

Imatinate 400mg Capsule (Imatinib)
Manufactured By
Khandelwal
Pack Of
30
Salt Composition
Imatinib
Storage
Keep in cold place
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Overview
Imatinate 400mg Capsule is a prescription medicine containing Imatinib. It is belongs to the tyrosine kinase inhibitor targeting bcr::abl1, kit and pdgfr class. The medicine should be used only under the supervision of a clinician experienced in the relevant disease area.
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), with dose and treatment strategy depending on disease phase and response. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in defined settings.
Imatinib 400mg capsule inhibits several abnormal or overactive tyrosine kinases, most importantly BCR::ABL1, KIT and PDGFR. By blocking the kinase that drives a susceptible malignancy, imatinib capsule reduces proliferative signalling and promotes disease control. Its mechanism makes biomarker/disease context essential. The 400mg strength describes the commercial presentation; it does not automatically represent the complete prescribed dose. However, the dose and duration depend on diagnosis, treatment protocol, organ function, concomitant medicines and treatment tolerance.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | imatinate |
| Generic / Active Ingredient | Imatinib |
| Strength | 400 |
| Dosage Form | Capsule |
| Manufacturer / Marketer | khandelwal |
| Pack Size | 30 |
| Prescription Required | Yes |
| Therapeutic Categories | Cancer Medicines |
| Uses | Bone Marrow Cancer |
Uses and Indications
Imatinate 400mg capsule may be prescribed in the following established clinical settings. The exact treatment line, combination regimen and duration depend on the diagnosis, current labeling and specialist assessment.
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), with dose and treatment strategy depending on disease phase and response.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in defined settings.
PDGFR-rearranged MDS/MPD, selected systemic mastocytosis, hypereosinophilic syndrome/chronic eosinophilic leukemia, KIT-positive gastrointestinal stromal tumour (GIST), and dermatofibrosarcoma protuberans (DFSP) according to biomarker status and applicable labeling.
How Imatinate 400mg Capsule Works
Imatinib capsule inhibits several abnormal or overactive tyrosine kinases, most importantly BCR::ABL1, KIT and PDGFR. By blocking the kinase that drives a susceptible malignancy, the medicine reduces proliferative signalling and promotes disease control. Its mechanism makes biomarker/disease context essential.
Clinical Evidence for Imatinate 400mg Capsule
- The clinical evidence referenced here based on imatinib 400mg capsules and the treatment regimens in which they are administered, and not the Imatinate capsule commercial product specifically.
- The use of imatinib 400mg has led to tremendous improvements in the management of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) and contributed in making targeted kinase inhibitors a valuable cancer treatment modality.
- Imatinib 400mg is also backed by extensive clinical evidence for the treatment of KIT-positive gastrointestinal stromal tumors (GIST) as well as other rare diseases characterized by certain molecular anomalies.
- The evidence available varies based on the disease and regimen used and pertains to imatinib 400mg as a drug and not as clinical trial evidence for the Imatinate 400mg commercial product specifically.
Side Effects of Imatinate 400mg Capsule
The side effects of Imatinib 400mg capsule vary by indication, dose, treatment duration, concomitant medicines and individual patient factors. Common or clinically relevant effects include:
- Edema/fluid retention
- Nausea
- Muscle cramps
- Musculoskeletal pain
- Diarrhea
- Rash
- Fatigue
- Myelosuppression
- Liver-enzyme elevations
Serious or persistent symptoms should be assessed promptly. The treating team should provide medicine-specific instructions on which symptoms require urgent medical attention.
Critical Safety Warning
- Imatinate 400mg tablet is a prescription medicine requiring appropriate medical supervision.
- Important risks include fluid retention/edema, cytopenias, hepatotoxicity, cardiac failure in susceptible patients, hemorrhage, gastrointestinal complications in some tumour settings, tumour lysis syndrome, renal toxicity, growth effects in children and embryo-fetal toxicity.
- Disease-specific molecular response monitoring is essential in CML.
- The user's product name states 'capsule'; current major regulatory Imatinib 400mg references commonly describe tablets. The exact Imatinate capsule dosage form must therefore be verified from the Indian pack/insert before publication.
Imatinate 400mg Capsule Dosage and How To Take It
The dose of Imatinate capsule depends on the indication and clinical setting. The 400mg presentation should not be confused with the total prescribed daily dose.
These are molecule-level examples from regulatory labeling or established product information and are not instructions for self-dosing. The treating specialist determines the actual dose, schedule, dose modifications and supportive medicines.
| Clinical situation | Dose |
|---|---|
| Adult chronic-phase Ph+ CML | 400mg/day. |
| Adult accelerated-phase or blast-crisis CML | 600mg/day; escalation may be considered in defined circumstances. |
| Adult relapsed/refractory Ph+ ALL | 600mg/day. |
| MDS/MPD or many ASM/HES-CEL settings | Often 400mg/day, with some FIP1L1-PDGFRα-positive settings beginning at 100mg/day. |
| Metastatic/unresectable GIST | 400mg/day; escalation may be considered for progression in appropriate patients. |
| DFSP | 800mg/day, generally divided as 400mg twice daily under tablet labeling. |
Imatinate 400mg Capsule Missed Dose
If a dose of Imatinate 400mg capsule is missed, follow the current patient leaflet and the treating team's instructions. Do not automatically double the next dose. If vomiting occurs after an oral dose, do not repeat the dose unless specifically instructed.
Safety Advice for Imatinate 400mg Capsule
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Avoid | Imatinate 400mg capsule can cause fetal harm, however, effective contraception is required. |
| Liver | Monitor | Monitor liver function; dose adjustment may be required while using Imatinib capsule. |
| Kidneys | Monitor | Monitor renal function during treatment. |
| Fluid retention | Monitor | Report rapid weight gain, edema or breathlessness. |
| Blood counts | Monitor | CBC monitoring is required, especially early in treatment. |
| Administration | Monitor | Standard imatinib capsule labeling recommends taking with a meal and a large glass of water; verify exact instructions as recommended by the doctor. |
Monitoring During Imatinate 400mg Capsule Treatment
Monitoring is individualized according to the disease and treatment regimen. It may include:
- CBC
- Liver function
- Renal function
- Weight and edema
- BCR::ABL1 molecular response in CML
- Disease-specific imaging/biomarkers in GIST and other indications
- Cardiac status in susceptible patients
Imatinate 400mg Capsule Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Imatinate |
| Molecule | Imatinib |
| Strength | 400mg |
| Dosage form | Capsule — verify India pack presentation |
| Therapy type | Tyrosine kinase inhibitor targeting BCR::ABL1, KIT and PDGFR |
| Route | Oral |
| Prescription required | Yes |
| Dose principle | Indication/protocol-specific; do not infer the patient dose from pack strength |
| Medical supervision | Required |
Imatinate 400mg Capsule Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Strong CYP3A4 inducers | May reduce Imatinib 400mg exposure and decrease its effectiveness. | Generally avoid; consult the treating doctor for suitable alternatives. |
| Strong CYP3A4 inhibitors | May increase Imatinib 400mg exposure and the risk of adverse effects. | Use with caution and monitor as advised by the doctor. |
| CYP3A4 substrates | Imatinib capsule may alter the exposure of certain CYP3A4 substrate medicines. | Review high-risk medicines and adjust treatment if required. |
| Supplements, herbal products and relevant foods | Some supplements, herbal products or foods may affect treatment or drug metabolism. | Discuss all supplements, herbal products and relevant foods with the healthcare provider. |
FAQs About Imatinate 400mg Capsule
What is Imatinate 400mg Capsule used for?
Imatinate 400mg is indicated in approved or specialist-directed indications for diseases like some kinds of CML, Ph+ ALL, GIST, DFSP, or any other molecularly defined disease.
Is Imatinate 400mg and imatinib capsule the same?
Imatinib capsule is the drug, while Imatinib 400mg is the commercial name of the medication.
What is imatinib 400mg used for?
Imatinib capsule is used in approved or specialist-directed indications in the treatment of certain cancers or disorders caused by specific abnormality of proteins or molecules.
How does Imatinate 400mg capsule work?
Imatinate 400mg blocks certain abnormal enzymes that transmit information and that may be overexpressed. This drug is known to block BCR::ABL1, KIT, PDGFR tyrosine kinases. Thus, Imatinate 400mg stops the signals transmitted from certain proteins that stimulate the growth of cancer cells.
Is Imatinate capsule chemotherapy?
Imatinate 400 mg capsule is an anticancer drug with a target rather than traditional cytotoxic chemotherapy.
How is Imatinate 400 mg administered?
Imatinib 400 mg capsule is taken orally and the dose and time depend on the recommended treatment regimen and up-to-date product data.
Are 400 mg Imatinate capsule given to everyone?
No, the dosage is 400 mg. The recommended dosage may differ based on many factors.
What monitoring is required when taking Imatinate 400mg?
The kind of monitoring required depends on the condition and treatment approach and can involve blood tests, organ function tests, treatment-specific monitoring, and monitoring of the effectiveness of treatment.
What do I need to discuss with my doctor before taking Imatinate 400mg?
All health conditions, infections, liver or kidney problems, relevant heart conditions, pregnancy and intention of becoming pregnant, breast feeding, allergies, medication use, and reactions to treatment should be discussed with the medical team.
References
1. DailyMed. Imatinib Mesylate Tablets prescribing information, updated September 2026 https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a819a954-41c9-4d49-a74e-c8c4b338b22a&version=3
2. Current CML/GIST and disease-specific oncology guidelines https://pmc.ncbi.nlm.nih.gov/articles/PMC12529753/
3. Current India-specific Imatinate package insert, including confirmation of capsule versus tablet presentation, before publication https://www.researchgate.net/publication/280402583_Formulation_and_evaluation_of_floating_controlled_release_tablets_of_Imatinib_mesylate_using_hydrophilic_matrix_system
4. European LeukemiaNet. 2025 European LeukemiaNet Recommendations for the Management of Chronic Myeloid Leukemia.Leukemia. 2025;39:1797–1813 https://pubmed.ncbi.nlm.nih.gov/40646132/
5. U.S. Food and Drug Administration. GLEEVEC (imatinib mesylate) Tablets Prescribing Information. Updated July 2026 https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021588s067lbl.pdf
Marketer Details
Khandelwal
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