Description
Insulin aspart-xjhz injection is a rapid-acting type of insulin. Insulin is one of many hormones that helps the body turn the food we eat into energy. 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.
Insulin aspart-xjhz starts to work faster than some other types of insulin, and its effects do not last as long. It should act more like the insulin your body would normally produce. Because the effects of insulin aspart-xjhz are short-acting, your doctor may also prescribe a longer-acting insulin for you to use.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin aspart-xjhz injection in children. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin aspart-xjhz injection in the elderly.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acarbose
- Acetazolamide
- Albuterol Sulfate
- Alclometasone
- Aldosterone
- Alogliptin
- Amcinonide
- Amphetamine
- Amprenavir
- Apraclonidine Hydrochloride
- Arformoterol Tartrate
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atomoxetine Hydrochloride
- Beclomethasone
- Bemetizide
- Bendroflumethiazide
- Betamethasone
- Bexagliflozin
- Boceprevir
- Brimonidine Tartrate
- Bromocriptine
- Budesonide
- Bumetanide
- Canagliflozin
- Canrenoate
- Canrenone
- Cariprazine
- Chloroquine
- Chlorothiazide
- Chlorotrianisene
- Chlorpropamide
- Chlorthalidone
- Ciclesonide
- Ciprofloxacin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Albiglutide
- Atenolol
- Betaxolol
- Bisoprolol
- Bitter Melon
- Carteolol
- Carvedilol
- Celiprolol
- Dulaglutide
- Esmolol
- Fenugreek
- Glecaprevir
- Glucomannan
- Guar Gum
- Isocarboxazid
- Labetalol
- Levobunolol
- Linezolid
- Lixisenatide
- Methylene Blue
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Ozanimod
- Penbutolol
- Phenelzine
- Pibrentasvir
- Pindolol
- Practolol
- Procarbazine
- Propranolol
- Psyllium
- Rasagiline
- Safinamide
- Selegiline
- Sotalol
- Timolol
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
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:
- Fever or
- Illness or
- Infection or
- Stress (eg, physical or emotional)—These conditions increase blood sugar and may increase the amount of insulin you need.
- 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
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 your skin (eg, stomach, thigh, buttocks, or upper arm) or into a vein.
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 check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use a pump or other device, make sure the insulin is made for that device.
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 Kirsty™ contains a patient information leaflet. Read this leaflet 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 in the prefilled pen or vial. It should be clear and colorless. Do not use it if it is cloudy, colored, thick, or has particles in it.
You should eat a meal within 5 to 10 minutes after taking this medicine.
When used in an insulin pump: Carefully read and follow the insulin pump manual for instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. The insulin aspart-xjhz in the pump should be changed at least every 7 days and the infusion set and insertion site changed according to the pump manual. If you do not understand how to use the insulin pump, contact your doctor or pharmacist.
To use the Prefilled pen:
- Wash your hands with soap and water.
- Pull off the pen cap. Attach the needle onto the pen. Keep the needle straight and screw it into the pen. Pull off the big outer needle cap. Then, pull off the inner needle cap.
- Give an airshot before each injection to make sure you receive the correct dose: Turn the dose selector to 2 units. Hold the prefilled pen with the needle pointing up. Gently tap the cartridge with your finger a few times to make any air bubbles collect at the top of the cartridge.
- Press the push-button all the way in. You should see "0" in the dose window.
- You should see insulin at the needle tip. If you do not see insulin, change the needle and repeat the steps, but not more than 6 times. If there is still no insulin after 6 times, do not use the pen.
- Turn the dose selector to your prescribed dose. Be careful not to press the push-button.
- Insert the needle into your skin and press the push-button all the way in. Keep pressing until you see "0" in the dose window. Keep the needle in the skin for at least 6 seconds to make sure you receive the full dose.
- Use a new needle each time you give yourself an injection. Always remove and throw away the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is damaged.
To use the vial:
- Wash your hands with soap and water.
- Wipe the rubber stopper. Hold the syringe with the needle pointing up. Pull down on the plunger until it reaches the prescribed dose.
- Push the needle through the rubber stopper of the vial. Push the plunger all the way in. Turn the vial upside down and slowly pull the plunger down. Slowly push the plunger up until the black tip reaches the prescribed dose.
- Gently tap the syringe with your finger a few times to make any air bubbles collect at the top. Slowly push the plunger up until the black tip reaches the prescribed dose.
- Insert the needle into your skin. Push the plunger all the way down to inject your dose. Keep the needle in the skin for at least 6 seconds to make sure you received the full dose.
- Use a new needle and syringe each time you give yourself an injection.
You should never mix insulin aspart-xjhz with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.
Follow the meal plan your doctor gave you carefully. 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 diabetes mellitus:
- Adults and children—Dose is based on your blood sugar and must be determined by your doctor.
- For diabetes mellitus:
Missed Dose
Call your doctor or pharmacist for instructions.
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 vials and pens in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze.
Opened vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days.
Opened prefilled pens: Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen after 28 days.
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 a doctor check your or your child's 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 cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are taking insulin aspart-xjhz unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
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-xjhz 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-xjhz can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin aspart-xjhz 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 require 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.
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 may make you dizzy, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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.
Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.
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:
More common
- Anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain
- chills
- cold sweats
- coma
- cool, pale skin
- depression
- difficult, burning, or painful urination
- dizziness
- fast heartbeat
- frequent urge to urinate
- headache
- increased hunger
- lower back or side pain
- nausea
- nervousness
- nightmares
- overactive reflexes, followed by underactive reflexes
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Incidence not known
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- confusion
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased thirst
- increased urination
- loss of consciousness
- mood changes
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- redistribution or accumulation of body fat
- stomach pain
- sweating
- trouble breathing
- unexplained weight loss
- weight gain
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:
More common
- Diarrhea
- fever
- pain or tenderness around eyes and cheekbones
- skin disorder
- stuffy or runny nose
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-80008472