Dasatinib Teva (Dasatinib)
Tyrosine kinase inhibitor for chronic myeloid leukaemia and acute lymphoblastic leukaemia
Dasatinib Teva is a prescription tyrosine kinase inhibitor (TKI) containing the active substance dasatinib. It is used to treat chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) in adults. Dasatinib works by blocking the abnormal BCR-ABL protein that drives the growth of leukaemia cells. This guide covers its uses, dosing, side effects, drug interactions, and important safety information based on EMA, FDA, and international oncology guidelines.
Quick Facts
Key Takeaways
- Dasatinib Teva is a second-generation tyrosine kinase inhibitor used for CML (all phases) and Ph+ ALL, including in patients resistant to or intolerant of imatinib.
- It is taken orally once daily and can be administered with or without food; tablets must not be crushed or chewed.
- Common side effects include myelosuppression, pleural effusion, headache, diarrhoea, and skin rash — regular blood monitoring is essential.
- Dasatinib has significant drug interactions with strong CYP3A4 inhibitors, inducers, and acid-reducing agents that affect its absorption.
- It is contraindicated in pregnancy and breastfeeding; effective contraception is required during treatment and for at least 30 days after the last dose.
What Is Dasatinib Teva and What Is It Used For?
Dasatinib Teva contains the active substance dasatinib, a potent second-generation tyrosine kinase inhibitor (TKI) developed to treat blood cancers driven by the Philadelphia chromosome — an abnormal genetic change that produces the BCR-ABL fusion protein. This protein acts as an uncontrolled signal that causes white blood cells to grow and multiply abnormally, leading to leukaemia. Dasatinib binds to this protein and blocks its activity, thereby slowing or stopping the growth of leukaemia cells.
The medicine is approved for use in several clinical settings. In newly diagnosed adult patients with chronic phase CML (CML-CP), dasatinib can be prescribed as a first-line treatment. It is also indicated for adults with chronic, accelerated, or blast phase CML who have shown resistance to or intolerance of prior therapy, including first-generation TKIs such as imatinib. Additionally, dasatinib is used for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to or intolerant of prior therapy.
Dasatinib is classified as a multi-targeted kinase inhibitor because it does not only block BCR-ABL. It also inhibits SRC family kinases (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFR-beta. This broader kinase inhibition profile contributes to its efficacy in patients who have developed resistance to imatinib through BCR-ABL mutations. In laboratory studies, dasatinib has been shown to be approximately 325-fold more potent than imatinib against unmutated BCR-ABL, and it retains activity against most imatinib-resistant BCR-ABL mutations, with the notable exception of the T315I mutation.
The development of dasatinib represented a significant advance in the treatment of CML. The landmark DASISION (Dasatinib versus Imatinib Study in Treatment-Naive CML Patients) trial demonstrated that dasatinib achieved faster and deeper molecular responses compared to imatinib in newly diagnosed CML-CP patients. Dasatinib Teva is a generic version of the originator product, containing the same active substance in bioequivalent formulations, ensuring comparable efficacy and safety profiles.
As a targeted therapy, dasatinib has transformed the prognosis for many CML patients. With appropriate treatment and monitoring, the majority of chronic phase CML patients treated with TKIs can expect near-normal life expectancy. The World Health Organization (WHO) includes dasatinib on its Model List of Essential Medicines, underscoring its critical role in oncology care globally.
What Should You Know Before Taking Dasatinib Teva?
Contraindications
Dasatinib Teva is contraindicated in patients with known hypersensitivity to dasatinib or any of the excipients in the formulation. Before starting treatment, your doctor will ensure that the diagnosis of Philadelphia chromosome-positive CML or ALL has been confirmed through appropriate laboratory testing, such as fluorescence in situ hybridisation (FISH) or polymerase chain reaction (PCR).
There are no absolute contraindications related to organ function, but significant caution is required in patients with severe hepatic impairment, as dasatinib is extensively metabolised by the liver. Patients with pre-existing severe cardiac conditions, particularly those with QT prolongation or uncontrolled heart failure, require careful risk-benefit assessment before treatment initiation.
Warnings and Precautions
Several important warnings apply to dasatinib therapy. Myelosuppression (suppression of bone marrow function) is one of the most significant risks. Complete blood counts should be performed weekly for the first 2 months of treatment, then monthly thereafter, or as clinically indicated. Severe neutropenia, thrombocytopenia, and anaemia may require dose interruption, dose reduction, or discontinuation of treatment.
Pleural effusion (fluid accumulation around the lungs) occurs in approximately 20–35% of patients taking dasatinib. Symptoms include shortness of breath, dry cough, and chest pain. Contact your healthcare provider immediately if you develop any respiratory symptoms. Treatment may need to be interrupted and may require thoracentesis and/or dose reduction.
Dasatinib can cause fluid retention in various forms beyond pleural effusion, including pericardial effusion, ascites, peripheral oedema, and pulmonary oedema. Patients should be weighed regularly and monitored for signs of fluid accumulation. Patients aged 65 and older, and those with a history of cardiac or pulmonary disease, are at higher risk.
Bleeding events, including serious gastrointestinal haemorrhage and central nervous system (CNS) bleeding, have been reported. Most bleeding events were associated with severe thrombocytopenia. Patients taking anticoagulants or antiplatelet agents may be at increased risk and should be closely monitored.
QT prolongation has been observed in clinical trials. Dasatinib should be used with caution in patients who have or may develop prolonged QTc intervals, including those taking anti-arrhythmic medicines or other drugs known to prolong QT. Hypokalaemia and hypomagnesaemia should be corrected before starting treatment.
Pulmonary arterial hypertension (PAH) has been reported in association with dasatinib treatment, sometimes occurring more than one year after initiation. Before starting treatment, patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease. If PAH is confirmed during treatment, dasatinib should be permanently discontinued.
Pregnancy and Breastfeeding
Dasatinib Teva must not be used during pregnancy unless clearly necessary and the potential benefit justifies the potential risk to the foetus. Animal studies have shown embryo-foetal toxicity, including skeletal malformations, at clinically relevant doses. Women of childbearing potential must use effective contraception during treatment and for at least 30 days after the last dose.
It is not known whether dasatinib is excreted in human breast milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding must be discontinued during treatment with dasatinib and for at least 2 weeks after the last dose. Male patients should be advised that dasatinib may impair fertility.
Dasatinib may cause side effects such as dizziness, blurred vision, and fatigue that can impair your ability to drive or operate machinery. If you experience these symptoms, avoid driving or operating heavy machinery until the effects have resolved.
How Does Dasatinib Teva Interact with Other Drugs?
Drug interactions are a critical consideration with dasatinib therapy, as the medicine is extensively metabolised by cytochrome P450 3A4 (CYP3A4) and its absorption is highly pH-dependent. Understanding these interactions is essential for maintaining therapeutic efficacy and minimising toxicity.
Major Interactions
Strong CYP3A4 inhibitors dramatically increase dasatinib plasma concentrations. Co-administration with ketoconazole increased dasatinib AUC (area under the curve) by approximately 5-fold in clinical pharmacokinetic studies. These combinations should be avoided. If a strong CYP3A4 inhibitor must be used, the dasatinib dose should be reduced and the patient closely monitored for toxicity.
Conversely, strong CYP3A4 inducers substantially decrease dasatinib plasma levels. Rifampicin, for example, reduced dasatinib AUC by approximately 82%. Co-administration with strong CYP3A4 inducers should be avoided if possible. If unavoidable, a dose increase of dasatinib may be considered with close monitoring.
| Interacting Drug | Type | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole, Itraconazole | Strong CYP3A4 inhibitor | Increases dasatinib levels ~5-fold | Avoid; if essential, reduce dasatinib dose |
| Ritonavir, Nelfinavir | Strong CYP3A4 inhibitor | Significantly increases dasatinib levels | Avoid combination |
| Clarithromycin, Telithromycin | Strong CYP3A4 inhibitor | Increases dasatinib levels | Avoid; use alternative antibiotic |
| Rifampicin, Rifabutin | Strong CYP3A4 inducer | Decreases dasatinib levels ~82% | Avoid; consider dose increase if unavoidable |
| Carbamazepine, Phenytoin, Phenobarbital | Strong CYP3A4 inducer | Significantly decreases dasatinib levels | Avoid; use alternative anti-epileptic |
| St John's Wort (Hypericum perforatum) | CYP3A4 inducer | Decreases dasatinib levels unpredictably | Do not use concurrently |
| Proton pump inhibitors (e.g. omeprazole) | Gastric acid suppression | Reduces dasatinib absorption | Avoid; use antacid with 2-hour separation |
| H2-receptor antagonists (e.g. famotidine) | Gastric acid suppression | Reduces dasatinib absorption | Administer at least 2 hours before or after dasatinib |
| Antacids (aluminium/magnesium hydroxide) | Gastric pH elevation | Reduces dasatinib absorption | Administer 2 hours before or after dasatinib |
Minor Interactions
Dasatinib is also a weak inhibitor of CYP3A4 itself. This means it may modestly increase plasma concentrations of other CYP3A4 substrates, such as simvastatin. While this interaction is generally not clinically significant, caution is advised when co-administering dasatinib with CYP3A4 substrates that have a narrow therapeutic index, such as alfentanil, ciclosporin, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus.
Grapefruit and grapefruit juice should be avoided during dasatinib treatment, as they inhibit CYP3A4 in the gut wall and may increase dasatinib levels. Additionally, patients should inform their healthcare provider about all over-the-counter medicines, herbal supplements, and vitamins they are taking, as several herbal products can affect CYP3A4 activity.
What Is the Correct Dosage of Dasatinib Teva?
Treatment with Dasatinib Teva should be initiated by a physician experienced in the diagnosis and treatment of leukaemia. The medicine is taken orally, once daily, either in the morning or evening. Tablets should be swallowed whole with water and should not be crushed, cut, or chewed. Dasatinib can be taken with or without food.
Adults
| Indication | Phase | Recommended Dose | Frequency |
|---|---|---|---|
| CML (newly diagnosed) | Chronic phase | 100 mg | Once daily |
| CML (resistant/intolerant) | Chronic phase | 100 mg | Once daily |
| CML (resistant/intolerant) | Accelerated phase | 140 mg | Once daily |
| CML (resistant/intolerant) | Blast phase (myeloid/lymphoid) | 140 mg | Once daily |
| Ph+ ALL | Resistant/intolerant | 140 mg | Once daily |
Dose escalation to 140 mg once daily (chronic phase) or 180 mg once daily (accelerated/blast phase or Ph+ ALL) may be considered in patients who do not achieve an adequate haematological or cytogenetic response at the recommended starting dose. This should only be done under careful medical supervision with increased monitoring for adverse effects.
Children and Adolescents
Dasatinib Teva 20 mg tablets may be used as part of a dosing regimen for paediatric patients with CML-CP. In children and adolescents (aged 1 year and older), the dose is calculated based on body weight or body surface area, as determined by the prescribing haematologist. The safety and efficacy in children under 1 year of age have not been established. Paediatric dosing requires careful calculation and should only be performed by specialists experienced in paediatric oncology.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, elderly patients may be more susceptible to certain adverse effects, particularly pleural effusion, fluid retention, and cardiac events. More frequent monitoring may be warranted, and dose modifications should be made as clinically indicated. The clinical trials enrolled patients up to 80 years of age, and no major differences in safety or efficacy were observed, although the incidence of pleural effusion was higher in patients aged 65 and older.
Missed Dose
If a dose is missed, patients should take the next scheduled dose at the regular time. Patients should not take a double dose to make up for a missed dose. If a dose is missed and the patient remembers on the same day, the dose can be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped.
Overdose
There is limited clinical experience with dasatinib overdose. In clinical trials, isolated cases of overdose with doses up to 280 mg per day were reported and were associated with severe myelosuppression and bleeding. There is no specific antidote for dasatinib overdose. In the event of overdose, the patient should be observed and given appropriate supportive care. Due to the low likelihood that dasatinib is removed by dialysis (given its high protein binding), haemodialysis is unlikely to be effective.
Dose reduction or temporary discontinuation may be required for haematological toxicity (neutropenia, thrombocytopenia) or non-haematological toxicity (pleural effusion, fluid retention). Your haematologist will guide any dose adjustments based on blood test results and clinical assessment. The minimum recommended dose is 80 mg once daily for chronic phase CML and 80 mg once daily for advanced disease.
What Are the Side Effects of Dasatinib Teva?
Like all medicines, Dasatinib Teva can cause side effects, although not everybody gets them. Some side effects may be serious and require medical attention. The side effects listed below are based on clinical trial data involving thousands of patients, as well as post-marketing surveillance reports. The frequency categories follow international conventions established by the Council for International Organizations of Medical Sciences (CIOMS).
Very Common
- Neutropenia (low white blood cell count)
- Thrombocytopenia (low platelet count)
- Anaemia (low red blood cell count)
- Pleural effusion (fluid around the lungs)
- Headache
- Diarrhoea
- Nausea
- Skin rash
- Musculoskeletal pain
- Fatigue
- Fluid retention (superficial oedema)
Common
- Upper respiratory tract infection
- Pneumonia
- Febrile neutropenia
- Pericardial effusion (fluid around the heart)
- Abdominal pain
- Vomiting
- Dyspnoea (shortness of breath)
- Cough
- Haemorrhage (bleeding events, including GI)
- Pyrexia (fever)
- Dizziness
- Appetite decreased
- Weight increase
- Pruritus (itching)
- Alopecia (hair thinning)
- Hypertension
- Arrhythmia
Uncommon
- Pulmonary arterial hypertension (PAH)
- QT prolongation
- Myocardial infarction (heart attack)
- Congestive heart failure
- Pancreatitis
- CNS bleeding
- Tumour lysis syndrome
- Hepatitis
- Renal failure
- Gynecomastia
Rare
- Thrombotic microangiopathy
- Livedo reticularis
- Interstitial lung disease
- Stevens-Johnson syndrome
- Pure red cell aplasia
Myelosuppression is the most predictable adverse effect of dasatinib. Grade 3-4 neutropenia and thrombocytopenia occur more frequently in patients with advanced CML or Ph+ ALL compared to chronic phase CML. Blood counts should be monitored weekly during the first 2 months and monthly thereafter. Dose modification guidelines are provided in the prescribing information to manage haematological toxicity.
Pleural effusion is a characteristic side effect of dasatinib that distinguishes it from other TKIs. The mechanism is thought to involve immune-mediated effects, possibly related to dasatinib's inhibition of PDGFR-beta and SRC family kinases in the pulmonary vasculature. The once-daily dosing schedule (compared to the original twice-daily schedule) has been shown to reduce the incidence of pleural effusion. Management includes dose interruption, diuretics, and in some cases thoracentesis (drainage of fluid).
Hepatotoxicity has been reported with dasatinib, including elevated transaminases (ALT, AST) and bilirubin. Liver function tests should be performed before starting treatment and periodically during therapy. Patients with pre-existing hepatic impairment require more frequent monitoring.
Contact your doctor or seek emergency medical care immediately if you experience: sudden shortness of breath or chest pain (possible pleural/pericardial effusion), unusual bleeding or bruising (possible severe thrombocytopenia), high fever with chills (possible febrile neutropenia), sudden weakness on one side of the body (possible stroke), or severe abdominal pain (possible gastrointestinal bleeding or pancreatitis).
How Should You Store Dasatinib Teva?
Dasatinib Teva film-coated tablets should be stored at temperatures not exceeding 30°C (86°F). The tablets should be kept in the original blister packaging until use to protect them from moisture. No special storage conditions regarding light protection are required, although it is good practice to store medicines away from direct sunlight.
As with all medicines, keep Dasatinib Teva out of the sight and reach of children. Do not use the medicine after the expiry date stated on the carton and blister pack after "EXP." The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Cytotoxic medicines require special disposal procedures in many jurisdictions to prevent environmental contamination. Unused or expired dasatinib tablets should be returned to a pharmacy or disposed of through an appropriate pharmaceutical waste programme.
If a tablet is accidentally crushed or broken, contact with the powder should be minimised. The broken tablet should not be taken, and hands should be washed thoroughly if any skin contact occurs. Caregivers and family members should avoid direct contact with crushed or broken tablets.
What Does Dasatinib Teva Contain?
The active substance in Dasatinib Teva is dasatinib. Each film-coated tablet contains 20 mg of dasatinib (as dasatinib monohydrate). Dasatinib monohydrate is a white to off-white powder with the molecular formula C22H26ClN7O2S·H2O and a molecular weight of 506.02 g/mol (monohydrate form).
The tablet core typically contains the following excipients: lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), hydroxypropylcellulose (E463), and magnesium stearate (E470b). The film coating contains hypromellose (E464), titanium dioxide (E171), and macrogol/polyethylene glycol.
Dasatinib Teva tablets contain lactose monohydrate. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Consult your doctor if you have been told you have an intolerance to some sugars.
The 20 mg tablets are typically white to off-white, round, biconvex film-coated tablets. The exact appearance may vary slightly between batches but will be consistent with the description on the packaging. Each pack contains the tablets in aluminium/aluminium blister packs designed to protect the medicine from moisture.
Frequently Asked Questions About Dasatinib Teva
Dasatinib Teva is used to treat chronic myeloid leukaemia (CML) in all phases (chronic, accelerated, and blast phase) and Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) in adults. It can be used as first-line treatment for newly diagnosed chronic phase CML, or for patients who are resistant to or cannot tolerate prior therapy with other tyrosine kinase inhibitors such as imatinib.
The most common side effects include myelosuppression (low blood cell counts including neutropenia, thrombocytopenia, and anaemia), pleural effusion (fluid around the lungs), headache, diarrhoea, nausea, skin rash, fatigue, and musculoskeletal pain. Pleural effusion is a characteristic side effect that occurs in approximately 20-35% of patients and may require dose adjustment.
Yes, Dasatinib Teva can be taken with or without food. However, it is important to swallow the tablets whole with water — do not crush, cut, or chew them. You should avoid grapefruit and grapefruit juice while taking dasatinib, as these can increase the medicine's levels in your blood. Also avoid antacids and proton pump inhibitors, as they reduce absorption.
Dasatinib is a second-generation tyrosine kinase inhibitor that is approximately 325 times more potent than imatinib against BCR-ABL in the laboratory. It binds to both active and inactive forms of the BCR-ABL protein and also targets SRC family kinases. This broader activity makes dasatinib effective against most imatinib-resistant BCR-ABL mutations (except T315I). Dasatinib is taken once daily, while imatinib is also taken once daily but at higher doses (400-800 mg).
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose. If you are unsure about what to do, contact your pharmacist or healthcare provider for advice.
No, Dasatinib Teva should not be used during pregnancy unless absolutely necessary and the benefits clearly outweigh the risks. Animal studies have shown that dasatinib can cause harm to a developing foetus. Women of childbearing potential must use effective contraception during treatment and for at least 30 days after the last dose. Breastfeeding must also be avoided during treatment and for at least 2 weeks after the last dose.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-2270. doi:10.1056/NEJMoa1002315
- European Medicines Agency (EMA). Summary of Product Characteristics: Dasatinib Teva. Available at: www.ema.europa.eu
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia. Version 2025.
- Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34:966-984. doi:10.1038/s41375-020-0776-2
- Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naive chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333-2340.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO.
- Shah NP, Guilhot F, Cortes JE, et al. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014;123(15):2317-2324.
- British National Formulary (BNF). Dasatinib. Available at: bnf.nice.org.uk
Editorial Team
This article has been reviewed and approved by the iMedic Medical Editorial Team, comprising licensed specialist physicians in oncology, haematology, and clinical pharmacology.
Reviewed by board-certified oncologists and haematologists with clinical expertise in chronic myeloid leukaemia management and tyrosine kinase inhibitor therapy.
All medical claims are based on Level 1A evidence from systematic reviews, randomised controlled trials, and international clinical guidelines (NCCN, ELN, EMA, FDA).
iMedic receives no funding from pharmaceutical companies. All content is independently produced and reviewed according to strict editorial standards.
This article is reviewed at least every 6 months or when significant new evidence emerges. Last reviewed: May 10, 2026.