BYETTA

Product name: Byetta

Manufacturer: Eli Lilly and Company

Active substance: Exenatide

Other names: Bydureon, Bydureon BCise,

Strength: 5 MCG, 10 MCG

Quantity: 1 – 25 Pens

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Description

BYETTA

DESCRIPTION

BYETTA  (exenatide) is a synthetic peptide thathas incretin-mimetic actions and was originally identified in the lizard Heloderma suspectum. BYETTA enhances glucose-dependent insulin secretion by the pancreatic beta-celldiffers in chemical structure and pharmacological action from insulin, sulfonylureas (i, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. Exenatide ncluding D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, and alpha-glucosidase inhibitors. Exenatide is a 39-amino acid peptide amide.

Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 BYETTA is supplied for subcutaneous (SC) injection as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as an antimicrobial preservative, mannitol as a

tonicity-adjusting agent, and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg or 10 mcg. Each prefilled pen will deliver 60 doses to provide 30 days of twice daily administration (BIDDESCRIPTION BYETTA®(exenatide) is a synthetic peptide that has incretin-mimetic actions and was originally identified in the lizard Heloderma suspectum.

BYETTA enhances glucose-dependent insulin secretion by the pancreaticbeta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, and alpha-glucosidase inhibitors.

Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 BYETTA is supplied for subcutaneous (SC) injection as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as an antimicrobial preservative, mannitol as a tonicity-adjusting agent, and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5.

Two prefilled pens are available to deliver unit doses of 5 mcg or 10 mcg. Each prefilled pen will deliver 60 doses to provide 30 days of twice daily administration (BID

INTERACTIONS

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar.Your doctor may need to adjust your diabetes medication, exercise program, or diet.

DOSAGE of  BYETTA

BYETTA should be initiated at 5 mcg administered twice daily (BID) at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal.

Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. Do not mix BYETTA with insulin. Do not transfer BYETTA from the pen to a syringe or a vial. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.

PRECAUTIONS

Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disorders (such as gastroparesis, digestion problems), kidney disease, disease of the pancreas (pancreatitis), stones in your gallbladder (gallstones).

You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.Precautions

Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disorders (such as gastroparesis, digestion problems), kidney disease, disease of the pancreas (pancreatitis), stones in your gallbladder (gallstones).

You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

SIDE EFFECTS of BYETTA

Tell your doctor or healthcare professional as soon as possible if you do not feel well while you are using BYETTA.

 helps most people with type 2 diabetes, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.Ask your doctor or healthcare professional to answer any questions you may have.When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycaemia can occur.

Tell your doctor if you experience hypoglycaemia.

Tell your doctor if you notice any of the following:

nausea,vomiting,diarrhoea,dizziness or light headedness,headache,feeling jittery,acid stomach,abdominal pain or distension,loss of energy and strengthredness, swelling or itching at the injection site (local allergy)indigestion (dyspepsia)excessive sweating (hyperhidrosis)These are the more common side effects of BYETTA. Mostly these are mild and short-lived.

When using BYETTA some patients have lost more than 1.5 kg of weight per week. Rapid weight loss of this rate may be harmful. Tell your doctor if you experience rapid weight loss.

Not all patients will lose weight. BYETTA may reduce your appetite. Nausea and vomiting were very commonly reported in patients using BYETTA. Mostly these were mild to moderate and short-lived. In most patients who initially experienced nausea, the frequency and severity decreased with continued therapy.

You may experience dehydration as a result of nausea, vomiting and/or diarrhoea. Some symptoms of mild to moderate dehydration are:dry mouth,decreased frequency of urination and concentrated urine,headache,muscle weakness,dizziness or light headedness.

Drink plenty of fluids if you are experiencing any of these symptoms. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you continue to experience these symptoms.

Tell your doctor immediately if you notice any of the following:passing little or no urine taste disturbance or loss of taste sleepiness or drowsiness swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing stomach discomfort relieved by belching or passing wind constipation,itching,hives, pinkish, itchy swellings on the skin, itchy rash,red raised skin rash,bleeding more easily than normal, if you are taking warfarin These are rare or very rare side effects of BYETTA. The above list includes serious side effects which may require medical attention.

Tell your doctor immediately if you are experiencing any of the following:persistent, severe abdominal pain and vomiting and/or diarrhoea and/or nausea. These can be symptoms of acute pancreatitis which has been reported rarely in patients taking BYETTA.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

DISCLAIMER

Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy.

This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient.

Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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