INTERACTIONS UGT1A1 Inhibitors: Avoid use or modify dosage if use is unavoidable. ( 2.6 , 7.1 )
7.1 UGT1A1 Inhibitors Avoid concomitant administration of Beleodaq with UGT1A1inhibitors. If concomitant use of a UGT1A1 inhibitor is unavoidable, modify the Beleodaq dose <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.6 )]</span> . Belinostat is primarily metabolized by UGT1A1. Concomitant use with a UGT1A1 inhibitor increases belinostat exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.3 )]</span> , which may increase the risk of Beleodaq adverse reactions.
7.1 UGT1A1 Inhibitors Avoid concomitant administration of Beleodaq with UGT1A1inhibitors. If concomitant use of a UGT1A1 inhibitor is unavoidable, modify the Beleodaq dose <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.6 )]</span> . Belinostat is primarily metabolized by UGT1A1. Concomitant use with a UGT1A1 inhibitor increases belinostat exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.3 )]</span> , which may increase the risk of Beleodaq adverse reactions.
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 tests and omit or modify dosage for hepatic toxicities. ( 2.2 , 5.3 ) Tumor lysis syndrome : Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions ( 5.4 )
Gastrointestinal
Toxicity : Nausea, vomiting and diarrhea occur with Beleodaq and may require antiemetic and antidiarrheal medications ( 5.5 ). Embryo-Fetal Toxicity : Can cause fetal harm. ( 5.6 )
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 <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2 ) and Adverse Reactions( 6.1 )]</span> .
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 <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span>.
5.3 Hepatotoxicity Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . 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 <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2) and Clinical Pharmacology ( 12.3 )]</span>.
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 <span class="opacity-50 text-xs">[see Clinical Studies ( 14 ) ]</span> . Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 ) ]</span> .
5.5 Gastrointestinal Toxicity Nausea, vomiting and diarrhea occur with Beleodaq <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> and may require the use of antiemetic and antidiarrheal medications.
5.6 Embryo-fetal Toxicity Based on its mechanism of action and findings of genotoxicity, Beleodaq can cause fetal harm when administered to a pregnant woman <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )]</span> . Advise pregnant women of the risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with Beleodaq and for 6 months after the last dose <span class="opacity-50 text-xs">[see Use in Specific Populations ( 8.1 , 8.3 ) . Advise males with female partners of reproductive potential to use effective contraception during treatment with Beleodaq and for 3 months after the last dose.
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 )]</span> .
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 <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span>.
5.3 Hepatotoxicity Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . 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 <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2) and Clinical Pharmacology ( 12.3 )]</span>.
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 <span class="opacity-50 text-xs">[see Clinical Studies ( 14 ) ]</span> . Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 ) ]</span> .
5.5 Gastrointestinal Toxicity Nausea, vomiting and diarrhea occur with Beleodaq <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> and may require the use of antiemetic and antidiarrheal medications.
5.6 Embryo-fetal Toxicity Based on its mechanism of action and findings of genotoxicity, Beleodaq can cause fetal harm when administered to a pregnant woman <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )]</span> . Advise pregnant women of the risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with Beleodaq and for 6 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 ) . Advise males with female partners of reproductive potential to use effective contraception during treatment with Beleodaq and for 3 months after the last dose.