CMLSupport: Facts About Gleevec (STI)

"The difference between fiction and reality is that fiction has to make sense."
— Tom Clancy

Facts About Gleevec (STI)

The median time to hematologic response in patients with chronic myelogenous leukemia in chronic phase undergoing clinical trials was 1 month. Response duration cannot be precisely defined because follow-up on most patients is relatively short interim data. In blast crisis, the estimated median duration of hematologic response is about 6 months. In accelerated phase, median duration of hematologic response is greater than 6 months but cannot yet be estimated. Follow-up is insufficient to estimate duration of cytogenetic response in all studies.

Do not get pregnant or father a child while on Gleevec

There are no long-term safety data yet

One patient, who was taking acetaminophen (Tylenol) regularly for fever, died of acute liver failure.

A variety of adverse events represent local or general fluid retention including pleural effusion, ascites, pulmonary edema and rapid weight gain with or without superficial edema. These events appear to be dose related, were more common in the blast crisis and accelerated phase studies (where the dose was 600 mg/day), and are more common in the elderly. These events were usually managed by interrupting Gleevec treatment and with diuretics or other appropriate supportive care measures. However, a few of these events may be serious or life threatening, and one patient with blast crisis died with pleural effusion, congestive heart failure, and renal failure.

Women have anecdotally been reporting problems relating to menstruation, e.g., heavy and irregular bleeding.

Do not drink grapefruit juice at all while taking Glivec; it could inhibit absorption. Do not exceed the recommended dosage of Tylenol. Do not take calcium supplements or antacids within 2 hours of taking Gleevec. Check with your doctor before consuming alcohol.

Store at 25 degrees Celsius (77 degress F); excursions permitted to 15 to 30 degrees C (59 to 86 F).

The safety and efficacy of Gleevec in patients under the age of 18 years have not been established.

Gleevec (Glivec/STI) has been approved in the following countries for prescription use: United States, Mexico, Brazil, Argentina, Syria, Jordan, Guatemala, Peru, Romania, Korea, and Switzerland.

The pills are orange to grayish-orange opaque capsules with “NVR SI” printed in red ink.

Some patients have suggested eating watermelon and avoiding salt as a way to control edema.

Gleevec is a signal transduction inhibitor. It works in CML by shutting down both the growth and survival signals of leukemic cells produced by an abnormal enzyme.

Contrary to media reports, patients DO experience numerous side effects. Among those reported: edema, fluid retention, blurry vision, swollen eyes and ankles, nausea, heartburn, GI irritation, hematologic toxicity, liver damage, muscle cramps, flatulence, diahhrea, weight gain, skin rash, bone pain, fatigue, low platelet count, low white blood count, anemia.

CML experts are suggesting that a combination treatment of Gleevec and interferon or ARA-C might work better than Gleevec alone.

There is concern that patients can develop resistance to Gleevec over time and it will no longer work.

Many patients have to cycle on and off Gleevec because their blood counts become so abnormal.

Source: Novartis Pharmaceuticals, patients, oncology experts

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