Imatinib Teva: Uses, Dosage & Side Effects

A tyrosine kinase inhibitor (TKI) used in the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors, and several other malignancies driven by specific oncogenic kinases

Rx ATC: L01EA01 Tyrosine Kinase Inhibitor
Active Ingredient
Imatinib (as mesylate)
Available Forms
Film-coated tablet, Hard capsule
Strength
100 mg
Manufacturer
Teva Pharmaceutical Industries

Imatinib Teva is a targeted cancer therapy containing the active substance imatinib, a selective tyrosine kinase inhibitor that revolutionized the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It works by blocking the BCR-ABL fusion protein, the KIT receptor, and platelet-derived growth factor receptors (PDGFR) that drive the uncontrolled growth of cancer cells. Imatinib Teva is a generic version of the original imatinib product and is approved for the treatment of CML in adults and children, Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), GIST, and several other rare cancers. It is taken orally as a tablet and requires a prescription from a specialist physician experienced in cancer treatment.

Quick Facts: Imatinib Teva

Active Ingredient
Imatinib mesylate
Drug Class
Tyrosine Kinase Inhibitor
ATC Code
L01EA01
Common Uses
CML, GIST, Ph+ ALL
Available Forms
Tablet, Capsule
Prescription Status
Rx Only

Key Takeaways

  • Imatinib Teva (imatinib mesylate) is a tyrosine kinase inhibitor that blocks the BCR-ABL protein responsible for chronic myeloid leukemia, as well as KIT and PDGFR kinases involved in GIST and other cancers, transforming previously fatal diseases into manageable chronic conditions.
  • It is approved for multiple indications including CML (all phases), Ph+ ALL, GIST (adjuvant and advanced/metastatic), MDS/MPD with PDGFR rearrangements, HES/CEL with FIP1L1-PDGFR-alpha, and DFSP.
  • Common side effects include nausea, diarrhea, muscle cramps, edema (particularly periorbital and lower limb swelling), skin rash, and fatigue; regular blood tests are essential to monitor for myelosuppression and liver toxicity.
  • Treatment must be taken with food to minimize gastrointestinal side effects, swallowed with a large glass of water, and continued for as long as the prescribing physician recommends — treatment interruption without medical guidance can lead to disease progression.
  • Imatinib Teva is not recommended during pregnancy or breastfeeding; effective contraception must be used during treatment and for 15 days after the last dose by both women and men of reproductive potential.

What Is Imatinib Teva and What Is It Used For?

Quick Answer: Imatinib Teva is a tyrosine kinase inhibitor containing the active substance imatinib. It works by selectively blocking the abnormal proteins (BCR-ABL, KIT, PDGFR) that drive the uncontrolled growth of cancer cells in chronic myeloid leukemia, gastrointestinal stromal tumors, and several other malignancies.

Imatinib Teva contains the active substance imatinib (as imatinib mesylate), which belongs to a class of medicines known as protein tyrosine kinase inhibitors. It was one of the first targeted cancer therapies to be developed and has fundamentally changed the outlook for patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Before imatinib became available in 2001, CML had a median survival of approximately 3–5 years from diagnosis; today, patients on imatinib therapy can expect near-normal life expectancy when they achieve and maintain good treatment responses.

The drug works by fitting into the ATP-binding site of specific tyrosine kinase enzymes, thereby preventing them from phosphorylating their downstream substrates and blocking the signaling cascades that promote cancer cell proliferation and survival. Imatinib is highly selective for a limited number of kinase targets: the BCR-ABL fusion protein (the hallmark of CML resulting from the Philadelphia chromosome translocation), the KIT receptor tyrosine kinase (c-Kit, which drives GIST), the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta), and the discoidin domain receptors DDR1 and DDR2. This selectivity means imatinib primarily affects cancer cells expressing these aberrant kinases while largely sparing normal cells, although off-target effects do occur and account for some side effects.

In CML, the Philadelphia chromosome arises from a reciprocal translocation between chromosomes 9 and 22, creating the BCR-ABL fusion gene. The resulting BCR-ABL protein has constitutive (always active) tyrosine kinase activity that drives the overproduction of abnormal white blood cells characteristic of the disease. Imatinib binds to the inactive conformation of BCR-ABL, locking the kinase in its off state and effectively shutting down the leukemic cell proliferation machinery. The European LeukemiaNet (ELN) and National Comprehensive Cancer Network (NCCN) guidelines both recommend imatinib as a standard first-line treatment for newly diagnosed chronic phase CML.

Imatinib Teva is a treatment for adults and children for the following conditions:

  • Chronic myeloid leukemia (CML): Leukemia is a cancer of the white blood cells. CML is a form in which certain abnormal myeloid white blood cells begin to grow uncontrollably. Imatinib Teva is used in all phases of CML (chronic, accelerated, and blast crisis) in adults, and in chronic phase CML in children aged 2 years and older. The landmark IRIS trial demonstrated that imatinib achieved complete cytogenetic responses in over 80% of newly diagnosed chronic phase CML patients, with 10-year overall survival rates exceeding 80%.
  • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL): This is an aggressive form of leukemia in which immature lymphocytes (lymphoblasts) proliferate uncontrollably and carry the Philadelphia chromosome. Imatinib Teva is used in both adults and children, typically in combination with chemotherapy, to improve remission rates and survival outcomes.
  • Gastrointestinal stromal tumors (GIST): GIST is a cancer arising in the supportive connective tissue cells (interstitial cells of Cajal) of the stomach and intestines. The vast majority of GISTs harbor activating mutations in the KIT gene. Imatinib Teva is used for unresectable and/or metastatic GIST, as well as adjuvant treatment after surgical removal of KIT-positive GIST to reduce the risk of recurrence.
  • Myelodysplastic/myeloproliferative diseases (MDS/MPD): These are a group of blood disorders in which certain blood cells proliferate abnormally. Imatinib Teva inhibits the growth of these cells in a specific subgroup of patients whose disease is associated with PDGFR gene rearrangements.
  • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL): These blood disorders involve the overproduction of eosinophils (a type of white blood cell). Imatinib Teva is effective in the subgroup of patients harboring the FIP1L1-PDGFR-alpha fusion kinase.
  • Dermatofibrosarcoma protuberans (DFSP): This is a rare soft tissue cancer of the skin that is driven by a COL1A1-PDGFB fusion gene leading to autocrine activation of PDGFR-beta. Imatinib Teva is used for unresectable, recurrent, or metastatic DFSP in adults who are not eligible for surgery.

Imatinib Teva is a generic version of the original imatinib product. Generic medicines are required to demonstrate bioequivalence to the reference product, meaning they deliver the same amount of active substance to the body at the same rate. The European Medicines Agency (EMA), FDA, and other regulatory authorities have confirmed that Imatinib Teva meets these standards and can be used interchangeably with the original product. Other generic versions available include Imatinib Accord, Imatinib Krka, Imatinib Viatris, Imatinib STADA, and Imatinib Cipla, as well as the originator brand Glivec (Gleevec in the United States).

A Revolution in Cancer Therapy

Imatinib is often cited as one of the most significant advances in the history of cancer treatment. Its development demonstrated that targeting a specific molecular abnormality driving a cancer could produce dramatic and durable responses with manageable side effects. This “targeted therapy” approach paved the way for the development of numerous subsequent kinase inhibitors and other precision oncology drugs. For CML patients, imatinib transformed a disease with a median survival of 3–5 years into a chronic, manageable condition with near-normal life expectancy.

What Should You Know Before Taking Imatinib Teva?

Quick Answer: Do not take Imatinib Teva if you are allergic to imatinib or any of its ingredients. Tell your doctor about any liver, kidney, or heart problems, hepatitis B infection, thyroid surgery, or if you are pregnant or breastfeeding. Imatinib Teva will only be prescribed by a doctor experienced in treating blood cancers or solid tumors.

Before starting treatment with Imatinib Teva, it is essential that your doctor has a complete picture of your health status. Imatinib is a potent medication that requires careful monitoring and can interact with many other drugs. Only physicians with experience in treating blood cancers or solid tumors should prescribe this medication, and all patients should follow their doctor’s instructions carefully, even if they differ from the general information provided here.

Contraindications

There is one absolute contraindication to taking Imatinib Teva:

  • Hypersensitivity: Do not take Imatinib Teva if you are allergic to imatinib or any of the other ingredients in the formulation (including calcium hydrogen phosphate, crospovidone, magnesium stearate, or the tablet film coating components). If you believe you may be allergic but are not certain, consult your doctor before taking the medication.

Warnings and Precautions

Talk to your doctor before taking Imatinib Teva if any of the following applies to you:

  • Liver disease: Imatinib is extensively metabolized by the liver and can cause hepatotoxicity. Patients with pre-existing liver conditions require dose adjustments and more frequent liver function monitoring. Cases of fatal liver failure have been reported, particularly in patients taking imatinib with other hepatotoxic medications.
  • Kidney disease: Impaired kidney function can affect the clearance of imatinib and its metabolites. Dose adjustments may be necessary, and kidney function should be monitored regularly throughout treatment.
  • Heart disease: Cardiac adverse events including congestive heart failure and left ventricular dysfunction have been reported with imatinib treatment, particularly in patients with pre-existing cardiac risk factors or advanced age. Your doctor will monitor your heart function.
  • Levothyroxine use: If you are taking levothyroxine because your thyroid gland has been removed, imatinib may affect thyroid hormone levels and your levothyroxine dose may need adjustment.
  • Hepatitis B infection: If you have ever had or may currently have hepatitis B, imatinib could cause reactivation of the virus, which in some cases can be fatal. Your doctor will check for hepatitis B before starting treatment and will monitor you for signs of reactivation during therapy.
Fluid Retention

Imatinib Teva can cause your body to retain significant amounts of fluid, leading to rapid weight gain, swelling around the eyes, ankles, or abdomen, and in severe cases, pleural effusion or ascites. Tell your doctor immediately if you notice rapid weight gain. Your weight will be monitored regularly during treatment. Severe fluid retention is more common in patients with blast crisis CML, advanced age, and higher doses.

During treatment with Imatinib Teva, you may become more sensitive to sunlight. It is important to protect exposed skin areas with clothing and use sunscreen with a high SPF. These precautions also apply to children taking the medication.

Your doctor will perform regular blood tests throughout treatment to check how well the medicine is working, to monitor your blood cell counts (since imatinib can cause myelosuppression), and to assess your liver and kidney function. You will also be weighed regularly to detect fluid retention early.

Children and Adolescents

Imatinib Teva is also used to treat children and adolescents with CML (aged 2 years and older) and Ph+ ALL. There is limited experience in children with MDS/MPD, DFSP, GIST, and HES/CEL. Some children and adolescents taking imatinib may experience slower growth than normal. Growth should be monitored regularly by the treating physician, and the potential benefits of treatment must be weighed against this risk. Studies have shown that growth velocity may be reduced, particularly in pre-pubertal children, although the long-term impact on final adult height requires further investigation.

Pregnancy and Breastfeeding

  • Pregnancy: Imatinib Teva is not recommended during pregnancy unless clearly necessary, as animal studies and post-marketing data suggest it may harm the developing fetus. There have been reports of spontaneous abortions and congenital abnormalities in infants born to women who took imatinib during pregnancy. Your doctor will discuss the potential risks of taking imatinib during pregnancy with you.
  • Contraception: Women who could become pregnant are advised to use effective contraception during treatment and for 15 days after the last dose. Men of reproductive potential should also be aware that imatinib may affect fertility, and those concerned should discuss sperm cryopreservation with their doctor before starting treatment.
  • Breastfeeding: Do not breastfeed during treatment with Imatinib Teva or for 15 days after the last dose, as imatinib and its metabolites are excreted into breast milk and may harm the nursing infant.

Driving and Using Machines

You may experience dizziness, drowsiness, or blurred vision while taking Imatinib Teva. If these side effects occur, do not drive or operate machinery until you feel well again. These symptoms are more common at the start of treatment and may diminish over time as your body adjusts to the medication.

How Does Imatinib Teva Interact with Other Drugs?

Quick Answer: Imatinib has significant drug interactions because it is both a substrate and an inhibitor of the CYP3A4 enzyme system. CYP3A4 inhibitors (e.g., ketoconazole) increase imatinib levels, while CYP3A4 inducers (e.g., rifampicin, St. John’s Wort) decrease its effectiveness. Imatinib also affects levels of warfarin, simvastatin, cyclosporine, and levothyroxine. Always tell your doctor about all medicines you take.

Imatinib is primarily metabolized by the liver enzyme CYP3A4 and is itself an inhibitor of CYP3A4, CYP2D6, and CYP2C9. This creates a complex interaction profile that requires careful management. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including over-the-counter products (such as paracetamol/acetaminophen) and herbal remedies (such as St. John’s Wort). Some medicines can increase or decrease the effectiveness of imatinib, and imatinib can alter the levels of other drugs in your body.

If you are taking medicines that prevent blood clot formation (anticoagulants), particularly warfarin, your doctor will need to monitor your coagulation parameters closely, as imatinib can alter warfarin metabolism and affect its effectiveness.

Major Interactions

Clinically Significant Drug Interactions
Drug / Class Effect on Imatinib Clinical Action
Ketoconazole, Itraconazole (strong CYP3A4 inhibitors) Significantly increases imatinib plasma levels Avoid combination or reduce imatinib dose; monitor for toxicity
Clarithromycin, Erythromycin (moderate CYP3A4 inhibitors) Moderately increases imatinib levels Use with caution; monitor for increased side effects
Rifampicin, Rifabutin (strong CYP3A4 inducers) Significantly decreases imatinib levels (up to 74%) Avoid combination; consider alternative antimicrobial agents
Phenytoin, Carbamazepine, Phenobarbital (CYP3A4 inducers) Significantly decreases imatinib levels Avoid combination; use alternative antiepileptic agents
St. John’s Wort (Hypericum perforatum) Unpredictably decreases imatinib levels Contraindicated; do not use during imatinib treatment
Grapefruit juice May increase imatinib levels via CYP3A4 inhibition Avoid regular consumption of large amounts

Drugs Affected by Imatinib

Because imatinib inhibits CYP3A4, CYP2D6, and CYP2C9, it can increase the blood levels and effects of many other medications. The following drugs require particular attention:

Drugs Whose Levels Are Increased by Imatinib
Drug Affected Pathway Clinical Consequence
Warfarin CYP2C9 and CYP3A4 Increased bleeding risk; use LMWH instead of warfarin if possible
Simvastatin CYP3A4 Increased statin levels; risk of myopathy/rhabdomyolysis
Cyclosporine CYP3A4 Increased cyclosporine levels; monitor closely and adjust dose
Levothyroxine Thyroid hormone metabolism May need levothyroxine dose increase in thyroidectomized patients
Paracetamol (Acetaminophen) Glucuronidation / CYP interaction Occasional use acceptable; avoid regular high-dose use

What Is the Correct Dosage of Imatinib Teva?

Quick Answer: The typical starting dose for adults with CML is 400–600 mg once daily, depending on the phase of disease. For GIST, the usual starting dose is 400 mg daily. All doses should be taken with a meal and a large glass of water. Your doctor will determine the exact dose based on your condition and response to treatment.

Always take Imatinib Teva exactly as your doctor, pharmacist, or nurse has told you. It is critical to continue taking the medication for as long as prescribed. Do not stop treatment or change your dose without consulting your doctor, even if you feel better, as disease relapse can occur rapidly upon discontinuation. If you are unable to take the medicine as prescribed or feel you no longer need it, contact your doctor immediately.

Adults

Your doctor will inform you of the exact number of tablets to take each day. The dose depends on your specific condition:

Chronic Myeloid Leukemia (CML)

Chronic phase: 400 mg once daily (4 tablets of 100 mg)

Accelerated phase or blast crisis: 600 mg once daily (6 tablets of 100 mg)

Your doctor may increase the dose to 800 mg daily (taken as 400 mg twice daily — morning and evening) if your response is insufficient and you tolerate the medication well. Dose reductions may be required for adverse effects.

Gastrointestinal Stromal Tumors (GIST)

Starting dose: 400 mg once daily (4 tablets of 100 mg)

Your doctor may increase or decrease the dose depending on your response and tolerability. For patients with disease progression, the dose may be escalated to 800 mg daily (400 mg twice daily).

Philadelphia Chromosome-Positive ALL (Ph+ ALL)

Starting dose: 600 mg once daily (6 tablets of 100 mg)

Typically used in combination with chemotherapy as part of a multi-agent treatment protocol.

Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)

Starting dose: 400 mg once daily (4 tablets of 100 mg)

Hypereosinophilic Syndrome (HES) / Chronic Eosinophilic Leukemia (CEL)

Starting dose: 100 mg once daily (1 tablet of 100 mg)

Your doctor may increase the dose to 400 mg once daily depending on your response to treatment.

Dermatofibrosarcoma Protuberans (DFSP)

Dose: 800 mg per day, taken as 400 mg in the morning and 400 mg in the evening (8 tablets of 100 mg total)

Children and Adolescents

The dose for children is calculated based on body weight and height (body surface area). The total daily dose must not exceed 800 mg for CML or 600 mg for Ph+ ALL. Treatment may be given as a single daily dose or split into two doses (morning and evening). Your doctor will determine the appropriate dose for your child.

How to Take Imatinib Teva

  • Take with a meal and a large glass of water to help protect against stomach problems.
  • Swallow the tablets whole. The tablet can be split into two equal halves along the score line.
  • If you cannot swallow tablets, dissolve them in a glass of non-carbonated water or apple juice (approximately 50 ml per 100 mg tablet). Stir with a spoon until fully dissolved, then drink the entire contents immediately.

Missed Dose

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. In that case, skip the missed dose and continue with your normal schedule. Do not take a double dose to make up for a forgotten one.

Overdose

If you accidentally take too many tablets, contact your doctor immediately. You may require medical attention. Bring the medicine packaging with you. Symptoms of overdose may include severe nausea, vomiting, diarrhea, muscle pain, swelling, and abnormalities in blood tests.

Do Not Stop Treatment Without Medical Advice

Discontinuing imatinib without your doctor’s guidance can lead to rapid disease progression. Even patients who have achieved complete molecular responses in CML should only attempt treatment-free remission under close specialist supervision with frequent molecular monitoring, as up to 50–60% of patients may experience molecular relapse upon stopping therapy.

What Are the Side Effects of Imatinib Teva?

Quick Answer: Common side effects include nausea, vomiting, diarrhea, muscle cramps, fatigue, headache, skin rash, and swelling (particularly around the eyes and lower limbs). Serious but less common effects include severe fluid retention, liver toxicity, low blood counts, heart problems, and bleeding. Report any new or worsening symptoms to your doctor.

Like all medicines, Imatinib Teva can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and can often be managed with dose adjustments or supportive care. However, some side effects can be serious and require immediate medical attention. Your doctor will discuss the expected side effects with you and explain when to seek help.

Serious Side Effects — Contact Your Doctor Immediately

The following serious side effects require immediate medical attention:

Very Common (Serious)

May affect more than 1 in 10 people

  • Rapid weight gain due to severe fluid retention (edema)
  • Signs of infection: fever, chills, sore throat, or mouth sores (due to low white blood cell count)
  • Unexpected bleeding or bruising without injury (due to low platelet count)

Uncommon to Rare (Serious)

May affect up to 1 in 100 to 1 in 1,000 people

  • Chest pain, irregular heartbeat (signs of heart problems)
  • Cough, breathing difficulties, or painful breathing (lung problems)
  • Dizziness, lightheadedness, or fainting (low blood pressure)
  • Nausea with dark urine, yellowing of skin or eyes (liver problems)
  • Severe skin rash, blistering, peeling skin, or fever (serious skin reactions)
  • Severe abdominal pain, blood in vomit or stool, black stool (gastrointestinal bleeding)
  • Severely reduced urine output, excessive thirst (kidney problems)
  • Severe headache, weakness, paralysis, difficulty speaking, sudden loss of consciousness (stroke or brain bleeding)
  • Paleness, fatigue, shortness of breath with dark urine (severe anemia)
  • Blood clots in small blood vessels (thrombotic microangiopathy)

Not Known Frequency (Serious)

Frequency cannot be estimated from available data

  • Widespread severe skin rash with fever, nausea, yellowing of skin (drug reaction with systemic symptoms)
  • Chronic kidney failure
  • Reactivation of hepatitis B infection

Other Common Side Effects

Very Common

May affect more than 1 in 10 people

  • Headache or fatigue
  • Nausea, vomiting, diarrhea, or indigestion
  • Skin rash
  • Muscle cramps, joint or bone pain (during or after treatment)
  • Swelling around joints or puffy eyelids (periorbital edema)
  • Weight gain

Common

May affect up to 1 in 10 people

  • Decreased appetite, weight loss, or taste disturbance
  • Dizziness or weakness
  • Insomnia (difficulty sleeping)
  • Watery, itchy, red, swollen eyes (conjunctivitis) or blurred vision
  • Nosebleeds
  • Abdominal pain, bloating, flatulence, heartburn, constipation
  • Itching or hair loss / hair thinning
  • Numbness or tingling in hands and feet (peripheral neuropathy)
  • Mouth sores
  • Dry mouth, dry skin, or dry eyes
  • Hot flushes, chills, or night sweats
  • Joint swelling or stiffness

Uncommon

May affect up to 1 in 100 people

  • Upper respiratory tract infection, sinusitis, influenza-like symptoms
  • Migraine
  • Urinary tract infection
  • Depression or anxiety
  • Drowsiness, tremor, or memory impairment
  • Restless legs syndrome, tinnitus (ringing in the ears)
  • High blood pressure (hypertension)
  • Difficulty swallowing, lip inflammation
  • Increased sweating, skin discoloration, brittle nails
  • Folliculitis (inflammation of hair follicles)
  • Breast enlargement (gynecomastia), erectile dysfunction
  • Heavy or irregular menstrual periods, decreased libido
  • Gastric ulcer, joint and muscle stiffness
  • Frequent urination, increased appetite

Rare

May affect up to 1 in 1,000 people

  • Confusion
  • Nail discoloration

Not Known

Frequency cannot be estimated from available data

  • Redness and/or swelling of palms and soles (palmar-plantar erythrodysesthesia)
  • Painful skin changes with or without blisters
  • Slowed growth in children and adolescents
Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed here. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you help provide more information on the safety of this medicine.

How Should You Store Imatinib Teva?

Quick Answer: Store Imatinib Teva out of sight and reach of children. No special storage conditions are required. Do not use after the expiry date on the packaging, and do not use if the packaging appears damaged or tampered with.

Proper storage of Imatinib Teva is important to ensure the medication remains effective and safe throughout its shelf life. Follow these guidelines:

  • Keep out of reach of children: Store the medicine in a safe location where children cannot see or access it.
  • Check the expiry date: Do not use Imatinib Teva after the expiry date printed on the blister pack and carton after “EXP”. The expiry date refers to the last day of that month.
  • Storage conditions: No special storage conditions are required for Imatinib Teva 100 mg film-coated tablets.
  • Packaging integrity: Do not use the medicine if any packaging appears damaged, has been opened, or shows signs of tampering.
  • Disposal: Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

What Does Imatinib Teva Contain?

Quick Answer: Each film-coated tablet contains 100 mg of imatinib (as imatinib mesylate). The tablets are dark yellow to brown-orange, round, scored on one side, and marked with “IT” and “1”.

Understanding the composition of your medicine can help you identify it and be aware of any excipients that could potentially cause allergic reactions in sensitive individuals.

Active Substance

The active substance is imatinib mesylate. Each Imatinib Teva 100 mg film-coated tablet contains 100 mg of imatinib (as the mesylate salt).

Other Ingredients (Excipients)

  • Tablet core: Calcium hydrogen phosphate, crospovidone, and magnesium stearate
  • Film coating: Partially hydrolyzed polyvinyl alcohol, macrogol, yellow iron oxide (E172), talc, titanium dioxide (E171), and red iron oxide (E172)

Appearance and Pack Sizes

Imatinib Teva 100 mg film-coated tablets are dark yellow to brown-orange, round, film-coated tablets with a score line on one side. They are marked with “IT” and “1” on each side of the score line. The tablets are approximately 9 mm in diameter and can be divided into equal halves.

Available pack sizes include 60 or 120 film-coated tablets in blister packs, or 20×1, 60×1, 120×1, or 180×1 film-coated tablets in perforated unit-dose blisters. Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands. The tablets are manufactured at several Teva facilities across Europe, including sites in Hungary, Czech Republic, Spain, Germany, Poland, and Croatia.

Frequently Asked Questions About Imatinib Teva

Imatinib Teva is a tyrosine kinase inhibitor used to treat chronic myeloid leukemia (CML) in adults and children, Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), gastrointestinal stromal tumors (GIST), myelodysplastic/myeloproliferative diseases (MDS/MPD), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), and dermatofibrosarcoma protuberans (DFSP). It works by blocking specific abnormal proteins that drive uncontrolled cancer cell growth.

The most common side effects (affecting more than 1 in 10 patients) include nausea, vomiting, diarrhea, muscle cramps, musculoskeletal pain, fatigue, headache, skin rash, swelling (particularly around the eyes and in the lower limbs), and weight gain. Most side effects are mild to moderate and can be managed with supportive care or dose adjustments. Serious effects like severe fluid retention, low blood counts, and liver problems require regular monitoring by your doctor.

Take Imatinib Teva with a meal and a large glass of water to reduce stomach upset. Swallow the tablets whole, or split them in half along the score line if needed. If you cannot swallow tablets, dissolve them in approximately 50 ml of non-carbonated water or apple juice per 100 mg tablet, stir until fully dissolved, and drink immediately. Do not stop taking the medicine or change your dose without consulting your doctor.

Imatinib Teva is a generic version of Glivec (known as Gleevec in the United States). Both contain the same active substance, imatinib mesylate, at the same dose strength. Generic medicines must demonstrate bioequivalence to the original product, meaning they deliver the same amount of active substance to the body at the same rate. Regulatory authorities (EMA, FDA) have confirmed that Imatinib Teva meets these requirements and is interchangeable with the original product. The main differences are the manufacturer and typically a lower cost.

Imatinib Teva is not recommended during pregnancy unless clearly necessary, as it may harm the developing fetus. Women who could become pregnant should use effective contraception during treatment and for at least 15 days after the last dose. Breastfeeding must also be avoided during treatment and for 15 days after the final dose, as imatinib is excreted in breast milk. Men concerned about fertility should discuss sperm preservation with their doctor before starting treatment.

Yes, imatinib has important drug interactions. It is metabolized by the liver enzyme CYP3A4, so drugs that strongly inhibit this enzyme (such as ketoconazole) can increase imatinib levels, while drugs that induce CYP3A4 (such as rifampicin, phenytoin, or St. John’s Wort) can significantly reduce its effectiveness. Imatinib also affects the metabolism of warfarin, simvastatin, cyclosporine, and levothyroxine. Always inform your doctor about all medications you take, including herbal remedies and over-the-counter products.

References

  1. European Medicines Agency (EMA). Imatinib Teva — Summary of Product Characteristics. Available at: www.ema.europa.eu. Last updated 2024.
  2. U.S. Food and Drug Administration (FDA). Gleevec (imatinib mesylate) Prescribing Information. Reference ID: 5299072. Revised 2024.
  3. Hochhaus A, Larson RA, Guilhot F, et al. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017;376(10):917–927. doi:10.1056/NEJMoa1609324
  4. Demetri GD, von Mehren M, Blanke CD, et al. Efficacy and Safety of Imatinib Mesylate in Advanced Gastrointestinal Stromal Tumors. N Engl J Med. 2002;347(7):472–480. doi:10.1056/NEJMoa020461
  5. Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966–984. doi:10.1038/s41375-020-0776-2
  6. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia. Version 1.2025.
  7. World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Imatinib is listed as an essential medicine for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors.
  8. Druker BJ, Guilhot F, O’Brien SG, et al. Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia. N Engl J Med. 2006;355(23):2408–2417. doi:10.1056/NEJMoa062867
  9. British National Formulary (BNF). Imatinib. National Institute for Health and Care Excellence. Updated 2025.

Editorial Team

Medical Content

Written by iMedic Medical Editorial Team — specialists in oncology, hematology, and clinical pharmacology

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Reviewed by iMedic Medical Review Board according to EMA, FDA, and NCCN guidelines

Evidence Standard

Level 1A — Based on systematic reviews and meta-analyses of randomized controlled trials (GRADE framework)

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Last reviewed: . This article is reviewed at least every 6 months to ensure accuracy and alignment with current clinical guidelines.