Lispro-PFC (Intravenous, Subcutaneous)

Insulin lispro is a fast-acting type of insulin. Insulin is one of several hormones that helps the body convert the food we eat into energy. It does this by using the glucose (sugar) in the blood as quick energy. Insulin also helps store energy for later use. When you have diabetes mellitus, your body cannot make enough insulin or does not use insulin properly. Therefore, you need to take extra insulin to control your blood sugar and maintain your health. This is very important because too much sugar in your blood can be harmful to your health.

Insulin lispro starts working 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 normally produces. Since the effects of insulin lispro 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.

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 the transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully 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 during the time you are taking insulin lispro 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 lispro 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 a serious allergic reaction, 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 chest pain after you receive this medicine.

You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject insulin lispro into a skin area that is red, swollen, or itchy.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) 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, feeling extremely tired or weak, having trouble breathing, experiencing an uneven heartbeat, or having excessive swelling of the hands, wrist, ankles, or feet.

Too much insulin lispro can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin lispro with another antidiabetic medicine, have changes in your 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. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so that you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

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. Go 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, have 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. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

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 these symptoms 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. 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 inform 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

Studies have not shown any specific problems that would limit the usefulness of insulin lispro in children aged 3 years and older. However, safety and effectiveness of insulin lispro have not been established in children younger than 3 years or those with type 2 diabetes.

Geriatric

Studies have not shown any specific problems that would limit the usefulness of insulin lispro in elderly patients.

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 taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is particularly important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the 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 drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the 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

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on 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 frequency of this medicine, or provide you with special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Diarrhea or
• Underactive adrenal gland or
• Underactive pituitary gland or
• Vomiting—These conditions can lower blood sugar and may reduce the amount of insulin or insulin lispro you need.

• Fever or
• Illness or
• Infection or
• Stress (e.g., physical or emotional)—These conditions can increase blood sugar and may raise the amount of insulin you need.

• Heart failure or
• Hypokalemia (low potassium in the blood)—These conditions may worsen and increase your chance of serious side effects.

• Hypoglycemia (low blood sugar)—This medicine should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may become dangerously low.

• Kidney disease or
• Liver disease—The effects of insulin lispro may be stronger due to the slower removal of the medicine from the body.

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

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

More common

• Anxious or nervous feeling
• Behavior change similar to being drunk
• Blurred vision
• Chills
• Cold sweats
• Confusion or difficulty thinking
• Depression
• Dizziness or lightheadedness
• Drowsiness
• Excessive hunger
• Fast heartbeat
• Fever
• Headache
• Irritability or abnormal behavior
• Lower back or side pain
• Nightmares
• Painful or difficult urination
• Restless sleep
• Seizures
• Shakiness
• Slurred speech
• Tingling in the hands, feet, lips, or tongue

Less common

• Dry, red, hot, or irritated skin

Rare

• Depression of the skin at the injection site
• Dryness of the mouth
• Fast or weak pulse
• Itching, redness, or swelling at the injection site
• Muscle cramps or pain
• Nausea
• Skin rash or itching over the whole body
• Sweating
• Thickening of the skin at the injection site
• Trouble breathing
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Chest tightness
• Decreased urine
• Difficulty with swallowing
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast, pounding, or irregular heartbeat or pulse
• Hives or itching skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redistribution or accumulation of body fat
• Unusual weight gain or loss

Some side effects may happen 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:

More common

• Body aches or pain
• Sneezing
• Sore throat
• Stuffy nose or runny nose
• Tender, swollen glands in the neck
• Unusual tiredness or weakness
• Voice changes

Incidence not known

• Redness, swelling, 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.

• Humalog
• Lispro-PFC
• Lyumjev Kwikpen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

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 or into a vein.

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 insulin lispro 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 and when to change the insulin lispro 3 mL cartridge.
• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (eg, under the skin of your stomach, thigh, buttocks, or upper arm). Do not use the exact same spot for each injection. If you have questions about this, contact a member of your health care team.

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 within 15 minutes before a meal or immediately after a meal.

The insulin solution should look clear and colorless. Do not use insulin lispro if it is cloudy or thickened, discolored, or if there are particles in it. Do not mix this medicine with any other insulin. If you are told to mix lispro with a longer-acting insulin, draw up insulin lispro into the syringe first, then the longer-acting insulin. Inject it right away.

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 in the pump should be changed at least every 7 days and the infusion set and insertion site changed at least every 3 days. If you do not understand how you are to use the insulin pump or have concerns, contact your doctor or pharmacist.

Use a new needle for the Admelog® SoloStar® pen or prefilled pens 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.

Do not change the brand, type, or dose of your insulin unless your doctor tells you to. When you receive a new supply of insulin, check the label to be sure if it is the correct type of insulin.

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

To use the vial:

• Wash your hands with soap and water.
• Do not shake the vial.
• 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.

To use the Solostar® Prefilled Pen:

• 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 selector.
• Press the injection button until it stops. You should see a "0" in the dose window.
• You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 3 times. If there is still no insulin, change the needle and repeat the priming steps.
• Turn the dose selector, be careful not to press the injection button.
• You may see air bubbles in the insulin, which is normal.
• Insert the needle into your skin and press the injection button all the way in for at least 10 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
• 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.

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: For diabetes mellitus: Adults and children 3 years of age and older—The dose is based on your blood sugar and must be determined by your doctor. Children younger than 3 years of age—Use and dose 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.

Store unused vials, pens, or cartridges in the refrigerator. Do not freeze. This medicine may be refrigerated for only 28 days. Throw the medicine away after the expiration date has passed.

The vial that you are currently using may be kept in the refrigerator or at room temperature in a cool place, away from direct heat and light, for up to 28 days.

The cartridge or pen that you are currently using should not be refrigerated. You should store the cartridge or pen at room temperature in a cool place, away from direct heat and light, for up to 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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