LABELS · c8ba6520-445a-4934-85f4-6f706cb21585

Cesamet

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: 2021-01-19
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.

Full extracted label fields

application numbers

NDA018677

boxed warning exact

brand names

Cesamet

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83c7ac15-ece9-47de-b83c-d575544fa449

generic names

NABILONE

c8ba6520-445a-4934-85f4-6f706cb21585

indications and usage exact

INDICATIONS AND USAGE Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.

indications and usage tables exact

is original packager

true

manufacturer names

Bausch Health US LLC

matched search terms

cancer

package ndcs

0187-1231-50

product ndcs

0187-1231

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

104885
311891

source batch

file

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

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

NDA018677

brand names

Cesamet

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 422
end exclusive: true
exact text: INDICATIONS AND USAGE Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other
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current approval status

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extraction review status

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generic names

NABILONE

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label id

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positive predicate support span

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end exclusive: true
exact text: are indicated
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offset unit: unicode_code_points
source array index: 0
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source text sha256: d76767f4fd01deec851847dee011523bf232ad349e64555b5928fdee1c10c644
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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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end exclusive: true
exact text: INDICATIONS AND USAGE Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
label id: c8ba6520-445a-4934-85f4-6f706cb21585
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d76767f4fd01deec851847dee011523bf232ad349e64555b5928fdee1c10c644
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

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

supportive_care_candidate

Passage 2 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 640
end exclusive: true
exact text: esamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initia
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current approval status

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generic names

NABILONE

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label id

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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

end: 440
end exclusive: true
exact text: This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
label id: c8ba6520-445a-4934-85f4-6f706cb21585
offset unit: unicode_code_points
source array index: 0
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source text sha256: d76767f4fd01deec851847dee011523bf232ad349e64555b5928fdee1c10c644
start: 223

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

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 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 885
end exclusive: true
exact text: s required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to
label id: c8ba6520-445a-4934-85f4-6f706cb21585
offset unit: unicode_code_points
source array index: 0
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start: 241

current approval status

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extraction review status

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generic names

NABILONE

ind-span-acb53144b2ac6e510e63

label id

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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

end: 685
end exclusive: true
exact text: Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.
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source text sha256: d76767f4fd01deec851847dee011523bf232ad349e64555b5928fdee1c10c644
start: 441

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

spl set id

83c7ac15-ece9-47de-b83c-d575544fa449

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

Passage 4 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 981
end exclusive: true
exact text: state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are
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source array index: 0
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start: 486

current approval status

not_reconciled

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generic names

NABILONE

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label id

c8ba6520-445a-4934-85f4-6f706cb21585

positive predicate support span

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qualifier mentions

regulatory links

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source batch sha256

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source defined aliases

source span

end: 781
end exclusive: true
exact text: Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act.
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start: 686

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

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 5 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1037
end exclusive: true
exact text: ent by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a firs
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current approval status

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extraction review status

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generic names

NABILONE

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positive predicate support span

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qualifier mentions

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source defined aliases

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exact text: Schedule II substances have a high potential for abuse.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

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 6 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1160
end exclusive: true
exact text: ial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving
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end exclusive: true
exact text: Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
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source url

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spl effective date

2021-01-19

spl set id

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spl version

structured fields status

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structured indication

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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 7 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

context span

end: 1283
end exclusive: true
exact text: lled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include th
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exact text: Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient.
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source url

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spl effective date

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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 8 · unclassified context

application numbers

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brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

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context span

end: 1392
end exclusive: true
exact text: the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
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exact text: As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse.
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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

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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 9 · unclassified context

application numbers

NDA018677

brand names

Cesamet

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

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context span

end: 1392
end exclusive: true
exact text: ded basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
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current approval status

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NABILONE

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label id

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positive predicate support span

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qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1392
end exclusive: true
exact text: Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
label id: c8ba6520-445a-4934-85f4-6f706cb21585
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d76767f4fd01deec851847dee011523bf232ad349e64555b5928fdee1c10c644
start: 1215

source url

https://api.fda.gov/drug/label.json?search=id%3A%22c8ba6520-445a-4934-85f4-6f706cb21585%22

spl effective date

2021-01-19

spl set id

83c7ac15-ece9-47de-b83c-d575544fa449

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