

Imatib 400mg Tablet (Imatinib mesylate)
Manufactured By
Cipla
Pack Of
10
Salt Composition
Imatinib mesylate
Storage
Store below 30°C
ALL SUBSTITUTES
Overview
Imatib 400mg Tablet contains imatinib 400 mg, an oral tyrosine kinase inhibitor that blocks BCR::ABL1, KIT, and PDGFR kinases. It transformed chronic myeloid leukemia (CML) by directly targeting the BCR::ABL1 fusion oncoprotein generated by the Philadelphia chromosome.
Imatinib 400mg Tablet is also used in gastrointestinal stromal tumors (GIST) driven by KIT/PDGFRA and several rarer kinase-driven diseases. The Imatinib 400 mg tablet is commonly used for adult dose strength, but exact dosing varies by disease phase, mutation profile, age, and treatment response.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Imatib |
| Molecule / Combination | Imatinib |
| Strength / Composition | 400 mg |
| Dosage form | Tablet |
| Manufacturer / Marketer | Cipla |
| Pack / Presentation | 10 tablets |
| Storage | Store below 30°C; protect from moisture. |
| Prescription | Required |
Uses and Indications
Major indications include newly diagnosed Philadelphia-chromosome-positive CML in the chronic phase and other CML phases; Ph-positive ALL in appropriate combinations; unresectable/metastatic KIT-positive GIST and adjuvant GIST after resection in selected high-risk patients; and certain PDGFR-rearranged myelodysplastic/myeloproliferative disorders, hypereosinophilic syndrome, aggressive systemic mastocytosis, and dermatofibrosarcoma protuberans when the relevant molecular features are present. In GIST, PDGFRA D842V mutations are resistant to imatinib 400 mg tablet and require other treatment.
How Imatib 400mg Tablet Works
Imatinib 400mg tablets bind the ATP-binding site of BCR::ABL1, KIT, and PDGFR kinases and lock them in an inactive conformation, shutting down proliferative signalling.
Clinical Evidence for Imatib 400mg Tablet
IRIS trial: The imatinib 400 mg tablet produced dramatically better cytogenetic and long-term outcomes than interferon-based therapy in newly diagnosed chronic-phase CML.
GIST trials: Imatinib 400 mg tablets produced durable disease control in advanced KIT-positive GIST and improved recurrence-free survival as adjuvant therapy in high-risk resected GIST.
Side Effects of Imatib 400mg Tablet
Just like any other medication, the Imatib 400mg Tablet is also associated with some side effects. Most of the side effects are minor and usually go away within some time. Here are some of the symptoms, including:
Common side effects
- Fluid retention/edema
- Nausea
- Diarrhea
- Muscle cramps
- Rash
- Fatigue
- Low blood counts
Serious side effects
- Severe fluid retention/heart failure
- Hepatotoxicity
- Severe cytopenias
- Tumor lysis syndrome
- GI bleeding/perforation in GIST
- Growth retardation in children
Critical Safety Warning
MOLECULAR-TARGET WARNING: Diagnosis and mutation testing matter. Imatinib 400 mg tablets should not be used simply because a tumor expresses KIT; specific molecular alterations and resistance mutations can determine whether it will work.
Imatib 400mg Tablet Dosage and How To Take It
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.
| Clinical situation | Dose |
|---|---|
| CML chronic phase common adult dose | 400 mg once daily. |
| Advanced CML/selected Ph+ ALL settings | 600 mg daily or regimen-specific dosing may be used. |
| GIST | 400 mg once daily is common; selected KIT exon 9 disease may use 800 mg/day in divided doses. |
| Administration | Take it with a meal and a large glass of water to reduce GI irritation. |
Imatib 400mg Tablet Missed Dose
Take a missed dose when remembered unless close to the next dose; do not double. If vomiting occurs, do not automatically repeat the dose.
Safety Advice for Imatib 400mg Tablet
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Avoid | Can cause fetal harm. |
| Liver | Monitor | Hepatotoxicity can occur. |
| Fluid retention | Monitor | Report rapid weight gain, swelling, or breathlessness. |
| Growth in children | Monitor | Long-term therapy can affect growth. |
| Driving | Caution | Dizziness/blurred vision may occur. |
Monitoring During Imatib 400mg Tablet Treatment
- CBC
- Liver function
- BCR::ABL1 transcript levels in CML
- Mutation testing if treatment failure occurs
- Weight/edema
- Disease-specific imaging in GIST
Imatib 400mg Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Imatib |
| Generic / Combination | Imatinib |
| Strength | 400 mg |
| Form | Tablet |
| Manufacturer / Marketer | Cipla |
| Pack | 10 tablets |
| Storage | Store below 30°C; protect from moisture. |
| Major safety theme | MOLECULAR-TARGET WARNING |
| Prescription | Yes |
Imatib 400mg Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Strong CYP3A4 inhibitors | Increase imatinib 400 mg exposure | Review/avoid or monitor. |
| Strong CYP3A4 inducers | Reduce exposure | Avoid rifampicin, carbamazepine, phenytoin, and St. John’s wort. |
| Warfarin | Interaction/bleeding concerns | Alternative anticoagulation may be preferred under specialist guidance. |
| Paracetamol/other hepatotoxic drugs | Potential hepatic toxicity | Use cautiously and monitor. |
FAQs About Imatib 400mg Tablet
What is the imatinib 400 mg tablet used for?
Its best-known uses are BCR::ABL1-positive CML and KIT/PDGFR-driven GIST, plus several rarer kinase-driven diseases.
Why is molecular testing important?
Imatinib 400mg tablets only work when the relevant kinase target is present and not resistant.
Should the imatinib 400 mg tablet be taken with food?
Yes, the imatinib 400mg tablet can be taken with a meal and a large glass of water.
Is 400 mg always the dose?
No. Dose varies by disease and phase.
How is the CML response monitored?
BCR::ABL1 PCR testing tracks molecular response over time.
Can imatinib 400 mg treatment cause swelling?
Yes. Fluid retention and periorbital edema are common.
Can imatinib 400 mg treatment ever be stopped in CML?
Some patients with sustained deep molecular response may attempt treatment-free remission only under specialist criteria and intensive monitoring.
Who markets the Imatib 400mg Tablet?
It is possible to verify the availability of the Imatib 400mg tablet by looking at our website stock status before ordering. Its availability may depend on your location and supply status.
References
- Current imatinib 400 mg tablet prescribing information (Gleevec/reference). https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf
- O’Brien SG, et al. IRIS. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa1609324
- Demetri GD, et al. Imatinib in advanced GIST. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa020461
- Current ELN/NCCN CML and GIST guidelines. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1427
- Nature. Blood camcer journal. https://www.nature.com/articles/s41408-026-01485-z
Marketer Details
Cipla
Disclaimer
Globanspharma main goal is to ensure that its consumers get correct, authentic, and reliable information that has been examined by medical professionals. This website's content has only been created for informational purposes. However, this is not meant to replace the medical advice and treatment given by a qualified physician. The information presented herein may not cover everything about particular lab tests, medicines, and health conditions, all possible side effects, and warnings. Please discuss all your queries related to any medication and illness with your doctor. We intend to support and maintain the doctor-patient relationship, not to substitute it or take its place.




