Dasatinib (Sprycel)

Pronunciation: da-SA-ti-nib.

Generic name
dasatinib
Drug class
BCR-ABL / SRC-family tyrosine kinase inhibitor (antineoplastic agent)
Form
Film-coated tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, varying by market); oral suspension powder 10 mg/mL (UK/EU)
Route
Oral
Legal status
Prescription-only; treatment should be initiated by a physician experienced in the diagnosis and treatment of leukaemia

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Sprycel (6) · Full directory

What dasatinib is and how it works

Dasatinib is a targeted cancer medicine (a kinase inhibitor) used to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) and Ph+ acute lymphoblastic leukaemia (ALL). It works by blocking abnormal proteins that drive the growth of these leukaemia cells. (1) (3)

Dasatinib is a specialist cancer treatment, prescribed and monitored by a doctor experienced in leukaemia care. It requires regular blood tests and monitoring because it can cause serious effects on blood counts, bleeding risk, fluid retention, the heart and lungs, and other organs. Based on a direct check of the current official US, UK, and New Zealand regulatory sources, dasatinib does not carry a formal boxed warning, but it does carry an extensive, genuinely serious set of warnings that must never be minimised. Never start, stop, or change your dose of dasatinib without your specialist's direct guidance.

Mechanism of action: how dasatinib works

Dasatinib is a kinase inhibitor that targets BCR-ABL (the abnormal fusion protein driving Philadelphia chromosome-positive leukaemias) and SRC-family kinases, blocking the abnormal signalling that drives leukaemic cell proliferation. (1) (7)

What dasatinib is used for

Chronic myeloid leukaemia (CML), Philadelphia chromosome-positive

Used to treat newly diagnosed Ph+ CML in chronic phase, and chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML in adults with resistance or intolerance to prior therapy including imatinib. Also approved for paediatric patients 1 year and older with Ph+ CML in chronic phase in several markets (US, UK, EU, Australia, New Zealand). (1) (3) (6)

Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL)

Used to treat adults with Ph+ ALL with resistance or intolerance to prior therapy, and (in several markets) paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy. (1) (3) (7)

Before taking dasatinib

Do not take / not appropriate for

  • Do not take dasatinib if you have a known hypersensitivity (allergic reaction) to dasatinib or any ingredient of the tablets. (all countries where authorised) (3) (7)
  • Do not take dasatinib with grapefruit or grapefruit juice, as this can raise dasatinib levels in your blood. (all countries where authorised) (7)

Tell your clinician about

  • Any history of bleeding problems, low blood counts, or blood clotting issues.
  • Any heart problems, including irregular heart rhythm (including a condition called QT prolongation), heart failure, or heart attack.
  • Any lung problems, including shortness of breath, or a history of pulmonary arterial hypertension.
  • Any liver problems.
  • If you are a chronic carrier of hepatitis B, or have had hepatitis B in the past.
  • Whether you are pregnant, planning pregnancy, or breastfeeding -- dasatinib can cause serious harm to an unborn baby.
  • All other medicines you take, including antacids and any medicines affecting stomach acid, since these can affect how dasatinib is absorbed.
  • If you have difficulty swallowing tablets whole.
(1) (3)

How to take dasatinib

  • Swallow tablets whole. Do not crush, cut, or chew them.
  • Can be taken with or without food, but should be taken consistently either in the morning or in the evening.
  • Avoid grapefruit and grapefruit juice while taking dasatinib.
  • Only your specialist should start, stop, or change your dose or regimen -- never adjust it yourself.
  • If you are prescribed an antacid, take it several hours apart from dasatinib as directed by your clinician, since antacids and acid-reducing medicines can lower dasatinib levels.
(1) (7)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Contact your specialist or cancer care team for guidance on a missed dose. Do not take an extra dose to make up for a missed one without specific instructions from your clinician.

Overdose

Seek urgent medical attention if you think you have taken too much dasatinib, or contact a poisons information service. Overdose can worsen the effects described above, including bleeding and blood count problems, and needs specialist assessment and monitoring. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Low blood counts (anaemia, low white blood cells, low platelets).

What to notice: Low blood counts (anaemia, low white blood cells, low platelets).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Fluid retention, including swelling and shortness of breath.

What to notice: Fluid retention, including swelling and shortness of breath.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Diarrhoea, nausea, vomiting, abdominal pain.

What to notice: Diarrhoea, nausea, vomiting, abdominal pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Headache, fatigue, fever, muscle or joint pain.

What to notice: Headache, fatigue, fever, muscle or joint pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Skin rash.

What to notice: Skin rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)

Serious warnings

Signs of serious or fatal bleeding — emergency

Symptoms: Unusual bruising, blood in vomit/stool/urine, severe headache with confusion (possible brain bleeding), coughing up blood, or any unexplained heavy bleeding.

Action: Seek emergency medical help immediately -- dasatinib can cause serious and fatal bleeding, most commonly gastrointestinal, and fatal central nervous system haemorrhage has occurred in clinical trials, generally associated with severe low platelet counts. (1) (3) (7)

Signs of severe myelosuppression (low blood counts) — high caution

Symptoms: Unusual tiredness, frequent infections or fever, easy bruising or bleeding.

Action: Contact your specialist promptly -- dasatinib is associated with severe (Grade 3 or 4) thrombocytopenia, neutropenia, and anaemia, and requires regular blood count monitoring throughout treatment. (1) (3)

Signs of fluid retention (pleural or pericardial effusion, pulmonary oedema) — high caution

Symptoms: Shortness of breath, dry cough, swelling of the legs/ankles, or rapid weight gain.

Action: Contact your specialist promptly for assessment, which may include a chest X-ray -- dasatinib can cause fluid retention that is sometimes severe, including fluid around the lungs (pleural effusion) that may require drainage and oxygen therapy, and fluid around the heart (pericardial effusion) or fluid in the lungs (pulmonary oedema). (1) (3)

Signs of pulmonary arterial hypertension (PAH) — high caution

Symptoms: Progressive shortness of breath, fatigue, or swelling, which can develop even after more than a year of treatment.

Action: Contact your specialist promptly for evaluation -- PAH has been reported with dasatinib and may be reversible on stopping treatment, but if confirmed by right heart catheterisation, dasatinib must be permanently discontinued. (1) (3)

Signs of heart problems (cardiac dysfunction, congestive heart failure, myocardial infarction, or abnormal heart rhythm/QT prolongation) — emergency

Symptoms: Chest pain, palpitations, fainting, severe shortness of breath, or swelling of the legs/ankles.

Action: Seek urgent medical help -- dasatinib can cause cardiac dysfunction, congestive heart failure, and myocardial infarction, and may prolong the QT interval (a heart rhythm measurement), which is monitored more closely in those with existing heart problems or electrolyte imbalances. (1) (3)

Signs of a severe skin reaction (Stevens-Johnson syndrome or erythema multiforme) — emergency

Symptoms: Widespread blistering or peeling skin, painful rash, or sores in the mouth/eyes/genitals.

Action: Seek emergency medical help immediately and stop dasatinib -- severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported. (1)

Signs of tumour lysis syndrome — high caution

Symptoms: Nausea, vomiting, muscle cramps, seizures, or irregular heartbeat, usually early in treatment in patients with a high leukaemia cell burden.

Action: Seek urgent medical attention -- tumour lysis syndrome has been reported with dasatinib; adequate hydration and correction of uric acid levels before starting treatment help reduce this risk. (1)

Pregnancy and embryo-fetal toxicity — high caution

Symptoms: Not applicable -- this is a preventable risk requiring contraception, not a symptom.

Action: Dasatinib can cause serious harm to an unborn baby, including suspected congenital malformations. Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for 30 days after the last dose. Tell your specialist immediately if you are or may be pregnant. (1) (3)

Signs of liver problems (hepatotoxicity) — caution

Symptoms: Yellowing of the skin/eyes (jaundice), dark urine, unusual tiredness, or abdominal pain.

Action: Contact your specialist promptly -- dasatinib can cause liver toxicity, measured by changes in bilirubin and liver enzymes, and requires periodic liver function monitoring. (1)

Hepatitis B reactivation (in chronic carriers) — high caution

Symptoms: Not applicable -- risk depends on hepatitis B carrier status, checked before treatment.

Action: Tell your specialist if you are a chronic hepatitis B carrier or have had hepatitis B before starting dasatinib -- reactivation has occurred with BCR-ABL tyrosine kinase inhibitors as a class, sometimes resulting in acute liver failure or death. (3)

Effects on growth and development (paediatric patients) — caution

Symptoms: Slower than expected growth in height, or delayed bone development.

Action: Children and adolescents taking dasatinib should have their growth and bone development monitored by their treating specialist -- adverse reactions associated with bone growth and development have been reported. (1)

Interactions

  • Strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, ritonavir) may increase dasatinib levels -- your specialist may prescribe a lower dose or choose an alternative medicine. (1)
  • Strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, St John's Wort) may decrease dasatinib levels and should generally be avoided -- your specialist may prescribe a higher dose if one cannot be avoided. (1)
  • Antacids and H2 antagonists/proton pump inhibitors may decrease dasatinib absorption -- your clinician may advise timing antacids several hours apart, or choosing an alternative acid-reducing approach. (1)
  • Grapefruit and grapefruit juice may increase dasatinib levels and should be avoided. (7)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Dasatinib can cause serious fetal harm, including suspected congenital malformations (e.g. neural tube defects) and effects such as hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia. Effective contraception is required during treatment. Tell your specialist immediately if you are or may be pregnant. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Breastfeeding is not recommended during treatment and for 2 weeks after the last dose in the US label; Health Canada labelling states breastfeeding is contraindicated outright -- a genuine, disclosed difference between markets. Discuss with your specialist. (1) (2) (3) (4) (5) (6) (7)

Children

Approved in several markets (US, UK, EU, Australia, New Zealand) for paediatric patients 1 year and older with Ph+ CML chronic phase, and for newly diagnosed Ph+ ALL in combination with chemotherapy, with dosing based on body weight; Health Canada's approved indications differ and safety/efficacy under 18 have not been established in that market -- disclosed distinctly. (1) (2) (3) (4) (5) (6) (7)

Elderly

No clinically relevant age-related pharmacokinetic differences observed; no specific dose recommendation is necessary based on age alone. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

May receive the recommended starting dose, but caution is advised, with closer monitoring in patients with hepatic impairment. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

Renal clearance of dasatinib and its metabolites is low (under 4%), so a dose decrease is not generally expected to be necessary for renal impairment alone. (1) (2) (3) (4) (5) (6) (7)

Source_ids

US-FDA-SPRYCEL-LABEL-2024,UK-EMC-SPRYCEL-100MG-2026,NZ-MEDSAFE-SPRYCEL-2026 (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Full blood count and blood chemistry, including uric acid and electrolytes.
  • Cardiac assessment, including ECG if there are risk factors for QT prolongation.
  • Assessment for pulmonary hypertension risk factors and existing lung/heart conditions.
  • Hepatitis B status in at-risk patients.
  • Liver function tests.
  • Pregnancy status and contraception counselling.

During treatment

  • Regular complete blood counts (weekly initially in advanced-phase disease, then less frequently as directed).
  • Monitoring for signs of bleeding, fluid retention, breathlessness, and cardiac symptoms.
  • Periodic liver function testing.
  • Growth and bone development monitoring in children and adolescents.
  • Ongoing contraception for those of reproductive potential.
(1)

Storage

Store according to the instructions on your specific product packaging; keep out of reach of children. Tablets should not be crushed, cut, or chewed to minimise the risk of dermal exposure to the medicine.

Professional information

Clinician-facing context only, sourced from the current US prescribing information, UK SmPC, and NZ data sheet reviewed; verify against the current full label before prescribing.

United States, United Kingdom, European Union, Australia, New Zealand

Indication: Ph+ CML (chronic/accelerated/blast phase) and Ph+ ALL, adult and paediatric (1 year+) where approved

Dose summary: Adults: 100 mg once daily (chronic phase CML) or 140 mg once daily (accelerated/blast phase CML, Ph+ ALL); dose escalation to 140 mg (chronic phase) or 180 mg (advanced phase/Ph+ ALL) considered without adequate response. Paediatric: weight-based dosing (10 kg minimum; no data under 1 year), recalculated every 3 months. Dose reductions for myelosuppression and non-haematologic toxicity per structured tables in each label.

Renal context: Renal clearance of dasatinib is under 4%; no specific dose decrease generally expected necessary for renal impairment alone. (1) (7)

Canada

Indication: Ph+ CML and Ph+ ALL in adults

Dose summary: Health Canada's approved indications and paediatric position differ from the other 5 markets reviewed -- paediatric safety/efficacy under 18 not established per Health Canada labelling at the time of the sources reviewed; consult the current Canadian product monograph directly for paediatric status.

Renal context: Not separately detailed in the sources reviewed for Canada; refer to the current product monograph. (5)

Mechanism of action

Hepatic guidance

Caution advised in hepatic impairment; recommended starting dose may still be used with closer monitoring.

Overdose note

No specific antidote; manage supportively with close monitoring for bleeding, myelosuppression, and cardiopulmonary effects, and involve a poisons information service as needed. (1) (7)

Frequently asked questions

Does dasatinib (Sprycel) have an FDA boxed warning?

No. A direct check of the current (July 2024) US FDA prescribing information, the current UK SmPC, and the current New Zealand data sheet confirms there is no boxed warning. However, dasatinib does carry an extensive set of genuinely serious warnings in the standard Warnings and Precautions section, including serious and sometimes fatal bleeding, severe effects on blood counts, fluid retention, heart and lung effects (including pulmonary arterial hypertension), severe skin reactions, and a real risk of harm to an unborn baby. These are not boxed, but they are real and must never be minimised. (1) (3) (7)

Can I take dasatinib if I am pregnant or trying to become pregnant?

Dasatinib can cause serious harm to an unborn baby and is suspected to cause congenital malformations. If you are of reproductive potential (or your partner is), effective contraception is required during treatment and for a period afterwards (30 days per the US label). Tell your specialist immediately if you are, or may be, pregnant, and do not stop or change your treatment without their guidance. (1) (3)

Why do I need regular blood tests while taking dasatinib?

Dasatinib commonly causes severe reductions in blood counts (platelets, white blood cells, and red blood cells), and can also cause serious, sometimes fatal, bleeding. Regular full blood counts let your specialist catch and manage these effects early, adjusting your dose or pausing treatment if needed. (1) (3)

What is the mechanism of action of dasatinib?

Dasatinib is a kinase inhibitor that targets BCR-ABL (the abnormal fusion protein driving Philadelphia chromosome-positive leukaemias) and SRC-family kinases, blocking the abnormal signalling that drives leukaemic cell proliferation. (1) (7)

What is the generic name of Dasatinib (Sprycel)?

The generic name is dasatinib. (1) (4)

What class of drug is dasatinib?

Dasatinib (Sprycel) is classed as: BCR-ABL / SRC-family tyrosine kinase inhibitor (antineoplastic agent). (1) (4)

References

  1. SPRYCEL (dasatinib) tablets -- full prescribing information, Reference ID 5422933U.S. Food and Drug Administration, current approved prescribing information (accessdata.fda.gov) · United States · dated 2024-07-01 · accessed 2026-07-30 · source 1
  2. SPRYCEL (dasatinib) tablet -- current DailyMed labelU.S. Food and Drug Administration / DailyMed (NIH) · United States · dated 2024-07-01 · accessed 2026-07-30 · source 2
  3. Sprycel 100mg Film Coated Tablets -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Bristol-Myers Squibb Pharma EEIG · United Kingdom · dated 2026-01-01 · accessed 2026-07-30 · source 3
  4. Sprycel (dasatinib) -- EPAR medicine overviewEuropean Medicines Agency (EMA) -- centralised marketing authorisation · European Union · dated 2006-11-01 · accessed 2026-07-30 · source 4
  5. SPRYCEL (dasatinib) -- Product MonographHealth Canada product monograph, Bristol-Myers Squibb Canada · Canada · dated 2024-08-06 · accessed 2026-07-30 · source 5
  6. SPRYCEL (dasatinib) -- ARTG entries (e.g. 50 mg tablet 125559), sponsor Bristol-Myers Squibb Australia Pty LtdTherapeutic Goods Administration (TGA), Australia · Australia · dated 2007-01-15 · accessed 2026-07-30 · source 6
  7. SPRYCEL 20/50/70/100 mg film-coated tablets -- New Zealand Data Sheet (Version 23.0)Medsafe (New Zealand regulator) -- Bristol-Myers Squibb (NZ) Limited · New Zealand · dated 2026-01-01 · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient dasatinib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • PHYRAGO20 mg, 70 mg, 80 mg, 100 mg, 50 mg, 140 mg · cycle pharmaceuticals ltd
  • SPRYCEL70 mg, 140 mg, 50 mg, 20 mg, 100 mg, 80 mg · e.r. squibb & sons, l.l.c.

United Kingdom

  • Sprycel (3)MHRA licensed emc smpc confirmed no boxed warning · 20mg, 50mg, 70mg, 80mg, 100mg, 140mg tablets, 10mg/mL oral suspension powder · Bristol-Myers Squibb Pharma EEIG

Canada

  • SPRYCEL

Australia

  • Sprycel (6)TGA ARTG registered since 2007-01-15 · Bristol-Myers Squibb Australia Pty Ltd · Australian Product Information PDF could not be live-fetched this session (HTTP 421); registration/indication facts corroborated via TGA's own ARTG and AusPAR pages instead.

New Zealand

  • Sprycel (7)medsafe data sheet confirmed version 23.0 no boxed warning · 20mg, 50mg, 70mg, 100mg · Bristol-Myers Squibb (NZ) Limited
View brands in additional countries.

European Union

Sprycel (4)

This page provides general reference information about dasatinib (Sprycel), a specialist cancer treatment, and is not a substitute for advice from the specialist managing your leukaemia care. Never start, stop, or change your dose without their direct guidance.

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