Adlyxine

The recommended adult starting dose of Adlyxine (Lixisenatide) is 10 µg (micrograms) daily injected subcutaneously (under the skin) on your stomach area (abdomen), upper thigh, or upper arm, exactly as instructed by your doctor or diabetes educator. After 14 days, your doctor may increase the dose to 20 µg once daily. Do not change your dose unless your doctor has told you to do so.

Adlyxine (Lixisenatide) should be injected within an hour before a meal. Choose the most convenient meal and inject it before that same meal each day.

If you are also using insulin, each medication should be injected separately.

Adlyxine (Lixisenatide) is available as a prefilled pen for injection. Read the user manual for instructions on how to properly use Adlyxine (Lixisenatide). If you are not sure how to use Adlyxine (Lixisenatide), contact your doctor or pharmacist.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take Adlyxine (Lixisenatide) exactly as prescribed by your doctor. If you miss a dose, inject your dose less than 1 hour before your next meal. Do not inject a double dose or increase your dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Adlyxine (Lixisenatide) should be clear and colourless. Do not use Adlyxine (Lixisenatide) if you notice particles or anything unusual in the appearance of the solution.

Store Adlyxine (Lixisenatide) in the refrigerator, do not allow it to freeze, and keep it out of the reach of children. After the first use of the pen, Adlyxine (Lixisenatide) can be stored at room temperature or in the refrigerator for up to 14 days. After 14 days, discard the pen, even if there is medication left in it. To protect Adlyxine (Lixisenatide) from light, always keep the pen cap on when you are not using it. Always store Adlyxine (Lixisenatide) without a needle attached to prevent contamination, infection, and leakage.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

10 µg dose Pre-Filled Pen
Each mL of clear, colourless solution contains 0.05 mg of Adlyxine (Lixisenatide). Nonmedicinal ingredients: glycerol, hydrochloric acid/sodium hydroxide solution for pH adjustment, metacresol (2.7 mg/mL), methionine, sodium acetate trihydrate, and water for injection.

20 µg dose Pre-Filled Pen
Each mL of clear, colourless solution contains 0.1 mg of Adlyxine (Lixisenatide). Nonmedicinal ingredients: glycerol, hydrochloric acid/sodium hydroxide solution for pH adjustment, metacresol (2.7 mg/mL), methionine, sodium acetate trihydrate, and water for injection.

Do not use Adlyxine (Lixisenatide) if you:

• are allergic to Adlyxine (Lixisenatide) or any ingredients of the medication
• are pregnant
• are breast-feeding
• have Type 1 Diabetes
• have diabetic ketoacidosis (accumulation of ketones in blood and urine)

There may be an interaction between Adlyxine (Lixisenatide) and any of the following:

• Acetaminophen
• acetylsalicylic acid (Asa)
• androgens (e.g., testosterone)
• antibiotics
• Atorvastatin
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Basiliximab
• birth control pills
• Buserelin
• chloroquine
• corticosteroids (e.g., budesonide, Hydrocortisone, Prednisone)
• diabetes medications (e.g., chlorpropamide, glyburide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• diuretics ("water pills"; e.g., Furosemide, Hydrochlorothiazide, Indapamide)
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Glucagon
• Goserelin
• Hepatitis C antivirals (e.g., elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Lanreotide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• Pasireotide
• Pegvisomant
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Ceritinib, Dabrafenib, Nilotinib, Sunitinib)
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• quinine
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Tacrolimus
• Vorinostat
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Adlyxine (Lixisenatide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Adlyxine (Lixisenatide).

Antibiotics: Adlyxine (Lixisenatide) may slow the absorption of antibiotics from your stomach. If you are taking antibiotics, you should take your dose of antibiotic at least 1 hour before your dose of Adlyxine (Lixisenatide).

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking medication to manage your blood glucose levels.

Heart problems: Adlyxine (Lixisenatide) may increase your heart rate and may affect how electrical impulses travel through the heart muscle. If you have heart disease (e.g., recent Heart Attack, Angina, heart failure) or an abnormal heart rhythm (e.g., heart block or fast heart rate), discuss with your doctor how Adlyxine (Lixisenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adlyxine (Lixisenatide), and whether any special monitoring is needed.

If you experience dizziness, palpitations (a rapid, pounding, or irregular heartbeat), fainting or seizures, get immediate medical attention.

Kidney function: The safety and effectiveness of using Adlyxine (Lixisenatide) have not been studied for people with reduced kidney function. People taking similar medications have reported kidney problems. Dehydration may increase this risk. Ensure that you are drinking enough water to prevent dehydration if you experience nausea or vomiting with Adlyxine (Lixisenatide). If you have reduced kidney function or Kidney Disease, discuss with your doctor how Adlyxine (Lixisenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adlyxine (Lixisenatide), and whether any special monitoring is needed.

Low blood glucose (hypoglycemia): People who use Adlyxine (Lixisenatide) and are also taking a sulfonylurea (e.g., Glyburide, Gliclazide) or insulin to control high blood sugar are more at risk of experiencing hypoglycemia (low blood sugar). If you experience symptoms of hypoglycemia such as a cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue or lips, contact your doctor. Your doctor may need to adjust the dose of your medication(s).

Pancreatitis (inflammation of the pancreas): Adlyxine (Lixisenatide) may cause pancreatitis. If you experience symptoms of pancreatitis such as severe and persistent abdominal pain that may move to the back with or without vomiting, contact your doctor immediately. If you have previously had pancreatitis, discuss with your doctor how Adlyxine (Lixisenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Adlyxine (Lixisenatide), and whether any special monitoring is needed.

Risk of Thyroid cancer: In rare cases, people have developed thyroid cancer while using medications similar to Adlyxine (Lixisenatide). People with a personal or family history of thyroid cancer or people who have multiple endocrine neoplasia syndrome type 2 (a disease where people have tumours in more than one gland in their body) should not use Adlyxine (Lixisenatide).

Stomach and intestinal problems: The safety and effectiveness of using Adlyxine (Lixisenatide) for people with inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or who have slowed movement through the intestinal tract due to diabetes have not been established. If you have any of these conditions, you should not use Adlyxine (Lixisenatide).

Pregnancy: Adlyxine (Lixisenatide) has not been studied for use by pregnant women and should not be used during pregnancy. If you become pregnant while using Adlyxine (Lixisenatide), contact your doctor immediately.

Breast-feeding: It is not known if Adlyxine (Lixisenatide) passes into breast milk. If you are breast-feeding and are taking Adlyxine (Lixisenatide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Adlyxine (Lixisenatide) have not been established for children.

Seniors: Seniors may be more likely to experience side effects associated with Adlyxine (Lixisenatide).