What Is Lantus? (insulin glargine)

What is Lantus?

Lantus is the brand name of insulin glargine, a long-acting insulin used to treat adults and children with type 1 diabetes mellitus and adults with type 2 diabetes mellitusto control high blood sugar.

Lantus replaces the insulin that your body no longer produces. Insulin is a natural substance that allows your body to convert dietary sugar into energy and helps store energy for later use. In type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly, causing a rise in blood sugar. Like other types of insulin, Lantus is used to normalize blood sugar levels.

Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual dysfunction. Proper control of diabetes has also been shown to reduce your risk of a heart attack or stroke.

Lantus is meant to be used alongside a proper diet and exercise program recommended by your doctor.

Lantus is manufactured by Sanofi-Aventis. It was approved for use by the Food and Drug Administration (FDA) in 2000 as the first long-acting human insulin administered once a day with a 24-hour sugar-lowering effect.

Lantus (insulin glargine) is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Lantus is used to improve blood sugar control in adults and children with diabetes mellitus. Lantus is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 6 years old.

LANTUS (insulin glargine injection) is a sterile solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analog that is a long-acting, parenteral blood-glucose-lowering agent. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows oncedaily dosing as a basal insulin. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acidasparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21^A-Gly-30^Ba-L-Arg-30³⁰b-L-Arg-human insulin and has the empirical formula C₂₆₇H₄₀₄N₇₂O₇₈S₆ and a molecular weight of 6063. Insulin glargine has the following structural formula:

LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 Units (3.6378 mg) insulin glargine.

The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection.

The 3 mL prefilled pen presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4

Important information

You should not use Lantus if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis.

Never share a Lantus injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another. Lantus is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Before taking this medicine

You should not use Lantus if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Lantus is not approved for use by anyone younger than 6 years old, and should not be used to treat type 2 diabetes in a child of any age.

To make sure Lantus is safe for you, tell your doctor if you have:

liver or kidney disease;
low levels of potassium in your blood (hypokalemia); or
diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor’s instructions about using Lantus if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Uses

Insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidneydamage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Insulin glargine is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

How to use Lantus Vial

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist.

Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Wash your hands before measuring and injecting insulin. Before using, check the product visually for particles, thickening, or clumps. If any are present, discard that container. Insulin glargine should be clear and colorless. To avoid damaging the insulin, do not shake the container.

The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar. If you are using the cartridge form of this insulin and a special injecting device with a digital display, take care to read the display right-side up. If you read the display upside-down, you may inject the wrong amount of insulin. Ask your pharmacist if you are unsure how to properly use this type of injecting device.

Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually once daily or as directed by your doctor. Do not rub the injection site. Do not inject into a vein or muscle. Change the location of the injection site daily and do not reuse the same site for two weeks to avoid problem areas under the skin.

Use this medication regularly as directed by your doctor in order to get the most benefit from it. You may inject insulin glargine once daily at any time during the day (such as before breakfast or at bedtime) but you should inject at the same time each day. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended.

Do not mix this product with other insulins or solutions, or use it in an insulin pump.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose.

If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

Side Effects

Injection site reactions (such as pain, redness, irritation) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using insulin glargine, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across time zones, ask your doctor about how to adjust your insulinschedule. Take extra insulin and supplies with you.

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

Children may be more sensitive to the side effects of this drug, especially low bloodsugar.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

A product that may interact with this drug is: rosiglitazone.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugarsuch as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Lantus and Other Drug Interactions

When you are taking Lantus, it is especially important that your healthcare professional know if you are taking metreleptin ( Myalept). Using Lantus with metreleptin is usually not recommended, but may be required. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of them.

Using Lantus with any of the following medicines may cause an increased risk of certain side effects. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Iproniazid (Marsilid)
Isocarboxazid (Marplan)
Linezolid (Zyvox)
Methylene Blue (Urolene Blue)
Moclobemide (Aurorix)
Nialamide (Niamid)
Phenelzine (Nardil)
Procarbazine (Matulane, Matulane)
Rasagiline (Azilect)
Selegiline (Emsam)
Tranylcypromine (Parnate)

A medication that may affect your Lantus dosage is called rosiglitazone (Avandia). Tell your doctor if you are taking this medication before you take Lantus.

Beta-blockers such as metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran, Pronol), and glaucoma eye drops may prevent the fast or pounding heartbeat that often signals low blood sugar.

You should also check the labels on all over-the-counter medicines, such as cough and cold products. Products that contain sugar or alcohol may affect your blood sugar levels.

Other medicines can increase or decrease the effectiveness of insulin in lowering your blood sugar. Tell your doctor about all of your prescription and over-the-counter medicines and supplements, as well as any vitamin, supplements, or recreational drugs you are taking.

Lantusand Other Interactions

Your doctor may recommend a diabetic diet if you are taking Lantus or any other insulin.

The amount of food you eat can affect your insulin needs. If you eat less food, skip meals, or eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider if you change your diet so that you know how to adjust your Lantus and other insulin doses.

Alcohol, including beer and wine, may affect the way Lantus works and may affect your blood sugar levels. Avoid alcohol if you are taking Lantus.

Exercise or increased activity may also change the way your body uses insulin. Your dose may need to be adjusted if you start or change your exercise program.

Lantus Warnings

You will be taught how to properly inject this medication since that is the only way to use it. Do not inject cold insulin because this can be painful. Always wash your hands before measuring and injecting insulin. Lantus is always clear and colorless; look for cloudy solution or clumps in the container before injecting it.

Do not use Lantus to treat diabetic ketoacidosis. A short-acting insulin is used to treat this condition.

It is recommended that you take a diabetes education program to learn more about diabetes and how to manage it.

Other medical problems may affect the use of this medicine, so make sure you tell your doctor your complete medical history. For example, in liver disease, the effect of Lantus may be increased and the amount of Lantus or other insulin may need to be adjusted.

The following conditions increase blood sugar and may increase the amount of insulin or Lantus you need:

Emotional disturbances
Infection
Stress

Side Effects

Get emergency medical help if you have signs of an allergy reaction to Lantus: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Lantus side effects may include:

low blood sugar;
itching, mild skin rash; or
thickening or hollowing of the skin where you injected the medicine.

Common Side Effects of Lantus:Using too much of the medication can result in low blood sugar, which may cause the following symptoms:

Chills
Cold sweats
Blurred vision
Dizziness or drowsiness
Shaking
Fast heartbeat
Weakness
Tingling of the hands/feet
Hunger

Not using enough of the medication can result in high blood sugar, which can cause the following symptoms:

Thirst
Increased urination
Confusion
Drowsiness or flushing
Rapid breathing
Fruity breath odor

Let your doctor know if any of these symptoms occur because your Lantus dosage may need to be changed.

Serious Side Effects of Lantus:A very serious allergic reaction to this drug is rare. Seek immediate medical attention if you notice any of the following signs of a serious allergic reaction:

Rash
Itching/swelling (particularly the face, tongue, or throat)
Severe dizziness
Difficulty breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Dosage

Lantus is a long-acting insulin that works slowly over about 24 hours. You may have to use Lantus in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

Lantus injection is available as:

10 milliliter (ml) vial (1,000 units/10 ml)
3 ml cartridge systems for use only in OptiClik (300 units/3 ml)
3 ml SoloStar disposable insulin device (300 Units/3 ml)

The dosage of Lantus is based on your medical condition and your response to treatment. Your doctor will give you very specific instructions on how much Lantus to take daily.

Lantus may be administered any time during the day, but it should be taken at the same time each day. If you are on insulin therapy, it is essential that you monitor your blood glucose levels.

If you have type 1 diabetes, your doctor will prescribe Lantus with short-acting insulin. If you have type 2 diabetes, your doctor may start you on a dose of 10 units daily and then adjust Lantus according to your needs.

Missed Dose of Lantus

It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Keep extra supplies of insulin and an extra syringe and needle on hand. Talk to your doctor about what to do if you miss a dose, as treatment varies according to your medical condition.

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What is Lantus?

Important information

Before taking this medicine

Uses

How to use Lantus Vial

Side Effects

Precautions

Interactions

Lantus and Other Drug Interactions

Lantusand Other Interactions

Lantus Warnings

Side Effects

Dosage

Missed Dose of Lantus

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