GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Imatinib Mesylate Tablets 100mg
b) Imatinib Mesylate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Imatinib Mesylate Tablets 100mg
Imatinib Mesylate Equivalent to
Imatinib………………………..100mg
Excipients……………………..q.s.
Colours: Iron Oxide of Yellow

b) Imatinib Mesylate Tablets 400mg
Imatinib Mesylate Equivalent to
Imatinib…………………………400mg
Excipients………………………q.s.
Colours: Iron Oxide of Red


THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Warning: Cytotoxic Agent: To be sold by retail on the prescription of a Registered Medical Practitioner (Oncologist)
CAUTION: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.
Swallow complete tablet, do not crush or chew.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from moisture.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Imatinib Mesylate Tablets 400mg (Tyronib) Technical Specification:

Product Name:Imatinib Mesylate Tablets 400mg
Brand Name:Tyronib
Strength:100mg, 400mg
Dosage Form:Tablets
Packing:6s, 10s, 30s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).
Storage:Store at 20°C to 25°C (68° F to 77° F) [see USP Controlled Room Temperature]. Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Imatinib Mesylate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Imatinib Mesylate Tablets 400mg
    Imatinib Mesylate Equivalent to
    Imatinib………………………..400mg
    Excipients……………………..q.s.
    Colours: Iron Oxide of Yellow

THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Warning: Cytotoxic Agent: To be sold by retail on the prescription of a Registered Medical Practitioner (Oncologist)

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.

Swallow complete tablet, do not crush or chew.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Protect from moisture.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

When it comes to Imatinib Mesylate Tablets, Taj Pharma stands as a beacon of excellence in the pharmaceutical industry. With a rich legacy of trust and a commitment to advancing healthcare, we have become a leading provider of Imatinib Mesylate, a crucial medication for treating conditions like chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). Our dedication to quality is unwavering. Taj Pharma’s state-of-the-art manufacturing facilities adhere to strict global quality standards, ensuring that every Imatinib Mesylate Tablet we produce is of the highest quality and efficacy. We understand the significance of this medication in the lives of patients, and we spare no effort to maintain the integrity of our products. Accessibility and affordability are at the heart of our mission. We believe that life-saving treatments should be within reach for all patients, regardless of their financial circumstances. Taj Pharma’s commitment to making Imatinib Mesylate Tablets accessible empowers patients to embark on their healthcare journey with confidence.

Innovation is the cornerstone of our success. We continually invest in research and development to enhance the effectiveness and safety of our medications, contributing to better patient outcomes and improved quality of life. Choose Taj Pharma for Imatinib Mesylate Tablets and experience the difference that empowers patients and healthcare providers alike. Join us in the pursuit of better health and a brighter future. Taj Pharma’s dedication to quality, affordability, accessibility, and innovation, making it a trusted partner in healthcare for those in need of Imatinib Mesylate Tablets.

What is Imatinib Mesylate Tablets and its Use?

Imatinib Mesylate Tablets are a medication used in the treatment of certain types of cancer, particularly chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). Here’s a detailed explanation of Imatinib Mesylate Tablets and their uses:

What are Imatinib Mesylate Tablets?

Imatinib Mesylate Tablets contain the active ingredient imatinib mesylate, which is a tyrosine kinase inhibitor. It works by blocking specific proteins in cancer cells that promote their uncontrolled growth.

Uses of Imatinib Mesylate Tablets:

  • Chronic Myeloid Leukemia (CML): Imatinib is a cornerstone in the treatment of CML, a type of leukemia characterized by the overproduction of abnormal white blood cells in the bone marrow. It targets the BCR-ABL fusion protein, which is specific to CML cells, thereby inhibiting their growth.
  • Gastrointestinal Stromal Tumors (GISTs): Imatinib is also used to treat GISTs, which are tumors that arise in the digestive tract, particularly in the stomach or small intestine. It targets specific proteins, such as KIT and PDGFRA, which are often mutated in GISTs.
  • Other Cancers: Imatinib may also be used to treat other cancers where the same molecular targets (such as KIT) are involved, including some forms of acute lymphoblastic leukemia (ALL) and dermatofibrosarcoma protuberans.
  • Administration: Imatinib Mesylate Tablets are taken orally, usually with a meal and a full glass of water. The dosage and duration of treatment depend on the specific type of cancer being treated and the individual patient’s response to the medication.
  • Monitoring and Side Effects: Patients taking Imatinib should be closely monitored by their healthcare provider for any potential side effects or changes in blood counts. Common side effects may include nausea, vomiting, diarrhea, fatigue, muscle cramps, and fluid retention. In some cases, more serious side effects can occur, such as changes in liver function or low blood cell counts.
  • Importance of Adherence: It’s crucial for patients to take Imatinib Mesylate Tablets exactly as prescribed by their healthcare provider. Adherence to the prescribed regimen is vital for the medication to effectively control cancer cell growth.

How does Imatinib Mesylate Tablets Work?

Imatinib Mesylate Tablets work by targeting and inhibiting specific proteins in cancer cells that play a crucial role in promoting their uncontrolled growth. Here’s how Imatinib Mesylate Tablets work in detail:

  • Targeting Tyrosine Kinases: Imatinib is classified as a tyrosine kinase inhibitor (TKI). Tyrosine kinases are enzymes responsible for transmitting signals within cells that regulate cell growth and division. In cancer, these kinases can become overactive, leading to uncontrolled cell growth.
  • BCR-ABL Inhibition (in Chronic Myeloid Leukemia – CML): Imatinib is highly effective in treating chronic myeloid leukemia (CML), a type of blood cancer. CML is characterized by the presence of the BCR-ABL fusion gene, which produces a mutated protein (BCR-ABL tyrosine kinase) responsible for the uncontrolled growth of white blood cells.
  • Blocking BCR-ABL Activity: Imatinib specifically targets the BCR-ABL tyrosine kinase. It does so by binding to the active site of the kinase, preventing it from carrying out its function. This inhibition stops the abnormal signaling pathways initiated by BCR-ABL, ultimately halting the excessive proliferation of cancerous white blood cells in CML.
  • KIT/PDGFRA Inhibition (in Gastrointestinal Stromal Tumors – GISTs): Imatinib is also effective in treating gastrointestinal stromal tumors (GISTs). Many GISTs have mutations in the KIT or PDGFRA genes, leading to the activation of tyrosine kinases, particularly KIT and PDGFRA.
  • Disrupting Aberrant Signaling: Imatinib inhibits the activity of KIT and PDGFRA tyrosine kinases in GIST cells. By binding to the active sites of these kinases, Imatinib disrupts the signaling pathways that promote the growth and survival of GIST cells. This results in tumor shrinkage and a reduction in cancer-related symptoms.
  • Specificity: Imatinib’s action is highly specific to cancer cells that express the target proteins (e.g., BCR-ABL in CML or mutated KIT/PDGFRA in GISTs). It does not affect normal cells to the same extent, minimizing many of the side effects associated with traditional chemotherapy.
  • Chronic Treatment: Imatinib is typically administered as a long-term treatment, as discontinuation can lead to the resurgence of cancer cell growth. Patients are monitored regularly by their healthcare providers to assess treatment response and manage any side effects.

Benefits and Side effects of Imatinib Mesylate Tablets?

Imatinib Mesylate Tablets offer several benefits in the treatment of certain cancers, particularly chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). However, like all medications, they can also be associated with potential side effects. Here are the benefits and common side effects of Imatinib Mesylate Tablets:

Benefits:

  • Effective Cancer Treatment: Imatinib is highly effective in the treatment of CML and GISTs, leading to significant reductions in cancer cell growth and improved patient outcomes.
  • Targeted Therapy: Imatinib is a targeted therapy that specifically inhibits the activity of certain tyrosine kinases that are overactive or mutated in cancer cells. This precision targeting minimizes damage to healthy cells, reducing many of the side effects associated with traditional chemotherapy.
  • Increased Survival Rates: Imatinib has significantly increased survival rates in individuals with CML and GISTs, transforming these once life-threatening conditions into chronic diseases that can be managed effectively.
  • Symptom Relief: Imatinib often provides rapid relief from cancer-related symptoms, such as fatigue, abdominal pain, and organ compression caused by GISTs.
  • Oral Administration: Imatinib Mesylate Tablets are administered orally, making them convenient for long-term use, especially in the case of chronic conditions like CML.

Common Side Effects:

  • Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, and abdominal pain are common gastrointestinal side effects of Imatinib. These symptoms are usually manageable and can be addressed with supportive care.
  • Fluid Retention: Some individuals may experience fluid retention, leading to swelling (edema), particularly in the ankles and legs.
  • Muscle Cramps: Muscle cramps are a reported side effect of Imatinib, which can be uncomfortable but are generally not severe.
  • Fatigue: Fatigue is a common side effect that can affect daily activities. It’s important for patients to get adequate rest and manage their energy levels.
  • Skin Rash: A skin rash, often mild to moderate in severity, can occur in some patients taking Imatinib. It is typically managed with topical treatments and antihistamines.
  • Hematological Effects: Imatinib can affect blood cell counts, leading to anemia, thrombocytopenia (low platelet count), or neutropenia (low white blood cell count). Regular blood tests are conducted to monitor these effects.
  • Liver Enzyme Changes: Imatinib may lead to changes in liver enzyme levels, which are monitored by healthcare providers.
  • Possible Cardiovascular Effects: In rare cases, Imatinib may affect the heart, leading to conditions like heart failure or QT interval prolongation. Regular cardiac monitoring may be necessary in certain patients.
  • Interactions: Imatinib can interact with other medications, so it’s important for patients to inform their healthcare providers of all drugs they are taking.

Frequently Asked Questions about Imatinib Mesylate Tablets?

  1. What is Imatinib Mesylate, and what is it used for?

Imatinib Mesylate is a medication used in the treatment of certain types of cancer, including chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). It belongs to a class of drugs known as tyrosine kinase inhibitors.

  1. How does Imatinib Mesylate work to treat cancer?

Imatinib Mesylate works by inhibiting specific proteins called tyrosine kinases that play a crucial role in the uncontrolled growth of cancer cells. It blocks the abnormal signaling pathways that drive cancer cell proliferation.

  1. Is Imatinib Mesylate a cure for cancer?

Imatinib Mesylate can be highly effective in controlling cancer and improving survival rates, but it is generally considered a treatment rather than a cure. Treatment duration and outcomes vary depending on the type and stage of cancer.

  1. How is Imatinib Mesylate administered?

Imatinib Mesylate is administered orally in the form of tablets. Patients are usually instructed to take the medication with a meal and a full glass of water.

  1. What are the common side effects of Imatinib Mesylate Tablets?

Common side effects may include gastrointestinal symptoms (nausea, vomiting, diarrhea), fluid retention, muscle cramps, fatigue, skin rash, hematological effects (changes in blood cell counts), and changes in liver enzyme levels.

  1. Is Imatinib Mesylate safe during pregnancy and breastfeeding?

Imatinib Mesylate should be used during pregnancy or breastfeeding only when the potential benefits outweigh the risks. Patients should discuss the risks and benefits with their healthcare provider.

  1. Can I drink alcohol while taking Imatinib Mesylate?

Moderate alcohol consumption is generally considered safe while taking Imatinib Mesylate. However, it’s essential to consult with your healthcare provider, as alcohol can interact with certain medications.

  1. Is Imatinib Mesylate available as a generic medication?

Yes, generic versions of Imatinib Mesylate are available, typically at a lower cost than the brandname version. Generic medications contain the same active ingredient and are considered equally effective.

  1. Can I continue working and maintaining my daily activities while on Imatinib Mesylate treatment?

In many cases, individuals on Imatinib Mesylate treatment can continue with their regular activities, including work. However, some side effects may impact daily life, so it’s essential to communicate any concerns with your healthcare provider.

  1. Is it possible to stop taking Imatinib Mesylate once the cancer is under control?

The decision to stop Imatinib Mesylate treatment should be made by a healthcare provider. Discontinuing treatment prematurely can lead to a recurrence of cancer. Patients should follow their provider’s recommendations for the duration of therapy.

Patients should consult their healthcare providers for personalized information and guidance regarding Imatinib Mesylate Tablets and their specific medical condition.

As Imatinib Mesylate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Imatinib Mesylate Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Imatinib Mesylate Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Imatinib Mesylate Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274