Soliqua

Insulin glargine-lixisenatide is a combination of two medications. Insulin glargine is an extended, long-acting insulin. It begins to work 90 minutes after injection and is released slowly into the bloodstream for 24 hours to help the body use glucose. Lixisenatide belongs to a group of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It works by helping your body make more insulin and control blood glucose levels. Together, these medications are used to improve blood glucose (sugar) levels for people with type 2 diabetes. It may be used in addition to diet and exercise to improve blood glucose control when insulin with or without metformin or a GLP-1 receptor agonist with metformin is not working well enough.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose of insulin glargine-lixisenatide depends on your previous dose of insulin. Starting doses are usually either 15 units (15 units insulin glargine/5 µg lixisenatide) or 30 units (30 units insulin glargine/10 µg lixisenatide) injected once daily.

Insulin glargine-lixisenatide should be injected subcutaneously (under the skin) of the thigh, upper arm, or abdomen, once daily within 1 hour before your first meal of the day. Do not inject it into a vein or muscle. Do not use this medication in an insulin pump.

Depending on your body's needs and blood glucose monitoring, your doctor or diabetes educator will help you adjust your dose until your fasting blood glucose is appropriate for you. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values obtained while monitoring your blood glucose. The maximum daily dose is 60 units of insulin glargine/20 µg of lixisenatide daily.

If you need less than 15 units or more than 60 units of this medication to control your blood glucose, contact your doctor.

If you are unsure how to use the prefilled injection pen or this medication, ask your doctor, pharmacist, or diabetes educator to show you. Don't use this medication until you know how to administer it.

Insulin glargine-lixisenatide should be clear and colourless. Do not use this medication if you notice anything unusual in the appearance of the solution, such as cloudiness, discolouration, or clumping. It is not necessary to shake or rotate the vial before use. It should not be mixed with any other insulins or solutions.

Many things can affect the dose of 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 taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, inject within the hour before your next meal and continue with your regular dosing schedule. Do not take a double 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.

Store unopened prefilled pens in the original cartons, in the refrigerator. Protect from light and do not allow to freeze. Once a pen has been opened, keep it at room temperature and protect it from light. To protect the medication from light after first use, remove the needle, dispose of it safely, and attach the cap to the pen. After first use, a pen may be used for 28 days. Discard any solution that remains in the pen after this time, or if the pen is frozen or exposed to excessive heat.

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.

Each 1 mL of clear and colourless, preservative-free, sterile solution, contains 100 units insulin glargine and 33 µg of lixisenatide. Each unit dialed on the prefilled pen contains 1 unit of insulin glargine and 0.33 µg of lixisenatide. Nonmedicinal ingredients: glycerol, methionine, metacresol (2.7 mg/mL), zinc chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injection.

Do not take this medication if you:

• are allergic to insulin glargine, lixisenatide, or any ingredients of the medication
• have a personal or family history of medullary thyroid cancer
• have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• are experiencing low blood glucose
• are pregnant
• are breastfeeding

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• bruising, itching, redness, or pain at the injection area
• cough
• diarrhea
• dizziness
• headache
• mild hypoglycemia (e.g., fast heartbeat, feeling faint, hunger, sweating)
• nausea
• runny nose or nasal congestion
• sore throat
• toothache
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• falls
• flu-like symptoms (e.g., fever, tiredness, body aches)
• muscle pain
• nervousness
• pain with urination
• respiratory tract infections or inflammation (e.g., cough with mucous, fatigue, chest discomfort/pain, fever and chills, sweating, shortness of breath)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
• signs of kidney failure (e.g., confusion, itchiness or rash, puffiness in face and hands, decreased urine production, swelling, fatigue, weight gain)
• skin changes at the injection site (lumps or small dents in the skin)
• symptoms of gallbladder problems (e.g., upper abdominal pain, fever, nausea, vomiting, yellowing of the skin or eyes)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of severe hypoglycemia (low blood sugar; mood changes, vision changes, confusion, dizziness, loss of consciousness)
• symptoms of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

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 this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

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: Insulin glargine-lixisenatide may increase heart rate and may affect how electrical impulses travel through the heart muscle, causing changes to heart rhythm. It can cause fluid to build up in the body and can contribute to heart failure. 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Intestinal problems: The safety and effectiveness of using this medication 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 digestive system problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dehydration: Medications like lixisenatide can cause digestive system upset such as nausea, vomiting, and diarrhea. These effects can increase the risk of becoming dehydrated. If you experience digestive system side effects with insulin glargine - lixisenatide, make sure to drink enough fluids to replace what you are losing, to prevent dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness, or headaches, contact your doctor.

Drowsiness/reduced alertness: Insulin glargine-lixisenatide may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Gallbladder problems: People using lixisenatide have reported experiencing gallbladder problems. If you experience symptoms of gallstones, such as pain in the upper part of the abdomen, fever, nausea, vomiting or yellowing of the eyes or skin, contact your doctor.

Kidney function:  People with decreased kidney function or kidney disease may require lower doses of insulin to control blood glucose. Ensure that you are drinking enough water to prevent dehydration if you experience nausea or vomiting with this medication. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: People with decreased liver function or liver disease may require lower doses of insulin to control blood glucose. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood glucose (hypoglycemia): People who use insulin are more at risk of experiencing hypoglycemia (low blood sugar). Symptoms of mild-to-moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling (tongue, lips, or fingers).

Mild-to-moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). If you experience symptoms of hypoglycemia, eat one of these sources of sugar and then rest. If you feel symptoms of hypoglycemia coming on, don't take insulin.

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Pancreatitis (inflammation of the pancreas): Pancreatitis has been associated with the medication lixisenatide. 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

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

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if insulin glargine-lixisenatide passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 are more likely to experience side effects of taking insulin glargine-lixisenatide. Doses for seniors may need to be lower and increased more slowly than for other adults.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Soliqua