Tasigna Capsule 50 mg (Nilotinib Hydrochloride Monohydrate)

Adult dose

1. Treatment of adult patients with newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) : 300mg twice daily 2. Treatment of adult patients with chronic- or accelerated-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) who are resistant or intolerant to prior therapy including imatinib : 400mg twice daily This medicine should be taken approximately 12 hours apart and should not be taken with food. Do not eat for at least 2 hours before taking this medicine and for at least 1 hour after taking it. Swallow the capsules whole with water. For patients who have difficulty swallowing capsules, open the capsule and sprinkle the contents onto 1 teaspoon of applesauce (mashed apple), then take immediately. Do not use more than 1 teaspoon of applesauce or any food other than applesauce (mashed apple). QTc interval >480 msec 1. Interrupt treatment with this medicine and measure blood potassium and magnesium levels. If they are below the lower limit of normal, treat them to bring them within the normal range. Monitor concomitant medications. 2. If the measured QTcF returns to less than 450 msec and within 20 msec of baseline, resume treatment at the previous dose within 2 weeks. 3. If QTcF remains between 450 msec and 480 msec after 2 weeks, consider reducing the dose to 400mg once daily in adult patients and 230 mg/m2 once daily in pediatric patients. 4. Discontinue this medicine if the measured QTcF exceeds 480 msec even after dose reduction. 5. If the dose is adjusted, repeat ECG 7 days after the adjustment. If hematologic toxicity (neutropenia, thrombocytopenia) unrelated to the underlying disease (leukemia) occurs, temporary treatment interruption and/or dose reduction as described in <Table 3> may be required. Adult patients: ANC <1 × 109/L and/or platelet count <50 × 109/L 1. Interrupt treatment with this medicine and monitor blood cell counts. 2. If ANC >1 × 109/L and/or platelet count >50 × 109/L is restored within 2 weeks, resume treatment at the previous dose. 3. If blood cell counts remain low, consider reducing the dose to 400mg once daily. If clinically significant moderate or severe non-hematologic toxicity occurs, interrupt treatment with this medicine and monitor and treat patients appropriately. Newly diagnosed adult patients with CML-CP whose previous dose was 300mg twice daily and adult patients with resistant or intolerant CML-CP and CML-AP whose previous dose was 400mg twice daily may restart treatment at 400mg once daily after the toxicity resolves. Pediatric patients whose previous dose was 230mg/m2 twice daily may restart treatment at 230mg/m2 once daily after the toxicity resolves. Adult patients whose previous dose was 400mg once daily or pediatric patients whose previous dose was 230mg/m2 once daily should discontinue treatment. If considered clinically appropriate, attempt to re-escalate to the recommended dose (300mg twice daily for adult patients with newly diagnosed chronic-phase Ph+CML; 400mg twice daily for adult patients with resistant or intolerant chronic- or accelerated-phase Ph+CML; 230mg/m2 twice daily for pediatric patients). If serum lipase levels increase to Grade 3-4, consider reducing the dose to 400mg once daily or interrupting treatment in adult patients. Serum lipase levels should be measured monthly or when clinically indicated. If bilirubin levels increase to Grade 3-4 in adult patients, consider reducing the dose to 400mg once daily or interrupting treatment. Bilirubin and liver transaminase levels should be measured monthly or when clinically indicated. If a dose of this medicine is missed, do not take an additional dose; take the next dose as usual. For administration to patients with hepatic impairment, consider dose reduction as shown in <Table 4>. Newly diagnosed chronic-phase Ph+CML - 300mg twice daily Mild, moderate, severe Administer 200mg twice daily as the starting dose, and consider increasing the dose to 300mg twice daily depending on the patient's tolerability. Resistant or intolerant chronic- or accelerated-phase Ph+CML - 400mg twice daily Mild, moderate Administer 300mg twice daily as the starting dose, and consider increasing the dose to 400mg twice daily depending on the patient's tolerability. Severe Administer 200mg twice daily as the starting dose, and depending on the patient's tolerability, consider sequentially increasing the dose to 300mg twice daily and then to 400mg twice daily.

Child dose

Treatment of pediatric patients aged 2 years and older with newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML), and pediatric patients with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) who are resistant or intolerant to prior therapy including imatinib : The dose for pediatric patients is calculated individually based on body surface area (BSA, mg/m2). The recommended dose of this drug is 230 mg/m2 twice daily, rounded to the nearest multiple of 50 mg as shown in <Table 1> (maximum dose of 400 mg per administration). Capsules of different strengths may be combined to achieve the desired dose. Data for pediatric patients younger than 6 years are limited. ≤0.32 m2: 50 mg (twice daily) 0.33 – 0.54 m2: 100 mg (twice daily) 0.55 – 0.76 m2: 150 mg (twice daily) 0.77 – 0.97 m2: 200 mg (twice daily) 0.98 – 1.19 m2: 250 mg (twice daily) 1.20 – 1.41 m2: 300 mg (twice daily) 1.42 – 1.63 m2: 350 mg (twice daily) ≥1.64 m2: 400 mg (twice daily) This drug should be taken approximately 12 hours apart and should not be taken with food. Do not eat for at least 2 hours before taking this drug and for at least 1 hour after taking it. Swallow the capsules whole with water. For patients who have difficulty swallowing capsules, open the capsule, sprinkle the contents onto 1 teaspoon of applesauce (mashed apple), and take immediately. Do not use more than 1 teaspoon of applesauce or any food other than applesauce (mashed apple). QTc interval >480 msec 3. If QTcF remains between 450 msec and 480 msec after 2 weeks, consider reducing the dose to 400mg once daily for adult patients and 230 mg/m2 once daily for pediatric patients. Pediatric patients: ANC <1 × 109/L and/or platelet count <50 × 109/L 1. Interrupt treatment with this drug and monitor blood counts. 2. If recovery to ANC >1.5 × 109/L and/or platelet count >75 × 109/L occurs within 2 weeks, resume treatment at the previous dose. 3. If blood counts remain low, consider reducing the dose to 230mg/m2 once daily. 4. If neutrophil and platelet counts remain low after dose reduction, consider discontinuing this drug. Pediatric patients whose previous dose was 230mg/m2 twice daily may resume treatment at 230mg/m2 once daily after these toxicities resolve. Adult patients whose previous dose was 400mg once daily or pediatric patients whose previous dose was 230mg/m2 once daily should discontinue treatment. If considered clinically appropriate, attempt to re-escalate to the recommended dose (adults with newly diagnosed chronic-phase Ph+CML: 300mg twice daily; adults with resistant or intolerant chronic-phase or accelerated-phase Ph+CML: 400mg twice daily; pediatric patients: 230mg/m2 twice daily). In pediatric patients, interrupt treatment until serum lipase levels recover to Grade 1 or lower. Thereafter, pediatric patients whose previous dose was 230mg/m2 twice daily may resume treatment at 230mg/m2 once daily, and pediatric patients whose previous dose was 230mg/m2 once daily should discontinue treatment. In pediatric patients with a Grade 2 or higher increase in bilirubin levels or a Grade 3 or higher increase in hepatic transaminases, interrupt treatment until levels recover to Grade 1 or lower. Thereafter, pediatric patients whose previous dose was 230mg/m2 twice daily may resume treatment at 230mg/m2 once daily, and pediatric patients whose previous dose was 230mg/m2 once daily should discontinue this drug until recovery to Grade 1 or lower has persisted for at least 28 days.

This medication contains an active ingredient called nilotinib and is used to treat blood cancer known as chronic myeloid leukemia. This drug should not be administered to certain patients, including those with an allergy to the active ingredient or other components. Additionally, since it contains lactose, people with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Patients with hypokalemia, hypomagnesemia, or QT prolongation syndrome should consult a physician before taking this medication, as caution is required. This medication has the potential to prolong the QT interval, which reflects the electrical activity of the heart; therefore, it should be administered with caution to patients with heart disease or a prolonged QT interval. Especially in cases of low potassium and magnesium levels, the risk may increase, and electrolyte status should be monitored with regular blood tests. When taken with food or certain medications, the blood levels of this drug may change, so it should be avoided in combination with grapefruit juice, strong CYP3A4 inhibitors, and medications that can prolong the QT interval. Patients with impaired liver function might have reduced metabolism of this drug, requiring dose adjustments and regular liver function tests. Patients with a history of pancreatitis should exercise caution due to potentially elevated serum lipase levels associated with side effects. Patients who have undergone total gastrectomy may have reduced absorption of this medication, thus monitoring their condition more closely is necessary. During treatment, serious side effects such as tumor lysis syndrome can occur, hence dehydration or hyperuricemia must be corrected before administration. Blood lipid and blood glucose levels may increase, so regular blood tests before and during treatment should be conducted. If any cardiovascular symptoms or acute symptoms arise, healthcare personnel should be notified immediately, and signs of fluid retention should also be closely monitored. Patients who are hepatitis B virus carriers are at risk of hepatitis reactivation before and during the use of this drug, so they must consult a specialist and require monitoring. During pregnancy, this medication may harm the fetus, so women who are pregnant or planning to become pregnant should not take this drug, and if they become pregnant while on it, they must consult their doctor immediately. Lactating women should avoid breastfeeding during the period of treatment and for 2 weeks after the last dose of this medication. This drug may also be used in pediatric patients, but growth delays and other side effects have been reported, so growth status must be closely monitored. In the case of overdose, symptoms such as vomiting, drowsiness, and a decrease in blood cells may occur, necessitating immediate medical attention. When administering, care must be taken to avoid contact with the skin or eyes if the capsule is damaged; in case of contact with hands, wash immediately. Storage should be in a tightly sealed container to prevent exposure to air or humidity. It is important to keep the storage temperature between 1°C and 30°C room temperature. Storing this way helps to maintain the drug's efficacy and safety.

• Rash
• itching
• headache
• nausea
• fatigue
• hair loss
• myalgia
• upper abdominal pain
• constipation
• diarrhea

This medication should be stored in a tightly sealed container to prevent exposure to air or humidity. It is important to maintain a storage temperature between 1°C and 30°C room temperature. Proper storage will ensure the drug's effectiveness and safety.

Appearance

Opaque hard capsule with a red upper part and a light yellow lower part, containing a white or light yellow powder.

Package unit

40 capsules/box [(8 capsules/PTP packaging) x 5]