ISTODAX (ROMIDEPSIN) KIT [CELGENE CORPORATION]
Jun 05, 2023
- Route
- intravenous
- Form
- Kit
- Holder
- Celgene Corporation
- Scope
- Direct label match
Product·link reviewed
Romidepsin
ATLPD0000086
Product-level evidence profile for identity and molecular form, PK exposure, clinical context, safety context, label material, and reproducible data access.
Formulation context: Kit
- ADMETatlas IDATLPD0000086
- Peptide-link statusDefined molecular entity
- Linked peptides1
- Product routeintravenous
- PK summaries3
- Trial references25
- Matched label records2
- Regulatory-label PK6
Product evidence profile
Product identity and molecular form, PK exposure evidence, safety context, clinical and label context, interpretation boundaries, and reproducibility exits available for this product.
Profile overview
4 of 6 profile areas have current evidence, product context, or reviewed identity linkage.
AvailableNo current evidence
Linked peptides
1
Defined molecular entity
PK summaries
3
6 cited source records
Product-linked records
27
25 context · 2 identity support
Product-label scope
2 matches
2 matched records · 6 regulatory-label PK measurements
Profile areas
A compact route into product identity and molecular form, exposure evidence, context lanes, interpretation boundaries, and reproducible access.
Available
Molecular identity & structure
What is this product, which peptide does it map to, and what is its structure?
ATLPD0000086
intravenous · Kit
Empty
Pharmacology
What is the drug used for and how does it act?
—
not curated
Available
Pharmacokinetics
Are there curated exposure / PK summaries or cited observations?
3
3 summaries · 6 measurements
Empty
Safety & immunogenicity
What safety, postmarketing, and immune-recognition signals surround the product?
0
AE, immune & nonclinical context
Available
Clinical & regulatory
What trial and product-label context is attached to this product?
25 trials
25 trials · 2 matched label records · 6 label-derived PK measurements
Available
Provenance, scope & access
How is the evidence scoped, traced, cited, and reopened?
Trace
scope · lineage · access
One. Molecular identity & structure
What the product is, how its complete molecular form is defined, and which chemical or structural representations support that identity.
Identity
Scientific product record
Romidepsin
ATLPD0000086This product identity anchors product-level label, trial, postmarketing, and PK context. Route, form, and holder fields are shown when they are normalized from product or label references, not inferred from the product name.
Peptide link
Defined molecular entity
1 linked peptide
Product context
25 curated anchors
0 label context · 25 trial
Identity fields
- Product name
- Romidepsin
- ADMETatlas product ID
- ATLPD0000086
- Aliases / marketed names
- No additional aliases
- Route
- intravenous
- Dosage form / class
- Kit
Identity anchors
These anchors support product-level lookup and context attachment. They are identity evidence, not ADMET endpoint measurements.
Peptide identity
Defined molecular entity
1 linked peptide
Matched label records
2
Label/formulation matches; routes remain scoped to the source records.
Regulatory-label PK
6
Human PK measurements extracted from official product labeling.
Trial references
25
Clinical-trial context attached through product identity.
Name-normalization matches
not available
Review status: —.
Drug classification (ATC)
- L01XH02 · romidepsin
ATC classification © WHO Collaborating Centre for Drug Statistics Methodology; used unmodified for non-commercial research.
Label formulation evidence
Matched label records
2
source-matched product labels
Routes
intravenous
source-stated in these records, not a product-wide route
Forms
Kit
single parsed form
Veterinary labels
0
none explicitly identified
ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC]
May 28, 2026
- Route
- intravenous
- Form
- Kit
- Holder
- Fresenius Kabi USA, LLC
- Scope
- Direct label match
| Label / formulation | Route | Form | Holder | Context | Reference |
|---|---|---|---|---|---|
ISTODAX (ROMIDEPSIN) KIT [CELGENE CORPORATION] Jun 05, 2023 | intravenous | Kit | Celgene Corporation | Direct label match | DailyMed record |
ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC] May 28, 2026 | intravenous | Kit | Fresenius Kabi USA, LLC | Direct label match | DailyMed record |
Linked peptide identity
Link decision
Defined molecular entity
Product-level label, safety, trial, and PK context may be read beside the linked peptide identity. Endpoint truth still remains controlled by endpoint-specific evidence and compatibility rules.
Context link
Reviewed
context interpretation allowed
Linked identities
1
canonical peptide identities
Reference traces
1
source-matching records
Reference peptide identity
The public link view emphasizes sequence, identity role, reference support, and interpretation boundary rather than non-public peptide identifiers.
- Identity role
- Reference identity
- Sequence
- Open peptide profile for sequence
- Residue length
- Open peptide profile
- Reference support
- 1 supporting reference
Linked identity set
Multiple linked identities can reflect reviewed source-sequence differences, variant entries, or precursor-like entries. Use the reference identity as the main product-context link.
Source matching trace1 record
| Identity match | Reference | Link review |
|---|---|---|
| Reference identity | Evidence context | Linked peptide identity |
Interpretation boundary
The link supports product-context interpretation beside a peptide identity. It is not a measured endpoint, and it does not promote label, safety, or trial context into peptide-level endpoint truth by itself.
2D structure·RDKit.js
rendering molecule…
Canonical SMILES
C/C=C1\NC(=O)[C@H]2CSSCC/C=C/[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@H](C(C)C)NC1=OStructure shown for the reviewed peptide identity linked to this product (ATLPC0028808). Atom-level 2D depiction rendered from the reviewed SMILES.
A 2D graph describes connectivity, not conformation; a 3D reference describes one coordinate model, not the full ensemble.
Open linked peptide · ATLPC0028808Two. Pharmacology: indication & mechanism
What the drug is used for and how it acts, based on curated therapeutic indications and mechanism-of-action evidence for the product identity.
Indication & mechanism of action
No curated mechanism-of-action or indication evidence is attached to this product in the current release.
Three. Pharmacokinetics & exposure
Traceable exposure and PK properties across product labels, literature, and nonclinical evidence.
Pharmacokinetics & exposure
PK evidence
Traceable exposure properties
Human product-label values are shown first, followed by additional source-backed evidence.
PK properties
3
3 grouped summaries
Human label PK
3
6 cited measurements
Additional source values
3
3 source-reported values outside grouped summaries
Measurement trace
6
source observations
Curated PK property coverage
1
AUC
1
Cmax
1
PPB
Human label PK
Human exposure properties reported in official product labeling.
AUC
Regulatory product label
1,549 ng*h/mL
human · intravenous · plasma
1 trace
Cmax
Regulatory product label
377 ng/mL
human · intravenous · plasma
1 trace
PPB
Regulatory product label
92-94 %
human · plasma
1 trace
Additional PK evidence
Other source-backed PK properties across labels, literature, and nonclinical studies.
No additional PK summaries were found.
Additional source-reported values
Direct source values extend the product's PK endpoint profile.
AUC
Regulatory product label
The geometric mean AUC inf values in patients with mild, moderate, and severe hepatic impairment were approximately 144%, 114%, and 116% of the corresponding value in patients with normal hepatic function, respectively.
human
source value
Clearance
Regulatory product label
Romidepsin clearance decreased with increased severity of hepatic impairment.
human
source value
Cmax
Regulatory product label
the geometric mean C max values after administration of 14, 7, and 5 mg/m 2 romidepsin in patients with mild (B1: bilirubin ≤ULN and AST >ULN; B2: bilirubin >ULN but ≤1.5 x ULN and any AST), moderate (bilirubin >1.5 x ULN to ≤3 x ULN and any AST), and severe (bilirubin >3 x ULN and any AST) hepatic impairment were approximately 111%, 96%, and 86% of the corresponding value after administration of 14 mg/m 2 romidepsin in patients with normal (bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ULN) hepatic function, respectively.
human
source value
Cited measurement trace6 observations
1-6 / 6
AUC
1,549 ng*h/mL
- Context
- human · intravenous · plasma
- Measured material
- Reported analyte
- Evidence role
- Source-reported product-label value
- Reference
- Reference
Reported statement: 12.3 Pharmacokinetics In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma conce...
AUC
The geometric mean AUC inf values in patients with mild, moderate, and severe hepatic impairment were approximately 144%, 114%, and 116% of the corresponding value in patients with normal hepatic function, respectively.
- Context
- human
- Measured material
- Reported analyte
- Evidence role
- Source-reported observation
- Reference
- Reference
Reported statement: The geometric mean AUC inf values in patients with mild, moderate, and severe hepatic impairment were approximately 144%, 114%, and 116% of the corresponding value in patients with normal hepatic function, respectively.
Clearance
Romidepsin clearance decreased with increased severity of hepatic impairment.
- Context
- human
- Measured material
- Reported analyte
- Evidence role
- Source-reported observation
- Reference
- Reference
Reported statement: Romidepsin clearance decreased with increased severity of hepatic impairment.
Cmax
377 ng/mL
- Context
- human · intravenous · plasma
- Measured material
- Reported analyte
- Evidence role
- Source-reported product-label value
- Reference
- Reference
Reported statement: 12.3 Pharmacokinetics In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma conce...
Cmax
the geometric mean C max values after administration of 14, 7, and 5 mg/m 2 romidepsin in patients with mild (B1: bilirubin ≤ULN and AST >ULN; B2: bilirubin >ULN but ≤1.5 x ULN and any AST), moderate (bilirubin >1.5 x ULN to ≤3 x ULN and any AST), and severe (bilirubin >3 x ULN and any AST) hepatic impairment were approximately 111%, 96%, and 86% of the corresponding value after administration of 14 mg/m 2 romidepsin in patients with normal (bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ULN) hepatic function, respectively.
- Context
- human
- Measured material
- Reported analyte
- Evidence role
- Source-reported observation
- Reference
- Reference
Reported statement: the geometric mean C max values after administration of 14, 7, and 5 mg/m 2 romidepsin in patients with mild (B1: bilirubin ≤ULN and AST >ULN; B2: bilirubin >ULN but ≤1.5 x ULN and any AST), moderate (bilirubin >1.5 x...
PPB
92-94 %
- Context
- human · plasma
- Measured material
- Reported analyte
- Evidence role
- Source-reported product-label value
- Reference
- Reference
Reported statement: Distribution Romidepsin is highly protein bound in plasma (92% to 94%) over the concentration range of 50 ng/mL to 1000 ng/mL with α1-acid-glycoprotein (AAG) being the principal binding protein.
| PK property | Value | Context | Reference | Measured material | Evidence role | Reported statement |
|---|---|---|---|---|---|---|
| AUC | 1,549 ng*h/mL | human · intravenous · plasma | Reference | Reported analyte | Source-reported product-label value | 12.3 Pharmacokinetics In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma conce... |
| AUC | The geometric mean AUC inf values in patients with mild, moderate, and severe hepatic impairment were approximately 144%, 114%, and 116% of the corresponding value in patients with normal hepatic function, respectively. | human | Reference | Reported analyte | Source-reported observation | The geometric mean AUC inf values in patients with mild, moderate, and severe hepatic impairment were approximately 144%, 114%, and 116% of the corresponding value in patients with normal hepatic function, respectively. |
| Clearance | Romidepsin clearance decreased with increased severity of hepatic impairment. | human | Reference | Reported analyte | Source-reported observation | Romidepsin clearance decreased with increased severity of hepatic impairment. |
| Cmax | 377 ng/mL | human · intravenous · plasma | Reference | Reported analyte | Source-reported product-label value | 12.3 Pharmacokinetics In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma conce... |
| Cmax | the geometric mean C max values after administration of 14, 7, and 5 mg/m 2 romidepsin in patients with mild (B1: bilirubin ≤ULN and AST >ULN; B2: bilirubin >ULN but ≤1.5 x ULN and any AST), moderate (bilirubin >1.5 x ULN to ≤3 x ULN and any AST), and severe (bilirubin >3 x ULN and any AST) hepatic impairment were approximately 111%, 96%, and 86% of the corresponding value after administration of 14 mg/m 2 romidepsin in patients with normal (bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ULN) hepatic function, respectively. | human | Reference | Reported analyte | Source-reported observation | the geometric mean C max values after administration of 14, 7, and 5 mg/m 2 romidepsin in patients with mild (B1: bilirubin ≤ULN and AST >ULN; B2: bilirubin >ULN but ≤1.5 x ULN and any AST), moderate (bilirubin >1.5 x... |
| PPB | 92-94 % | human · plasma | Reference | Reported analyte | Source-reported product-label value | Distribution Romidepsin is highly protein bound in plasma (92% to 94%) over the concentration range of 50 ng/mL to 1000 ng/mL with α1-acid-glycoprotein (AAG) being the principal binding protein. |
1–6 / 6
How PK values are grouped
Summaries keep species, unit, route, dose, matrix, population, and source context separate. Each value retains its cited measurement trace.
Four. Safety & immunogenicity
Regulatory safety warnings, postmarketing and nonclinical safety context, and immune-recognition context. These describe available signals, not incidence rates or causality.
Safety & immunogenicity
Postmarketing safety
0
report entries
Immune recognition
0
assay entries
Nonclinical safety
0
context entries
Product context landscape shows 0 of 3 lanes with current signal support for this product.
LaneCountCurrent signalBoundary
Postmarketing safety
No report context attached
0
report entries
No postmarketing safety report context attached.
Serious: 0 (0%)Reactions: 0Countries: 0
Spontaneous reports are safety-surveillance context only. They do not establish incidence, comparative risk, or causality.External search
Immune recognition
No immune-assay context attached
0
assay entries
No immune-recognition assay context attached.
Positive: 0Negative: 0MHC classes: 0
Immune-assay entries show epitope or MHC recognition assay context. They are not clinical immunogenicity incidence.Context entries
Nonclinical safety
No nonclinical safety context attached
0
context entries
No nonclinical safety context attached.
Label refs: 0Reviewed refs: 0Species: 0
Nonclinical safety entries retain animal, toxicology, or label context and are not normalized human safety endpoints.Context entries
The source-level context signal index is deferred from the initial product profile. Use the context-lane links above or the structured product profile below to inspect all 25 retained context signal entries.
Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.
Five. Clinical & regulatory evidence
Clinical-trial context and structured product-label references attached by product identity.
Clinical & regulatory evidence
Human study context
25
trial signals
Regulatory label
0
label contexts
Product context landscape shows 1 of 2 lanes with current signal support for this product.
LaneCountCurrent signalBoundary
Human study context
Study registry context attached
25
trial signals
NCT01846390: Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma
Strong NCTs: 21Exact match: 17Has results: 6
Study registry references provide trial context. Phase, status, and posted-results metadata are not endpoint evidence by themselves.Registry search
Regulatory label
Supporting label context
0
label contexts
No structured label reference attached.
Label refs: 0Reviewed AE: 0Immunogenicity: 0
Product-label entries are regulatory product-label context unless an entry is separately promoted by endpoint-specific policy.Label search
The source-level context signal index is deferred from the initial product profile. Use the context-lane links above or the structured product profile below to inspect all 25 retained context signal entries.
Interpretation boundary Product-context signals are retained for interpretation and traceability. They are not incidence rates, causal safety findings, or normalized peptide endpoint measurements.
Six. Provenance, scope & access
How to read, trace, cite, and reopen this profile: evidence scope, reference lineage, and reproducible data access.
Evidence scope
How to read this profile
Evidence roles stay separate before interpretation
Endpoint summaries, product-context lanes, identity links, and source references answer different questions. This boundary keeps the page useful without converting context into stronger claims than the current review layer supports.
Endpoint comparison
Traceable within endpoint context
Compare PK results only when endpoint and experimental context are compatible.
Product-context reading
Context available, not endpoint truth
Label, trial, safety, immune, and nonclinical records remain contextual unless separately extracted as an endpoint.
Context propagation
Allowed for product-context reading
Defined molecular entity
Detailed interpretation and provenance guidance
Scientific interpretation details
SurfaceEvidence roleSupportsDoes not supportRelated evidence
Curated endpoint evidence
Evidence role
Comparable measurement layer
Supports
Endpoint-level interpretation when context fields match.
Does not support
Pooled product parameters across mismatched species, units, route, dose, matrix, population, or source context.
Product-context signals
Evidence role
Clinical, label, safety, immune, and nonclinical context
Supports
Reading the product's evidence surroundings and source-backed context lanes.
Does not support
Incidence rates, causality claims, product safety ranking, or normalized ADMET endpoint values.
Peptide identity
Evidence role
Molecular identity context
Supports
Reading product context beside a reviewed peptide identity.
Does not support
Automatic transfer of every product-level signal to peptide-level endpoint evidence.
Reference lineage
Evidence role
Reproducibility and source trace
Supports
Checking where labels, trials, safety reports, identity links, and curated measurements came from.
Does not support
A substitute for normalized evidence, context grouping, or endpoint review.
External source references
Evidence role
Original-source reading path
Supports
Reading the source reference in its native regulatory, registry, literature, or source context.
Does not support
Bypassing ADMETatlas curation status, interpretation boundaries, or endpoint-promotion policy.
Scientific interpretation limits
Endpoint interpretation
Requires compatible endpoint and context
Identity context
Reviewed identity context available
Causality and incidence
Not claimed from context counts
Reference lineage
Reference role map
Source families are separated by scientific role
Label, trial, safety, immune, identity-link, and PK evidence enter the product profile through different review paths. This module keeps their roles visible so users can trace evidence without over-reading context counts.
Source material
4
active reference families
Identity review
1
source-matching traces
Evidence lanes
31
PK plus context entries
Release view
public
current product profile
Reference role matrix
Source familyEvidence roleSupportsBoundaryRelated evidence
Label material
0 label · 0 sections
Evidence role
Regulatory product-label context
Supports
Label sections, label-derived PK statements, safety wording, route, formulation, and immunogenicity context when extracted.
Boundary
Label material supports product context. It becomes endpoint evidence only through the reviewed PK or endpoint extraction path.
Trial registry context
25 references
Evidence role
Human study-registration context
Supports
Trial identity, phase/status, intervention matching, and availability of results context around the product.
Boundary
Trial registry entries are study context unless endpoint-compatible results are extracted and reviewed separately.
Postmarketing reports
0 AE context entries
Evidence role
Safety surveillance context
Supports
Signal-aware reading of reported adverse-event context around marketed products.
Boundary
Report counts do not establish causality, incidence, or comparative product safety.
Immune and nonclinical context
0 entries
Evidence role
Assay and nonclinical support context
Supports
Immune-recognition assays, nonclinical safety context, and neighboring signals that help interpret the product profile.
Boundary
These entries are not clinical incidence or endpoint truth unless a review policy promotes a specific endpoint.
Product identity records
2 RxNorm identifiers
Evidence role
Named-product identity support
Supports
Matching named and dosed product presentations to a stable medication identity.
Boundary
Identity records do not provide an endpoint value, administration outcome, or route-specific clinical result.
Identity source traces
1 traces
Evidence role
Source-matching and identity-review context
Supports
Source records used to assess product-to-peptide identity relationships and retained audit context.
Boundary
Only an exact match to the current authoritative canonical identity supports a linked identity; all other traces remain product context.
Cited PK evidence
6 entries
Evidence role
Endpoint measurement trace
Supports
Rechecking source values, units, route, dose, matrix, population, and source context for PK summaries.
Boundary
PK entries remain context-bound measurements and should not be pooled across incompatible contexts.
Traceability note
Link references and selected label entries carry direct source links. Product-context entries may instead carry source labels and curated summaries in the structured profile. Both are provenance, but only direct reference fields should be displayed as citation links.
Data access & citation
Reproducible product view
The structured profile access reopens the same product view used by this page, including molecular identity, PK evidence, product context, and reference lineage for the current public release.
Current public release
ATL product ID
ATLPD0000086
public product profile
Linked peptides
1
identity link scope
PK evidence
6
cited measurement trace
Product-linked records
27
25 context · 2 identity support
References
1
label plus link traces
Analysis-ready access
Use the product profile access for product-specific reproducibility. Use full-release downloads for catalog-scale analysis, with the current source policy and data dictionary.
Structured product profile
Scope
Current product
Contents
Machine-readable profile for molecular identity, PK evidence summaries, product context, and reference lineage.
Boundary
Uses the public ATL product ID in the URL. Non-public product identifiers remain outside the navigation label.
Programmatic access
The request returns the structured product profile used by this page. It is the current product-specific reproducibility path while product-only tabular exports remain a release follow-up.
GET /api/v1/products/ATLPD0000086
curl -sS 'https://admetatlas.scbdd.com/api/v1/products/ATLPD0000086' \
-H 'accept: application/json' \
-H 'X-Visibility: public_release'Use boundary
Use this module to reproduce the current product profile and locate full-release exports. Cross-product comparison still depends on compatible endpoint, species, route, dose, matrix, population, source, identity-link, and review context.