Comparable safety and tolerability with GLIVEC in both the adjuvant and advanced settings1

Most patients receiving GLIVEC for KIT+ GIST will experience some type of side effect1

  • The most commonly reported (≥10%) drug-related adverse reactions were mild nausea, vomiting, diarrhea, abdominal pain, fatigue, myalgia, muscle cramps, and rash1
  • Adverse reactions were similar in the adjuvant and metastatic settings, except for more GI bleeds and intratumoural bleeds in advanced GIST patients1
  • Encourage patients to discuss any side effects they may be experiencing

GLIVEC has an established safety profile1

  • GLIVEC has had an established safety profile for more than 10 years in metastatic KIT+ GIST2,3
    Only 4% of patients discontinued therapy due to adverse events in GIST trials1
  • Patients who tolerated the 400-mg dose prior to dose escalation were less likely to require dose reductions at the 800-mg level than patients initiated at the higher dose3
  • Some serious adverse reactions, including fluid retention and edema, blood disorders, infections, hepatitis B reinfection, and lung and cardiac problems, have been reported1
  • Supportive care may help resolve some adverse reactions, while other adverse reactions may require discontinuation or dosage adjustment1,4
Adverse reactions Suggested supportive care options1,4

Edema

  • Weigh patients regularly
  • In mild cases, monitor
  • For unexpected rapid weight gain or severe edema, administer diuretics
  • If severe and unresolved, consider drug interruption or dose reduction

Diarrhea

  • Recommend antidiarrheals if severe

Nausea/vomiting

  • Recommend GLIVEC be taken with a meal and a large glass of water
  • Administer antinausea medications if severe

Muscle cramps

  • For mild pain, recommend nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen, though caution should be exercised when using high doses of GLIVEC and acetaminophen—also known as paracetamol—concomitantly
  • Recommend calcium and magnesium supplements

Rash

  • Depending on severity, recommend over-the-counter or prescription antihistamines or topical or systemic steroids
  • If severe, consider drug interruption or dose reduction

Musculoskeletal pain

  • Recommend NSAIDs

Fatigue

  • Examine for anemia, hypothyroidism, cardiac, or metabolic causes

Liver transaminase elevations

  • Perform thorough hepatic assessment
  • Perform liver ultrasonography or biopsy if indicated
  • Consider dose reduction for Grade 2 transaminitis
  • AST/ALT >5 x institutional upper limit of normal (IULN) requires dose interruption; see SmPC for more details

Myelosuppression (thrombocytopenia, neutropenia, or anemia)

  • Measure serum iron, ferritin, and transferrin levels
  • If hemoglobin <100 g/L, erythropoietin/darbepoetin or blood transfusion may be considered
  • Profound neutropenia (<1.0 x 109/L) or thrombocytopenia (<50 x 109/L) requires therapy interruption; see SmPC for more details

Hemorrhage (not associated with thrombocytopenia)

  • Educate patients about signs/symptoms of acute internal bleeding and emergency procedures
  • Monitor hemoglobin during the first 4 to 8 weeks of therapy; decreases of >2 g/dL may require treatment interruption until hemoglobin levels stabilize
  • Symptomatic bleeding may require transfusion or surgical intervention

Please see Warnings and Precautions page for more information.

References: 1. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2016. 2. Blanke CD, Demetri GD, von Mehren M, et al. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008;26(4):620-625. 3. Patel S, Zalcberg JR. Optimizing the dose of imatinib for treatment of gastrointestinal stromal tumours: lessons from the phase 3 trials. Eur J Cancer. 2008;44(4):501-509. 4. Joensuu H, Trent JC, Reichardt P. Practical management of tyrosine kinase inhibitor-associated side effects in GIST. Cancer Treat Rev. 2011;37(1):75-88.