This website is best viewed using the vertical display on your mobile device.
Some patients treated with SPRYCEL® (dasatinib) may experience fluid retention, including pleural effusion1
*Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.1
3% (7/258) of SPRYCEL patients developed grade 3 or 4 pleural effusion and 28% (73/258) developed all grades of pleural effusion.2
Management of pleural effusion or other fluid retention adverse reactions includes: symptom recognition, treatment interruption, and dose adjustments1
Perform chest x-ray or additional diagnostic imaging, as appropriate, promptly on observation of symptoms such as:
Identify severity of fluid retention event
For general management:
(In addition to general management strategies)
May resume treatment as appropriate at a reduced dose, depending on severity and recurrence of the event
Dosing adjustments may help in the management of pleural effusion1
IMPORTANT SAFETY INFORMATION ABOUT FLUID RETENTION
SPRYCEL may cause fluid retention. After 5 years of follow-up in the randomized newly diagnosed chronic phase CML study (n=258), grade 3/4 fluid retention was reported in 5% of patients, including 3% of patients with grade 3/4 pleural effusion. In patients with newly diagnosed or imatinib-resistant or -intolerant chronic phase CML, grade 3/4 fluid retention occurred in 6% of patients treated with SPRYCEL at the recommended dose (n=548). In patients with advanced phase CML or Ph+ ALL treated with SPRYCEL at the recommended dose (n=304), grade 3/4 fluid retention was reported in 8% of patients, including grade 3/4 pleural effusion reported in 7% of patients.
IMPORTANT SAFETY INFORMATION ABOUT ADVERSE REACTIONS
†Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.
‡Includes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.
§Adverse reaction of special interest with <10% frequency.
‖Includes conjunctival hemorrhage, ear hemorrhage, ecchymosis, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemoptysis, intra-abdominal hematoma, petechiae, scleral hemorrhage, uterine hemorrhage, and vaginal hemorrhage.
For newly diagnosed adults with Ph+ CML in CP, the recommended starting dose of SPRYCEL is 100 mg.¶
¶Alternative dosing options are available.