Adlyxin

Name: Adlyxin

Adlyxin Interactions

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Antibiotics
  • Birth control pills
  • Over-the-counter (OTC) medicines, especially those that contain acetaminophen
  • Other medicines to treat diabetes, especially insulin or sulfonylureas
  • Vitamins or dietary supplements

Adlyxin and Other Interactions

Adlyxin may cause dizziness.

Don't drive or perform activities that require alertness until you know how this medicine affects you.

Lixisenatide side effects

Get emergency medical help if you have signs of an allergic reaction: hives, itching, severe rash; rapid heartbeats; trouble swallowing; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or

  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • nausea, vomiting, diarrhea;

  • headache;

  • dizziness; or

  • low blood sugar.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Advice to Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).1

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions, including anaphylaxis, have been reported in clinical trials of lixisenatide and during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, inform patients that they must stop taking lixisenatide and seek medical advice promptly.1

Risk of Pancreatitis

Inform patients that persistent severe abdominal pain that may radiate to the back and which may or may not be accompanied by vomiting is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue lixisenatide and contact their physician if persistent severe abdominal pain occurs.1

Never Share Lixisenatide Pen Between Patients

Advise patients that they should never share their lixisenatide pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens.1

Risk of Hypoglycemia

Inform patients that the risk of hypoglycemia is increased when lixisenatide is used in combination with a sulfonylurea or basal insulin.1

Dehydration and Renal Failure

Advise patients treated with lixisenatide of the potential risk of dehydration due to gastrointestinal adverse reactions and to take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function, which in some cases may require dialysis.1

Use in Pregnancy

Advise patients to inform their physicians if they are pregnant or intend to become pregnant.1

Proper Use of Adlyxin

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is usually given within 1 hour before the first meal of the day.

You will be using lixisenatide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Allow the medicine to warm at room temperature before you inject it. If the medicine in the pen has changed color, looks cloudy, or if you see particles in it, do not use it.

This medicine also works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to use the doses at the same time each day.

Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.

Throw away used needles in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Take acetaminophen or antibiotics at least 1 hour before you inject this medicine.

Take birth control pills at least 1 hour before or 11 hours after you inject lixisenatide.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For diabetes mellitus:
      • Adults—At first, 10 micrograms (mcg) injected under the skin once a day for 14 days. Your doctor may increase your dose to 20 mcg once a day starting on Day 15 and until your blood sugar is controlled.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, use it within 1 hour before your next meal.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store your new, unused prefilled pen in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the opened prefilled pen in the refrigerator, or at room temperature for up to 14 days.

Precautions While Using Adlyxin

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
  • Other medicines—Do not take other medicines during the time you are using lixisenatide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use lixisenatide with other medicines that can lower blood sugar, such as insulin, metformin, or a sulfonylurea. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

  • Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
  • If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

  • Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.
  • If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

How is this medicine (Adlyxin) best taken?

Use Adlyxin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Take Adlyxin within the hour before the first meal every day.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Wash your hands before and after use.
  • Prepare pen before first use.
  • Move site where you give the shot each time.
  • Put the cap back on after you are done using your dose.
  • Attach new needle before each dose.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Take a missed dose within the hour before your next meal.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Administration

SC Preparation

The pen must be activated before the first use

Instruct patients and caregivers on preparation and use of the pen prior to first use

Training should include a practice injection

Visually inspect solution, it should appear clear and colorless; do not use if particulate matter or coloration is observed

SC Administration

Administer by SC injection in abdomen, thigh, or upper arm once daily

Rotate injection sites with each dose; do not use the same site for each injection

Administer an injection within 1 hr before the first meal of the day, preferable the same meal each day

Missed dose: If a dose is missed, administer within 1 hr prior to the next meal

Storage

Before first use

  • Keep refrigerated at 36-46°F (2-8°C)
  • Do not freeze
  • Protect the pen from light by keeping it in its original packaging

After first use

  • Store at <86°F (30°C)
  • Replace the pen cap after each use to protect from light
  • Discard the pen 14 days after its first use

What is Adlyxin?

Adlyxin (lixisenatide) is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

Adlyxin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Adlyxin is not for treating type 1 diabetes.

Important information

Stop using Adlyxin and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

What should I avoid while using Adlyxin?

Adlyxin can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

  • If you also take acetaminophen (Tylenol), take it at least 1 hour before you use this medicine.

  • If you also take any type of antibiotic, take it at least 1 hour before you use Adlyxin.

  • If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use this medicine.

What other drugs will affect Adlyxin?

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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