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Bynfezia Pen Generic Name & Formulations
Legal Class
Rx
General Description
Octreotide acetate 2500mcg/mL; soln for SC inj.
Pharmacological Class
Somatostatin analogue.
How Supplied
Single-patient-use prefilled pens (2.8mL)—1, 2
Manufacturer
Generic Availability
NO
Bynfezia Pen Indications
Indications
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.
Bynfezia Pen Dosage and Administration
Adult
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
Not established.
Bynfezia Pen Contraindications
Not Applicable
Bynfezia Pen Boxed Warnings
Not Applicable
Bynfezia Pen Warnings/Precautions
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 Pharmacokinetics
See Literature
Bynfezia Pen Interactions
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.
Bynfezia Pen Adverse Reactions
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.
Bynfezia Pen Clinical Trials
See Literature
Bynfezia Pen Note
Not Applicable
Bynfezia Pen Patient Counseling
See Literature
Bynfezia Pen Generic Name & Formulations
Legal Class
Rx
General Description
Octreotide acetate 2500mcg/mL; soln for SC inj.
Pharmacological Class
Somatostatin analogue.
How Supplied
Single-patient-use prefilled pens (2.8mL)—1, 2
Manufacturer
Generic Availability
NO
Bynfezia Pen Indications
Indications
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.
Bynfezia Pen Dosage and Administration
Adult
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
Not established.
Bynfezia Pen Contraindications
Not Applicable
Bynfezia Pen Boxed Warnings
Not Applicable
Bynfezia Pen Warnings/Precautions
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 Pharmacokinetics
See Literature
Bynfezia Pen Interactions
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.
Bynfezia Pen Adverse Reactions
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.
Bynfezia Pen Clinical Trials
See Literature
Bynfezia Pen Note
Not Applicable
Bynfezia Pen Patient Counseling
See Literature
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