Version July 2025
Dosage guidance
Safety: ANC should be ≥1,000/mm3 and platelets should be ≥50,000/mm3 prior to initiating each cycle and prior to resuming treatment following toxicity. Do not administer in patients with an active infection.
Peripheral T-cell lymphoma, relapsed or refractory: IV: 1,000 mg/m2 once daily on days 1 to 5 of a 21-day cycle; continue until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for patients with reduced UGT1A1 activity: Reduce initial dose to 750 mg/m2 once daily on days 1 to 5 of a 21-day cycle for patients known to be homozygous for UGT1A1*28 allele.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function prior to treatment initiation :
CrCl 60 to <90 mL/minute: No dosage adjustment necessary.
CrCl 30 to <60 mL/minute: Reduce dose to 500 mg/m2 once daily on days 1 to 5 of a 21-day cycle.
CrCl <30 mL/minute: Avoid the use of belinostat.
Liver impairment prior to treatment initiation:
Mild hepatic impairment (total bilirubin ≤1.5 times ULN and any AST): No dosage adjustment necessary (Ref).
Moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST): Reduce dose to 500 mg/m2 once daily on days 1 to 5 of a 21-day cycle; belinostat exposure is increased, which may increase the risk for adverse reactions.
Severe hepatic impairment (total bilirubin >3 times ULN and any AST): Avoid the use of belinostat (Ref).
Acute hepatotoxicity during treatment: Interrupt treatment, adjust dose until recovery, or permanently discontinue belinostat depending on the severity (Ref).
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight (full weight) for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).
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Adverse reaction and severity |
Belinostat dosage modification |
|---|---|
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a Steele 2008. | |
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Hematologic toxicity Note: ANC should be ≥1,000/mm3 and platelets should be ≥50,000/mm3 prior to initiating each cycle and prior to resuming treatment following a delay due to toxicity. | |
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Platelets ≥25,000/mm3 and nadir ANC ≥500/mm3 |
No dosage adjustment necessary (continue treatment without modification). |
|
Nadir ANC <500/mm3 and any platelet count |
Reduce belinostat dose by 25% (to 750 mg/m2). |
|
Platelets <25,000/mm3 and any nadir ANC |
Reduce belinostat dose by 25% (to 750 mg/m2). |
|
Recurrent nadir ANC <500/mm3 and/or recurrent nadir platelets <25,000/mm3 following 2 dosage reductions |
Discontinue belinostat. |
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Nonhematologic toxicities Note: Nonhematologic toxicities should be ≤ grade 2 prior to treatment. | |
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GI toxicity: Grade 3 or 4 nausea, vomiting, or diarrhea |
Manage with supportive care (may require antiemetics and antidiarrheal medications); dose modification may not be necessary if nausea and vomiting duration is <7 days with supportive management. If symptoms persist beyond 7 days despite optimized supportive care, may consider reducing the belinostat dose by 25% (to 750 mg/m2). In a phase 1 study, nausea/vomiting generally occurred at the end of the infusion each day (rarely persisting beyond day 5 each cycle) and was managed with standard antiemetics.a |
|
Tumor lysis syndrome |
Manage as clinically appropriate. |
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Other nonhematologic grade 3 or 4 toxicity (except nausea, vomiting, or diarrhea) |
Reduce belinostat dose by 25% (to 750 mg/m2). |
|
Other recurrent nonhematologic grade 3 or 4 toxicity following 2 dosage reductions |
Discontinue belinostat. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Peripheral edema (20%), prolonged QT interval on ECG (11%)
Dermatologic: Pruritus (16%), skin rash (20%)
Endocrine & metabolic: Hypokalemia (12%), increased lactate dehydrogenase (16%)
Gastrointestinal: Abdominal pain (11%), constipation (23%), decreased appetite (15%), diarrhea (23%; grades 3/4: 2%), nausea (42%; grades 3/4: 1%), vomiting (29%; grades 3/4: 1%)
Hematologic & oncologic: Anemia (32%; grades 3/4: 11%), thrombocytopenia (16%; grades 3/4: 7%)
Local: Pain at injection site (14%)
Nervous system: Chills (16%), fatigue (37%), headache (15%)
Respiratory: Cough (19%), dyspnea (22%)
Miscellaneous: Fever (35%)
1% to 10%:
Cardiovascular: Hypotension (10%), phlebitis (10%)
Infection: Infection (>2%; including sepsis)
Nervous system: Dizziness (10%)
Renal: Increased serum creatinine (>2%)
Respiratory: Pneumonia (>2%)
Miscellaneous: Multi-organ failure (>2%)
<1%:
Cardiovascular: Ventricular fibrillation
Hepatic: Hepatic failure
Frequency not defined: Hematologic & oncologic: Febrile neutropenia, tumor lysis syndrome
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Bone marrow suppression: Belinostat may cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia.
• Gastrointestinal toxicity: Nausea, vomiting, and diarrhea occur with belinostat.
• Hepatotoxicity: Belinostat may cause LFT abnormalities and fatal hepatotoxicity.
• Infection: Serious infections (occasionally fatal), including pneumonia and sepsis, have occurred with belinostat. Heavily pretreated patients (history of extensive or intensive prior chemotherapy) may be at higher risk for life-threatening infections.
• Tumor lysis syndrome: Tumor lysis syndrome has been observed in belinostat-treated patients.
Special populations:
• Reduced UGT1A1 activity: Belinostat is primarily metabolized by UGT1A1; the initial dose should be reduced in patients known to be homozygous for UGT1A1*28 allele.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Beleodaq: 500 mg (1 ea)
No
Solution (reconstituted) (Beleodaq Intravenous)
500 mg (per each): $3,006.28
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Infuse over 30 minutes using a 0.22-micron inline filter; if infusion site pain or other symptoms associated with infusion occur, may increase infusion time to 45 minutes.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Peripheral T-cell lymphoma, relapsed or refractory: Treatment of relapsed or refractory peripheral T-cell lymphoma in adults.
Belinostat may be confused with belatacept, belimumab, belumosudil, belzutifan, berotralstat, imetelstat, givinostat, tazemetostat, vorinostat.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP2A6 (Minor), CYP2C9 (Minor), CYP3A4 (Minor), P-glycoprotein (Minor), UGT1A1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Taurursodiol: Histone Deacetylase Inhibitors may increase adverse/toxic effects of Taurursodiol. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
UGT1A1 Inhibitors: May increase serum concentration of Belinostat. Management: Avoid if possible; when required decrease belinostat dose by 25% if receiving a dose of 1,000 m/m2 or 750 mg/m2. If receiving 500 mg/m2, interrupt belinostat therapy during UGT1A1 inhibitor treatment. Risk D: Consider Therapy Modification
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last belinostat dose. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of belinostat.
Based on the mechanism of action and findings of genotoxicity, in utero exposure to belinostat may cause fetal harm.
It is not known if belinostat is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer and for 2 weeks after the last belinostat dose.
Monitor CBC with platelets and differential at baseline and weekly during treatment; serum chemistries (including kidney and hepatic functions tests) at baseline and before each cycle. Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for signs/symptoms of GI toxicity (eg, nausea, vomiting, diarrhea), tumor lysis syndrome (closely monitor patients with advanced disease and/or high tumor burden), hepatoxicity, and infection.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Belinostat is a histone deacetylase (HDAC) inhibitor which catalyzes acetyl group removal from protein lysine residues (of histone and some nonhistone proteins). Inhibition of histone deacetylase results in accumulation of acetyl groups, leading to cell cycle arrest and apoptosis. Belinostat has preferential cytotoxicity toward tumor cells versus normal cells.
Distribution: ~114 L/m2 (Steele 2008); mean volume of distribution approaches total body water (indicating limited body tissue distribution).
Protein binding: ~93% to 96%.
Metabolism: Hepatic; primarily via UGT1A1, also via CYP2A6, CYP2C9, and CYP3A4.
Half-life elimination: 1.1 hours.
Time to peak: At end of infusion (Steele 2008).
Excretion: Urine (84.8% ± 9.8% over 168 hours, predominantly as metabolites; <2% as unchanged drug); feces (9.7% ± 6.5% over 168 hours).
Clearance: 1.24 L/minute.
Kidney function impairment: Belinostat Cmax increased by 1.7-fold and AUC0-∞ increased by 1.3-fold in patients with mild kidney impairment (CrCl 60 to <90 mL/minute). Belinostat Cmax and AUC0-∞ increased by 1.7-fold and CLtot decreased by 26% in patients with moderate kidney impairment (CrCl 30 to <60 mL/minute).
Hepatic function impairment: Mean belinostat clearance was reduced by 18% in mild (total bilirubin ≤ ULN and AST > ULN, or total bilirubin ˃1 to 1.5 times ULN), 24% in moderate (total bilirubin ˃1.5 to 3 times ULN and any AST), and 33% in severe hepatic impairment (total bilirubin ˃3 to 10 times ULN and any AST).
