Jospata Tablets 40 mg (Gilteritinib Fumarate)

Adult dose

[Administration] This medicine is administered orally once daily, regardless of food. Do not cut or crush the tablets. Take this medicine at the same time each day. If you miss a dose or do not take it at the scheduled time, take it as soon as possible on the same day and at least 12 hours before the next dose, then resume the usual schedule the following day. Do not take 2 doses within 12 hours. If you vomit after taking this medicine, do not take an additional dose; resume the normal dosing schedule the next day. [Dosage] The recommended starting dose of this medicine is 120mg of gilteritinib once daily. Treatment with this medicine should continue until clinical benefit is no longer observed or toxicity becomes unacceptable. Because the response to treatment with this medicine may be delayed, continuing treatment at the prescribed dose for at least 6 months until a response is achieved should be considered. Before starting this medicine, on days 8 and 15 of the first cycle, every 2 weeks during the second cycle, and monthly thereafter during treatment, assess blood chemistry values, including creatine phosphokinase. In addition, perform electrocardiograms before starting this medicine, on days 8 and 15 of the first treatment cycle, and before starting each of the next two consecutive treatment cycles. The daily dose may be reduced from 120mg to 80mg. Adjust the dose or interrupt treatment with this medicine for toxicity as shown in Table 1 below. [Table 1] Dose adjustment for toxicity associated with this medicine Criterion Administration of this medicine Symptoms of differentiation syndrome If differentiation syndrome is suspected, administer corticosteroids and monitor hemodynamic status (see “1. Warnings” under Precautions for Use). If symptoms persist or show signs of worsening 48 hours after corticosteroid administration, discontinue this medicine. If symptoms or signs improve to Grade 2a or lower, resume this medicine at the same dose. Symptoms of posterior reversible encephalopathy syndrome (PRES) Discontinue this medicine. QTc interval greater than 500 msec Interrupt treatment with this medicine. If the QTc interval improves to within 30 msec of baseline or to 480 msec or less, resume treatment at a reduced dose of 80mg. QTc interval increases by more than 30 msec on the ECG on day 8 of the first cycle Check the ECG on day 9. If confirmed, consider reducing the dose to 80mg. Symptoms of pancreatitis Interrupt treatment with this medicine until pancreatitis resolves. Resume treatment at a reduced dose of 80mg. Other Grade 3a or higher toxicity associated with this medicine Interrupt treatment until the toxicity resolves or improves to Grade 1a. Resume treatment at a reduced dose of 80mg. a. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening. Patients with hepatic impairment No dose adjustment of this medicine is required in patients with mild or moderate hepatic impairment. This medicine has not been evaluated in patients with severe hepatic impairment.

This drug is used for the treatment of acute myeloid leukemia and requires several precautions during administration. First, serious side effects such as differentiation syndrome may occur in some patients taking this medication. Differentiation syndrome arises from the rapid proliferation and differentiation of myeloid cells, and if untreated, it can be life-threatening. Symptoms of this syndrome may include fever, shortness of breath, edema, skin rash, and renal dysfunction, so if any symptoms are suspected, immediate consultation with medical personnel is required. Additionally, this drug can cause a brain-related side effect known as Posterior Reversible Encephalopathy Syndrome (PRES), with symptoms including seizures and changes in mental status. If such symptoms occur, discontinue drug administration and appropriate diagnosis and treatment are necessary. Cardiac-related side effects such as QT interval prolongation have been reported, thus requiring an electrocardiogram (ECG) test, and the risk of side effects increases in cases of hypokalemia or hypomagnesemia, so these should be corrected. This drug should not be administered to patients who have hypersensitivity to any of its components, and those presenting symptoms of pancreatitis must use the medication cautiously. During treatment, monitoring of liver and kidney function is necessary. Although patients with liver dysfunction or renal dysfunction can use the drug without dose adjustments, caution is required based on their condition. Women who are pregnant or may become pregnant should not use this medication and effective contraception must be practiced during and for a period after treatment. It is also recommended that breastfeeding women discontinue breastfeeding when taking this drug. This drug may affect driving or machine operation ability, so caution is needed if experiencing dizziness during treatment. Furthermore, this drug may interact with other medications; especially when taking drugs related to CYP3A, P-gp, or BCRP, inform medical personnel and manage carefully. Lastly, keep this medication out of reach of children and do not transfer it to other containers. Considering all of these matters, ensure safe administration under the guidance of healthcare professionals.

• Differentiated syndrome
• fever
• respiratory distress
• pleural effusion
• pericardial effusion
• pulmonary edema
• hypotension
• rapid weight gain
• peripheral edema
• rash

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablets

Package unit

42 tablets/box [21 tablets/PTP (X 2)]