LABELS · ee3c8bae-88f0-4b76-80af-98a3e3312585

BYNFEZIA Pen

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: 2025-02-21
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1 .1) Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (1 .3) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects. (1.4) 1.1 Acromegaly BYNFEZIA PEN is indicated to reduce blood levels of growth hormone (GH) and insulin gro wth factor-1 (I GF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors BYNFEZIA PEN is indicated for treat ment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors BYNFEZIA PEN is indicated for the treat ment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tu mors. 1.4 Important Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects.

Full extracted label fields

application numbers

NDA213224

boxed warning exact

brand names

BYNFEZIA Pen

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20ed4e79-ad4c-426f-859d-83790c00439b

generic names

OCTREOTIDE ACETATE

ee3c8bae-88f0-4b76-80af-98a3e3312585

indications and usage exact

1 INDICATIONS AND USAGE BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1 .1) Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (1 .3) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects. (1.4) 1.1 Acromegaly BYNFEZIA PEN is indicated to reduce blood levels of growth hormone (GH) and insulin gro wth factor-1 (I GF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors BYNFEZIA PEN is indicated for treat ment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors BYNFEZIA PEN is indicated for the treat ment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tu mors. 1.4 Important Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects.

indications and usage tables exact

is original packager

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manufacturer names

Sun Pharmaceutical Industries, Inc.

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package ndcs

62756-452-37
62756-452-36

product ndcs

62756-452

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

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routes

SUBCUTANEOUS

rxcuis

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source batch

file

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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

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exact text: 1 INDICATIONS AND USAGE BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1 .1) Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with t
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exact text: 1 INDICATIONS AND USAGE BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
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use intent

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Passage 2 · positive indication candidate

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exact text: somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1 .1) Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (1 .3) Limitations of Use Improvement in clinical signs and
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Passage 3 · positive indication candidate

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Passage 4 · limitation of use

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exact text: diarrhea and flushing episodes associated with the disease. (1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (1 .3) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects. (1.4) 1.1 Acromegaly BYNFEZIA PEN is indicated to reduce blood levels of growth hormone (GH) and insulin gro wth factor-1 (I GF-1; somatomedin C) in acromegaly patients who have had inadequate respon
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Passage 5 · unclassified context

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exact text: d symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects. (1.4) 1.1 Acromegaly BYNFEZIA PEN is indicated to reduce blood levels of growth hormone (GH) and insulin gro wth factor-1 (I GF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors BYNFEZIA PEN is indicated for treat ment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors BYNFEZIA P
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non_oncology_or_unclear_candidate

Passage 7 · positive indication candidate

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exact text: somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors BYNFEZIA PEN is indicated for treat ment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors BYNFEZIA PEN is indicated for the treat ment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tu mors.
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