Lyumjev Kwikpen (Intravenous, Subcutaneous)

Insulin lispro-aabc, recombinant injection is a fast-acting insulin. Insulin is used by people with diabetes to help control blood sugar levels. When you have diabetes mellitus, your body either cannot make enough insulin or does not use it properly. Therefore, you need to take extra insulin to manage your blood sugar and maintain your health. This is very important because having too much sugar in your blood can be harmful to your health.

Insulin lispro-aabc works faster than some other types of insulin, but its effects do not last as long. It is designed to act more like the insulin your body would normally produce. Because insulin lispro has a short duration of action, your doctor may also prescribe a longer-acting insulin for you.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits, especially during the first few weeks you use this medicine. Blood and urine 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 (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines while you are taking insulin lispro-aabc 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 changes in diabetes medicine dosing that might happen due to 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 normally would. 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 times 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 states that you have diabetes and lists all of your medicines.
• Keep an extra supply of insulin lispro-aabc 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Too much insulin lispro-aabc can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin lispro-aabc with another antidiabetic medicine, changes in insulin regimen (e.g., 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 or insulin, make changes in your 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 make you dizzy or drowsy. 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.

Using this medicine together with other diabetes medicine (e.g., 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of insulin lispro-aabc injection in children. Its safety and effectiveness have been confirmed.

Geriatric

Studies have not shown any specific problems that would limit the use of insulin lispro-aabc injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if there is a chance of an interaction. In these cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant, but this list may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Bexagliflozin
• Bromocriptine
• Canagliflozin
• Chloroquine
• Chlorpropamide
• Ciprofloxacin
• Dapagliflozin
• Delafloxacin
• Empagliflozin
• Enoxacin
• Ertugliflozin
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydroxychloroquine
• Lanreotide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metformin
• Metoclopramide
• Metreleptin
• Miglitol
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Pramlintide
• Repaglinide
• Rosiglitazone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Trovafloxacin
• Vildagliptin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or frequency of one or both medicines.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are important to note, but this list may not cover everything.

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 adjust the dose or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical conditions may affect how you use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Heart failure or
• Hypokalemia (low potassium in the blood)—Use with caution. This condition may worsen and increase the chance of 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 drop to dangerously low levels.

• Illness or
• Stress (e.g., physical or emotional)—These conditions may alter blood sugar levels and affect the amount of insulin you require.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased due to slower elimination of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety
• blurred vision
• body aches or pain
• chills
• cold sweat
• confusion
• cool, pale skin
• cough
• depression
• difficulty breathing
• dizziness
• ear congestion
• fast heartbeat
• fever
• headache
• increased hunger
• loss of consciousness
• loss of voice
• muscle aches
• nausea
• nervousness
• nightmares
• runny or stuffy nose
• seizures
• shakiness
• slurred speech
• sneezing
• sore throat
• unusual tiredness or weakness

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness
• difficulty swallowing
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, weak pulse
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redistribution or accumulation of body fat
• redness of the skin
• sweating
• thickening of the skin at the injection site
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Decreased urine
• dry mouth
• irregular heartbeat
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• reddish brown itchy, thick, and scaly patches with small bumps at the injection site
• 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. Your health care professional may also 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

• Redness, swelling, bruising, rash, or itching 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.

In the U.S.

• Lyumjev Kwikpen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Lispro, Recombinant

Find detailed information on biosimilars for this medication.

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.

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 Lyumjev™ contains a patient information leaflet and patient instructions. Read this leaflet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to use a disposable insulin delivery device.
• How to use an external insulin pump.
• How and when to change the infusion set, cartridge adapter, and insulin in the external insulin pump reservoir.
• 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.

Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.

When used as a mealtime insulin, it should be taken at the start of a meal or within 20 minutes after you start a meal.

This medicine should be clear and colorless before you use it. Do not use it if it is cloudy, or has particles in it.

To use the KwikPen®, Tempo Pen™, or Junior KwikPen®:

• Wash your hands with soap and water.
• Prime the pen by removing the air from the needle and cartridge. Select 2 units when turning the dose knob.
• Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
• Push the dose knob until it stops. You should see a "0" in the dose window. Hold the dose knob in and slowly count to 5.
• You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 4 times. If there is still no insulin, change the needle then repeat the priming steps.
• If your dose is more than 60 units (30 units for Junior KwikPen®), you will need to give more than 1 injection. Use a new needle for each injection and repeat the priming steps.
• When taking your dose, turn the dose knob to select the number of units you need to inject. The pen dials 1 unit (0.5 unit for Junior KwikPen®) at a time and the dose knob clicks as you turn it. Do not dial your dose by counting the clicks as this can lead to you getting too much or too little insulin.
• Insert the needle into your skin and push the knob all the way in. Continue to hold it, then slowly count to 5 before removing it.
• If you see "0" in the dose window, you have received the full dose. Do not redial if you do not see a "0". Reinsert the needle into your skin and finish the injection.
• If you need 2 injections for a full dose, be sure to take the second injection.
• 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.

To use the vial:

• Wash your hands with soap and water.
• Use only syringes that are made for insulin injections. Use a new syringe and needle each time you give yourself an injection.
• Do not mix this medicine with any other insulin.
• When used in an insulin pump: Carefully read and follow the external insulin pump instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. The insulin lispro-aabc in the pump should be changed at least every 9 days or any time that the insulin is over 98.6°F (37°C). If you do not understand how you are to use the insulin pump, contact your doctor or pharmacist.

Do not transfer Lyumjev™ U-200 from the prefilled pen to a syringe for use.

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 diabetes mellitus:Adults and children—The dose is based on your blood sugar and must be determined by your doctor.

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, pens, and cartridges in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze. Do not use the insulin if it has been frozen. Throw away any unused medicine after 28 days.

Opened pens and cartridges: Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen or cartridge after 28 days.

Opened vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days.

Throw away used syringes and needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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