Awiqli

The recommended dose of insulin depends on how much natural insulin your pancreas is producing and how well your body is able to use the insulin. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and your blood glucose levels.

Your dose of insulin should be injected subcutaneously (under the skin) exactly as instructed by your doctor or diabetes educator. Do not inject insulin icodec into a vein and do not use insulin icodec in insulin infusion pumps. Insulin icodec is injected under the skin once a week. It should be used on the same day each week.  In addition to insulin icodec, a fast-acting insulin may be used to control the impact of food intake on blood glucose levels during the day. There are many variations of insulin dosing.

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.

Insulin icodec should be clear and colourless. Do not use the insulin 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 pen before use. It should not be mixed with any other insulins.

It is important to take this medication exactly as prescribed by your doctor. There must be at least 4 days between doses. If you miss a dose by 3 days or less, inject it as soon as you remember and continue with your usual dosing schedule. If it is 4 or more days since your missed dose, inject it as soon as you remember and continue weekly dosing from the day of the injection.

Unopened pens should be stored in the refrigerator. If necessary, an unopened pen may be stored at room temperature for up to 12 weeks. After 12 weeks, any medication remaining in the pen should be safely discarded. Pens that are in use may be stored at room temperature or in the refrigerator. Any medication remaining in the pen 12 weeks after starting to use it, regardless of storage conditions, should be safely discarded and a new pen started.

Do not allow insulin icodec to freeze. Protect it from light and moisture, and keep it out of the reach of children.

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 mL of clear, colourless, sterile solution contains 700 units of insulin icodec. Nonmedicinal ingredients: glycerol, metacresol, phenol, sodium chloride, water for injection, and zinc acetate.

Insulin icodec is available in cartridges of 1 mL, 1.5 mL, or 3 mL solution in a prefilled multidose disposable pen.

Do not take this medication if you:

• are allergic to insulin icodec or any ingredients of the medication

• are experiencing low blood sugar

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. ** **

• pain, swelling, or itching at the injection site

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:

• signs of low blood glucose (hypoglycemia; e.g., anxiety; blurred vision; changes in vision; confusion; difficulty concentrating; difficulty speaking; dizziness; drowsiness; fast heartbeat; headache; hunger; nausea; nervousness; numbness or tingling of the lips, fingers, or tongue; sweating; tiredness; trembling; weakness)

• swelling in the arms or legs

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

• symptoms of a serious allergic reaction (e.g., swelling of face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat, itchy skin rash, and dizziness)

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.

Appearance of insulin: The contents of the prefilled pen or insulin cartridge icodec should be clear and colourless. Do not use this medication if you notice anything unusual about its appearance, such as cloudiness, discolouration, or clumping.

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.

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.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Driving and operating machinery: High and low blood sugar levels can affect the physical and mental abilities needed to safely drive or operate machinery. It is important to be aware of your blood sugar levels when driving.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose, or you lose consciousness.

High blood glucose (hyperglycemia): Hyperglycemia may occur if your insulin dose is too low or you miss a dose of insulin. Symptoms of hyperglycemia generally build up over hours or days. Contact your doctor or diabetes educator if you experience symptoms of hyperglycemia, such as increased need to urinate, nausea, vomiting, drowsiness, dry mouth, flushed dry skin, loss of appetite, and a fruity odour to your breath.

If hyperglycemia is permitted to continue, a condition known as *diabetic ketoacidosis *may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma, or death. To prevent this from occurring, you may need to have your insulin dose adjusted.

**Kidney function: **Kidney disease or reduced kidney function may change the amount of insulin needed by the body. If you have kidney 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. Your doctor may want to test your kidney function regularly with blood tests while you are taking this medication.

**Liver function: **Liver disease or reduced liver function may change the amount of insulin needed by the body. If you have liver 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. 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.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. Therefore, contact your doctor if you are pregnant or are thinking about pregnancy.

Breast-feeding: It is not known if insulin icodec passes into breast milk. If you are breast-feeding and using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. People who are breast-feeding may require adjustments in their insulin dose or diet.

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

**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/Awiqli