INSULIN GLARGINE/LIXISENATIDE - INJECTION

INSULIN GLARGINE/LIXISENATIDE - INJECTION

PHONETIC PRONUNCIATION: (IN-su-lin GLAR-jeen/LIX-i-SEN-a-tide)

COMMON BRAND NAME(S): Soliqua

GENERIC NAME(S): insulin glargine,human recombinant analog/lixisenatide

Uses

USES: This medication is a combination of insulin glargine and lixisenatide and is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Insulin glargine is a man-made product that is similar to human insulin. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Lixisenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes.


How to use INSULIN GLARGINE/LIXISENATIDE - INJECTION

HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once daily within 1 hour before the first meal of the day. Use a new needle for each injection. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. The dosage is based on your medical condition and response to treatment. Lixisenatide can slow down or decrease the absorption of other drugs such as birth control pills, antibiotics, or acetaminophen. Take other medications at least 1 hour before using this medication. Take birth control pills at least 1 hour before or 11 hours after using this medication. If you must take these other medications with food, take them with a meal or snack when you are not using this product. Ask your doctor or pharmacist if you have any questions about when to take your medications. Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely. Use this medication regularly to get the most benefit from it. To help you remember, use it with the same meal each day. Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach upset, decreased appetite, diarrhea, constipation, stuffy/runny nose, or pain/redness/irritation at the injection site may occur. Nausea usually lessens as you continue to use this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn't stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat), signs of kidney problems (such as change in the amount of urine). Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain). This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to insulin glargine or lixisenatide; 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. Do not use this medication when you have low blood sugar (hypoglycemia). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, disease of the pancreas (pancreatitis), stomach/intestinal disorders (such as gastroparesis, digestion problems). You may experience blurred vision, 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 using 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). Check your blood sugar before and after exercise. You may need a snack beforehand. Older adults may be more sensitive to the side effects of this drug, especially low blood sugar. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. 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. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. 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. A product that may interact with this drug is: rosiglitazone. 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 not affected by these drugs. Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. 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 by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

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Faq for INSULIN GLARGINE/LIXISENATIDE - INJECTION

Insulin Glargine/Lixisenatide injection is a combination medication used to treat type 2 diabetes. It helps to control blood sugar levels by regulating insulin levels and reducing glucose production in the liver.

Insulin Glargine/Lixisenatide injection is typically injected once daily within one hour before the first meal of the day. It should be given as directed by your healthcare provider and the injection site should be rotated to avoid lipodystrophy (changes in the fatty tissue under the skin).

Common side effects may include nausea, vomiting, diarrhea, headache, and injection site reactions such as redness or pain. Contact your doctor if you experience more severe side effects like signs of hypoglycemia (low blood sugar) such as sweating, shakiness, or dizziness.

Insulin Glargine/Lixisenatide injection should only be used during pregnancy if clearly needed and prescribed by your doctor. It is important to discuss the potential risks and benefits with your healthcare provider.

The safety and effectiveness of Insulin Glargine/Lixisenatide injection have not been established in children under the age of 18. Consult with a pediatric specialist for appropriate treatment options for children with type 2 diabetes.

If you miss a dose, take it as soon as you remember, unless it is within 3 hours of the next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

It is important to inform your healthcare provider about all the medications you are taking, including prescription, over-the-counter, and herbal products. Some medications may interact with Insulin Glargine/Lixisenatide injection, including insulin or oral diabetes medications.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.