Imatinib Mesylate Tablets 400mg ( IMARECH)

Product Description

Imatinib Mesylate Tablets 400mg (IMARECH) is a medication primarily used for the treatment of certain types of cancer and blood disorders. Imatinib, the active ingredient, is a tyrosine kinase inhibitor that targets and blocks specific enzymes involved in the growth of cancer cells.

Key Details about Imatinib Mesylate 400mg Tablets (IMARECH):

Active Ingredient:

• Imatinib Mesylate (400 mg per tablet) is the active ingredient in IMARECH tablets. It works by inhibiting abnormal tyrosine kinases, which are proteins involved in cell growth and division. Imatinib is effective in treating cancers that are driven by these abnormal kinases.

Mechanism of Action:

Imatinib works by specifically targeting and inhibiting BCR-ABL, a protein produced by certain leukemia cells, and KIT, a protein involved in gastrointestinal stromal tumors (GISTs). By blocking these proteins, imatinib prevents cancer cells from proliferating and spreading.

• BCR-ABL inhibition: This is the key action in Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
• KIT inhibition: This action is particularly useful in treating gastrointestinal stromal tumors (GISTs) and dermatofibrosarcoma protuberans (DFSP).
• Imatinib is also used to inhibit other tyrosine kinases involved in various forms of cancer.

Indications (Uses):

Imatinib Mesylate (IMARECH) is used to treat various cancers and blood disorders, including:

1. Chronic Myeloid Leukemia (CML): Particularly for patients with the Philadelphia chromosome-positive (Ph+) form.
2. Acute Lymphoblastic Leukemia (ALL): For Philadelphia chromosome-positive (Ph+) ALL.
3. Gastrointestinal Stromal Tumors (GISTs): Imatinib is used for tumors expressing the KIT protein.
4. Systemic Mastocytosis: A rare disorder involving abnormal growth of mast cells.
5. Chronic Eosinophilic Leukemia (CEL): A condition involving an overproduction of eosinophils (a type of white blood cell).
6. Dermatofibrosarcoma Protuberans (DFSP): A rare skin cancer, where imatinib is used for tumors that are KIT-positive.

Dosage:

• The usual dose for adults is 400 mg once daily, although the exact dosage and schedule may vary depending on the condition being treated and the patient's response.
• For certain cancers like GISTs, higher doses (up to 800 mg per day) may be prescribed.
• Administration: Imatinib should be taken orally, with a glass of water. It can be taken with or without food, though taking it with food may reduce stomach irritation.
• Tablets should be swallowed whole and should not be chewed or crushed.

Side Effects:

Common side effects of Imatinib 400mg tablets (IMARECH) include:

• Fatigue,
• Nausea and vomiting,
• Muscle cramps or muscle pain,
• Rash or itching,
• Fluid retention or swelling (edema), particularly around the eyes, ankles, and abdomen,
• Headache,
• Loss of appetite,
• Diarrhea or constipation.

Serious Side Effects:

Although rare, more severe side effects may include:

• Liver problems: Symptoms such as jaundice (yellowing of the skin/eyes), dark urine, or unexplained weight loss.
• Heart issues: Imatinib can lead to heart failure, particularly in patients with pre-existing heart conditions.
• Low blood counts: Neutropenia (low white blood cell count), anemia (low red blood cell count), or thrombocytopenia (low platelet count) can occur, leading to a higher risk of infection or bleeding.
• Severe fluid retention: Can cause difficulty breathing, swelling in the abdomen or extremities, or sudden weight gain.
• Gastrointestinal perforations: In rare cases, especially in patients with GISTs, imatinib can cause perforations in the gastrointestinal tract.

Precautions:

• Liver Function: Imatinib can affect liver function, so liver tests should be conducted regularly. If there are signs of liver problems, your doctor may adjust your dosage or stop the medication.
• Heart Conditions: Patients with heart conditions or a history of heart failure should use imatinib with caution, as it can exacerbate these conditions.
• Pregnancy and Breastfeeding: Imatinib is classified as Category D by the FDA for pregnancy, meaning it can harm the fetus. It should not be used during pregnancy unless absolutely necessary. Imatinib can also pass into breast milk, so breastfeeding should be avoided while taking this medication.
• Interaction with Other Medications: Imatinib can interact with several other drugs, including:
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase imatinib levels.
  • CYP3A4 inducers (e.g., rifampin) may reduce imatinib levels.
  • Warfarin: Imatinib can affect the metabolism of warfarin, a blood thinner, which may require dose adjustments.
  • Certain chemotherapies: If being used in combination with chemotherapy, your doctor will monitor you closely for interactions.

Storage:

• Room temperature: Store the tablets at 20C to 25C (68F to 77F), away from moisture and heat.
• Keep out of reach of children to avoid accidental ingestion.

Conclusion:

Imatinib Mesylate 400mg (IMARECH) is a tyrosine kinase inhibitor used to treat several types of cancers, particularly those with genetic mutations like Philadelphia chromosome-positive CML and GISTs. By inhibiting the growth of cancer cells and blocking blood vessel formation, it can help control disease progression and improve patient outcomes. As with any cancer treatment, careful monitoring for side effects such as liver damage, fluid retention, and blood count changes is essential.