Medically reviewed by Drugs.com. Last updated on Feb 9, 2023.
Laboratory Testing Prior to BYNFEZIA Pen Initiation
- Assess baseline thyroid function before initiation of BYNFEZIA Pen therapy and monitor periodically [see Warnings and Precautions (5.3)].
Recommended Dosage in Acromegaly
- Initiate dosing at 50 mcg subcutaneously three times a day to improve tolerability to gastrointestinal adverse reactions [see Adverse Reactions (6.1)].
- Measure IGF-I levels every 2 weeks after BYNFEZIA Pen initiation or dosage change to guide titration. Alternatively, measuring growth hormone levels at 1-4 hour intervals for 8-12 hours after BYNFEZIA Pen administration can guide titration of dose. The goal is to achieve growth hormone levels less than 5 ng/mL or IGF-I levels within normal reference ranges for age and sex.
- The typical dosage is 100 mcg subcutaneously three times a day, but some patients require up to 500 mcg three times a day. Doses greater than 300 mcg daily seldom result in additional benefit; if an increase in dose fails to provide additional benefit, reduce the dosage. Once biochemical normalization, or maximal benefit is achieved, re-evaluate IGF-I or growth hormone levels at 6-month intervals.
- Withdraw BYNFEZIA Pen yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If growth hormone or IGF-I levels increase and signs and symptoms recur, BYNFEZIA Pen therapy may be resumed at the dose used at the time of BYNFEZIA Pen discontinuation.
Recommended Dosage for Carcinoid Tumors
- The recommended daily dosage of BYNFEZIA Pen during the first 2 weeks of therapy ranges from 100 mcg daily to 600 mcg daily in 2 to 4 divided doses (mean daily dosage is 300 mcg).
- In 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 daily. Experience with doses above 750 mcg daily is limited.
- Monitor patient’s urinary 5-hydroxyindole acetic acid (5-HIAA), plasma serotonin, and plasma Substance P.
Recommended Dosage for VIPomas
- The recommended daily dosage of BYNFEZIA Pen during the first 2 weeks of therapy ranges from 200 mcg daily to 300 mcg daily in 2 to 4 divided doses. Adjust the dosage to achieve a therapeutic response; daily dosage is 150 mcg to 750 mcg but usually doses above 450 mcg daily are not required.
- Monitor patient’s plasma vasoactive intestinal peptide (VIP).
Important Administration Instructions
- 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”.
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