Gleevec

Generic name: Imatinib mesylate

What is Gleevec?

Gleevec is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML), a cancer of white blood cells, and also for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor (GIST). It is also used to treat certain tumors of the stomach and digestive system. Gleevec works by turning off specific proteins in cancer cells that cause cancer to replicate.

What is the most important information I should know about Gleevec?

Women of childbearing potential should be advised to avoid becoming pregnant.

Gleevec is often associated with edema (swelling caused by fluid in your body's tissues) and occasionally serious fluid retention. Patient should be weighed and monitored regularly for signs and symptoms of fluid retention.

Treatment with Gleevec is also associated with low levels of certain blood cells. Complete blood counts should be performed weekly for the first month, biweekly for the second, and periodically thereafter.

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported in patients taking Gleevec. Liver problems, muscle or bone pain (including gastrointestinal bleeding), and skin blistering have also been reported with Gleevec. Your doctor should check you closely for any serious complications periodically throughout treatment.

Gleevec is sometimes associated with gastrointestinal irritation. It is important to take Gleevec with food and a large glass of water to minimize this problem.

Who should not take Gleevec?

Patients who are allergic to imatinib or to any other component of Gleevec should not use this drug.

What should I tell my doctor before I take the first dose of Gleevec?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Gleevec. Also, talk to your doctor about your complete medical history, especially if you are experiencing swelling or weight gain from water retention, have a history of liver, kidney, or heart disease, are pregnant or could be pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Ph+ CML, Chronic Phase

Adults: 400 milligrams (mg) per day; a dose increase from 400 to 600 mg may be considered in the absence of severe adverse reactions and failure to achieve adequate response.

Children: The recommended dose of Gleevec for children with newly diagnosed Ph+ CML is 340 mg/m²/day (not to exceed 600 mg). The recommended dose for children with Ph+ chronic phase CML recurrent after stem cell transplant or who are resistant to interferon-alpha therapy is 260 mg/m²/day.

Ph+ CML, Accelerated Phase and Blast Crisis

Adults: 600 mg/day; a dose increase from 600 to 800 mg may be considered in the absence of adverse reactions and failure to achieve adequate responses

Ph+ Acute Lymphoblastic Leukemia (ALL), Relapsed/Refractory

Adults: 600 mg/day

Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)

Adults: 400 mg/day

Aggressive Systemic Mastocytosis (ASM) Without D816V C-Kit Mutation or C-Kit Mutational Status Unknown Not Responding to Other Therapies

Adults: 400 mg/day

ASM Associated with Eosinophilia

Adults: 100 mg/day starting dose, a dose increase from 100 to 400 mg may be considered in the absence of adverse reactions if assessments demonstrate insufficient response to therapy.

Hypereosinophilic Syndrome/Chronic Eosinophilic Leukemia (HES/CEL)

Adults: 400 mg/day; for patients with HES/CEL with FIP1L1-PDGFR_alpha fusion kinase, a starting dose of 100 mg/day is recommended; a dose increase from 100 to 400 mg may be considered in the absence of adverse reactions

Dermatofibrosarcoma Protuberans (DFSP)

Adults: 800 mg/day

Unresectable and/or Metastatic, Malignant GIST:

Adults: 400 to 600 mg/day

How should I take Gleevec?

Gleevec should be taken with food and a large glass of water. For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water or apple juice.

What should I avoid while taking Gleevec?

Gleevec should not be taken with grapefruit juice. Females of child-bearing age should avoid becoming pregnant. Sexually active females should use adequate contraception.

What are possible food and drug interactions associated with Gleevec?

If Gleevec is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Gleevec with the following: acetaminophen, alfentanil, atanazavir, carbamazepine, clarithromycin, cyclosporine, dexamethasone, diergotamine, dihydropyridine calcium channel blockers, erythromycin, ergotamine, fentanyl, grapefruit juice, HMG-CoA reductase inhibitors or "statins," indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir, phenobarbital, phenytoin, pimozide, quinidine, rifampicin, ritonavir, saquinavir, sirolimus, St. John's wort, tacrolimus, telithromycin, triazolobenzodiazepines, voriconazole, warfarin

What are the possible side effects of Gleevec?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: nausea, vomiting, fluid retention, muscle cramps, rash, diarrhea, heartburn, headache

Can I receive Gleevec if I am pregnant or breastfeeding?

Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Women of childbearing age should avoid becoming pregnant while being treated with Gleevec.

What should I do if I miss a dose of Gleevec?

If you miss a dose, take the medicine as soon as you remember, making sure you also eat a meal and drink a large glass of water. If it is almost time for your next meal, skip the missed dose and take the medicine when you eat your next meal. Do not take extra medicine to make up the missed dose.

How should I store Gleevec?

Store at room temperature in a tightly closed container. Protect from moisture.