Web PLR Content Directory Federated States of Micronesia: imatinib

Generic Name: imatinib (im MA ta nib)

Brand Names: Gleevec

What is imatinib?

Imatinib interferes with the growth of some cancer cells.

Imatinib is used to treat a certain types of leukemia (blood cancer) such as Philadelphia chromosome positive chronic myeloid leukemia (CML). It is also used to treat certain tumors of the stomach and digestive system.

Imatinib may also be used for purposes not listed in this medication guide.

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

Do not use imatinib if you are pregnant. It could harm the unborn baby.

Before using this medication, tell your doctor if you have liver disease, kidney disease, underactive thyroid, congestive heart failure, a history of stomach ulcer or bleeding, or if you are receiving chemotherapy.

Take this medicine with a large glass of water. Imatinib should be taken with a meal. Do not take the medicine on an empty stomach.

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. Skip the missed dose if it is almost time for your next meal. Do not take extra medicine to make up the missed dose.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking imatinib?

You should not use this medication if you are allergic to imatinib.

To make sure you can safely take imatinib, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease;

underactive thyroid, recent or upcoming thyroid surgery;

heart disease, congestive heart failure;

history of stomach ulcer or bleeding; or

if you are receiving chemotherapy.

FDA pregnancy category D. Do not use imatinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether imatinib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Imatinib can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not give this medication to anyone under 2 years old without medical advice.

How should I take imatinib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a large glass of water.

You may dissolve the imatinib tablet in water or apple juice to make swallowing easier.

Imatinib should be taken with a meal. Do not take imatinib on an empty stomach.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your weight and liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

See also: Imatinib dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe muscle cramps.

What should I avoid while taking imatinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Imatinib side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

swelling, rapid weight gain, feeling short of breath (even with mild exertion);

black, bloody, or tarry stools;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

coughing up blood or vomit that looks like coffee grounds;

lower back pain, blood in your urine;

urinating less than usual or not at all;

numbness or tingly feeling around your mouth;

muscle weakness, tightness, or contraction, overactive reflexes;

fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting; or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

mild nausea or stomach pain, vomiting, diarrhea;

muscle cramps;

joint or muscle pain;

headache, feeling tired; or

stuffy nose, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Imatinib Dosing Information

Usual Adult Dose for Chronic Myelogenous Leukemia:

Chronic phase: 400 mg orally once a day.
Accelerated phase: 600 mg orally once a day.

Disease progression chronic phase: 600 mg orally once a day.
Disease progression accelerated phase: 400 mg orally twice a day.

A dose increase from 400 mg to 600 mg in adult patients with chronic phase disease, or from 600 mg to 800 mg (given as 400 mg twice daily) in adult patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least three months of treatment, failure to achieve a cytogenetic response after six to twelve months of treatment, or loss of a previously achieved hematologic or cytogenetic response.

Dose adjustments for Chronic Phase CML (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

Dose adjustments for Ph+ CML: Accelerated Phase and Blast Crisis (starting dose 600 mg)
ANC less than 0.5 x 10(9)/L and/or Platelets less than 10 x 10(9)/L:
1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2. If cytopenia is unrelated to leukemia, reduce dose of imatinib to 400 mg.
3. If cytopenia persists 2 weeks, reduce further to 300 mg.
4. If cytopenia persists 4 weeks and is still unrelated to leukemia, stop imatinib until ANC greater than or equal to 1 x 10(9)/L and platelets greater than or equal to 20 x 109/L and then resume treatment at 300 mg.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

For adult patients with unresectable and/or metastatic, malignant GIST:
Recommended dose: 400 mg/day
A dose increase up to 800 mg daily (given as 400 mg twice daily) may be considered, as clinically indicated, in patients showing clear signs or symptoms of disease progression at a lower dose and in the absence of severe adverse drug reactions.

For the adjuvant treatment of adult patients following complete gross resection of GIST:
Recommended dose: 400 mg/day
In the clinical study, imatinib was administered for one year. The optimal treatment duration with imatinib is not known.

Dose adjustments for GIST (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at the original starting dose of 400 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at a reduced dose of 300 mg.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

For use in the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL):

Recommended dose: 600 mg/day for adult patients with relapsed/refractory Ph+ ALL

Dose adjustments for ALL (starting dose 600 mg)
ANC less than 0.5 x 10(9)/L and/or Platelets less than 10 x 10(9)/L:
1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2. If cytopenia is unrelated to leukemia, reduce dose of imatinib to 400 mg.
3. If cytopenia persists 2 weeks, reduce further to 300 mg.
4. If cytopenia persists 4 weeks and is still unrelated to leukemia, stop imatinib until ANC greater than or equal to 1 x 10(9)/L and platelets greater than or equal to 20 x 109/L and then resume treatment at 300 mg.

Usual Adult Dose for Systemic Mastocytosis:

Recommended dose: 400 mg/day for patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with imatinib 400 mg/day may be considered for patients with ASM not responding satisfactorily to other therapies.

Dose adjustments for ASM (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

For patients with ASM associated with eosinophilia (a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRalpha):
Recommended starting dose: 100 mg/day
A dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

Dose adjustments for ASM associated with eosinophilia (starting dose 100 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).

Usual Adult Dose for Hypereosinophilic Syndrome:

For patients with hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL):
Recommended dose: 400 mg/day

Dose adjustments for HES/CEL (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

For patients with HES/CEL patients with demonstrated FIP1L1-PDGFRalpha fusion kinase:
Recommended starting dose: 100 mg/day
Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

Dose adjustments for HES/CEL with FIP1L1-PDGFRalpha fusion kinase (starting dose 100 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).

Usual Adult Dose for Chronic Eosinophilic Leukemia:

Usual Adult Dose for Dermatofibrosarcoma Protuberans:

Recommended dose: 800 mg/day for patients with dermatofibrosarcoma protuberans (DFSP)

Dose adjustments for DFSP (starting dose 800 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 X 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at 600 mg.
3. In the event of recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at reduced dose of 400 mg.

Usual Adult Dose for Myeloproliferative Disorders:

Recommended dose: 400 mg/day for patients with myelodysplastic/myeloproliferative diseases (MDS/MPD)

MDS/MPD (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

Usual Adult Dose for Myelodysplastic Diseases:

Usual Pediatric Dose for Chronic Myelogenous Leukemia:

Greater than 3 years: Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase: 260 mg/m2 orally once a day or 130 mg/m2 twice a day (morning and evening)

Dose adjustments for pediatric patients with chronic phase CML recurring after transplant or resistant to interferon (starting dose 260 mg/m2)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
3. In the event of recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at reduced dose of 200 mg/m2.

Dose adjustments for newly diagnosed pediatric chronic phase CML (starting dose 340 mg/m2)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop imatinib until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
3. In the event of recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.

What other drugs will affect imatinib?

Many drugs can interact with or be affected by imatinib. Below is just a partial list. Tell your doctor if you are using:

bosentan (Tracleer);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

digoxin (digitalis, Lanoxin, Lanoxicaps);

fentanyl (Actiq, Duragesic, Fentora);

isoniazid (for treating tuberculosis);

nefazodone;

pimozide (Orap);

sirolimus (Rapamune) or tacrolimus (Prograf);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketex);

antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

a blood thinner such as warfarin (Coumadin, Jantoven);

cholesterol-lowering medicines such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), simvastatin (Zocor, Simcor, Vytorin);

ergot medicine such as ergotamine (Ergomar, Cafergot) or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray);

heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), divalproex (Depakote), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), primidone (Mysoline), valproic acid (Depakene).

This list is not complete and other drugs may interact with imatinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More imatinib resources

Imatinib Side Effects (in more detail)
Imatinib Dosage
Imatinib Use in Pregnancy & Breastfeeding
Imatinib Drug Interactions
Imatinib Support Group
12 Reviews for Imatinib - Add your own review/rating

imatinib Advanced Consumer (Micromedex) - Includes Dosage Information

Imatinib Professional Patient Advice (Wolters Kluwer)

Imatinib MedFacts Consumer Leaflet (Wolters Kluwer)

Gleevec Prescribing Information (FDA)

Gleevec Monograph (AHFS DI)

Gleevec Consumer Overview

Compare imatinib with other medications

Acute Lymphoblastic Leukemia
Chronic Eosinophilic Leukemia
Chronic Myelogenous Leukemia
Dermatofibrosarcoma Protuberans
Gastrointestinal Stromal Tumor
Hypereosinophilic Syndrome
Myelodysplastic Diseases
Myeloproliferative Disorders
Systemic Mastocytosis

Where can I get more information?

Your pharmacist can provide more information about imatinib.

See also: imatinib side effects (in more detail)

Web PLR Content Directory Federated States of Micronesia

Thursday, 22 September 2016

imatinib