No black box warning on record for Beleodaq

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

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) Infection : Serious and fatal infections (e.g., pneumonia and sepsis) ( 5.2 ) Hepatotoxicity : Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function test
5.1 Hematologic Toxicity Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration ( 2.2 ) and Adverse Reactions( 6.1 )] .
5.2 Infections Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections [see Adverse Reactions ( 6.1 )].
5.3 Hepatotoxicity Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities [see Adverse Reactions ( 6.1 )] . Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity [see Dosage and Administration ( 2.2) and Clinical Pharmacolog
5.4 Tumor Lysis Syndrome Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL [see Clinical Studies ( 14 ) ] . Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions [see Adverse Reactions ( 6.1 ) ] .

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Hematologic Toxicity : Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) Infection : Serious and fatal infections (e.g., pneumonia and sepsis) ( 5.2 ) Hepatotoxicity : Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function test

5.1 Hematologic Toxicity Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration ( 2.2 ) and Adverse Reactions( 6.1 )] .

5.2 Infections Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections [see Adverse Reactions ( 6.1 )].

5.3 Hepatotoxicity Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities [see Adverse Reactions ( 6.1 )] . Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity [see Dosage and Administration ( 2.2) and Clinical Pharmacolog

5.4 Tumor Lysis Syndrome Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL [see Clinical Studies ( 14 ) ] . Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions [see Adverse Reactions ( 6.1 ) ] .

Beleodaq Black Box Warning

No black box warning on record for Beleodaq

Other warnings & precautions

Beleodaq Black Box Warning

No black box warning on record for Beleodaq

Other warnings & precautions