Dasatinib (SPRYCEL)

Philadelphia chromosome positive (Ph+) Chronic myeloid leukemia  

Philadelphia chromosome positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Philadelphia chromosome positive (Ph+) Chronic myeloid leukemia

• Oral: Chronic phase - 100mg once daily continuously until disease progression or unacceptable toxicity  
• Oral: Accelerated or blast phase - 140mg once daily continuously until disease progression or unacceptable toxicity  

Philadelphia chromosome positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

• Oral: 140mg once daily continuously until disease progression or unacceptable toxicity

Available as 20 mg, 50 mg, 70 mg, 80 mg, 100mg and 140 mg film-coated tablets. Contains lactose. Tablets should NOT be crushed or broken. Store at room temperature.

BCR-ABL Tyrosine Kinase Inhibitor

Take with or without food

If a dose is missed, patients should be instructed to take it as soon as they can if it is within 12 hours of the missed dose. If it is over 12 hours since the missed dose, patients should skip the missed dose and resume with the next scheduled dose.

Common: Myelosuppression, Anemia, Neutropenia, Thrombocytopenia, Rash, Diarrhea, Hemorrhage, Fluid retention, Musculoskeletal pain, Dyspnea.

Less Common: Congestive heart failure/cardiac dysfunction, Pericardial effusion, Gastrointestinal hemorrhage, Pleural effusion, Pulmonary infiltration.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, ALT, bilirubin, serum creatinine, BUN, body weight, bone marrow examination for cytogenetic analysis, FISH, RT-PCR (for BCR/ABL transcripts), BCR-ABL mutational analysis, ECG, HBsAg, HBcoreAb.

For disease progression:

• CBC & differential, platelets: weekly until complete hematological response, then monthly.
  • After 6 months and if patient is clinically stable, may increase interval to every 3 months at the physician’s discretion.
• Serum creatinine, uric acid, ALT, bilirubin: weekly until stable then monthly.
  • After 6 months and if patient is clinically stable, may increase interval to every 3 months at the physician’s discretion.
• BCR-ABL transcripts every 3 months until MMR achieved and maintained for at least 12 months.
  • Frequency of transcript testing can then move to every 6 months.

Monitoring for dose modifications:

• First month: Weekly CBC & differential, Platelets, ALT, Bilirubin
• Month 2-6: Monthly CBC & differential, Platelets, ALT, Bilirubin
• After 6 months: CBC & differential, Platelets, ALT, Bilirubin every 3 months
• ECG should be repeated 1 week after initially starting Dasatinib, and 1 week after any dose change.

• Proton pump inhibitors may decrease dasatinib drug levels. Short-acting antacids should be considered as an alternative. Administration of dasatinib and antacids should be separated (e.g take dasatinib in the morning, and antacids in the evening).
• May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Fluid retention including pleural and pericardial effusions, severe ascites, severe pulmonary edema, and generalized edema have been reported with dasatinib. Patients should be weighed regularly and monitored for signs and symptoms of fluid retention.
• Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported in patients treated with Dasatinib. Discontinue permanently in patients who experience a severe mucocutaneous reaction during treatment if no other etiology can be identified.
• Reactivation of hepatitis B virus (HBV) has been reported in patients who are chronic carriers of HBV and received BCR-ABL TKIs. Patients should be tested for HBV infection prior to initiating treatment. Carriers of HBV must be monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.

BC Cancer. BC Cancer Drug Manual. Dasatinib.  Vancouver, British Columbia: BC Cancer Agency. Available at: http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Dasatinib_monograph.pdf. Updated January  1, 2024. Accessed January 22, 2024.

Lexicomp. Dasatinib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/517823?cesid=3voMPwsHfqA&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Ddasatinib%26t%3Dname%26acs%3Dtrue%26acq%3Ddasatinib. Updated January 24, 2024. Accessed January 31, 2024.

Cancer Care Ontario. Dasatinib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/44006. Updated May 2022. Accessed January 22, 2024.

Bristol-Myers Squibb Canada. SPRYCEL® Product Monograph. Montreal, Quebec. Updated November 3, 2021.