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Adlyxin (Generic Lixisenatide Injection)

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Why is this medication prescribed?

Injectable lixisenatide is used to treat type 2 diabetes together with diet and exercise (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Type 1 diabetes is not treated with lixisenatide injection (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). When treating diabetics who require insulin, lixisenatide is not utilised in place of the hormone. Incretin mimetics, which include lixisenatide injection, are a group of drugs. When blood sugar levels are elevated, it encourages the pancreas to release insulin. In order to get sugar from the blood into other bodily tissues where it can be used as fuel, insulin is necessary. The injection of lixisenatide also slows stomach emptying and reduces hunger.

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.

Whenever you need a prescription refill for lixisenatide 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 Food and Drug Administration (FDA) website at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

How should this medicine be used?

A prefilled dosage pen for lixisenatide injection is available for subcutaneous injection (under the skin). Typically, it is injected once daily, no later than 60 minutes prior to the first meal of the day. Loxisenatide injection should be administered daily at around the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the lixisenatide injection instructions precisely. Use it only as directed by your doctor, neither more nor less often.

Most likely, your doctor will put you on a low dose of lixisenatide and then gradually raise it over the course of 14 days.

The injection of lixisenatide manages diabetes but does not cure it. Lixisenatide injection should still be administered even if you feel OK. Lixisenatide injection shouldn’t be stopped abruptly without consulting a physician.

Needles must be purchased separately. What kind of needles you will need to inject your medication into your body, ask your doctor or pharmacist. When injecting lixisenatide, be sure to read and comprehend the manufacturer’s instructions. Be careful to also understand when and how to set up a new pen. Do not use this pen alone if you are blind or have poor vision. You can get the pen’s instructions from your doctor or pharmacist. Observe the instructions precisely.

Before injecting, always check the lixisenatide solution. It should be free of particulates, clean, and colourless. Lixisenatide should not be used if it is coloured, foggy, thickened, or includes solid particles. It should also not be used after the expiration date printed on the pen.

A lixisenatide injection can be given in the upper arm, thigh (upper leg), or abdominal. For each injection, choose a different location. If the pen is kept in the refrigerator, let it come to room temperature before using it.

Never share pens or needles, and never reuse them. Always discard the needle soon away after administering the medication. Needles should be disposed of in a container that won’t puncture. For disposal instructions on the puncture-resistant container, consult your doctor or pharmacist.

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 taking lixisenatide injection,

  • If you have an allergy to lixisenatide, exenatide (Bydureon, Byetta), liraglutide (Saxenda, Victoza), any other medications, or any of the ingredients in lixisenatide injection, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Given that lixisenatide may alter how these medications are absorbed by your body, it is crucial that you inform your doctor about all oral medications you take. Take any antibiotics or painkillers, such as acetaminophen (Tylenol), at least an hour before receiving the lixisenatide injection. If you use oral contraceptives (birth control pills), wait at least an hour before using them or wait 11 hours afterward. Additionally, make sure to mention any of the following medicines: digoxin (Lanoxin), chlorpropamide (Diabinese), glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase, in Glucovance), tolazamide, and tolbutamide. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor if you regularly consume large amounts of alcohol, have ever experienced severe stomach issues such as gastroparesis (slow movement of food from the stomach to the small intestine), or have trouble digesting food. Also mention any kidney disease, pancreatitis, gallstones, or other organ swelling.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you get pregnant while taking lixisenatide injection.
  • Ask your doctor what to do if there is a large change in your diet, exercise, or weight; or if you get sick, develop an infection or fever, experience unusual stress, or are injured. These changes and conditions can affect your blood sugar and the amount of lixisenatide injection you may need.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.

What should I do if I forget a dose?

One hour (60 minutes) before your next meal, administer the missed dose by injection. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not provide a second injection.

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.

There may be adverse consequences from lixisenatide injection. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Indigestion
  • Bloating
  • Headache
  • Redness, throbbing, or discomfort at the injection site

Some adverse effects can be very harmful. Stop using lixisenatide injection and seek emergency medical attention if you suffer any of the following symptoms:

  • Persistent stomach discomfort with or without vomiting that starts in the upper left or centre of the stomach and may
  • Move to the back
  • Hives
  • Rash
  • Itching
  • Rapid heartbeat
  • Feeling faint or lightheaded
  • Swelling of the lower legs, feet, ankles, face, lips, tongue, throat, or eyes
  • Breathing or swallowing challenges
  • Hoarseness
  • Less urinations,
  • Extremely dry mouth, skin, or thirst

Other negative effects from lixisenatide injection are possible. If you experience any strange issues while taking this medicine, contact 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?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it out of the way of heat, light, dust, and grime. Lixisenatide pens should be kept in the refrigerator (36°F to 46°F [2°C to 8°C]) when not in use. When not in use, keep lixisenatide pens at room temperature (below 86°F [30°C]) with the cap on. Avoid freezing. If lixisenatide has been frozen, do not use it. After 14 days from the time of first use, discard lixisenatide pens in a puncture-resistant container, even if there is still some solution inside.

Make sure to keep lixisenatide pens dry when travelling. Pens that aren’t in use should be kept cold, between 36°F and 46°F (2°C and 8°C), or in the refrigerator. In-use pens can be kept at room temperature for up to 86°F [30°C] (not in a car glove compartment or other hot place).

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.

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

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
  • Diarrhea
  • Bloating or pain in the abdomen
  • Indigestion
  • Constipation

What other information should I know?

Keep all of your appointments with your physician and the lab. You should check your blood sugar and glycosylated haemoglobin (HbA1c) frequently to see how well the injection of lixisenatide is working for you. Your doctor will 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.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Adlyxin®
  • Soliqua® (as a combination product containing Insulin Glargine and Lixisenatide)
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