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Imatinib Package Insert

imatinib package insert

imatinib package insert is the trade name for the generic drug name Imatinib Mesylate. STI-571 is another name for Imatinib Mesylate. In some cases, health care professionals may use the trade name Gleevec or other name STI-571 when referring to the generic drug name Imatinib Mesylate. 

What imatinib package insert  Is Used For

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Ph+ CML in blast crisis, accelerated phase, or chronic phase after failure of interferon-alpha therapy.

Adult patients with relapsed or refractory Philadelphia chromosome + acute lymphoblastic leukemia (Ph+ ALL).

Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR gene rearrangements. 

How imatinib package insert Is Given

Gleevec is a pill, taken by mouth, once or twice daily.

Gleevec should be taken with a large glass of water, after a meal.

The amount of Gleevec that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

How to take imatinib package insert

Your doctor has prescribed Glivec because you suffer from a serious condition. Glivec can help you tofight this condition.However, always take this medicine exactly as your doctor or pharmacist has toldyou. It is important thatyou do this as long as your doctor or pharmacist tells you to. Check with your doctor or pharmacist if youare not sure.Do not stop taking Glivec unless your doctor tells you to. If you are not able to take the medicine as yourdoctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

Warnings and Precautions

GLEEVEC is often associated with edema (swelling) and serious fluid retention (holding water). It is important that patients be weighed and monitored regularly for signs and symptoms of serious fluid retention or unexpected weight gain. Patients experiencing unexpected, rapid weight gain should speak to their doctor about appropriate supportive care treatment. Studies have shown that edema tended to occur more often among patients who are 65 and older or those taking higher doses of GLEEVEC. If you experience severe fluid retention, your doctor may treat you with diuretics and may stop your GLEEVEC treatment until the fluid retention has been managed. Treatment can be resumed as appropriate depending on the initial severity of the event.

Side Effects

Almost all patients treated with GLEEVEC experience side effects at some time. Some common side effects that you may experience include:

  • Fluid retention (holding water)
  • Muscle cramps, pain, or bone pain
  • Abdominal pain
  • Anorexia (loss of appetite)
  • Vomiting
  • Diarrhea
  • Decreased hemoglobin (decrease in blood cells which carry oxygen)
  • Hemorrhage (abnormal bleeding)
  • Nausea
  • Fatigue
  • Rash

Safety Information

The following serious side effects have been reported by patients taking GLEEVEC:

  • Severe fluid retention (holding water), which can cause swelling around the eyes or swelling of the lower legs, lungs, and heart; fatal in rare cases
  • Increased pressure in the heart or brain; fatal in rare cases
  • Low levels of certain blood cells
  • Heart failure
  • Liver problems
  • Hemorrhage (abnormal bleeding)
  • Skin blistering
  • Low levels of thyroid hormone

Elimination

  • Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib,
  • approximately 81% of the dose was eliminated within 7 days in faeces (68% of dose) and
  • urine (13% of dose). Unchanged imatinib accounted for 25% of the dose (5% urine, 20%
  • faeces), the remainder being metabolites.

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