Bynfezia Dosage

Dosage and Administration Overview

• Inspect visually for particulate matter and discoloration. Only use BYNFEZIA PEN if the solution appears colorless with no visible particles.
• BYNFEZIA PEN should be at room temperature before injecting to reduce potential injection site reactions.
• Administer BYNFEZIA PEN by subcutaneous injection into the abdomen, the front of the middle thighs, or the back/outer area of the upper arms.
• Rotate injection sites so that the same site is not used repeatedly. Injection sites should be at least 2 inches away from your last injection site.
• Provide proper training to patients and/or caregivers on the administration of BYNFEZIA PEN prior to use according to the “Instructions for Use”.

Recommended Dosage and Monitoring for Acromegaly

The recommended initial dosage of BYNFEZIA PEN is 50 mcg three times daily to be administered subcutaneously. Increase BYNFEZIA dose based upon GH or IGF-1 levels. The goal is to achieve GH levels less than 5 ng/mL or IGF-I levels within normal range. Monitor GH or IGF-1 every two weeks after initiating BYNFEZIA PEN therapy or with dosage change, and to guide titration.

The most common dosage is 100 mcg three times daily, but some patients require up to 500 mcg three times daily for maximum effectiveness. Doses greater than 300 mcg/day seldom result in additional biochemical benefit, and if an increase in dose fails to provide additional benefit, the dose should be reduced.

BYNFEZIA PEN should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If GH or IGF-I levels increase and signs and symptoms recur, BYNFEZIA PEN therapy may be resumed.

Recommended Dosage and Monitoring for Carcinoid Tumors

The recommended daily dosage of BYNFEZIA PEN during the first 2 weeks of therapy ranges from 100 to 600 mcg/day in two to four divided doses given subcutaneously (mean daily dosage is 300 mcg). In the clinical studies, the median daily maintenance dosage was approximately 450 mcg, but clinical and biochemical benefits were obtained in some patients with as little as 50 mcg, while others required doses up to 1,500 mcg/day. However, experience with doses above 750 mcg/day is limited. Measurement of urinary 5-hydroxyindole acetic acid, plasma serotonin, plasma Substance P may be useful in monitoring the progress of therapy.

Recommended Dosage and Monitoring for Vasoactive Intestinal Peptide Tumors

Daily dosage of 200 mcg to 300 mcg in two to four divided doses given subcutaneously are recommended during the initial 2 weeks of therapy (range, 150 mcg to 750 mcg) to control symptoms of the disease. On an individual basis, dosage may be adjusted to achieve a therapeutic response; but usually doses above 450 mcg/day are not required. Measurement of Plas ma vasoactive intestinal peptide (VIP) may be useful in monitoring the progress of therapy.