LABELS · c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1

AKYNZEO

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-06-23
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. ( 1 )

Full extracted label fields

application numbers

NDA205718
NDA210493

boxed warning exact

brand names

AKYNZEO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e47618e-af46-4d82-94e8-1507c042252d

generic names

NETUPITANT AND PALONOSETRON
FOSNETUPITANT AND PALONOSETRON

c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1

indications and usage exact

1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Helsinn Therapeutics (U.S.), Inc.

matched search terms

cancer

package ndcs

69639-101-01
69639-101-04
69639-102-01
69639-105-01
69639-106-01

product ndcs

69639-101
69639-102
69639-105
69639-106

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL
INTRAVENOUS

rxcuis

1552343
1552349
2044429
2044431
2374366
2374368

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 600
total: 830

terms

https://open.fda.gov/terms/

sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1%22

spl effective date

2026-06-23

spl effective time

20260623

spl set id

8e47618e-af46-4d82-94e8-1507c042252d

spl version

substance names

NETUPITANT
PALONOSETRON
FOSNETUPITANT
PALONOSETRON HYDROCHLORIDE

uniis

5D06587D6R
23310D4I19
T672P80L2S
7732P08TIR

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA205718
payload
all indexed label documents
Appl No
205718
Application Docs Date
2014-10-14 00:00:00
Application Docs ID
19675
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
205718
Application Docs Date
2015-05-06 00:00:00
Application Docs ID
19676
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
205718
Application Docs Date
2015-05-04 00:00:00
Application Docs ID
19677
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
205718
Application Docs Date
2021-06-03 00:00:00
Application Docs ID
67686
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf
Submission No
9
Submission Type
SUPPL
all submission records
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
8
Submission No
1
Submission Status
AP
Submission Status Date
2014-10-10 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
2015-02-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2015-04-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2015-04-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2015-05-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
5
Submission Status
AP
Submission Status Date
2015-07-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
6
Submission Status
AP
Submission Status Date
2016-04-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2016-12-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205718
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2021-06-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA205718
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205718
has approved submission record
true
latest approved submission date
2021-06-02
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
205718
Application Docs Date
2021-06-03 00:00:00
Application Docs ID
67686
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf
Submission No
9
Submission Type
SUPPL
official application record
Appl No
205718
Appl Public Notes
Appl Type
NDA
Sponsor Name
HELSINN HLTHCARE
openfda application present
true
products
Active Ingredient
NETUPITANT; PALONOSETRON HYDROCHLORIDE
Appl No
205718
Drug Name
AKYNZEO
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
300MG;EQ 0.5MG BASE
marketing status
Prescription
application number
NDA210493
payload
all indexed label documents
Appl No
210493
Application Docs Date
2018-04-20 00:00:00
Application Docs ID
53747
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
210493
Application Docs Date
2020-08-05 00:00:00
Application Docs ID
64206
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
210493
Application Docs Date
2020-10-30 00:00:00
Application Docs ID
65084
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
210493
Application Docs Date
2021-06-03 00:00:00
Application Docs ID
67685
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210493s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
210493
Application Docs Date
2023-04-14 00:00:00
Application Docs ID
73532
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210493Orig1s005lbl.pdf
Submission No
5
Submission Type
SUPPL
all submission records
Appl No
210493
Review Priority
STANDARD
Submission Class Code ID
8
Submission No
1
Submission Status
AP
Submission Status Date
2018-04-19 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
210493
Review Priority
N/A
Submission Class Code ID
4
Submission No
1
Submission Status
AP
Submission Status Date
2020-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210493
Review Priority
N/A
Submission Class Code ID
4
Submission No
2
Submission Status
AP
Submission Status Date
2020-05-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210493
Review Priority
N/A
Submission Class Code ID
4
Submission No
3
Submission Status
AP
Submission Status Date
2020-10-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210493
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2021-06-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210493
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2023-02-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA210493
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210493
has approved submission record
true
latest approved submission date
2023-02-15
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
210493
Application Docs Date
2023-04-14 00:00:00
Application Docs ID
73532
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210493Orig1s005lbl.pdf
Submission No
5
Submission Type
SUPPL
official application record
Appl No
210493
Appl Public Notes
Appl Type
NDA
Sponsor Name
HELSINN HLTHCARE
openfda application present
true
products
Active Ingredient
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Appl No
210493
Drug Name
AKYNZEO
Form
POWDER;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
marketing status
Discontinued
Active Ingredient
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Appl No
210493
Drug Name
AKYNZEO
Form
SOLUTION;INTRAVENOUS
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA205718
NDA210493

brand names

AKYNZEO

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

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end exclusive: true
exact text: 1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute an
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current approval status

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duplicate text group

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extraction review status

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generic names

NETUPITANT AND PALONOSETRON
FOSNETUPITANT AND PALONOSETRON

ind-span-151442261f67caf552cc

label id

c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1

positive predicate support span

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qualifier mentions

context exact
capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting
kind
age
polarity
not_inferred
span
end
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end exclusive
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exact text
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source text sha256
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start
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context exact
1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
kind
regimen
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exact text
in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, includin
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source text sha256
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regulatory links

schema version

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source batch sha256

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source defined aliases

source span

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exact text: 1 INDICATIONS AND USAGE AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
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source url

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spl effective date

2026-06-23

spl set id

8e47618e-af46-4d82-94e8-1507c042252d

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 2 · unclassified context

application numbers

NDA205718
NDA210493

brand names

AKYNZEO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 729
end exclusive: true
exact text: in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat co
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generic names

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FOSNETUPITANT AND PALONOSETRON

ind-span-7fdf28c4f3ffda25a7cc

label id

c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1

positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

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exact text: AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · positive indication candidate

application numbers

NDA205718
NDA210493

brand names

AKYNZEO

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

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end exclusive: true
exact text: osetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea a
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current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

NETUPITANT AND PALONOSETRON
FOSNETUPITANT AND PALONOSETRON

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source text sha256: 2c8d9459acd9b539db9844f21fe419f03603d16d1ab9f7094ad40a3f6b9764bf
start: 2114

current approval status

not_reconciled

duplicate text group

dup-b282b8f31095007f4c80

extraction review status

automated_candidate_pending_source_review

generic names

NETUPITANT AND PALONOSETRON
FOSNETUPITANT AND PALONOSETRON

ind-span-e0f864f0ab8ce87525eb

label id

c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 2319
end exclusive: true
exact text: ( 1 )
label id: c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2c8d9459acd9b539db9844f21fe419f03603d16d1ab9f7094ad40a3f6b9764bf
start: 2314

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c1a46993-d1bf-4f84-8fac-e9c04a7d6bf1%22

spl effective date

2026-06-23

spl set id

8e47618e-af46-4d82-94e8-1507c042252d

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice