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Byetta (Generic Exenatide Injection)

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WARNING

The risk of thyroid cancers, particularly medullary thyroid carcinoma, may rise if you receive exenatide extended-release injection (Bydureon BCISE) (MTC; a type of thyroid cancer). Although it is unknown if exenatide extended-release injectable raises the risk of cancers in humans, laboratory animals that received it developed tumours. Tell your doctor if you or anybody in your family has Multiple Endocrine Neoplasia syndrome type 2 (MTC) now or previously had it (MEN 2; condition that causes tumours in more than one gland in the body). If this is the case, your doctor would likely advise against using exenatide extended-release injection. Call your doctor right away if you have any of the following symptoms: Hoarseness, difficulty swallowing, a lump or swelling in the neck, or shortness of breath.

Keep all of your appointments with your physician and the lab. To determine how your body is responding to exenatide, your doctor may prescribe specific tests.

Whenever you need a prescription refill for exenatide injection, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of using exenatide injection with your doctor.

Why is this medication prescribed?

Exenatide is used to treat type 2 diabetes (condition in which the body does not use insulin normally and cannot control the quantity of sugar in the blood) in adults (Byetta) and adults and children 10 years of age and older in conjunction with diet and exercise (Bydureon BCISE). Exenatide belongs to a group of drugs known as incretin mimetics. When blood sugar levels are high, it causes the pancreas to release insulin. Insulin aids in the transfer of blood sugar to different bodily tissues where it is used as an energy source. Additionally, exenatide slows stomach emptying and reduces hunger. Type 1 diabetes is not treated with enatide (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Exenatide is not used to treat diabetics who require insulin in lieu of insulin.

People with diabetes and high blood sugar over time may experience serious or fatal complications, such as heart disease, stroke, kidney issues, nerve damage, and vision issues. It may be possible to control your diabetes and enhance your health by using medication(s), making lifestyle changes (such as diet, exercise, and quitting smoking), and routinely checking your blood sugar. This treatment may also lower your risk of heart attack, stroke, kidney failure, nerve damage (resulting in numb, cold legs or feet and diminished sex capacity in both men and women), eye issues, such as changes in eyesight or blindness, or gum disease, which are all symptoms of diabetes. The optimal strategy to manage your diabetes will be discussed with you by your doctor and other healthcare professionals.

How should this medicine be used?

Byettaexenatide ®’s immediate-release medication is available as a solution (liquid) to be injected subcutaneously (just under the skin). Exenatide extended-release (long-acting) (Bydureon® BCISE) is a suspension (liquid) that is administered subcutaneously by an autoinjector. Typically, exenatide immediate-release solution is injected twice daily, 60 minutes before breakfast and dinner (or the two main meals of the day, approximately 6 hours apart). Never administer it after eating. In the event that your blood sugar management does not improve after using exenatide for a month, your doctor may move you to a pen with a larger dose of the drug. Exenatide extended-release suspension is injected once per week, regardless of mealtime. Use exenatide extended-release at any time on the same day every week. If it has been three days or more since your last dose of exenatide extended-release suspension, you may switch the day of the week that you take it. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Exenatide injection products should be used exactly as prescribed. Use it only as directed by your doctor, neither more nor less often.

Your glucose (sugar) levels may temporarily rise for 2 to 4 weeks after switching from exenatide immediate-release solution to exenatide extended-release suspension.

Diabetes is not cured by exenatide, rather it is controlled. Exenatide should still be taken even if you feel fine. Exenatide should not be stopped without consulting your doctor.

When using products containing exenatide injection, be sure to read and comprehend the manufacturer’s instructions. To learn how to use the pen or autoinjector, ask your doctor or pharmacist for assistance. Pay close attention to these guidelines.

Needles must be purchased separately if you plan to use exenatide immediate-release (Byetta®) prefilled dosing pens. What kind of needles you will need to inject your medication into your body, ask your doctor or pharmacist. Never share pens or needles, and never reuse them. Always discard the needle soon away after administering the medication. Put needles in a container that won’t puncture. For disposal instructions on the puncture-resistant container, consult your doctor or pharmacist.

Before injecting, always check your exenatide immediate-release solution. It should be completely clear, colourless, and particle-free. Exenatide immediate-release injection should not be used if it is coloured, hazy, includes solid particles, or has beyond its expiration date.

Before administering the medication, take the prefilled exenatide extended-release (Bydureon BCISE®) autoinjector out of the refrigerator and let it warm to room temperature for 15 minutes. Before usage, shake the prefilled autoinjector thoroughly for at least 15 seconds.

Before injecting your exenatide extended-release suspension, always check it. It should turn from white to off-white and hazy after 15 seconds of shaking. Use only if it is undiscolored, doesn’t have solid particles, or is past its expiration date.

To combine into a single injection, avoid mixing exenatide products with insulin.

Exenatide injection products can be given in the upper arm, belly, or thigh (upper leg). Exenatide must never be injected into a vein or muscle. With each dose of the exenatide extended-release suspension, switch (rotate) the injection site within the selected area.

Extended release exenatide and insulin can both be injected in the same approximate location of the body, but they shouldn’t be administered close together.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using exenatide injection,

  • Inform your doctor and pharmacist if you have any allergies prior to using exenatide injection, whether it be to exenatide, other medications, or any of the substances in that medication. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any vitamins, nutritional supplements, herbal items, and prescription and over-the-counter medicines you are now taking or intend to take. Given that exenatide may alter the way these medications are absorbed by your body, it is crucial that you inform your doctor about all oral medications you take. Any of the following should be mentioned: acetaminophen (Tylenol); ACE inhibitors such benazepril (Lotensin, in Lotrel); captopril; enalapril; fosinopril; lisinopril; prinivil; qbrelis; zestril; ramipril; altace; diuretics (‘water pills’); lovastatin (Altoprev), medications for high blood pressure, insulin, or other drugs to treat diabetes such as sulfonylureas, such as glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), and tolbutamide; and warfarin. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) like (Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Take oral contraceptives (birth control pills) and antibiotics at least one hour before using exenatide immediate-release solution injection if you are using them. If you were instructed to take these drugs with food, do so at a mealtime or snack when you are not also taking exenatide immediate-release solution injection.
  • If you have ever experienced severe bleeding brought on by thrombocytopenia (a lack of platelets, a type of blood cell essential for blood clotting) after using exenatide drugs, let your doctor know. Most likely, your doctor will advise against using exenatide products.
  • Inform your doctor if you have or have ever had severe stomach issues, such as gastroparesis (slow movement of food from the stomach to the small intestine) or other issues with digestion; pancreatitis (pancreatic swelling); gallstones (solid deposits that form in the gallbladder); high levels of triglycerides (fats) in the blood; or liver or kidney disease. Additionally, let your doctor know if you have experienced diarrhoea, nausea, or vomiting or if you are unable to swallow liquids, as these conditions can lead to dehydration (loss of a large amount of body fluids).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking exenatide.

What special dietary instructions should I follow?

Make sure to abide by all dietary and exercise advice given to you by your physician or nutritionist. Eating a balanced diet is vital.

What should I do if I forget a dose?

You should continue taking exenatide immediate-release injectable (Byetta®) according to your regular dosing schedule if you forget to take a dose. To make up for a missing dose, do not provide a second injection.

Exenatide extended-release injection (Bydureon BCISE®) should be used as soon as you realise that you missed a dose. After that, carry on with your regular weekly routine. Skip the missed dose and carry on with your regular dosing plan if there are less than 3 days (72 hours) until your next scheduled dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Your blood sugar levels may alter as a result of this drug. You should be aware of the signs of low and high blood sugar as well as what to do if you experience these signs.

The injection of exenatide could have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Reduction in appetite
  • Uneasy feeling
  • Dizziness
  • Heartburn
  • Headache
  • Weakness
  • Sweating

Some adverse effects can be very harmful. Exenatide should not be used if you have any of the following symptoms or those noted in the IMPORTANT WARNINGS section. Instead, call your doctor right away or seek emergency medical attention:

  • Persistent stomach pain that may start in the upper left or middle and move to the back with or without vomiting
  • Hives
  • Rash
  • Itching
  • Swelling of the lips, eyes, tongue, cheeks, or throat
  • Lightheadedness
  • Rapid heartbeat
  • Difficulty breathing or swallowing
  • Discomfort, swelling, blisters, itching, or nodules at the injection site
  • Nausea, vomiting, fever, right or upper middle stomach pain, or yellowing of the skin or eyes
  • Urine’s colour or volume changing
  • More or less frequent urination than normal
  • Edoema of the lower legs, lower arms, feet, ankles, or hands
  • Uncommon bruising or bleeding

Other side effects of exenatide are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

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

Exenatide immediate-release pens should be kept in the refrigerator, away from light, in their original carton. Avoid freezing. Exenatide immediate-release pens can be kept at room temperature for up to 30 days after use (up to 77°F [25°C]). Exenatide pens shouldn’t be kept with the needle still in them. Keep exenatide immediate-release pens dry when travelling.

Exenatide extended-release autoinjectors should be kept flat, dark, and in their original container in the refrigerator. Exenatide extended-release autoinjectors can be kept at room temperature for a total of 4 weeks if necessary (up to 80°F [30°C]).

Keep youngsters away from exenatide pens and autoinjectors.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Nausea
  • Vomiting
  • Signs of hypoglycemia

What other information should I know?

You should routinely check your blood sugar levels and HbA1c to see how exenatide is impacting you. Your doctor will also instruct you on how to measure your blood or urine sugar levels at home in order to monitor your response to this medicine. Pay close attention to these directions.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.

Brand names

  • Bydureon®
  • Bydureon BCISE®
  • Byetta®
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