bynfezia pen
Bynfezia Pen (Octreotide Acetate) is a somatostatin analog used to treat Acromegaly, Adenoma, Diarrhea, Pancreatic Neoplasms.
Octreotide Acetate · by Sun Pharm
Key facts
- Active ingredient
- Octreotide Acetate
- Drug class
- Somatostatin Analog
- Form
- Injectable
- Strength
- Octreotide Acetate EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- acromegaly, adenoma, diarrhea
- Manufacturer
- Sun Pharm
- What the pharmacy pays
- ~$5.34 per ml — not your price
- FDA application
- NDA213224
What is Bynfezia Pen?
From the FDA label: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 49 H 66 N 10 O 10 S 2 and its molecular weight is 1019.3 and its structural formula as acetate salt is: 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. spl-octreotide-structure.jpg
How to use
BYNFEZIA PEN is administered subcutaneously; alternate injection site periodically (2.1) • Acromegaly: Recommended initial BYNFEZIA dosage is 50 mcg three times daily during the initial 2 weeks of therapy. Maintenance dose 100 mcg to 500 mcg three times daily. (2.2) • Carcinoid Tumors: Recommended dosage range of 100 mcg to 600 mcg daily in two to four divided doses during the initial 2 weeks of therapy. (2.3) • VIPomas: Recommended dosage range of 200 mcg to 300 mcg daily in two to four divided doses during the initial 2 weeks of therapy. (2.4) 2.1 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”. 2.2 Recommended Dosage and Monitoring for Acromegaly The recommended initial dosage of BYNFEZIA PEN is 50 mcg three times…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Conduction Abnormalities [Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.3)] Thyroid Function Abnormalities [see Warnings and Precautions (5.4)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.5)] Changes in Vitamin B 12 Levels [see Warnings and Precautions (5.6)] Most common adverse reactions (> 10%): (6.1) Acromegaly: Gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools nausea, abdominal discomfort, hyperglycemia, and hypothyroidism. Carcinoid Tumors and VIPomas: Gallbladder abnormalities. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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…
Warnings
Important safety information
Cardiac Conduction Abnormalities: Bradycardia, arrhythmias, or conduction abnormalities may occur. Use with caution in at-risk patients. Dosage adjustment of cardiac medications may be necessary. (5.1) • Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. (5.2) • Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and anti-diabetic treatment may need adjustment. (5.3) • Thyroid Function: Hypothyroidism may occur. Monitor thyroid levels periodically. (5.4) • Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency. (5.5) 5.1 Cardiac Conduction Abnormalities Cardiac conduction abnormalities have occurred during treatment with octreotide. In acromegalic patients, bradycardia (< 50 bpm) developed in 25%; conduction abnormalities occurred in 10% and arrhythmias occurred in 9% of patients during octreotide therapy [see Adverse Reactions (6)] . Other electrocardiogram (ECG) changes observed included QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R-wave progression. These ECG changes are not uncommon in acromegalic patients. Dose adjustments in drugs such as beta-blockers that have bradycardia effects may be necessary. In one acromegalic patient with severe congestive heart failure (CHF), initiation of octreotide therapy resulted in worsening of CHF with improvement when drug was discontinued. Confirmation of a drug effect was obtained with a positive rechallenge. 5.2 Cholelithiasis and Complications of Cholelithiasis BYNFEZIA PEN may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. Acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis have been reported with octreotide therapy. In clinical trials (primarily patients with acromegaly or 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. One patient developed ascending cholangitis during octreotide therapy and died. If complications of cholelithiasis are suspected, discontinue BYNFEZIA PEN and treat appropriately. 5.3 Hyperglycemia and Hypoglycemia BYNFEZIA PEN alters the balance between the counter-regulatory hormones, insulin, glucagon and GH, which may result in hypoglycemia or hyperglycemia. The hypoglycemia or hyperglycemia which occurs during octreotide therapy is usually mild but may result in overt diabetes mellitus or necessitate dose changes in insulin or other anti-diabetic agents. Hypoglycemia and hyperglycemia occurred on octreotide in 3% and 16% of acromegalic patients, respectively [ see Adverse Reactions (6)] . Severe hyperglycemia, subsequent pneumonia, and death following initiation of octreotide therapy was reported in one patient with no history of hyperglycemia. Monitor glucose levels during BYNFEZIA PEN therapy. Adjust dosing of insulin or other anti-diabetic therapy accordingly. 5.4 Thyroid Function Abnormalities Octreotide suppresses secretion of thyroid stimulating hormone (TSH), which may result in hypothyroidism. Baseline and periodic assessment of thyroid function (TSH, total, and/or free T4) is recommended during chronic therapy [see Adverse Reactions (6)] . 5.5 Steatorrhea and Malabsorption of Dietary Fats New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including octreotide. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new occurrence or worsening of these symptoms are reported in patients receiving octreotide, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly. 5.6 Changes in Vitamin B12 Levels Depressed vitamin B 12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide therapy and monitoring of vitamin B 12 levels is recommended during BYNFEZIA PEN therapy.
Who should not take Bynfezia Pen
Sensitivity to this drug or any of its co mponents. Sensitivity to this drug or any of the components (4)
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
The following drugs require monitoring and possible dose adjustment when used with BYNFEZIA PEN : cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. (7) Lutetium Lu 177 Dotatate Injection : Discontinue BYNFEZIA PEN at least 24 hours prior to each lutetium Lu 177 dotatate dose. (7.6) 7.1 Cyclosporine Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of BYNFEZIA PEN with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection. 7.2 Insulin and Oral Hypoglycemic Drugs Octreotide inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when BYNFEZIA PEN treatment is initiated or when the dose is altered and anti-diabetic treatment should be adjusted accordingly. 7.3 Bromocriptine Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. 7.4 Other Concomitant Drug Therapy Concomitant administration of bradycardia-inducing drugs (e.g., beta-blockers) may have an additive effect on the reduction of heart rate associated with octreotide. Dose adjustments of concomitant medication may be necessary. Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. 7.5 Drug Metabolism Interactions Li mited published data indicate that so matostatin analogs might decrease the metabolic clearance of co mpounds known to be metabolized by cytochro me P450 enzy mes, which may be due to the suppression of GH. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution. 7.6 Lutetium Lu 177 Dotatate Injection Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue BYNFEZIA PEN at least 24 hours prior to each lutetium Lu 177 dotatate dose.
Drug class
May treat (source: NIH RxClass)
See how Bynfezia Pen ranks — best-rated somatostatin analog for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Bynfezia Pen treat?
- Bynfezia Pen (Octreotide Acetate) may be used to treat acromegaly, adenoma, diarrhea, pancreatic neoplasms, pituitary neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Bynfezia Pen cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $5.34 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Bynfezia Pen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bynfezia Pen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bynfezia Pen?
- Bynfezia Pen is marketed by Sun Pharm. You can see Sun Pharm's full profile, rating, and other products on pharmaranks.
- Is Bynfezia Pen a brand-name or generic drug?
- Bynfezia Pen is a brand-name product with the active ingredient Octreotide Acetate.
- Is Bynfezia Pen available over the counter?
- No. Bynfezia Pen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bynfezia Pen come in?
- Bynfezia Pen is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Bynfezia Pen?
- Bynfezia Pen is classified as somatostatin analog, per the FDA's Established Pharmacologic Class.
- Is Bynfezia Pen FDA-registered?
- Bynfezia Pen is on record with the U.S. FDA under application number NDA213224. You can verify this on its official FDA label.
- Is Bynfezia Pen safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Bynfezia Pen. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Bynfezia Pen?
- Bynfezia Pen's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Conduction Abnormalities [Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [see Warnings and P… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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