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Generic Name
Octreotide Acetate
Brand Names
Bynfezia, Octreotide, Sandostatin
FDA approval date: October 21, 1988
Classification: Somatostatin Analog
Form: Injection, Kit
What is Bynfezia (Octreotide Acetate)?
BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone and insulin growth factor 1 in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with octreotide injection; these trials were not optimally designed to detect such effects.
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Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
Summary: Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance imagi...
A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly
Summary: The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs
Summary: The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
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Brand Information
BYNFEZIA Pen (octreotide acetate)
1DOSAGE FORMS AND STRENGTHS
BYNFEZIA PEN is available as:
- Injection: 7,000 mcg/2.8 mL (2,500 mcg/mL) octreotide (as acetate) as a clear, colorless solution in a single-patient-use prefilled pen.
2CONTRAINDICATIONS
Sensitivity to this drug or any of its co mponents.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cardiac Conduction Abnormalities
- Cholelithiasis and Complications of Cholelithiasis
- Hyperglycemia and Hypoglycemia
- Thyroid Function Abnormalities
- Steatorrhea and Malabsorption of Dietary Fats
- Changes in Vitamin B
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of BYNFEZIA PEN has been established based on clinical studies of octreotide acetate injection. Below is a description of the adverse reactions from the clinical studies.
Gallbladder Abnormalities
Gallbladder abnormalities, especially stones and/or biliary sludge, frequently develop in patients on chronic octreotide therapy [see Warnings and Precautions (5.1)]. In clinical trials (primarily patients with acromegaly or psoriasis) (BYNFEZIA PEN is not indicated for the treatment of psoriasis)], the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received octreotide for 12 months or longer was 52%. Less than 2% of patients treated with octreotide for 1 month or less developed gallstones.
Cardiac
In acromegalics, sinus bradycardia (<50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias developed in 9% of patients during octreotide therapy [see Warnings and Precautions (5.1)].
Gallbladder abnormalities, especially stones and/or biliary sludge, frequently develop in patients on chronic octreotide therapy [see Warnings and Precautions (5.1)]. In clinical trials (primarily patients with acromegaly or psoriasis) (BYNFEZIA PEN is not indicated for the treatment of psoriasis)], the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received octreotide for 12 months or longer was 52%. Less than 2% of patients treated with octreotide for 1 month or less developed gallstones.
Cardiac
In acromegalics, sinus bradycardia (<50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias developed in 9% of patients during octreotide therapy [see Warnings and Precautions (5.1)].
Gastrointestinal
Diarrhea, loose stools, nausea, and abdominal discomfort were each seen in 34% to 61% of acromegalic patients in U.S. studies. 2.6% of the patients discontinued therapy due to these symptoms. These symptoms were seen in 5% to 10% of patients with carcinoid tumors and VIPomas.
Diarrhea, loose stools, nausea, and abdominal discomfort were each seen in 34% to 61% of acromegalic patients in U.S. studies. 2.6% of the patients discontinued therapy due to these symptoms. These symptoms were seen in 5% to 10% of patients with carcinoid tumors and VIPomas.
The frequency of these symptoms was not dose related, but diarrhea and abdominal discomfort generally resolved more quickly in patients treated with 300 mcg/day than in those treated with 750 mcg/day. Vomiting, flatulence, abnormal stools, abdominal distention, and constipation were each seen in less than 10% of patients.
In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness, and guarding.
Hypo/Hyperglycemia
Hypoglycemia and hyperglycemia occurred in 3% and 16% of acromegalic patients, respectively, but only in about 1.5% of other patients. Symptoms of hypoglycemia were noted in approximately 2% of patients.
Hypoglycemia and hyperglycemia occurred in 3% and 16% of acromegalic patients, respectively, but only in about 1.5% of other patients. Symptoms of hypoglycemia were noted in approximately 2% of patients.
Hypothyroidism
In acromegalics, biochemical hypothyroidism alone occurred in 12% while goiter occurred in 8% and 4% required initiation of thyroid replacement therapy during octreotide therapy [see Warnings and Precautions (5.4)]. In patients without acromegaly, hypothyroidism has only been reported in several isolated patients and goiter has not been reported.
In acromegalics, biochemical hypothyroidism alone occurred in 12% while goiter occurred in 8% and 4% required initiation of thyroid replacement therapy during octreotide therapy [see Warnings and Precautions (5.4)]. In patients without acromegaly, hypothyroidism has only been reported in several isolated patients and goiter has not been reported.
Other Adverse Events
Pain on injection was reported in 7.7%, headache in 6%, and dizziness in 5%. Pancreatitis was also observed [see Warnings and Precautions (5.2)].
Pain on injection was reported in 7.7%, headache in 6%, and dizziness in 5%. Pancreatitis was also observed [see Warnings and Precautions (5.2)].
Other Adverse Events 1% to 4%
Other events, each observed in 1% to 4% of patients, included fatigue, weakness, pruritus, joint pain, backache, urinary tract infection, cold symptoms, flu symptoms, injection site hematoma, bruise, edema, flushing, blurred vision, pollakiuria, fat malabsorption, hair loss, visual disturbance, and depression.
Other events, each observed in 1% to 4% of patients, included fatigue, weakness, pruritus, joint pain, backache, urinary tract infection, cold symptoms, flu symptoms, injection site hematoma, bruise, edema, flushing, blurred vision, pollakiuria, fat malabsorption, hair loss, visual disturbance, and depression.
Anaphylactoid reactions, including anaphylactic shock, have been reported in several patients receiving octreotide.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of octreotide acetate injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatobiliary: cholelithiasis, cholecystitis, cholangitis and pancreatitis, which have sometimes required cholecystectomy
Gastrointestinal: intestinal obstruction, pancreatic exocrine insufficiency
Hematologic: thrombocytopenia
Gastrointestinal: intestinal obstruction, pancreatic exocrine insufficiency
Hematologic: thrombocytopenia
4OVERDOSAGE
A limited number of accidental overdoses of octreotide in adults have been reported. In adults, the doses ranged from 2,400 to 6,000 mcg/day administered by continuous infusion (100 to 250 mcg/hour) or subcutaneously (1,500 mcg 3 times a day). Adverse events in some patients included arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.
If overdose occurs, symptomatic management is indicated. Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at 1-800-222-1222.
5DESCRIPTION
BYNFEZIA PEN (octreotide acetate) injection contains octreotide as its acetate salt.Octreotide is a somatostatin analogue. Octreotide acetate known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt.
The molecular formula of octreotide free base is C
BYNFEZIA PEN (octreotide acetate) injection is available as a disposable single-patient-use prefilled pen containing 7,000 mcg of octreotide (as acetate)/2.8 mL. Each milliliter of octreotide acetate injection contains 2,500 mcg octreotide (present as octreotide acetate, USP), 3.4 mg lactic acid, 22.5 mg mannitol, 5 mg phenol, and Water for Injection (q.s.). The pH of the solution is adjusted to 4.2 ± 0.3 by the addition of aqueous sodium bicarbonate solution.
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
BYNFEZIA PEN ( octreotide acetate) injection, 7,000 mcg/2.8 mL (2,500 mcg /mL) octreotide is a clear colorless solution and it is available as:
Dispense in the original sealed carton with the enclosed Instructions for Use.
Storage and Handling
Before first use, store BYNFEZIA PEN in the refrigerator between 2°C to 8°C (36°F to 46°F) and store in outer carton in order to protect from light. After first use, store pens at controlled room temperature between 20°C to 25°C (68°F to 77°F). Excursions between 15°C (59°F) and 30°C (86°F) are allowed for up to 28 days. Discard the pen 28 days after first use. Do not freeze.
7PATIENT COUNSELING INFORMATION
Advise patient and/or caregivers to read the FDA-approved patient labeling (Instructions for Use).
Sterile Subcutaneous Injection Technique
Careful instruction in sterile subcutaneous injection technique should be given to the patients and to other persons who may administer BYNFEZIA PEN.
Cholelithiasis and Complications of Cholelithiasis
Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis, and pancreatitis)
Steatorrhea and Malabsorption of Dietary Fats
Advise patients to contact their healthcare provider if they experience new or worsening of steatorrhea, stool
discoloration, loose stools, abdominal bloating, and weight loss
Pregnancy
Inform female patients that treatment with BYNFEZIA PEN may result in unintended pregnancy
All trademarks are the property of their respective owners.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
8INSTRUCTIONS FOR USE
BYNFEZIA PEN
(octreotide acetate) Prefilled Pen
Read these instructions before you start using the BYNFEZIA PEN. It is important that you understand and follow these instructions to use the pen correctly. BYNFEZIA PEN is a prefilled pen that you or your caregiver can use to give more than 1 dose of medicine.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
For more information, call 1-800-818-4555.
Issued: 10/2024
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rx only
NDC 62756-452-37
Bynfezia Pen
7,000 mcg/2.8mL (2,500 mcg/mL)
Two 2.8 mL disposable single-patient-use prefilled pens
For doses of 50 mcg, 100 mcg, 150 mcg, and 200 mcg of octreotide per injection.
For Single Patient Use Only
SUN PHARMA
NDC 62756-452-37
Bynfezia Pen
7,000 mcg/2.8mL (2,500 mcg/mL)
Two 2.8 mL disposable single-patient-use prefilled pens
For doses of 50 mcg, 100 mcg, 150 mcg, and 200 mcg of octreotide per injection.
For Single Patient Use Only
SUN PHARMA
