Description
Insulin icodec-abae injection is used to treat a type of diabetes mellitus called type 2 diabetes.
Insulin icodec-abae injection is a long-acting type of insulin that works slowly. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use for later. When you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of insulin icodec-abae injection in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness insulin icodec-abae injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart failure or
- Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse and increase your chance of having serious side effects.
- Hypoglycemia (low blood sugar)—Should not be used during episodes of hypoglycemia. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under the skin of your stomach, thigh (upper leg), or upper arm.
This medicine comes with patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
Each package of Awiqli® contains a patient information sheet. Read this sheet carefully and make sure you understand:
- How to prepare the medicine.
- How to inject the medicine.
- How to dispose of syringes, needles, and injection devices.
If you use this medicine at home, you will be shown the body areas where this shot can be given. 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. Do not use the exact same spot for each injection. This will help prevent skin problems from the injections.
Do not inject into skin areas that are tender, bruised, scaly, hard, thickened, damaged, or has pits, lumps, or scars.
Check the liquid inside the pen. It should be clear and colorless. Do not use the medicine if it looks cloudy or has particles in it. Do not mix this medicine with any other insulin or liquids.
Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.
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.
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 (solution):
- For type 2 diabetes mellitus:
- Adults—Dose is based on your blood sugar and must be determined by your doctor. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For type 2 diabetes mellitus:
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 and it is 4 days or less, take the missed dose as soon as possible. Then, continue your once a week schedule 1 week from the day your missed dose was taken. If you missed a dose and it is more than 4 days, skip the dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
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.
Unopened medicine: Store the pen in the refrigerator until the expiration date. You may store the pen at room temperature for 12 weeks, away from heat or light. Do not freeze. Do not use this medicine if it has been frozen.
Opened pen: You may store the pen in the refrigerator or at room temperature for up to 12 weeks, away from heat or light. Do not freeze. Do not use the medicine if it has been frozen.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits especially during the first few weeks you use this medicine. Blood tests may be needed to check for unwanted effects.
Never share insulin pens or needles with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing these can pass hepatitis viruses, HIV, or other illnesses from one person to another.
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.
- Keep an extra supply of insulin aspart and syringes with needles or injection devices on hand in case high blood sugar occurs.
- Keep some kind of quick-acting sugar handy to treat low blood sugar.
- Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.
Too much insulin aspart can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin aspart with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.
Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.
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. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household should also 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, changes in insulin regimen, 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, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, and unusual thirst.
If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after you get the injection.
This medicine may cause low levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.
Using this medicine together with other diabetes medicine (eg, thiazolidinedione [TZD] medicine) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.
This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Bloating or swelling of face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
Incidence not known
- Anxiety
- blurred vision
- chest pain or tightness
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- decreased urine
- depression
- difficulty swallowing
- dilated neck veins
- dizziness
- dry mouth
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- headache
- hives, itching, skin rash
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- nightmares
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redistribution or accumulation of body fat
- seizures
- shakiness
- slurred speech
- stomach pain
- sweating
- swelling of fingers, hands, feet, or lower legs
- trouble breathing
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80010474