No black box warning on record for Dasatinib

As of the latest FDA labeling reviewed, Dasatinib (DASATINIB) does not carry a black box warning. Standard warnings and precautions still apply — see the full Dasatinib medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt dasatinib tablets when indicated. ( 2.5 , 5.1 , 5.2 ) Fluid Retention: Fluid retention, sometimes severe, inc
5.1 Myelosuppression Treatment with dasatinib is associated with severe (NCI CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML [ see Adverse Reactions (6.1) ] . In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks
5.2 Bleeding-Related Events Dasatinib can cause serious and fatal bleeding. In all CML or Ph+ ALL clinical studies, Grade ≥3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving dasatinib. The incidence of Grade 3/4 hemorrhage occurred in 5.8% of adult patients and generally required treatment interruptions and transfusions. The incidence of Grade 5
5.3 Fluid Retention Dasatinib may cause fluid retention [ see Adverse Reactions (6.1) ] . After 5 years of follow-up in the adult randomized newly diagnosed chronic phase CML study (n=258), Grade 3 or 4 fluid retention was reported in 5% of patients, including 3% of patients with Grade 3 or 4 pleural effusion. In adult patients with newly diagnosed or imatinib-resistant or -intolerant chronic phas
5.4 Cardiovascular Toxicity Dasatinib can cause cardiac dysfunction [ see Adverse Reactions (6.1) ] . After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial in adults (n=258), the following cardiac adverse reactions occurred: cardiac ischemic events (3.9% dasatinib vs 1.6% imatinib), cardiac-related fluid retention (8.5% dasatinib vs 3.9% imatinib), and conduction sys

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt dasatinib tablets when indicated. ( 2.5 , 5.1 , 5.2 ) Fluid Retention: Fluid retention, sometimes severe, inc

5.1 Myelosuppression Treatment with dasatinib is associated with severe (NCI CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML [ see Adverse Reactions (6.1) ] . In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks

5.2 Bleeding-Related Events Dasatinib can cause serious and fatal bleeding. In all CML or Ph+ ALL clinical studies, Grade ≥3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving dasatinib. The incidence of Grade 3/4 hemorrhage occurred in 5.8% of adult patients and generally required treatment interruptions and transfusions. The incidence of Grade 5

5.3 Fluid Retention Dasatinib may cause fluid retention [ see Adverse Reactions (6.1) ] . After 5 years of follow-up in the adult randomized newly diagnosed chronic phase CML study (n=258), Grade 3 or 4 fluid retention was reported in 5% of patients, including 3% of patients with Grade 3 or 4 pleural effusion. In adult patients with newly diagnosed or imatinib-resistant or -intolerant chronic phas

5.4 Cardiovascular Toxicity Dasatinib can cause cardiac dysfunction [ see Adverse Reactions (6.1) ] . After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial in adults (n=258), the following cardiac adverse reactions occurred: cardiac ischemic events (3.9% dasatinib vs 1.6% imatinib), cardiac-related fluid retention (8.5% dasatinib vs 3.9% imatinib), and conduction sys

Dasatinib Black Box Warning

No black box warning on record for Dasatinib

Other warnings & precautions

Dasatinib Black Box Warning

No black box warning on record for Dasatinib

Other warnings & precautions