Cytoprotective and supportive care agents:
Indications for: BYNFEZIA PEN
Severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. Profuse watery diarrhea associated with vasoactive intestinal peptide-secreting tumors (VIPomas).
Limitations of Use:
The effect on size, rate of growth and development of metastases, has not been determined.
Adult Dosage:
See full labeling. Give by SC inj into abdomen, front of middle thighs, or deltoids. Rotate inj sites. Carcinoid tumors: 100–600mcg daily in 2–4 divided doses for the 1st 2 weeks; usual maintenance: 450mcg/day; max 1500mcg/day. VIPomas: 200–300mcg daily in 2–4 divided doses for the 1st 2 weeks; max 750mcg/day.
Children Dosage:
Not established.
BYNFEZIA PEN Warnings/Precautions:
Diabetes. Thyroid function abnormalities. Assess baseline thyroid function prior to initiation and monitor periodically. Cardiac conduction abnormalities. Monitor gallbladder, glucose, vitamin B12. Carcinoid tumors: also monitor urinary 5-HIAA, plasma serotonin, plasma Substance P. VIPomas: also monitor plasma vasoactive intestinal peptide. Discontinue and treat if cholelithiasis complications are suspected. Hepatic or renal impairment. Dialysis patients. Elderly. Pregnancy. Nursing mothers.
BYNFEZIA PEN Classification:
Somatostatin analogue.
BYNFEZIA PEN Interactions:
Potentiates bromocriptine, CYP450 substrates (eg, quinidine). Concomitant bradycardia-inducing drugs (eg, β-blockers, calcium channel blockers) or agents used to control fluid and electrolyte balance; may need dose adjustments. Antagonizes cyclosporine. May need to adjust antidiabetic agents.
Adverse Reactions:
Diarrhea, loose stools, nausea, abdominal discomfort, gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia; conduction abnormalities, hyperglycemia, hypoglycemia, hypothyroidism, headache, dizziness, pancreatitis, inj site pain.
Generic Drug Availability:
NO
How Supplied:
Single-patient-use prefilled pens (2.8mL)—1, 2
Pituitary disorders:
Indications for: BYNFEZIA PEN
Acromegaly unresponsive to or that cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
Limitations of Use:
The effect on improvement in clinical signs/symptoms, reduction in tumor size and rate of growth, has not been determined.
Adult Dosage:
See full labeling. Give by SC inj into abdomen, front of middle thighs, or deltoids. Rotate inj sites. Initially 50mcg three times daily. Usual maintenance: 100mcg 3 times daily; max 500mcg 3 times daily. Reevaluate every 6 months. Pituitary irradiation recipients: withdraw therapy for approx. 4 weeks once yearly to assess disease activity; resume if growth hormone or IGF-1 levels increase or signs/symptoms recur.
Children Dosage:
Not established.
BYNFEZIA PEN Warnings/Precautions:
Diabetes. Thyroid function abnormalities. Assess baseline thyroid function prior to initiation and monitor periodically. Cardiac conduction abnormalities. Monitor growth hormone, IGF-1 levels, gallbladder, glucose, vitamin B12. Discontinue and treat if cholelithiasis complications are suspected. Hepatic or renal impairment. Dialysis patients. Elderly. Pregnancy. Nursing mothers.
BYNFEZIA PEN Classification:
Somatostatin analogue.
BYNFEZIA PEN Interactions:
Potentiates bromocriptine, CYP450 substrates (eg, quinidine). Concomitant bradycardia-inducing drugs (eg, β-blockers, calcium channel blockers) or agents used to control fluid and electrolyte balance; may need dose adjustments. Antagonizes cyclosporine. May need to adjust antidiabetic agents.
Adverse Reactions:
Diarrhea, loose stools, nausea, abdominal discomfort, gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia; conduction abnormalities, hyperglycemia, hypoglycemia, hypothyroidism, headache, dizziness, pancreatitis, inj site pain.
Generic Drug Availability:
NO
How Supplied:
Single-patient-use prefilled pens (2.8mL)—1, 2
