Medication info
Leukovac Tablet 100 mg (Imatinib Mesylate)

Leukovac Tablet 100 mg (Imatinib Mesylate)

Prescription medicationTabletOral
Ingredient · strength
Imatinib Mesylate›119.5mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
This drug is a round film-coated tablet that is dark yellow to brown in color.
Packaging
60 tablets (10 tablets/PTP*6)
Approval status
Active

MFDS item code 201306400 · Approved 2013.03.22

Summary

Main use
Treatment of chronic myeloid leukemia, other sensitive hematologic diseases and sarcomas, and gastrointestinal stromal tumors
Who takes it
Adults · Children
Adult dose
For adult patients with chronic myeloid leukemia (CML), the recommended dose is 400mg once daily in the chronic phase with Philadelphia chromosome-positive disease. For the accelerated or blast phase, the recommended dose is 600mg once daily. For adult patients with gastrointestinal stromal tumors (GIST), the recommended dose is 400mg daily. For myelodysplastic/myeloproliferative diseases, the recommended dose is 400mg daily. For hypereosinophilic syndrome/chronic eosinophilic leukemia, the recommended dose is 100mg daily, which may be increased to 400mg daily. For recurrent or metastatic dermatofibrosarcoma protuberans, the recommended dose is 800mg daily (take 400mg twice daily). Take with a meal and plenty of water. The 400mg or 600mg dose is taken once daily; the 800mg dose is taken as 400mg twice daily.
Child dose
For pediatric patients with chronic myeloid leukemia, the recommended dose is 340mg/m2 daily based on body surface area. The total daily dose should not exceed 600mg. It may be administered once daily or in 2 divided doses, in the morning and evening. Pediatric patients may take the medicine once daily or, optionally, divide the daily dose into 2 doses taken in the morning and evening.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic myeloid leukemia, other sensitive hematologic diseases and sarcomas, and gastrointestinal stromal tumors

  • Chronic myeloid leukemia
  • gastrointestinal stromal tumors
  • myelodysplastic syndromes
  • myeloproliferative disorders
  • hypereosinophilia
  • chronic eosinophilic leukemia
  • dermatofibrosarcoma
View approved original text

This drug is used for the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors, and specific rare blood disorders and dermatofibrosarcoma associated with certain gene rearrangements. It is effective in improving overall hematological response and survival rates in adult patients with chronic myeloid leukemia and some pediatric patients. Additionally, it contributes to improved recurrence-free survival rates in cases of unresectable or metastatic gastrointestinal stromal tumors that are Kit-positive, as well as in adjuvant therapy after surgery. It is also utilized for the treatment of myelodysplastic syndromes, hypereosinophilia, chronic eosinophilic leukemia confirmed with PDGFR gene rearrangement, and unresectable or recurrent dermatofibrosarcoma. These conditions are particularly suitable for treatment when previous therapies have failed or alternatives are limited. Overall, this drug plays a crucial role in the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors, as well as certain rare blood and tumor conditions, aiming to improve the patient's condition.

How to take

Adult dose

For adult patients with chronic myeloid leukemia (CML), the recommended dose is 400mg once daily in the chronic phase with Philadelphia chromosome-positive disease. For the accelerated or blast phase, the recommended dose is 600mg once daily. For adult patients with gastrointestinal stromal tumors (GIST), the recommended dose is 400mg daily. For myelodysplastic/myeloproliferative diseases, the recommended dose is 400mg daily. For hypereosinophilic syndrome/chronic eosinophilic leukemia, the recommended dose is 100mg daily, which may be increased to 400mg daily. For recurrent or metastatic dermatofibrosarcoma protuberans, the recommended dose is 800mg daily (take 400mg twice daily). Take with a meal and plenty of water. The 400mg or 600mg dose is taken once daily; the 800mg dose is taken as 400mg twice daily.

Child dose

For pediatric patients with chronic myeloid leukemia, the recommended dose is 340mg/m2 daily based on body surface area. The total daily dose should not exceed 600mg. It may be administered once daily or in 2 divided doses, in the morning and evening. Pediatric patients may take the medicine once daily or, optionally, divide the daily dose into 2 doses taken in the morning and evening.

Precautions

This drug should not be used by individuals who have hypersensitivity to this drug or any other component. Women who are pregnant or may become pregnant should not take this drug. Additionally, it is recommended that nursing mothers do not take this drug as a safety precaution. This drug should be used cautiously in patients with impaired liver or kidney function, in which case careful monitoring by a physician is required. Patients with a history of heart disease, heart failure, or kidney failure need to exercise special caution when taking this drug, and should seek immediate diagnosis and treatment if symptoms appear. For patients with hypereosinophilia who may have heart problems, it is advisable to undergo cardiac function tests before starting this treatment and to consider steroid therapy if necessary. Patients who take thyroid hormones after thyroid surgery should have their thyroid function checked regularly. In pediatric patients, growth delays have been reported when taking this drug, so growth status should be monitored regularly. Tumor lysis syndrome may occur in patients taking this drug; therefore, dehydration should be corrected before treatment, and appropriate therapy should be provided if uric acid levels are elevated. Patients who are carriers of the hepatitis B virus must undergo viral testing before taking this drug, and should closely monitor for hepatitis reactivation during and after treatment. During the course of taking this drug, abnormalities in liver function, decreased blood cells, gastrointestinal symptoms, skin rashes, edema, fatigue, and other side effects can frequently occur; therefore, any unusual symptoms should be discussed with a physician. Depending on the severity of drug side effects, dosage adjustments or treatment discontinuation may be necessary, and regular health status checks are important during treatment.

Side effects

  • Neutropenia
  • thrombocytopenia
  • anemia
  • headache
  • indigestion
  • edema
  • weight gain
  • nausea
  • vomiting
  • muscle cramps
Show 17 more
  • musculoskeletal pain
  • diarrhea
  • rash
  • fatigue
  • abdominal pain
  • hepatotoxicity
  • acute renal failure
  • hypophosphatemia
  • severe respiratory adverse reactions
  • tumor lysis syndrome
  • growth delay in children
  • hypothyroidism
  • growth delay
  • tumor lysis syndrome
  • reactivation of hepatitis B
  • cardiogenic shock
  • left ventricular dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This drug is sensitive to air and moisture and should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the drug's efficacy.

Appearance and packaging

Appearance

This drug is a round film-coated tablet that is dark yellow to brown in color.

Package unit

60 tablets (10 tablets/PTP*6)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.