Safety, Tolerance and Bio-equivalence of Imatinib (Gleevec) Tablets over Capsules

1. Safety, Tolerance and Bio-equivalence of Imatinib(Gleevec) Tablets over Capsules

2. Generic: Imatinib • Brand: Gleevec • Imatinib Mesylate is a medication used for the treatment of certain kinds of cancers such as • chronic myeloid leukemia • gastrointestinal stomach tumours • acute lymphoblastic leukemia • myelodysplastic / myeloproliferativediseases • Imatinib / Gleevec is a chemotherapeutic medication which is used to slow down or stop tumour growth. • Imatinib / Gleevec cost information

3. Imatinib (Gleevec) is proven to be highly effective in treating chronic myeloid leukemia and gastrointestinal tumors. However, the recommended daily dose of 400-600 mg requires taking several capsules of 100 mg dosage or a combination of 100 mg and 400 mg capsules. Swallowing multiple capsules at the same time may have negative impact on treatment adherence. In response to this problem, imatinib 100 mg and 400 mg film-coated tablets were developed. Additionally, a research test was conducted to study their effectiveness.

4. Research Overview • A group of 33 candidates were on random assigned to 1 of the 6 treatment combination of imatinib capsules / tablets. • The candidates were given either of the following: • Four 100 mg capsules as a reference point • Four 100 mg scored tablets for testing • One 400 mg tablet for testing

5. After 96 hours of taking the doses, blood sampling tests were performed. This was followed by a 10 day period of washout before the next sequence can start. After receiving the 3rd dose, the candidates were observed for adverse events due to the medication.

6. Results 95% of the confidence intervals were within the pre-determined intervals. 1 moderate and 8 mild adverse events were reported that could have been related to the medication. However, these events were of no clinical significance as no clustering by type of the dosage form was observed.

7. Conclusion The 100 mg film coated tablets (scored) and the 400 mg tablets were deemed to be as safe and tolerated as the commercial 100 mg hard gelatin capsules.

8. Imatinib MesylateUsage Imatinib (Gleevec) tablets are generally taken once or twice in a day with a meal and a glass of water (240 ml or 8 ounces) or as directed by a doctor. Do not crush, chew or break the tablet.

9. If you are facing difficulty in swallowing the tablet. You can dissolve it in a glass of water or apple juice, stir it thoroughly and drink it immediately. The amount of liquid to be consumed depends on the dosage required. Several factors such as your response to treatment, other medications that you may take and your medical condition are considered by your doctor when determining the dosage to be taken.

10. Inform your doctor about all the medications that you are taking such as prescription medications, non-prescription medications, vitamins and/or herbal products. Imatinib / Gleevec side effects and interactions

11. Some common Imatinib side effects include: • Low levels of white and/or red blood cells • Vomiting and/or nausea • Skin rashes • Pain in bone and/or muscles cramps • Bleeding problems (haemorrhage) • Fever • Diarrhea

12. Avoid the use of grapefruit or grapefruit products as they can interact with Imatinib to cause unwanted side effects. Do not increase or decrease the dosage taken of this medication as they cause other side effects to occur and reduce the medication’s effectiveness.

13. Imatinib can be absorbed through the skin and lungs. Therefore, pregnant women should avoid handling this medication to prevent harm to the unborn baby. Imatinib Cost Information The information provided on the page is meant for the purpose of being helpful and educational. It should not be considered as medical advice.

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