Fruza Clara Capsule 1 mg (Prucalopride)

Adult dose

1. Recommended Dosage and Administration This drug is administered in 28-day cycles: take 5mg orally once daily for 21 consecutive days, followed by a 7-day rest period. Continue taking this drug until disease progression or unacceptable toxicity occurs. Take this drug with water at the same time each day, with or without food. Swallow this drug whole; do not chew or dissolve it, or open the capsule. If you miss a dose and less than 12 hours have passed, take the missed dose as soon as possible, then take the prescribed dose at the next scheduled time. If 12 hours or more have passed, skip the missed dose and take the prescribed dose at the next scheduled time. If you vomit after taking a dose, do not take an additional dose; take the prescribed dose the next day. 2. Dose Adjustments Based on individual safety and tolerability, this drug may be withheld, the dose may be reduced, or treatment may be permanently discontinued. If an adverse reaction occurs, withhold this drug until the adverse reaction resolves to Grade 1 or baseline, and adjust the dose in steps as shown in Table 1. If the adverse reaction persists at a dose of 3mg once daily, permanently discontinue this drug. Table 1. Recommended Dose Reduction Steps Dose reduction step Dosage and administration First dose reduction 4mg once daily (equivalent to four 1mg capsules) Second dose reduction 3mg once daily (equivalent to three 1mg capsules) Recommended dose modifications for adverse reactions are shown in Table 2. Table 2. Dose Modifications of This Drug for Adverse Reactions Adverse reaction Severity1 Dose modification Hypertension Grade 3 • If Grade 3 hypertension persists despite initiating or adjusting antihypertensive treatment, withhold treatment. • Once hypertension resolves to Grade 1 or baseline, resume treatment at the reduced dose according to Table 1. If Grade 3 hypertension continues at a dose of 3mg once daily, permanently discontinue this drug. Grade 4 Permanently discontinue this drug. Hemorrhage Grade 2 • Withhold treatment until the hemorrhage has completely resolved or improves to Grade 1. • Resume treatment at the reduced dose according to Table 1. If Grade 2 hemorrhage continues at a dose of 3mg once daily, permanently discontinue this drug. Grade 3 or higher Permanently discontinue this drug. Proteinuria ≥2g/24 hours • Withhold treatment until proteinuria has completely resolved or is less than 1g/24 hours (Grade 1). • Resume treatment at the reduced dose according to Table 1. If proteinuria continues to exceed 2g/24 hours at a dose of 3mg once daily, permanently discontinue this drug. Permanently discontinue this drug if nephrotic syndrome occurs. Abnormal liver function tests Grade 2 or Grade 3 abnormal liver function tests • Withhold treatment until the abnormality resolves to Grade 1 or baseline. • Resume treatment at the reduced dose according to Table 1. If Grade 2 or Grade 3 abnormal liver function tests continue at a dose of 3mg once daily, permanently discontinue this drug. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels increased to Grade 2 or higher (> 3 x ULN), with a concurrent increase in total bilirubin to > 2 x ULN in the absence of cholestasis; Grade 4 abnormal liver function tests Permanently discontinue this drug. Palmar-plantar erythrodysesthesia syndrome (PPES) Grade 2 • Provide supportive care. • Withhold treatment until PPES resolves to Grade 1 or baseline. • Resume treatment at the same dose. Grade 3 • Provide supportive care. • Withhold treatment until PPES resolves to Grade 1 or baseline. • Resume treatment at the reduced dose according to Table 1. If Grade 3 PPES continues at a dose of 3mg once daily, permanently discontinue this drug. Other adverse reactions Grade 3 • Withhold treatment until the reaction resolves to Grade 1 or baseline. • Resume treatment at the reduced dose according to Table 1. If Grade 3 other adverse reactions continue at a dose of 3mg once daily, permanently discontinue this drug. Grade 4 Discontinue this drug. If the toxicity resolves to Grade 1 or baseline and the potential benefits of treatment outweigh the risks, consider resuming treatment at the reduced dose according to Table 1. 1According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5)

This medication should not be used in patients who are allergic to the active ingredient or excipients. Patients with hypertension or at high risk of bleeding, severe hepatic impairment, end-stage renal impairment, high risk of infection, history or risk of thrombosis, risk of gastrointestinal perforation, pregnant or fertile women should use this drug with caution. This medication contains certain pigment components; patients allergic or hypersensitive to these components should also exercise caution. Various adverse reactions such as hypertension, bleeding, gastrointestinal perforation, proteinuria, skin adverse syndromes could occur while taking this medication, therefore immediate consultation with a healthcare provider is advised if such symptoms arise. In particular, hypertension may appear quickly after administering this medication, so it is essential to monitor blood pressure frequently and adjust medications if needed. Due to the risk of bleeding, prompt testing is required if there are bleeding symptoms or blood-related anomalies, and if severe bleeding occurs, discontinue this medication. Should gastrointestinal perforation symptoms appear, treatment must be stopped immediately, and emergency measures are necessary. Proteinuria should be regularly checked before and during treatment; if abnormalities are found, dosage adjustment or discontinuation of treatment may be required. If symptoms of hand-foot erythema or sensory adverse syndromes appear, treatment adjustment is necessary. Rarely, reversible posterior leukoencephalopathy syndrome may occur; thus, immediate reporting to healthcare providers is necessary if headache, seizures, confusion, or other neurological symptoms present. This medication should be discontinued for a certain period before and after surgery to allow for wound healing. Patients with a recent history of thrombosis should avoid using this drug, and if thrombosis is suspected, treatment must be stopped immediately. This drug can interact with certain medications, so if other medications are being taken, inform the healthcare provider. Women of childbearing potential must use effective contraception during and at least 2 weeks after taking this medication, and avoid use during pregnancy due to potential fetal risks. Breastfeeding women are recommended to stop breastfeeding during the administration period and for at least 2 weeks after the last dose. Safety and efficacy in pediatric patients under 18 years have not been established, hence usage is not recommended. Elderly patients over 65 years or patients with mild to moderate hepatic impairment or renal impairment do not require dosage adjustments; however, patients with severe hepatic impairment or end-stage renal impairment should not use this medication. This medication does not require specific storage temperature conditions but should be kept away from moisture and out of reach of children. Fatigue may occur after administration, requiring caution while driving or operating machinery.

Hypertension, loss of appetite, proteinuria, palmoplantar erythrodysaesthesia syndrome, hypothyroidism, speech disorder, diarrhea, weakness, pneumonia, upper respiratory tract infection, bacterial infection, thrombocytopenia, leukopenia, neutropenia, hypokalemia, reversible pontine myelinolysis syndrome, epistaxis, sore throat, stomatitis, gastrointestinal bleeding, gastrointestinal perforation, increased pancreatic enzymes, oral pain, pancreatitis, increased aspartate aminotransferase, elevated total bilirubin, increased alanine aminotransferase, cholecystitis, rash, musculoskeletal discomfort, arthralgia, weakness, fatigue, mucosal inflammation, wound healing impairment, aortic dissection, hypertensive crisis, fatal hemorrhage, fatal gastrointestinal perforation, fatal infection, abnormal liver function tests, fatal abnormal liver function tests

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is best stored at room temperature, between 1 degree and 30 degrees Celsius, rather than in excessively hot or cold conditions.

Appearance

A hard capsule with a yellow upper part and a white lower part containing white to off-white powder

Package unit

21 capsules/bottle