BYNFEZIA Pen octreotide acetate 2.5 mg/mL Injection, 2 cartridges
Other active recalls for Octreotide Acetate (different manufacturers) — 4 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Somatostatin Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Octreotide immediate-release injection is used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery, radiation, or another medication. Octreotide immediate-release injection is also used to control diarrhea and flushing caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms) and vasoactive intestinal peptide secre...
Read the full MedlinePlus article ↗- Octreotide injection is used for three conditions. First, it lowers abnormally high growth hormone levels in people with acromegaly — a condition where the pituitary gland produces...
- What exactly is octreotide injection used for?
- It depends on your treatment plan. Subcutaneous doses — injections under the skin — can be self-administered once you've been trained, similar to how some people give themselves in...
- How is this injection given — do I give it to myself or does a nurse do it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Octreotide Acetate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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3.4 mg / 1 mL
UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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22.5 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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5 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| BYNFEZIA Pen 2.5 mg/mLthis 62756-0452-37 | Sun | 2 cartridges | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12350475 ↗ | Method of use | U-4007 | Dec 29, 2041 |
| US 12350475 ↗ | Method of use | U-4008 | Dec 29, 2041 |
| US 12350475 ↗ | Method of use | U-4009 | Dec 29, 2041 |
| US 11246991 ↗ | Method of use | U-4007 | Nov 3, 2040 |
| US 11246991 ↗ | Method of use | U-4008 | Nov 3, 2040 |
| US 11246991 ↗ | Method of use | U-4009 | Nov 3, 2040 |
| US 11534553 ↗ | Method of use | U-4007 | Nov 3, 2040 |
| US 11534553 ↗ | Method of use | U-4008 | Nov 3, 2040 |
| US 11534553 ↗ | Method of use | U-4009 | Nov 3, 2040 |
| US 11052196 ↗ | Method of use | U-4007 | Nov 3, 2040 |
| US 11052196 ↗ | Method of use | U-4008 | Nov 3, 2040 |
| US 11052196 ↗ | Method of use | U-4009 | Nov 3, 2040 |
| US 10342850 ↗ | Drug product | — | May 15, 2038 |
Is there a generic version of BYNFEZIA 7,000 MCG/2.8 ML PEN?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
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Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62756-0452-36 | 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE | 2025-02-24 | Active |
| 62756-0452-37 You're viewing this | 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE | 2025-02-24 | Active |
Pack size FAQ
What quantity is in NDC 62756-0452-37?
What is the difference between NDC 62756-0452-37 and NDC 62756-0452-36?
What NDC number is used to bill for this package of BYNFEZIA Pen octreotide acetate 2.5 mg/mL Injection?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) 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. (1 .1) 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.
(1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (1 .3) 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. (1.4)
1.1Acromegaly BYNFEZIA PEN is indicated to reduce blood levels of growth hormone (GH) and insulin gro wth factor-1 (I GF-1; somatomedin C) 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.
1.2Carcinoid Tumors BYNFEZIA PEN is indicated for treat ment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
1.3Vasoactive Intestinal Peptide Tumors BYNFEZIA PEN is indicated for the treat ment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tu mors.
1.4Important 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • 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)
2.1Dosage 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”.
2.2Recommended 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.
2.3Recommended 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.
2.4Recommended 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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. Injection: 7,000 mcg/2.8 mL (2,500 mcg/mL) octreotide (as acetate) in a 2.8 mL single-patient-use prefilled pen (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sensitivity to this drug or any of its co mponents. Sensitivity to this drug or any of the components (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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)
5.1Cardiac 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.
5.2Cholelithiasis 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.
5.3Hyperglycemia 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.
5.4Thyroid 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)] .
5.5Steatorrhea and Malabsorption of Dietary Fats New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including octreotide. Somatost…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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
6.1Clinical 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)] . 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. 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. 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.
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)] . Other Adverse Events 1% to 4% Other events, each observed in 1% to 4% of patients, included fatigue, weakness, pruritus, joint pain,…
🔄 Drug Interactions ▾
7 DRUG 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)
7.1Cyclosporine 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.
7.2Insulin 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.
7.3Bromocriptine Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine.
7.4Other 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.
7.5Drug 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.
7.6Lutetium 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3)
8.1Pregnancy Risk Summary The limited data with octreotide acetate in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse developmental-effects were observed with IV administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively the maximum recommended human dose (MRHD) of 1.5 mg/day based on body surface area (BSA). Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at IV doses below the MRHD based on BSA ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In postmarketing data, a limited number of exposed pregnancies have been reported in patients with acromegaly.
Most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100 to 300 mcg/day of octreotide or 20 mg to 30 mg once a month of octreotide acetate for injectable suspension, however some women elected to continue octreotide therapy throughout pregnancy. In cases with a known outcome, no congenital malformations were reported. Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received IV doses of octreotide up to 1 mg/kg/day during the period of organogenesis.
A slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. There were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. At 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7 and 13 times, respectively, at the highest recommended human dose of 1.5 mg/day based on BSA.
In a pre- and post-natal development rat study at IV doses of 0.02–1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of GH inhibition by octreotide. The doses attributed to the delayed growth are below the human dose of 1.5 mg/day, based on BSA.
8.2Lactation Risk Summary There is no information available on the presence of octreotide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Studies show that octreotide administered subcutaneously passes into the milk of lactating rats; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk ( see Data ). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BYNFEZIA PEN, and any potential adverse effects on the breastfed child from BYNFEZIA PEN or from the underlying maternal condition.
Data Following a subcutaneous dose (1 mg/kg) of octreotide to lactating rats, transfer of octreotide into milk was observed at a low concentration compared to plasma (milk/plasma ratio of 0.009).
8.3Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in GH levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in acromegalic females treated with octreotide may lead to improved fertility.
8.4Pediatric Use Safety and efficacy of octreotide injection in the pediatric population have not been demonstrated. No formal controlled clinical trials have been performed to evaluate the safety and effectiveness of octreotide injection in pediatric patients under age 6 years. In post-marketing reports,…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited data with octreotide acetate in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse developmental-effects were observed with IV administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7 and 13 times, respectively the maximum recommended human dose (MRHD) of 1.5 mg/day based on body surface area (BSA). Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at IV doses below the MRHD based on BSA ( see Data ).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In postmarketing data, a limited number of exposed pregnancies have been reported in patients with acromegaly.
Most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100 to 300 mcg/day of octreotide or 20 mg to 30 mg once a month of octreotide acetate for injectable suspension, however some women elected to continue octreotide therapy throughout pregnancy. In cases with a known outcome, no congenital malformations were reported. Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received IV doses of octreotide up to 1 mg/kg/day during the period of organogenesis.
A slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. There were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. At 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7 and 13 times, respectively, at the highest recommended human dose of 1.5 mg/day based on BSA.
In a pre- and post-natal development rat study at IV doses of 0.02–1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of GH inhibition by octreotide. The doses attributed to the delayed growth are below the human dose of 1.5 mg/day, based on BSA.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of octreotide injection in the pediatric population have not been demonstrated. No formal controlled clinical trials have been performed to evaluate the safety and effectiveness of octreotide injection in pediatric patients under age 6 years. In post-marketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide injection use in children, most notably in children under 2 years of age.
The relationship of these events to octreotide has not been established as the majority of these pediatric patients had serious underlying co-morbid conditions. The efficacy and safety of octreotide injection using the octreotide acetate for injectable suspension formulation was examined in a single randomized, double-blind, placebo-controlled, 6 month pharmacokinetics study in 60 pediatric patients age 6 to 17 years with hypothalamic obesity resulting from cranial insult. The mean octreotide concentration after 6 doses of 40 mg octreotide acetate for injectable suspension administered by intramuscular (IM) injection every 4 weeks was approximately 3 ng/mL.
Steady-state concentrations was achieved after 3 injections of a 40 mg dose. Mean body mass index (BMI) increased 0.1 kg/m 2 in octreotide acetate for injectable suspension-treated subjects compared to 0.0 kg/m 2 in saline control-treated subjects. Efficacy was not demonstrated.
Diarrhea occurred in 11 of 30 (37%) patients treated with octreotide acetate for injectable suspension. No unexpected adverse events were observed. However, with octreotide acetate for injectable suspension at 40 mg once a month, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in other adult indications such as acromegaly (22%) or malignant carcinoid syndrome (24%), where octreotide acetate for injectable suspension was 10 mg to 30 mg once a month.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of octreotide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action BYNFEZIA PEN (octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, VIP, secretin, motilin, and pancreatic polypeptide.
By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and VIP secreting adenomas (watery diarrhea).
12.2Pharmacodynamics Octreotide substantially reduces GH and/or IGF-I (somatomedin C) levels in patients with acromegaly. Single doses of octreotide have been shown to inhibit gallbladder contractility and to decrease bile secretion in normal volunteers. In controlled clinical trials, the incidence of gallstone or biliary sludge formation was markedly increased [see Warnings and Precautions (5.2)] . Octreotide suppresses secretion of TSH.
12.3Pharmacokinetics Absorption After subcutaneous injection, octreotide is absorbed rapidly and co mpletely from the injection site. Peak concentrations of 5.2 ng/ mL (100 mcg dose) were reached 0.4 hours after dosing. Peak concentrations and area under the curve (AUC) values were dose proportional after subcutaneous single doses up to 500 mcg and after subcutaneous multiple doses up to 500 mcg 3 times a day (1,500 mcg/day).
In patients with acromegaly, a mean peak concentration of 2.8 ng/mL (100 mcg dose) was reached in 0.7 hours after subcutaneous dosing. Distribution In healthy volunteers, the distribution of octreotide from plas ma was rapid (t α1/2 = 0.2 h), the volu me of distribution (Vd ss ) was esti mated to be
13.6L, and the total body clearance ranged from 7 L/hr to 10 L/hr. In blood, the distribution into the erythrocytes was found to be negligible and about 65% was bound in the plas ma in a concentration-independent manner. Binding was mainly to lipoprotein and, to a lesser extent, to albu min. In patients with acromegaly, the volume of distribution (Vdss) was estimated to be 21.6 ±
8.5L, and the total body clearance was increased to 18 L/h. The mean percent of the drug bound was 41.2%. Elimination The eli mination of octreotide from plas ma had an apparent half-life of 1.7 to 1.9 hours co m pared with 1 to 3 minutes with the natural hor mone.
The duration of action of octreotide injection is variable but extends up to 12 hours depending upon the type of tu mor. About 32% of the dose is excreted unchanged into the urine. In an elderly population, dose adjustments may be necessary due to a significant increase in the half-life (46%) and a significant decrease in the clearance (26%) of the drug.
In patients with acromegaly, the disposition and elimination half-lives were similar to normal subjects. Specific Populations Renal Impairment In patients with mild renal i mpair ment (C L CR 40 to 60 m L/ min), octreotide t 1/2 was 2.4 hours and total body clearance was
8.8L/hr, in moderate i mpair ment (CL CR 10 to 39 m L/ min) t 1/2 was 3.0 hours and total body clearance
7.3L/hr. In patients with severe renal i mpairment not requiring dialysis (CL CR <10 m L/ min), octreotide t 1/2 was 3.1 hours and total body clearance was
7.6L/hr. In patients with severe renal failure requiring dialysis, total body clearance was reduced to about half that found in healthy subjects (from approximately 10 L/hr to
4.5L/hr). Hepatic Impairment Patients with liver cirrhosis showed prolonged elimination of drug, with octreotide t 1/2 increasing to 3.7 hr and total body clearance decreasing to
5.9L/hr, whereas patients with fatty liver disease showed t 1/2 increased to 3.4 hr and total body clearance of
8.2L/hr.
12.6Immunogenicity Evaluation of 20 patients treated for at least 6 months has failed to demonstrate titers…
🧬 Mechanism of Action ▾
12.1Mechanism of Action BYNFEZIA PEN (octreotide acetate) exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, VIP, secretin, motilin, and pancreatic polypeptide.
By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (flushing and diarrhea), and VIP secreting adenomas (watery diarrhea).
📦 How Supplied / Storage and Handling ▾
16 HOW 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: Dosage Unit Package Size NDC # 2.8 mL single -patient-use prefilled pen Carton of 1 NDC 62756-452-36 2.8 mL single -patient-use prefilled pen Carton of 2 NDC 62756-452-37 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.
📋 Description ▾
11 DESCRIPTION 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
💬 Information for Patients ▾
17 PATIENT 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) [see Warnings and Precautions (5.2)].
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 [see Warnings and Precautions (5.5)]. Pregnancy Inform female patients that treatment with BYNFEZIA PEN may result in unintended pregnancy [see Use in Specific Populations (8.3)]. All trademarks are the property of their respective owners.
Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd., India At M/s. OneSource Specialty Pharma Limited Plot No.
2-D1, Obadenahalli, Doddaballapura, 3rd Phase, Industrial Area, Doddaballapura Taluk, Bengaluru Rural, 561203, Karnataka INDIA