This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Dasatinib oral

Presentation

Oral formulations of dasatinib.

Drugs List

  • dasatinib 100mg tablets
  • dasatinib 10mg/ml powder for oral suspension
  • dasatinib 110.6mg tablets
  • dasatinib 140mg tablets
  • dasatinib 15.8mg tablets
  • dasatinib 20mg tablets
  • dasatinib 39.5mg tablets
  • dasatinib 50mg tablets
  • dasatinib 63.2mg tablets
  • dasatinib 79mg tablets
  • dasatinib 80mg tablets
  • SPRYCEL 100mg film coated tablets
  • SPRYCEL 10mg/ml powder for oral suspension
  • SPRYCEL 140mg film coated tablets
  • SPRYCEL 20mg film coated tablets
  • SPRYCEL 50mg film coated tablets
  • SPRYCEL 80mg film coated tablets
  • UXIL 110.6mg tablets
  • UXIL 15.8mg tablets
  • UXIL 39.5mg tablets
  • UXIL 63.2mg tablets
  • UXIL 79mg tablets
  • Therapeutic Indications

    Uses

    Lymphoid blast chronic myeloid leukaemia
    Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia
    Philadelphia chromosome positive CML - accelerated phase
    Philadelphia chromosome positive CML - chronic phase

    Sprycel tablets and oral suspension

    Adult patients
    Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase.

    Chronic, accelerated or blast phase CML with resistance or intolerance to previous therapy including imatinib mesilate.

    Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

    Paediatric patients
    Ph+ CML in the chronic phase, newly diagnosed or with resistance/intolerance to prior therapy.

    Newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

    Uxil tablets

    Adult patients
    Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.

    Paediatric patients
    Newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

    Dosage

    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    Adults

    Dasatinib tablets (Sprycel)

    Chronic phase CML
    The recommended dose of dasatinib is 100mg once a day. The dose may be increased to 140mg once a day in those who do not respond to the lower dose.

    Accelerated, myeloid, or lymphoid blast phase (advanced phase) CML or Ph+ALL
    The recommended dose of dasatinib is 140mg once daily. The dose may be increased to 180mg once a day in those who do not respond to the lower dose.

    Treatment is continued until disease progression or until no longer tolerated by the patient.

    Dasatinib powder for oral suspension (Sprycel)

    Ph+ Chronic phase CML
    Body weight 45kg or higher: 12ml (120mg) once daily. Body weight 30kg to less than 45kg: 10.5ml (105mg) once daily. Body weight 20kg to less than 30kg: 9ml (90mg) once daily. Body weight 10kg to less than 20kg: 6ml (60mg) once daily. Body weight 5kg to less than 10kg: 4ml (40mg) once daily.

    Dasatinib tablets (Uxil)

    Ph+ALL
    The recommended dose of dasatinib is 110.6mg once a day. The dose may be increased to 142.2mg once a day in those who do not respond to the lower dose.

    Treatment is continued until disease progression or until no longer tolerated by the patient.

    Children

    Dasatinib tablets (Sprycel)

    Ph+ CML in the chronic phase, newly diagnosed or with resistance/intolerance to prior therapy
    Children aged 1 to 18 years:
    Body weight 45kg or higher: 100mg once daily. Body weight 30kg to less than 45kg: 70mg once daily. Body weight 20kg to less than 30kg: 60mg once daily. Body weight 10kg to less than 20kg: 40mg once daily. Body weight below 10kg: Contraindicated. Dose escalations in children who fail to receive a haematologic/cytogenetic response at starting dose: Starting dose of 100mg: Escalate to 120mg. Starting dose of 70mg: Escalate to 90mg. Starting dose of 60mg: Escalate to 70mg. Starting dose of 40mg: Escalate to 50mg. Newly diagnosed Ph+ ALL
    Children aged 1 to 18 years:
    Body weight 45kg or higher: 100mg once daily. Body weight 30kg to less than 45kg: 70mg once daily. Body weight 20kg to less than 30kg: 60mg once daily. Body weight 10kg to less than 20kg: 40mg once daily. Body weight below 10kg: Contraindicated. Since dasatinib is used in combination with chemotherapy for this indication, dose escalation is not recommended for paediatric patients with Ph+ ALL.

    Dasatinib powder for oral suspension (Sprycel)

    Ph+ CML in the chronic phase, newly diagnosed or with resistance/intolerance to prior therapy
    Children aged 1 to 18 years:
    Body weight 45kg or higher: 12ml (120mg) once daily. Body weight 30kg to less than 45kg: 10.5ml (105mg) once daily. Body weight 20kg to less than 30kg: 9ml (90mg) once daily. Body weight 10kg to less than 20kg: 6ml (60mg) once daily. Body weight 5kg to less than 10kg: 4ml (40mg) once daily. Dose escalations in children who fail to receive a haematologic/cytogenetic response at starting dose: Starting dose of 12ml (120mg): Escalate to 16ml (160mg). Starting dose of 10.5ml (105mg): Escalate to 14ml (140mg). Starting dose of 9ml (90mg): Escalate to 12ml (120mg). Starting dose of 6ml (60mg): Escalate to 8ml (80mg).
    Starting dose of 4ml (40mg): Escalate to 5ml (50mg).

    Newly diagnosed Ph+ ALL
    Children aged 1 to 18 years:
    Body weight 45kg or higher: 12ml (120mg) once daily. Body weight 30kg to less than 45kg: 10.5ml (105mg) once daily. Body weight 20kg to less than 30kg: 9ml (90mg) once daily. Body weight 10kg to less than 20kg: 6ml (60mg) once daily. Body weight 5kg to less than 10kg: 4ml (40mg) once daily.

    Since dasatinib is used in combination with chemotherapy for this indication, dose escalation is not recommended for paediatric patients with Ph+ ALL.

    Dasatinib tablets (Uxil)

    Newly diagnosed Ph+ ALL
    Children aged 1 to 18 years:
    Body weight 45kg or higher: 79mg once daily. Body weight 30kg to less than 45kg: 55.3mg once daily. Body weight 20kg to less than 30kg: 47.4mg once daily. Body weight 10kg to less than 20kg: 31.6mg once daily. Body weight below 10kg: Contraindicated. Since dasatinib is used in combination with chemotherapy for this indication, dose escalation is not recommended for paediatric patients with Ph+ ALL.

    Additional Dosage Information

    Dasatinib tablets (Sprycel)

    Dose adjustments for myelosuppression

    Chronic phase CML in adults
    Absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L, and/or platelets less than 50 x 10 to the power of 9/L: Interrupt treatment. Resume at the original starting dose when ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 50 x 10 to the power of 9/L.

    If platelet count below 25 x 10 to the power of 9/L and/or recurrence of ANC less than 0.5 x 10 to the power of 9/L persists for more than 7 days: Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 50 x 10 to the power of 9/L then resume treatment at the reduced dose of 80mg once daily.

    Third recurrence of absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L, and/or platelets less than 50 x 10 to the power of 9/L: Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 50 x 10 to the power of 9/L then resume treatment at the reduced dose of 50mg once daily.

    Chronic phase CML in children
    Patients with persistent cytopenia (persists for more than 3 weeks, and is unrelated to leukaemia): Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 75 x 10 to the power of 9/L then resume treatment at either the original starting dose, or at one reduced dose level.
    Patients with recurrent persistent cytopenia (persists for more than 3 weeks, and is unrelated to leukaemia): Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 75 x 10 to the power of 9/L then resume treatment at one reduced dose level.

    Dose reductions for a starting dose of 100mg: Reduce dose to 80mg if a single dose reduction is needed. Reduce to 70mg if a further dose reduction is needed.
    Dose reductions for a starting dose of 70mg: Reduce dose to 60mg if a single dose reduction is needed. Reduce to 50mg if a further dose reduction is needed.
    Dose reductions for a starting dose of 60mg: Reduce dose to 40mg if a single dose reduction is needed. Reduce to 20mg if a further dose reduction is needed.
    Dose reductions for a starting dose of 40mg: Reduce dose to 20mg if a single dose reduction is needed. No further dose reductions are available below 20mg.

    Accelerated and blast phase CML and Ph+ ALL
    Absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at original starting dose.
    First recurrence of absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at reduced dose of 100mg daily.
    Second recurrence of absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at reduced dose of 80mg daily.

    Where cytopenia is related to leukaemia: Consider increasing dose to 180mg once daily.

    Ph+ ALL in Children Haematologic Grade 1 to 4 toxicities: no dose modification is recommended.
    If neutropenia and/or thrombocytopenia result in delay of the next block of treatment by more than 14 days, interrupt treatment. Resume at the same dose level once the next block of treatment is started.
    If neutropenia and/or thrombocytopenia persist and the next block of treatment is delayed another 7 days, perform a bone marrow assessment of cellularity and percentage of blasts. If marrow cellularity is less than 10%: interrupt treatment until ANC more than 0.5 x 10 to the power of 9/L, then resume at full dose. If marrow cellularity is more than 10%, consider resumption of treatment.
    Dose adjustments for non-haematological adverse reaction (including cardiopulmonary symptoms)
    Chronic phase CML
    Adults
    Moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then be resumed at the same dose.
    Severe (grade 3 or 4) or recurrent moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then resume 80mg once daily. Further reduction to 50mg may be used as necessary.

    Children Follow dose reductions stated for myelosuppression in chronic phase CML in children.
    Accelerated and blast phase CML and Ph+ ALL
    Moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then be resumed at the same dose.
    Severe (grade 3 or 4) or recurrent moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then resume 100mg once daily. Further reduction to 50mg may be used as necessary.

    Ph+ ALL in children Follow one level of dose reduction, according to dose reductions stated for myelosuppression in chronic phase CML in children.
    Dose adjustments for pleural effusion
    Interrupt dasatinib until patient is asymptomatic or has returned to baseline. Upon resolution of the first episode, consider reintroduction of dasatinib at the same dose. Following resolution of subsequent episodes, reintroduce dasatinib at one reduced dose level. Severe episodes (grade 3 or 4) are resumed at a reduced dose dependent on the initial severity of the event. If the episode does not improve within approximately one week, consider a course of either diuretics, corticosteroids or both concurrently.

    Dose adjustments for cardiac symptoms
    Mild or moderate (grade 1 or 2)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at the original dose.
    Severe (grade 3 or above)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at a reduced dose as indicated for non-haematological adverse reactions.

    Dasatinib powder for oral suspension (Sprycel)

    Dose adjustments for myelosuppression

    Chronic phase CML in children
    Patients with persistent cytopenia (persists for more than 3 weeks, and is unrelated to leukaemia): Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 75 x 10 to the power of 9/L then resume treatment at either the original starting dose, or at one reduced dose level.
    Patients with recurrent persistent cytopenia (persists for more than 3 weeks, and is unrelated to leukaemia): Interrupt treatment. When ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 75 x 10 to the power of 9/L then resume treatment at one reduced dose level.

    Dose reductions for a starting dose of 12ml (120mg): Reduce dose to 10ml (100mg) if a single dose reduction is needed. Reduce to 8ml (80mg) if a further dose reduction is needed.
    Dose reductions for a starting dose of 10.5ml (105mg): Reduce dose to 9ml (90mg) if a single dose reduction is needed. Reduce to 7ml (70mg) if a further dose reduction is needed.
    Dose reductions for a starting dose of 9ml (90mg): Reduce dose to 7ml (70mg) if a single dose reduction is needed. Reduce to 6ml (60mg) if a further dose reduction is needed.
    Dose reductions for a starting dose of 6ml (60mg): Reduce dose to 5ml (50mg) if a single dose reduction is needed. Reduce to 4ml (40mg) if a further dose reduction is needed.
    Dose reductions for a starting dose of 4ml (40mg): Reduce dose to 3 ml (30mg) if a single dose reduction is needed. Reduce to 2ml (20mg) if a further dose reduction is needed.

    Ph+ ALL in Children Haematologic Grade 1 to 4 toxicities: no dose modification is recommended.
    If neutropenia and/or thrombocytopenia result in delay of the next block of treatment by more than 14 days, interrupt treatment. Resume at the same dose level once the next block of treatment is started.
    If neutropenia and/or thrombocytopenia persist and the next block of treatment is delayed another 7 days, perform a bone marrow assessment of cellularity and percentage of blasts. If marrow cellularity is less than 10%: interrupt treatment until ANC more than 0.5 x 10 to the power of 9/L, then resume at full dose. If marrow cellularity is more than 10%, consider resumption of treatment.

    Dose adjustments for non-haematological adverse reaction (including cardiopulmonary symptoms)
    Chronic phase CML
    Moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then be resumed at the same dose.
    Severe (grade 3 or 4) or recurrent moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then be resumed at a reduced dose dependent on the initial severity of the event.

    Ph+ ALL in children Follow one level of dose reduction, according to dose reductions stated for myelosuppression in chronic phase CML in children.
    Dose adjustments for pleural effusion
    Interrupt dasatinib until patient is asymptomatic or has returned to baseline. Upon resolution of the first episode, consider reintroduction of dasatinib at the same dose. Following resolution of subsequent episodes, reintroduce dasatinib at one reduced dose level. Severe episodes (grade 3 or 4) are resumed at a reduced dose dependent on the initial severity of the event. If the episode does not improve within approximately one week, consider a course of either diuretics, corticosteroids or both concurrently.

    Dose adjustments for cardiac symptoms
    Mild or moderate (grade 1 or 2)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at the original dose.
    Severe (grade 3 or above)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at a reduced dose as indicated for non-haematological adverse reactions.

    Dasatinib tablets (Uxil)

    Dose adjustments for myelosuppression

    Ph+ ALL in adults
    Absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at original starting dose.
    First recurrence of absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at reduced dose of 79mg daily.
    Second recurrence of absolute neutrophil count (ANC) less than 0.5 x 10 to the power of 9/L and/or platelets less than 10 x 10 to the power of 9/L, where unrelated to leukaemia: Interrupt treatment until ANC is equal to or more than 1 x 10 to the power of 9/L and platelets are equal to or more than 20 x 10 to the power of 9/L, then resume treatment at reduced dose of 63.2mg daily.

    Where cytopenia is related to leukaemia: Consider increasing dose to 142.2mg once daily.

    Ph+ ALL in children Haematologic Grade 1 to 4 toxicities: no dose modification is recommended.
    If neutropenia and/or thrombocytopenia result in delay of the next block of treatment by more than 14 days, interrupt treatment. Resume at the same dose level once the next block of treatment is started.
    If neutropenia and/or thrombocytopenia persist and the next block of treatment is delayed another 7 days, perform a bone marrow assessment of cellularity and percentage of blasts. If marrow cellularity is less than 10%: interrupt treatment until ANC more than 0.5 x 10 to the power of 9/L, then resume at full dose. If marrow cellularity is more than 10%, consider resumption of treatment.

    Dose adjustments for non-haematological adverse reaction (including cardiopulmonary symptoms)

    Ph+ ALL in adults
    Moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then be resumed at the same dose.
    Severe (grade 3 or 4) or recurrent moderate (grade 2): Interrupt treatment until the event has resolved. Treatment can then resume 79mg once daily. Further reduction to 39.5mg may be used as necessary.

    Ph+ ALL in children Follow one level of dose reduction, according to dose reductions stated for myelosuppression in Ph+ ALL in children.
    Dose adjustments for pleural effusion
    Interrupt dasatinib until patient is asymptomatic or has returned to baseline. Upon resolution of the first episode, consider reintroduction of dasatinib at the same dose. Following resolution of subsequent episodes, reintroduce dasatinib at one reduced dose level. Severe episodes (grade 3 or 4) are resumed at a reduced dose dependent on the initial severity of the event. If the episode does not improve within approximately one week, consider a course of either diuretics, corticosteroids or both concurrently.

    Dose adjustments for cardiac symptoms
    Mild or moderate (grade 1 or 2)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at the original dose.
    Severe (grade 3 or above)
    Interrupt dasatinib and consider the need for alternative treatment. Conduct functional assessment prior to resuming treatment. Upon resolution, resume at a reduced dose as indicated for non-haematological adverse reactions.

    Contraindications

    Children under 1 year
    Breastfeeding
    Long QT syndrome
    Pregnancy
    Torsade de pointes

    Precautions and Warnings

    Children weighing less than 10kg
    Family history of long QT syndrome
    History of anthracycline therapy
    Patients over 65 years
    Risk factors for cardiovascular disorder
    Cardiovascular disorder
    Electrolyte imbalance
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of cardiac disorder
    History of hepatitis B
    History of torsade de pointes
    Lactose intolerance

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient to avoid H2 antagonists
    Before initiating screen all patients for hepatitis B infection
    Evaluate patients for cardiovascular disease prior to treatment
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Hepatitis B: Refer prior to initiation to liver disease specialist
    Not all available products are licensed for all uses
    Treatment to be initiated and supervised by a specialist
    Some formulations contain benzoic acid
    Some formulations contain lactose
    Some formulations contain sucrose
    Some presentations may contain benzyl alcohol
    Different oral formulations are not interchangeable (not bioequivalent)
    Advise patient on concurrent use of proton pump inhibitors
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Consider echocardiogram before treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor blood counts regularly
    Monitor for active hepatitis B during therapy and for several months after
    Monitor patient with history of severe cardiac disease for signs of failure
    Monitor patients receiving concurrent anticoagulants
    Monitor patients with cardiac disorders
    Monitor serum electrolytes
    Take chest X-ray if fever,cough,dyspnoea or other respiratory signs occur
    Advise patient to report breathlessness or cough immediately
    Advise patient to report severe sore throat with fever, headache and nausea
    Consider treatment with blood growth factors if severe cytopenias develop
    Reactivation of hepatitis B may occur in chronic carriers
    Consider interrupting treatment if symptoms of cardiac dysfunction occur
    Consider treatment interruption & dose reduction in haematological toxicity
    Discontinue if pulmonary arterial hypertension occurs
    Discontinue if thrombotic microangiopathy is confirmed
    Interrupt treatment if pleural effusion occurs
    Suspend treatment if grade 2 non-haematological toxicity occurs
    Dose reduction may be required after resolution of pleural effusion
    Not licensed for all indications in all age groups
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid aluminium / magnesium hydroxide containing antacids
    Advise patients to avoid aspirin and NSAID use
    Advise patient to avoid grapefruit products
    Male & female: Ensure adequate contraception during treatment

    Advanced phase CML or Ph+ ALL: Perform complete blood counts weekly for the first 2 months, and then monthly thereafter, or as clinically indicated.
    Newly diagnosed chronic phase CML: Perform complete blood counts every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated.

    Newly diagnosed children with Ph+ ALL: Perform complete blood counts prior to start each block of chemotherapy and as clinically indicated. During consolidation of chemotherapy, perform complete blood counts every 2 days until recovery.

    An echocardiography should be performed at initiation in every patient presenting with symptoms of cardiac disease and considered in patients with risk factors for cardiac or pulmonary disease. Patients who develop dyspnoea and fatigue after initiation of therapy should be evaluated for common aetiologies including pleural effusion, pulmonary oedema, anaemia, or lung infiltration. The dose of dasatinib should be reduced or interrupted during this evaluation. If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of pulmonary arterial hypertension (PAH) should be considered.

    When treating confirmed pleural effusion, diuretics and short courses of steroids are usually sufficient, but in severe cases thoracocentesis and oxygen therapy may be required. Patients aged 65 years and over are more likely to experience fluid retention and should be monitored closely.

    Pregnancy and Lactation

    Pregnancy

    Dasatinib is contraindicated during pregnancy.

    The manufacturer states that dasatinib should not be used in pregnancy unless the clinical condition of the woman requires treatment with dasatinib. Dasatinib is suspected to have harmful pharmacological effects on the foetus, as well as to cause congenital malformations. Animal studies have shown reproductive toxicity.

    Lactation

    Dasatinib is contraindicated during breastfeeding.

    The manufacturer recommends that breastfeeding should be stopped during treatment with dasatinib. Dasatinib is suspected to be excreted in breast milk, and a risk to the breastfed infant cannot be excluded. LactMed suggests that due to the high plasma-protein binding of dasatinib, the amount of the drug in the milk is likely to be low. Despite this, LactMed contraindicate the use of the drug while breastfeeding, and for two weeks after the last dose.

    Side Effects

    Abdominal pain
    Acute respiratory distress syndrome
    Alopecia
    Amnesia
    Anal fissure
    Angina pectoris
    Arrhythmias
    Ascites
    Asthenia
    Asthma
    Blood pressure changes
    Bronchospasm
    Cardiac disorders
    Cardiomegaly
    Cerebrovascular accident
    Chest pain
    Chills
    Cholecystitis
    Cholestasis
    CNS haemorrhage
    Colitis
    Congestive cardiac failure
    Conjunctivitis
    Convulsions
    Cough
    Creatine phosphokinase increased
    Depression
    Diarrhoea
    Disturbances of appetite
    Dizziness
    Dry eyes
    Dysgeusia
    Dysphagia
    Dyspnoea
    Fatigue
    Febrile neutropenia
    Flushing
    Gastritis
    Gastro-intestinal ulceration
    Gastrointestinal disorder
    Gynaecomastia
    Haemorrhage
    Headache
    Hepatitis
    Hyperhidrosis
    Hypersensitivity reactions
    Hyperuricaemia
    Hypoalbuminaemia
    Hypocalcaemia
    Hypophosphataemia
    Increase in serum transaminases
    Increased urinary frequency
    Infections
    Insomnia
    Livedo reticularis
    Malaise
    Menstrual disturbances
    Mucosal inflammation
    Musculoskeletal disturbances
    Myelosuppression
    Myocardial infarction
    Nausea
    Neuropathy
    Oedema
    Pain
    Palmar-Plantar Erythrodysaesthesia syndrome
    Palpitations
    Pancreatitis
    Panniculitis
    Pericardial effusion
    Pericarditis
    Photosensitivity
    Pleural effusion
    Pneumonitis
    Prolongation of QT interval
    Proteinuria
    Psychiatric disorders
    Pulmonary hypertension
    Pulmonary infiltration
    Pulmonary oedema
    Pyrexia
    Red cell aplasia
    Renal impairment
    Rhabdomyolysis
    Serum bilirubin increased
    Skin disorder
    Skin pigmentation changes
    Somnolence
    Syncope
    Tendon inflammation
    Thromboembolic disorders
    Thrombophlebitis
    Tinnitus
    Transient ischaemic attack
    Tremor
    Tumour lysis syndrome
    Vertigo
    Visual disturbances
    Vomiting
    Weight changes

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: November 2018

    Reference Sources

    Summary of Product Characteristics: Sprycel Film Coated Tablets 20mg, 50mg, 70mg, 80mg, 100mg, 140mg. Bristol-Myers Squibb Ltd. Revised June 2019.
    Summary of Product Characteristics: Sprycel 10mg/ml powder for oral suspension. Bristol-Myers Squibb Ltd. Revised June 2019.
    Summary of Product Characteristics: Uxil 15.8mg film-coated tablets. Zentiva Pharma UK Ltd. Revised November 2021.
    Summary of Product Characteristics: Uxil 39.5mg film-coated tablets. Zentiva Pharma UK Ltd. Revised November 2021.
    Summary of Product Characteristics: Uxil 63.2mg film-coated tablets. Zentiva Pharma UK Ltd. Revised November 2021.
    Summary of Product Characteristics: Uxil 79mg film-coated tablets. Zentiva Pharma UK Ltd. Revised November 2021.
    Summary of Product Characteristics: Uxil 110.6mg film-coated tablets. Zentiva Pharma UK Ltd. Revised November 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Dasatinib Last revised: 10 October 2017
    Last accessed: 7 November 2018

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.