitoring. It is advisable to take this medication along with iron; consider iron supplementation if iron levels are low. Monitor blood pressure frequently as it may increase. During hemodialysis, care should be taken as there may be occlusion or stenosis in the dialysis machine or shunt. The effect of this medication may decrease when taken with certain phosphate binders or medications containing calcium, iron, or magnesium, hence it should be spaced apart in terms of timing. Women who are pregnant or may become pregnant should not take this medication, and effective contraception should be ensured after use. It is also safest for breastfeeding women to avoid this medication. Safety and efficacy in pediatric patients have not been established; do not use in children. In cases of overdose, hemoglobin levels may rise excessively, necessitating dose reduction or discontinuation of the medication. Keep this medication out of reach of children and avoid transferring it to other containers as it may compromise the quality.

nasopharyngitis, diarrhea, contusion, constipation, hypertension, vomiting, pneumonia, occlusion, chronic kidney disease, peritonitis, colon polyps, congestive heart failure, coronary artery stenosis, cholangitis, stenosis, peripheral artery occlusive disease, fibrin D dimer increase, increased blood pressure, retinal hemorrhage, edema, anti-neutrophil cytoplasmic antibody positive vasculitis, fluid retention, hyperkalemia, bone cancer, brain stem infarction, renal dysfunction, deep vein thrombosis, arthralgia, lumbago, muscle cramps, dizziness, upper respiratory inflammation, eczema, pruritus, stenosis, conjunctival hemorrhage, dry eyes, dental caries, gastroesophageal reflux disease, influenza, bronchitis, cystitis, gastroenteritis, periodontitis, pharyngitis, wounds, procedure-related hypotension, hyperphosphatemia, myalgia, limb pain, oropharyngeal pain, contact dermatitis, subcutaneous hemorrhage, skin exfoliation, internal bleeding, generalized edema, angina, abnormal uterine bleeding

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to preserve its efficacy and safety for a prolonged period.

Appearance

White round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP x 3)]