Difference between revisions of "Dasatinib (Sprycel)"

Revision as of 18:11, 3 February 2020

General information

Class/mechanism: Tyrosine kinase inhibitor of BCR-ABL, the SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Binds to multiple conformations of the ABL kinase.^[1]^[2]^[3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

6/28/2006: Initial approval for the treatment of adults with:
- Chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
11/8/2007: New accelerated approval for the treatment of adults with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including imatinib mesylate. The new dosing regimen is 100 mg taken orally once daily. (New dosing instruction)
10/28/2010: New indication for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (Approval expanded to the first-line setting)
11/10/2017: New indication for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. (Approval expanded to include the pediatric population)

Also known as

Code name: BMS-354825
Brand name: Sprycel

References

[insert-1] 1.0 ^1.1 ^1.2 Dasatinib (Sprycel) package insert

[2] Dasatinib (Sprycel) package insert (locally hosted backup)

[3] Sprycel maufacturer's website

[4] Dasatinib (Sprycel) patient drug information (Chemocare)

[5] Dasatinib (Sprycel) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

@@ Line 17: / Line 17: @@
 ==History of changes in FDA indication==
-*6/28/2006: Initial approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase [[Chronic myelogenous leukemia | chronic myeloid leukemia]] with resistance or intolerance to prior therapy including [[Imatinib (Gleevec) | imatinib]]. Also indicated for the treatment of adults with [[Biomarkers#BCR-ABL1| Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] with resistance or intolerance to prior therapy.
+*6/28/2006: Initial approval for the treatment of adults with:
+**Chronic, accelerated, or myeloid or lymphoid blast phase [[Chronic myelogenous leukemia | chronic myeloid leukemia]] with resistance or intolerance to prior therapy including [[Imatinib (Gleevec) | imatinib]].
+**[[Biomarkers#BCR-ABL1| Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] with resistance or intolerance to prior therapy.
 *11/8/2007: New accelerated approval for the treatment of adults with chronic phase (CP) [[Chronic myelogenous leukemia |chronic myeloid leukemia (CML)]] with resistance or intolerance to prior therapy, including imatinib mesylate. The new dosing regimen is 100 mg taken orally once daily. ''(New dosing instruction)''
 *10/28/2010: New indication for newly diagnosed adults with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive (Ph+)]] [[Chronic myelogenous leukemia | chronic myeloid leukemia (CML)]] in chronic phase. ''(Approval expanded to the first-line setting)''