BYNFEZIA Pen

BYNFEZIA PEN — octreotide acetate injection
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

1.1 Acromegaly

BYNFEZIA Pen is indicated to reduce blood levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly 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 the treatment of adult patients with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.

1.3 Vasoactive Intestinal Peptide Tumors (VIPomas)

BYNFEZIA Pen is indicated for the treatment of adult patients with the profuse watery diarrhea associated with VIP-secreting tumors.

1.4 Limitations of Use

In patients with acromegaly, the effect of BYNFEZIA Pen on improvement in clinical signs and symptoms, reduction in tumor size, and rate of growth has not been determined.

In patients with carcinoid syndrome and VIPomas, the effect of BYNFEZIA Pen on the tumor size, rate of growth and development of metastases has not been determined.

2 DOSAGE AND ADMINISTRATION

2.1 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)].

2.2 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.

2.3 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.

2.4 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).

2.5 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”.

3 DOSAGE FORMS AND STRENGTHS

BYNFEZIA Pen is available as:

  • Injection: 2,500 mcg/mL octreotide as a clear, colorless solution in a 2.8 mL single-patient-use pen.

4 CONTRAINDICATIONS

BYNFEZIA Pen is contraindicated in patients with:

  • Hypersensitivity to octreotide or any of the components of BYNFEZIA Pen. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Cholelithiasis and Complications of Cholelithiasis

BYNFEZIA Pen may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, pancreatitis and requiring cholecystectomy in patients taking octreotide [see Adverse Reactions (6)]. Patients should be monitored periodically. If complications of cholelithiasis are suspected, discontinue BYNFEZIA Pen and treat appropriately.

5.2 Hyperglycemia and Hypoglycemia

BYNFEZIA Pen alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone, which may result in hypoglycemia, hyperglycemia, or overt diabetes mellitus. In patients with acromegaly, 3% developed hypoglycemia and 16% developed hyperglycemia during treatment with octreotide. Severe hyperglycemia, subsequent pneumonia, and death following initiation of octreotide was reported in one patient with no history of hyperglycemia [see Adverse Reactions (6)].

In patients with type 1 diabetes mellitus, BYNFEZIA Pen is likely to affect glucose regulation, and insulin requirements may be reduced. Symptomatic hypoglycemia, sometimes severe, has been reported in these patients. In patients without diabetes and patients with type 2 diabetes with partially intact insulin reserves, BYNFEZIA Pen may result in decreases in plasma insulin levels and hyperglycemia. Monitor glycemic control for all patients and adjust antidiabetic treatment as necessary.

5.3 Thyroid Function Abnormalities

BYNFEZIA Pen suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism. In patients with acromegaly, 12% developed biochemical hypothyroidism, 8% developed goiter, and 4% required initiation of thyroid replacement therapy while receiving octreotide. Assess thyroid function at baseline and periodically during treatment with BYNFEZIA Pen [see Adverse Reactions (6)].

5.4 Cardiac Function Abnormalities

Cardiac conduction abnormalities have occurred during treatment with octreotide. In patients with acromegaly, bradycardia (<50 bpm) developed in 25%, conduction abnormalities occurred in 10% and arrhythmias occurred in 9% of patients during treatment with octreotide. Other ECG changes observed included QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R wave progression. These ECG changes may occur in patients with acromegaly. In one patient with acromegaly and severe congestive heart failure (CHF), initiation of octreotide resulted in worsening of CHF with improvement when drug was discontinued and worsened when octreotide was restarted [see Adverse Reactions (6)]. Dosage adjustments of concomitantly used drugs that have bradycardia effects (i.e. beta-blockers) may be necessary [see Drug Interactions (7.4)].

5.5 Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests

BYNFEZIA Pen may alter absorption of dietary fats in some patients. Decreased vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment with BYNFEZIA Pen.

6 ADVERSE REACTIONS

The following important adverse reactions are described below and elsewhere in the labeling:

  • Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1)]
  • Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2)]
  • Thyroid Function Abnormalities [see Warnings and Precautions (5.3)]
  • Cardiac Function Abnormalities [see Warnings and Precautions (5.4)]
  • Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests [see Warnings and Precautions (5.5)]

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