Sprycel (Dasatinib)

Last updated on February 15, 2024

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Other names of Sprycel

Dosanat, Invista.

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(British Approved Name, US Adopted Name, rINN)

DasatinibWhat Is Sprycel (Dasatinib)?

Sprycel, or Dasatinib, is a medication used in the treatment of certain types of cancer, specifically chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It belongs to a class of drugs known as tyrosine kinase inhibitors, which block specific proteins that promote the growth of cancer cells. Dasatinib is typically prescribed when other treatments are ineffective or when a patient cannot tolerate alternative therapies. It is administered orally in tablet form and should be taken as directed by a healthcare professional. Like all medications, Dasatinib may have side effects, and patients should communicate any concerns or symptoms to their healthcare team for proper management. Regular monitoring and follow-up appointments are essential to assess treatment efficacy and address potential complications.

Pharmacokinetics

Maximum plasma concentrations of Dasatinib are achieved between 0.5 and 6 hours after an oral dose. The mean terminal half-life is about 5 hours. Consumption of a high-fat meal may increase exposure to Dasatinib, but this effect is not considered to be of clinical significance. Dasatinib is extensively distributed and metabolized. Metabolism occurs primarily by the cytochrome P450 isoenzyme CYP3A4, forming an active metabolite. Plasma protein binding of Dasatinib and its active metabolite is about 96% and 93%, respectively. Elimination is mainly via the feces; about 4% is recovered in the urine.

Uses and Administration

Dasatinib is a tyrosine kinase inhibitor that is used for the treatment of adults with all phases of chronic myeloid leukemia (CML) who have resistance or intolerance to previous therapy, including imatinib. It is also used for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of prior therapy.

A recommended oral starting dose of Dasatinib in chronic phase CML is 100 mg once daily: tablets, which should be swallowed whole, not crushed or chewed, should be taken consistently in the morning or the evening. The recommended starting dose for accelerated, myeloid, or lymphoid blast phase CML or Philadelphia chromosome-positive ALL is 70 mg twice daily. Dosage may be adjusted according to response and tolerability; doses of up to 140 mg once daily have been used in patients with chronic phase CML, anduptolOOmg twice daily in those with advanced phase or with ALL. Treatment is continued until disease progression or unacceptable toxicity occurs.

If concurrent use of potent inhibitors or inducers of cytochrome P450 isoenzyme CYP3A4 cannot be avoided, dose adjustments are necessary. A dose increase should be considered in those patients given strong CYP3A4 inducers, and the patient should be monitored for toxicity. For those given a potent CYP3A4 inhibitor, the dose of Dasatinib should be reduced to 20 mg daily. If this is not tolerated, either drug should be stopped; if the inhibitor is stopped, a washout period of about one week should be allowed before the dose of Dasatinib is increased.

Adverse Effects, Treatment, and Precautions

The most common adverse effects of Dasatinib include fluid retention, gastrointestinal disturbances, and bleeding. Fluid retention may be severe, resulting in pleural and pericardial effusion, pulmonary edema, and ascites. 

Severe CNS hemorrhages, sometimes fatal, have been reported. Gastrointestinal bleeding may require interruption of therapy and transfusions. 

Myelosuppression, which manifests as neutropenia, thrombocytopenia, or anemia, occurs more frequently in patients with advanced chronic myeloid leukemia (CML) or acute lymphoblastic leukemia than in patients in the chronic phase. 

Recovery generally occurs after dose interruption and/or reduction, although treatment may need to be stopped.

Febrile neutropenia has been reported. In patients with chronic phase CML, myelosuppression and fluid retention occur more often with twice daily dosing than once daily dosage. Other adverse effects include headache, pyrexia, musculoskeletal pain, fatigue, skin rashes, dyspnoea, cough, dizziness, chest pain, neuropathy, chills, and pruritus. 

Infections, including pneumonia, have been reported. 

Cardiac failure and arrhythmias can occur. 

Dasatinib has the potential to prolong the QT interval. It should be given with caution to patients at risk of this, such as those with hypokalaemia, hypomagnesemia, or those on antiarrhythmic therapy or receiving cumulative high doses of anthracyclines.

Effects on the Skin

Parmiculitis has been reported with Dasatinib, which resolved upon stopping therapy. In one case, Dasatinib was restarted with prednisone, and no recurrence of parmiculitis was noted. In another patient, however, a rash recurred on restarting therapy that was not sensitive to corticosteroid treatment.

Interactions

The cytochrome P450 isoenzyme CYP3A4 metabolizes Dasatinib, and drugs that inhibit this enzyme, such as azole antifungals, macrolide antibacterials, HIV-protease inhibitors, and nefazodone, may increase blood concentrations of Dasatinib. Equally, inducers of CYP3A4 (such as carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin) may reduce blood concentrations of Dasatinib. When use with such drugs cannot be avoided, dose adjustment of Dasatinib may be necessary (see Uses and Administration section). Since St John’s wort may decrease dasatinib concentrations unpredictably, these drugs should not be given together.

Dasatinib is a cytochrome P450 isoenzyme CYP3 A4 substrate and may alter blood concentrations of other drugs that are substrates of this enzyme. Since the solubility of Dasatinib is dependent on pH, use with antacids should be avoided. If antacid therapy is needed, it should be given at least 2 hours before or 2 hours after the dose of Dasatinib. Similarly, with Dasatinib, histamine H2-receptor antagonists or proton pump inhibitors such as famotidine or omeprazole should not be given as long-term suppression of gastric acid secretion is likely to reduce dasatinib exposure.

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