Octreotide

What is Octreotide?

• Octreotide (Bynfezia; Sandostatin) immediate-release injection is a somatostatin analogue used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly, 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 secreting adenomas (VIPomas).
• Octreotide long-acting injection (Sandostatin LAR Depot) is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often.

Octreotide

Octreotide3d

What are the uses of this medicine?

Octreotide (Bynfezia; Sandostatin) is used for the:

• Reduction 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.
• Treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients.
• Treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients.

• Octreotide long-acting injection (Sandostatin LAR Depot) is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often.

Limitations of use:

• In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and SANDOSTATIN LAR DEPOT on tumor size, rate of growth and development of metastases, has not been determined.

How does this medicine work?

• Octreotide (ok tree' oh tide) is a synthetic cyclic octapeptide and analogue of somatostatin that is used for its ability to suppress levels and activities of other hormones (growth hormone, insulin, gastrin, secretin, glucagon) or active neuropeptides (serotonin, vasoactive intestinal polypeptide [VIP]).
• Natural somatostatin is produced in the hypothalamus and acts to suppress growth hormone release from the pituitary.
• Somatostatin is also found in other neurons throughout the body and particularly in intestinal and pancreatic neurons, where it is active in suppressing release of other hormones and neuropeptides such as insulin, glucagon, gastrin, secretin, motilin, VIP, serotonin and cholecystokinin.
• Octreotide has a longer half-life (1 to 2 hours) than somatostatin (~3 minutes) and yields effective suppression of hormone production when given three times daily.
• More recently, longer acting formulations of octreotide have been developed that can be administered weekly or monthly.
• Octreotide appears to interact largely with the somatostatin subtype 2 and possibly subtype 5 receptors, with little effect on subtypes 1, 3 and 4, explaining its focused effects.
• Octreotide therapy has been shown to improve symptoms and complications of several neuroendocrine tumors including abnormal growth in acromegaly due to growth hormone secreting pituitary tumors, diarrhea due to VIP secreting intestinal tumors and flushing due to carcinoid tumors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to octreotide or any of the components.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• bromocriptine (Cycloset, Parlodel)
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• insulin and oral medications for diabetes
• quinidine
• terfenadine (Seldane) (not available in the U.S.)

Is this medicine FDA approved?

• Octreotide was approved for use in the United States in 1988 and current listed indications include acromegaly, watery diarrhea from VIP producing tumors and diarrhea and flushing due to metastatic carcinoid tumors.
• Octreotide has been used off-label for portal hypertension to control variceal hemorrhage as well as for dumping syndrome and other gastrointestinal motility disorders.

How should this medicine be used?

Recommended dosage:

Octreotide (Bynfezia; Sandostatin) immediate-release injection:

• Acromegaly: Initiate dosage at 50 mcg three times daily. Typical dosage is 100 mcg three times a day.
• Carcinoid Tumors: 100-600 mcg daily in 2-4 divided doses for first 2 weeks.
• VIPomas: 200-300 mcg daily in 2-4 divided doses for first 2 weeks.

Octreotide long-acting injection (Sandostatin LAR Depot):

• Acromegaly: 50 mcg three times daily Sandostatin Injection subcutaneously for 2 weeks followed by SANDOSTATIN LAR DEPOT 20 mg intragluteally every 4 weeks for 3 months.
• Carcinoid Tumors and VIPomas: Sandostatin Injection subcutaneously 100 to 600 mcg/day in 2-4 divided doses for 2 weeks followed by SANDOSTATIN LAR DEPOT 20 mg every 4 weeks for 2 months.

Patients Currently Receiving Sandostatin Injection Subcutaneously:

• Acromegaly: 20 mg every 4 weeks for 3 months.
• Carcinoid Tumors and VIPomas: 20 mg every 4 weeks for 2 months.

Renal Impairment, Patients on Dialysis:

• 10 mg every 4 weeks.

Hepatic Impairment, Patients With Cirrhosis:

• 10 mg every 4 weeks.

Administration:

• Octreotide comes as an immediate-release solution (liquid) for injection to be injected subcutaneously (under the skin) or intravenously (into a vein) Octreotide also comes as a long-acting injection to be injected into the muscles of the buttocks by a doctor or nurse.
• Octreotide immediate-release injection is usually injected 2 to 4 times a day.
• Octreotide long-acting injection is usually injected once every 4 weeks.
• Inject octreotide immediate-release injection at around the same times every day.
• If you are not already being treated with octreotide injection, you will begin your treatment with immediate-release octreotide injection. You will be treated with the immediate-release injection for 2 weeks, and your doctor may gradually increase your dose during that time. If the medication works for you and does not cause severe side effects, your doctor may give you the long-acting injection after 2 weeks.
• If you are being treated for a carcinoid tumor or VIP-oma, you may experience worsening of your symptoms from time to time during your treatment. If this happens, your doctor may tell you to use the immediate-release injection for a few days until your symptoms are controlled.
• If you have acromegaly and have been treated with radiation therapy, your doctor will probably tell you not to use octreotide immediate-release injection for 4 weeks every year or not to receive the octreotide long-acting injection for 8 weeks every year.
• Octreotide immediate-release injection comes in vials, ampules, and dosing pens that contain cartridges of medication.
• If you are using the immediate-release injection from a vial, ampule or dosing pen, you may be able to inject the medication yourself at home or have a friend or relative perform the injections. Ask your doctor to show you or the person who will be performing the injections how to inject the medication. Also talk to your doctor about where on your body you should inject the medication and how you should rotate injection spots so that you do not inject in the same spot too often.
• Inspect visually for particulate matter and discoloration. Only use solution for injection 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”.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As an immediate-release solution (liquid) for injection
• long-acting injection

This medicine is available in fallowing brand namesː

• Bynfezia; Sandostatin; Sandostatin LAR Depot

What side effects can this medication cause?

The most common side effects of this medicine include: In Acromegalic Patients:

• Diarrhea
• Abdominal Pain
• Flatulence
• Influenza-Like Symptoms
• Constipation
• Headache
• Anemia
• Injection-Site Pain
• Cholelithiasis
• Hypertension
• Dizziness
• Fatigue

In Carcinoid Tumor and VIPoma Patients:

• Abdominal Pain
• Arthropathy
• Back Pain
• Dizziness
• Fatigue
• Flatulence
• Generalized Pain
• Headache
• Musculoskeletal Pain
• Myalgia
• Nausea
• Pruritus
• Rash
• Sinusitis
• URTI
• Vomiting

What special precautions should I follow?

• Octreotide Acetate Injection may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. If complications of cholelithiasis are suspected, discontinue octreotide acetate and treat appropriately.
• Patients who receive Octreotide Acetate Injection intravenously may be at increased risk for higher degree atrioventricular blocks. The safety of continuous intravenous infusion has not been established in patients receiving octreotide acetate for the approved indications. Consider cardiac monitoring in patients receiving octreotide acetate intravenously.
• Octreotide Acetate Injection alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone (GH), which may result in hypoglycemia or hyperglycemia. Blood glucose levels should be monitored. Anti-diabetic treatment should be adjusted accordingly.
• Octreotide suppresses the 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 octreotide therapy.
• In both acromegalic and carcinoid syndrome patients, bradycardia, arrhythmias and conduction abnormalities have been reported during octreotide therapy.
• Octreotide may alter absorption of dietary fats. Depressed vitamin B12 levels and abnormal Schilling tests have been observed in some patients receiving octreotide therapy, and monitoring of vitamin B12 levels is recommended during therapy.
• Octreotide has been investigated for the reduction of excessive fluid loss from the GI tract in patients with conditions producing such a loss. If such patients are receiving total parenteral nutrition (TPN), serum zinc may rise excessively when the fluid loss is reversed. Patients on TPN and octreotide should have periodic monitoring of zinc levels.
• Several cases of pancreatitis have been reported in patients receiving octreotide acetate therapy.
• In patients with severe renal failure requiring dialysis, the half-life of octreotide acetate may be increased, necessitating adjustment of the maintenance dosage.
• It is not known whether octreotide is excreted into human milk. Because many drugs are excreted in human milk, caution should be exercised when Octreotide Acetate Injection is administered to a nursing woman.
• Octreotide has many side effects including suppression of gall bladder contractility and bile production, and maintenance therapy can cause cholelithiasis, pancreatitis as well as clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• arrhythmia, complete atrioventricular block, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If overdose occurs, symptomatic management is indicated.

Can this medicine be used in pregnancy?

• The limited data with octreotide in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
• There are reports of pregnancy in acromegalic women.
• In women with active acromegaly who have been unable to become pregnant, normalization of GH and IGF-1 (somatomedin C) may restore fertility.
• Female patients of childbearing potential should be advised to use adequate contraception during treatment with octreotide.

Can this medicine be used in children?

• Safety and efficacy of Octreotide Acetate Injection in the pediatric population have not been demonstrated.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• OCTREOTIDE ACETATE

Inactive ingredients:

• SODIUM CHLORIDE
• ACETIC ACID
• SODIUM ACETATE

Who manufactures and distributes this medicine?

Sandostatin® Injection and SANDOSTATIN LAR DEPOT: Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, NJ

BYNFEZIA Pen: Distributed by:

• Sun Pharmaceutical Industries, Inc.
• Cranbury, NJ

Manufactured by:

• Sun Pharmaceutical Industries Ltd.
• Halol-Baroda Highway,
• Halol, Gujarat, India

What should I know about storage and disposal of this medication?

• For prolonged storage, octreotide acetate single dose and multiple dose vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and protected from light.
• At room temperature (20°C to 30°C or 70°F to 86°F), octreotide acetate injection is stable for 14 days if protected from light.
• The solution can be allowed to come to room temperature prior to administration.
• Do not warm artificially.
• After initial use, multiple dose vials should be discarded within 14 days.
• Single dose vials should be opened just prior to administration and the unused portion discarded.
• Dispose unused product or waste properly.

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• Dailymed label info on Octreotide
• FDA Octreotide

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