GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Givosiran injection (Givlaari, adults)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug1 sources available - open source summaries, references and comparisons

Givlaari

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Official source

Givosiran injection (Givlaari, adults) - selected U.S. label sections

Product / population
Adult GIVLAARI subcutaneous injection for acute hepatic porphyria.
Renal measure
MDRD eGFR in mL/min/1.73 m2

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Renal pharmacokinetics

No clinically meaningful pharmacokinetic or pharmacodynamic differences were found across eGFR 15 to below 89. The effect in end-stage disease below 15 is unknown. This is not an ESRD dosing recommendation.

Renal toxicity monitoring

Serum creatinine increases and eGFR decreases have occurred. Monitor renal function during treatment as clinically indicated.

Source revision: 9/2025 | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa

Scope: Local label summary; independent clinical review pending. Not a two-source validated protocol. GlobalRPh v6.6.

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Official product label

Givosiran injection (Givlaari, adults) - selected U.S. label sections

Adult GIVLAARI subcutaneous injection for acute hepatic porphyria.

Renal method: MDRD eGFR in mL/min/1.73 m2
Retrieved: 2026-09-05

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Original content / product scopeGivosiran injection (Givlaari, adults) - selected U.S. label sections
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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa

Product and population scope

Adult GIVLAARI subcutaneous injection for acute hepatic porphyria.

RDM32-givosiran-givlaari-scope · Source section: Editorial scope for the selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Givosiran injection (Givlaari, adults) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult GIVLAARI subcutaneous injection for acute hepatic porphyria.

Renal method: MDRD eGFR in mL/min/1.73 m2
Source date: 9/2025
Retrieved: 2026-09-05

Local label summary; independent clinical review pending. Not a two-source validated protocol.

Renal pharmacokinetics

No clinically meaningful pharmacokinetic or pharmacodynamic differences were found across eGFR 15 to below 89. The effect in end-stage disease below 15 is unknown. This is not an ESRD dosing recommendation.

RDM32-givosiran-givlaari-1 · Source locator: 12.3

Renal toxicity monitoring

Serum creatinine increases and eGFR decreases have occurred. Monitor renal function during treatment as clinically indicated.

RDM32-givosiran-givlaari-2 · Source locator: 5.3

Source-specific limits

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa
Retrieved
2026-09-05
DailyMed Set ID
167e663c-11e1-497b-a3fc-951d65d58eaa
Label revision
9/2025
Renal-function method
MDRD eGFR in mL/min/1.73 m2
Source date/version
9/2025
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256
0f9b45620dee8e767ec63c48f22c072ab5c409a911f8ccf0d6552a43471404a5

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167e663c-11e1-497b-a3fc-951d65d58eaa
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
91607a971022b7c539b0d1ce5f893c545890d68fc3f580a1dff5da612f92fdc1
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.

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