Prescribing GLIVEC in KIT+ GIST

The following recommendations for appropriate dosing and administration of GLIVEC for KIT+ GIST are consistent with the European Summary of Product Characteristics (SmPC). Please refer to local prescribing information for country-specific information.

GLIVEC tablets 

  • GLIVEC is supplied as 50-mg hard capsules, 100-mg hard capsules or film-coated tablets, and 400-mg film-coated tablets1

100-mg GLIVEC pills*

400-mg GLIVEC tablets*

*Not actual size.

Dosing for adjuvant treatment of KIT+ GIST

  • The recommended dose of GLIVEC is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST1
  • Optimal treatment duration is not yet established1
  • The treatment duration in the clinical trial supporting this indication was 36 months1

Dosing for treatment of advanced KIT+ GIST

  • The recommended dose of GLIVEC is 400 mg/day for patients with unresectable and/or metastatic malignant GIST1
  • In 2 clinical studies, the daily dose of GLIVEC was escalated to 800 mg in patients progressing at lower daily doses and achieved an overall clinical benefit of 26%1
  • In clinical trials in KIT+ GIST patients, treatment with GLIVEC was continued until disease progression1

Administration

  • The prescribed dose should be administered orally with a meal and large glass of water to minimize the risk of gastrointestinal irritation1 Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening1
  • For patients unable to swallow the capsules:
    Content may be diluted in a glass of either still water or apple juice1

We stand by the name

Behind every GLIVEC tablet is our promise of authenticity to you and your patients. As part of this promise, Novartis Oncology is proud to deliver each prescription in packaging that is more informative and secure than ever before. The pharmacologic makeup and dose availability of GLIVEC remain unchanged.

400-mg GLIVEC tablet and packaging features include:

 

400-mg tablet embossed with the trusted GLIVEC name

Picture of the tablet on the outside of the box and enhanced blister strips

Unique code to trace the source and lot number of the medication

 
 

100-mg GLIVEC packaging features include:

 

Picture of the tablet on the outside of the box and enhanced blister strips

 
 
 

The design changes to the 400-mg tablet and packaging apply to the following EU countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Ireland, Latvia, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.

Only available in countries equipped with this technology.

Patient Profiles
 

Reference: 1. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2016.