# Hepatic dose adjustment of anticancer drugs in reduced liver function

Source: https://onco.cc/protocols/hepatic-dose-adjustment-of-anticancer-drugs/  
OnCo record `hepatic-dose-adjustment-of-anticancer-drugs` (Protocol). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Many cancer drugs are broken down by the liver, so if your liver is not working well the dose may need lowering or a different drug may be safer. Your liver blood tests are checked before each cycle, and the team follows the drug's own instructions, which grade liver function in one of two ways that do not always agree.

## Summary

No international consensus covers anticancer dosing in liver impairment; the dose comes from each drug's label, set from dedicated pharmacokinetic studies. Labels use one of two scales. Child-Pugh scores encephalopathy, ascites, bilirubin, albumin and prothrombin time or INR into mild (A, 5 to 6), moderate (B, 7 to 9) and severe (C, 10 to 15); the NCI Organ Dysfunction Working Group criteria use only total bilirubin and AST, in groups A (normal) to D (severe). The FDA's September 2026 draft guidance, which replaces the 2003 guidance, recommends Child-Pugh for cirrhosis, allows NCI criteria in cancer studies except hepatobiliary cancers, warns that a Child-Pugh score taken during or just after an acute event can overstate impairment, and notes non-liver causes of a raised bilirubin or INR (Gilbert's syndrome, vitamin K deficiency, anticoagulants).

The two scales disagree: across five drugs, 64.9%, 73.7% and 61.5% of people with mild, moderate and severe impairment by Child-Pugh were at least one category less impaired by NCI criteria (Elmeliegy 2021), so the clinician should apply the scale the label used. People with moderate or severe impairment are usually excluded from cancer trials, so labels often rest on studies in people without cancer and on modelling (Yang 2022). In practice, BOPA (2025) asks the pharmacist to check liver function and modify doses as the drug or regimen literature directs at each cycle. A worked example: ibrutinib for B-cell cancers is 140 mg daily in Child-Pugh A, 70 mg in Child-Pugh B, and avoided in Child-Pugh C.

## Fields

- Kind: Protocol
- Last checked: 2026-11-11
- Also known as: liver impairment chemotherapy dosing; hepatic impairment dose reduction; Child-Pugh dosing; NCI Organ Dysfunction Working Group criteria; NCI ODWG; chemotherapy and raised bilirubin; liver metastases dose adjustment

## Connected records

- terms: [Child-Pugh score](https://onco.cc/terms/child-pugh/), [Pharmacokinetics (PK), half-life and exposure](https://onco.cc/terms/pharmacokinetics/)
- protocols: [Anticancer treatment prescribing and pharmacy verification before each cycle](https://onco.cc/protocols/sact-prescribing-and-pharmacy-verification/), [Renal dose adjustment of anticancer drugs in reduced kidney function](https://onco.cc/protocols/renal-dose-adjustment-of-anticancer-drugs/)
- drugs: [Ibrutinib](https://onco.cc/drugs/ibrutinib/)

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