BYNFEZIA Pen

INDICATIONS AND USAGE

Quoted from the FDA label

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.

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