Gleevec

Gleevec Medication Information:

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Gleevec medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Gleevec 100 mg
Gleevec 400 mg

About Gleevec

What Gleevec is used for

  • GLEEVEC is indicated for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase.

  • GLEEVEC is also indicated for the treatment of adult patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase or in chronic phase (after failure of interferon-alpha therapy).

Leukemia is a cancer of white blood cells. (normal white cells usually help the body to fight infection). Chronic myeloid leukemia is a form of leukemia in which certain abnormal white cells, named myeloid cells, start growing out of control.

  • GLEEVEC is also indicated for use as a single agent for induction phase therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

  • GLEEVEC is also indicated for the treatment of adult patients with relapsed or refractory Ph+ ALL as single agent.

Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal white cells named lymphoblasts start growing out of control.

  • GLEEVEC is also indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

MDS/MPD diseases are a group of blood diseases in which some blood cells start growing out of control.

  • GLEEVEC is also indicated for the treatment of adult patients with aggressive sub-types of systemic mastocytosis (ASM and SM-AHNMD*) without the D816V c-Kit mutation. If c-Kit mutational status in patients with ASM or SM-AHNMD* is not known or unavailable, treatment with GLEEVEC may be considered if there is no satisfactory response to other therapies.

ASM is a cancer in which certain blood cells (named “mast” cells) start growing out of control.

  • GLEEVEC is also indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα rearrangement.

HES and/or CEL are blood diseases in which some blood cells (named “eosinophils”) start growing out of control.

  • GLEEVEC is also indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.

  • GLEEVEC is also indicated for the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

GIST is a cancer of the gastrointestinal system (stomach and the bowels). It arises from uncontrolled cell growth of the supporting tissue of this system.

What Gleevec does

GLEEVEC specifically targets the activity of certain enzymes called tyrosine kinases that play an important role within certain cancer cells.

GLEEVEC inhibits the growth of abnormal white blood cells by blocking an enzyme involved in the development of certain cancers such as Ph+CML and Ph+ALL.

GLEEVEC inhibits the uncontrolled growth cells of the supportive tissues involved in the development of cancers of the gastrointestinal system (stomach and the bowels).

When Gleevec should not be used

If you are allergic (hypersensitive) to imatinib mesylate or any of the other ingredients of GLEEVEC listed under What the important nonmedicinal ingredients are:.

What the medicinal ingredient is

GLEEVEC contains an active ingredient called imatinib mesylate.

What the important nonmedicinal ingredients for Gleevec are

GLEEVEC (imatinib mesylate) 100 mg tablets

Each tablet contains 100 mg of imatinib (as mesylate) and the following inactive ingredients: Cellulose (microcrystalline), crospovidone, colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate. The coating contains ferric oxide (red), ferric oxide (yellow), hydroxypropyl methylcellulose, polyethylene glycol, and talc.

GLEEVEC (imatinib mesylate) 400 mg tablets

Each tablet contains 400 mg of imatinib (as mesylate) and the following inactive ingredients: Cellulose (microcrystalline), crospovidone, colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate. The coating contains ferric oxide (red), ferric oxide (yellow), hydroxypropyl methylcellulose, polyethylene glycol, and talc.

What dosage forms Gleevec comes in

GLEEVEC is supplied as a tablet.

GLEEVEC (imatinib mesylate) 100 mg tablets.

GLEEVEC (imatinib mesylate) 400 mg tablets.


Warnings and Precautions

Serious Warnings and Precautions

GLEEVEC should only be prescribed to you (or your child) by a doctor who is experienced in the use of anti-cancer drugs. Serious and/or common side effects that may occur with GLEEVEC include:

  • Severe heart failure and decrease in the amount of blood pumped by the heart,

  • Rhabdomyolysis has been rarely observed,

  • Serious bleeding,

  • Fluid retention.

Before you (or your child) take GLEEVEC talk to your doctor or pharmacist:

  • if you have or ever have had a liver, kidney or heart problem,

  • if you are or plan to get pregnant. Women who might get pregnant are advised to use an effective method of birth control while taking GLEEVEC,

  • if you are breast-feeding, GLEEVEC can get to the breast milk and may cause harm to your child,

  • if you had your thyroid removed and are receiving treatment with a thyroid hormone such as levothyroxine.

While taking GLEEVEC, if you feel dizzy or if you have blurred vision, do not drive a vehicle or operate any tools or machinery.

Use in children

There is no experience with the use of GLEEVEC in children under 2 years of age.


Interactions with Gleevec

Inform your doctor or pharmacist before or while taking GLEEVEC if you are taking or have recently taken any other medicines, even those not prescribed by a doctor or natural health products, including nonprescription drugs.

Drugs that interact with GLEEVEC include:

  • some medicines used to treat infections such as ketoconazole, itraconazole, erythromycine, or clarithromycin,

  • some medicines used to treat epilepsy such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, fosphenytoin, or primidone,

  • some medicines used to treat high cholesterol such as simvastatin,

  • some medicines used to treat mental disorders such as pimozide,

  • some medicines used to treat high bood pressure or heart disorders such as calcium channel blockers or metoprolol,

  • rifampicin, a medicine used to treat tuberculosis,

  • St. John’s Wort—a herbal product used to treat depression and other conditions (also known as Hypericum Perforatum),

  • dexamethasone, an anti-inflammatory medicine,

  • cyclosporine, an immunosuppressant medicine,

  • acetaminophen, a medicine used to relieve the pain or to reduce fever,

  • warfarin, a medicine used to treat blood coagulation disorders (such as blood clots or thromboses).

You should also tell your doctor if you are already taking GLEEVEC and you are prescribed a new medicine you have not previously taken during GLEEVEC treatment.

In addition, do not drink grapefruit juice while you are being treated with GLEEVEC.


Proper Use of Gleevec

Usual dose

Adults

Usual adult dose:

  • 400 mg/day in newly diagnosed CML or Chronic phase CML.

  • 600 mg/day in accelerated phase and blast crisis CML.

  • 400 mg/day or 600 mg/day for GIST.

  • 600 mg/day for Ph+ALL.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If a dose of 800 mg is administered, it should be taken as 400 mg twice a day, in the morning and in the evening.

  • If you are being treated for MDS/MPD: the starting dose in adult patients with myelodysplastic/myeloproliferative diseases is 400 mg/day.

  • If you are being treated for ASM: the starting dose in adult patients with aggressive sub-types systemic mastocytosis (ASM and SM-AHNMD) without the D816V c-Kit mutation or with c-Kit mutational status unknown is 400 mg, to be taken once a day. For patients with ASM or SM-AHNMD associated with eosinophilia, the starting dose is 100 mg once a day.

  • If you are being treated for HES/CEL: the usual starting dose in adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) is 100 mg to be taken once a day.

    For ASM/SM-AHNMD and HES/CEL patients receiving 100 mg/day, your doctor may decide to increase the dose to 400 mg once a day depending on how you respond to treatment.

  • If you are being treated for DFSP: the starting dose is 800 mg/day, to be taken as 400 mg twice a day, in the morning and in the evening.

Children

The doctor will tell you how many tablets of GLEEVEC to give your child. The amount of GLEEVEC given, will depend on your child’s condition, and also his or her body weight and height.

Usual dose for children (2 years of age and older): 340 mg/m2 body surface area/day, rounded up to the nearest 100 mg and not to exceed 600 mg/day.

The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (one in the morning and one in the evening).

GLEEVEC should be taken during a meal and with a large glass of water. Avoid drinking grapefruit juice while being treated with GLEEVEC. Swallow the tablet whole. The 400 mg tablet can be broken in half.

If you (or your child) cannot swallow the tablet(s), you can place them in water or apple juice, use 200 mL for 400 mg tablet or 50 mL for 100 mg tablet. Stir with a spoon to completely disintegrate the tablet(s), then drink the whole content immediately. Rinse the container with water or apple juice and drink it to make sure no trace of disintegrated tablet(s) is left.

When and how long to take GLEEVEC

Your doctor will determine when you will be given GLEEVEC and for how long you should receive it. Do not exceed the recommended dosage and make sure you take GLEEVEC for as long as prescribed.

Missed dose

If you forget to take a dose of GLEEVEC, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not double doses.

 

Technical Information