Lispro-PFC

Pronunciation

Generic Name: insulin lispro (Intravenous route, Subcutaneous route)

IN-su-lin LIS-pro, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

  • Humalog
  • Lispro-PFC

Available Dosage Forms:

  • Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

Uses For Lispro-PFC

Insulin lispro is a fast-acting type of insulin. 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 later. When you have diabetes mellitus (sugar diabetes), 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.

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Insulin lispro 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 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.

Before Using Lispro-PFC

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 lispro in children 3 years of age and older. However, safety and efficacy of insulin lispro have not been established in children younger than 3 years of age.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin lispro have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of this medicine in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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.

  • Alatrofloxacin
  • Balofloxacin
  • Ciprofloxacin
  • Clinafloxacin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Levofloxacin
  • Lomefloxacin
  • Metreleptin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Pioglitazone
  • Prulifloxacin
  • Rosiglitazone
  • Rufloxacin
  • Sparfloxacin
  • Temafloxacin
  • Tosufloxacin
  • Trovafloxacin Mesylate

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
  • Alprenolol
  • Atenolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Dilevalol
  • Esmolol
  • Fenugreek
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Rasagiline
  • Selegiline
  • Sotalol
  • Talinolol
  • Tertatolol
  • Timolol
  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol

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.

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:

  • Diarrhea or
  • Underactive adrenal gland or
  • Underactive pituitary gland or
  • Vomiting—These conditions lower blood sugar and may lower the amount of insulin or insulin lispro you need.
  • Emotional disturbances or
  • Fever or
  • Illness or
  • Infection or
  • Stress—These conditions increase blood sugar and may increase the amount of insulin you need.
  • Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
  • Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.
  • Kidney disease or
  • Liver disease—Effects of insulin lispro may be increased because of the slower removal of the medicine from the body.

Proper Use of insulin lispro, recombinant

This section provides information on the proper use of a number of products that contain insulin lispro, recombinant. It may not be specific to Lispro-PFC. Please read with care.

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.

Each package of insulin lispro 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 use disposable insulin delivery device.
  • How to use 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 abdomen or stomach, thigh, buttocks, or upper arm). If you have questions about this, contact a member of your health care team.

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.

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.

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.

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, teenagers, 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. The expiration date on the insulin package tells you how long you can keep the medicine in the refrigerator. 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 only 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 only 28 days.

Precautions While Using Lispro-PFC

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 blood-borne 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 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, shortness of breath, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the 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 problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Too much insulin lispro can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin lispro with another antidiabetic medicine, 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 also should 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, you 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, troubled 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.

Lispro-PFC 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
  • Anxious or nervous feeling
  • behavior change similar to being drunk
  • blurred vision
  • cold sweats
  • confusion or difficulty thinking
  • convulsions (seizures)
  • depression
  • dizziness or lightheadedness
  • drowsiness
  • excessive hunger
  • fast heartbeat
  • fever or chills
  • headache
  • irritability or abnormal behavior
  • lower back or side pain
  • nightmares
  • painful or difficult urination
  • restless sleep
  • shakiness
  • slurred speech
  • tingling in the hands, feet, lips, or tongue
  • unconsciousness
Less common
  • Dry, red, hot, or irritated skin
Less common or 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 or vomiting
  • shortness of breath
  • skin rash or itching over the whole body
  • sweating
  • thickening of the skin at the injection site
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • decreased urine
  • difficult or labored breathing
  • 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
  • tightness in the chest
  • unusual weight gain or loss

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
  • Body aches or pain
  • congestion
  • runny nose
  • sneezing
  • stuffy nose
  • tender, swollen glands in the neck
  • 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.

See also: Side effects (in more detail)

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