Berotralstat (ORLADEYO) | GlobalRPh Renal Dosing Master

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (1)

Display order is not a clinical ranking. Date of retrieval is not the label revision date. Sources are never merged into one regimen. Other sources and conflicts remain below.

1 additional source qualifications - review before use

Severe-impairment advice differs by age

The source permits no renal modification in severe impairment from age 12 but advises avoidance at ages 2 to less than 12. It separately excludes ESRD or hemodialysis.

Before applying: Check age, formulation and the full product-specific prescription. Never substitute adult renal guidance for an unestablished pediatric regimen.

Also check: Severe-impairment advice differs by age

Rxlist source

GlobalRPh RX List - Orladeyo

Product / population: Adults and children at least 2 years; capsules versus oral pellets and age-specific restrictions must be distinguished.
Renal measure: Source gives both CrCl and indexed eGFR for ESRD; severe PK study used Cockcroft-Gault CrCl below 30 mL/min.

RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.

Renal dosing, restrictions and evidence limits

For mild to moderate impairment, no renal modification is recommended from age 2 years. In severe impairment, no modification is recommended from age 12, but avoid use at ages 2 to less than 12. ESRD was not studied and use is not recommended when CrCl is below 15 mL/min, indexed eGFR is below 15 mL/min/1.73 m2, or hemodialysis is required. Keep the age- and formulation-specific prescription separate; the adult statement is not a pediatric fallback. This product is prophylaxis, not acute HAE rescue treatment.

Source revision: Source revision date not established in selected retrieval. | Retrieved: 2026-09-07. Retrieval date is not the revision date.

Source: https://globalrph.com/rx-list/orladeyo-drug/

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

Full source card / provenance

All sources, comparison tools and evidence navigation

Source-first renal review

Evidence sources and renal implications

Choose a source to jump directly to its locally stored result. Qualitative precautions and evidence gaps remain visible even when no numerical clearance schedule is supplied.

Read 1 source difference / applicability notes

GlobalRPh RX List

GlobalRPh RX List - Orladeyo

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

Adults and children at least 2 years; capsules versus oral pellets and age-specific restrictions must be distinguished.

Renal method: Source gives both CrCl and indexed eGFR for ESRD; severe PK study used Cockcroft-Gault CrCl below 30 mL/min.
Retrieved: 2026-09-07

Read local renal resultOpen original reference

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Find text within this drug

Find a term without leaving this drug

Search the stored clinical text

Locate a word or phrase within this drug's source summaries. Choose all sources or one source to focus the search. The selection never hides warnings or source text, changes a dose, or proves that a renal finding is absent.

Find:

Enter at least two characters. Searches stay on this page and are not saved or sent.

All source summaries, original wording and provenance

Before applying a renal protocol

Check the setting. Compare whole sources.

No patient-specific dose is calculated. Context choices only display reminders; they do not validate, hide or change any regimen.

Share a reproducible source review

Choose sources below, then open a print-ready comparison with product scope, renal method, dates and cautions. Links can pin the exact local cards; they never contain patient values or choose a dose.

Open / share selected sources

Jump to renal guidance Read 1 difference / caution notes Clinician guide

Only one eligible source version is stored here. No second source is inferred from a reference link. Independent corroboration is still needed.

Build a source-review outline for documentation

This creates a blank decision outline with the source identities you select, not a dose recommendation or completed clinical assessment. No patient fields are collected, saved or sent. Complete the clinical decisions in your approved documentation system.

Choose one or two sources above or use the source checkboxes below.

Source-review outline (read-only; copy and complete elsewhere)

Renal-context checklist: population, kidney trend and dialysis

These prompts are a reading aid, not a prescription checklist or proof that all requirements have been met. No selections are stored or sent to a server.

Population Kidney-function trend Renal replacement setting

Read the exact source scope, renal metric and date before selecting a row. No applicability assessment has been performed.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

population specific restriction

Severe-impairment advice differs by age

The source permits no renal modification in severe impairment from age 12 but advises avoidance at ages 2 to less than 12. It separately excludes ESRD or hemodialysis.

How to use this: Check age, formulation and the full product-specific prescription. Never substitute adult renal guidance for an unestablished pediatric regimen.

GlobalRPh RX List - Orladeyo

Source-specific interpretation; independent clinician adjudication pending.

Go directly to the relevant source section

Renal dosing and precautions

Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.

New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.

Rxlist source

GlobalRPh RX List - Orladeyo

Adults and children at least 2 years; capsules versus oral pellets and age-specific restrictions must be distinguished.

Method: Source gives both CrCl and indexed eGFR for ESRD; severe PK study used Cockcroft-Gault CrCl below 30 mL/min.

Renal dosing, restrictions and evidence limits Read this complete source summary

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

Compare or copy source versions

All content below is stored locally. Read a whole source version; do not combine its dose with another source's interval, renal metric or dialysis assumptions.

Original content / product scope GlobalRPh RX List - Orladeyo

Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.

Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://globalrph.com/rx-list/orladeyo-drug/

Exact product and population

Adults and children at least 2 years; capsules versus oral pellets and age-specific restrictions must be distinguished.

RDM34-SCOPE-berotralstat-orladeyo · Source section: Selected source product scopeRenal section finder

Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist Compare this source

GlobalRPh RX List - Orladeyo

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · Adults and children at least 2 years; capsules versus oral pellets and age-specific restrictions must be distinguished.

Renal method: Source gives both CrCl and indexed eGFR for ESRD; severe PK study used Cockcroft-Gault CrCl below 30 mL/min.
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-07

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.

Restriction or avoidance guidance. Read the specific threshold, age, formulation and dialysis exclusions; do not generalize across products.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

RDM34-rxlist-orladeyo-drug-C1 · Source locator: Use in specific populations: renal impairment; limitations of use.

Source identity and provenance

Source family: product_label_mirror
Source: https://globalrph.com/rx-list/orladeyo-drug/
Retrieved: 2026-09-07
Renal-function method: Source gives both CrCl and indexed eGFR for ESRD; severe PK study used Cockcroft-Gault CrCl below 30 mL/min.
Source date/version: Source revision date not established in selected retrieval.
Hash meaning: SHA-256 of local authored summary only, not original HTML, PDF or SPL bytes.
Local summary SHA-256: 3e0f3cabfc2eea75d23521a57d38eccc2ba9f0103b1e6cd266b6871b7d97d950

Provenance and preservation

Additional summaries stored on this page: 0 official-label, 1 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source: https://globalrph.com/rx-list/orladeyo-drug/
Source retrieval: 2026-09-07. This is not the source publication or label revision date.
Original source type: rxlist summary
Local text SHA-256: 93915790753a07e8ffbe5441a1c650834959933707ab8015664d6456ee45a75e
Import versus clinical validation: Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

Read the full coverage report