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Insulin glargine

 
Drug Info: Insulin Glargine
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Brand names: Lantus®



Insulin Glargine injection

What is Insulin Glargine injection?

INSULIN GLARGINE (Lantus®) is a human-made form of insulin. Insulin is a hormone produced naturally by the pancreas. Insulin lowers the amount of sugar in your blood. Keeping your blood sugar close to normal prevents or reduces long-term complications of diabetes including damage to the blood vessels, eyes, kidneys, or nerves. Insulin glargine is a long-acting insulin that is usually given once a day. The time-course of action of insulin may vary in different people and at different times in the same person. The time-course of action of insulin may also vary depending on the place where the insulin is injected, your body temperature, and your physical activity. A prescription is needed to buy insulin glargine. A prescription to obtain insulin syringes may or may not be required in the state where you live.

There are different types of insulin available. Each type has a different onset of action and a different duration of action in the body. You should learn which types you take and how you should administer them, and how each type acts in your body. Insulin glargine is labeled with its name, Lantus®. Insulin is obtained from beef, pork, or human sources.Beef insulin is no longer made in the US because of concerns of cow tissues spreading certain infections.

Do not change the type of insulin you are taking without talking to your prescriber. If you must switch the type of insulin you use, you should realize that you may need to monitor your blood sugar more frequently and that dosage adjustments may be needed before you are stabilized on the new type. Take care to learn and recognize the symptoms of hypoglycemia (low blood sugar) and know how you should treat these reactions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• adrenal or pituitary gland problems
• diarrhea
• fever or infection
• injury or trauma
• kidney disease
• liver disease
• nausea, vomiting
• recent surgery
• thyroid disease
• pregnant or trying to get pregnant
• breast-feeding
• an unusual or allergic reaction to insulin, metacresol, other medicines, foods, dyes, or preservatives

How should this medicine be used?

Insulin is for injection under the skin. Use exactly as directed. Do not use more insulin than prescribed. Do not use more or less often than prescribed. It is important to follow the directions given to you by your health care professional or prescriber. You will be taught how to inject insulin. If you utilize an insulin injector device, you will be taught how to use it, prime it, and how to refill the device with the insulin cartridges.

You will be taught how to administer doses before meals. You will also be taught how to adjust doses for activities and illness.

Always check the appearance of your insulin before using it. Insulin glargine should be clear and colorless like water. Do not use insulin glargine if it is cloudy, thickened, colored, or has solid particles in it.

Do not mix insulin glargine with any other insulin or diluent.

What drug(s) may interact with Insulin Glargine?

• other medicines for diabetes

Many medications may cause changes (increase or decrease) in blood sugar, these include:
• alcohol containing beverages
• angiotensin converting enzyme inhibitors (ACE inhibitors), often used for high blood pressure or heart problems (examples include captopril, enalapril, lisinopril)
• antiretroviral protease inhibitors (examples include indinavir, ritonavir, saquinavir)
• aspirin and aspirin-like drugs
• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
• certain medicines used for mental depression, emotional, or psychotic disturbances
• chromium
• cisapride
• clonidine
• cyclosporine
• danazol
• diazoxide
• disopyramide
• epinephrine
• female hormones, such as estrogens, progestins, or contraceptive pills
• fenofibrate
• gemfibrozil
• glucagon
• growth hormone (somatropin)
• guanethidine
• isoniazid
• lithium
• metoclopramide
• male hormones or anabolic steroids
• medications to suppress appetite or for weight loss
• medicines for allergies, asthma, cold, or cough
• niacin
• nicotine (including nicotine found in patches and gum)
• pentamidine
• pentoxifylline
• phenytoin
• propoxyphene
• quinolone antibiotics, medicines used for infections (examples include ciprofloxacin, levofloxacin, norfloxacin)
• some herbal dietary supplements
• steroid medicines such as prednisone or cortisone
• sulfonamides, medicines for infection ( examples include Azulfidine®, Bactrim®, Gantrisin® Septra®)
• tacrolimus
• thyroid hormones
• water pills (diuretics)

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
• clonidine
• guanethidine
• reserpine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Insulin Glargine?

Visit your health care professional or prescriber for regular checks on your progress. To control your diabetes properly you must use insulin regularly and follow a regular diet and exercise schedule. Diabetes cannot be cured. Careful, daily control of blood sugar can postpone or prevent many of the long-term complications of diabetes.

Dangerously high or low blood sugar can occur when meals and insulin are not spaced properly. Checking and recording your blood glucose and urine ketone levels regularly is important. Sometimes it is hard to tell the difference between low and high blood sugar (see side effects). Use a glucometer (blood glucose or sugar measuring device), whenever possible, before you treat high or low blood sugar.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar (hypoglycemia). Examples include hard sugar candy or glucose tablets.

Make sure that you have the right kind of syringe for the type of insulin you use. Try not to change the brand and type of insulin syringe unless your health care professional or prescriber tells you to. Use a syringe one time only. Throw away syringe and needle in a closed container to prevent accidental needle sticks.

Do not switch brands or types of insulin without consulting your health care professional or prescriber. Switching insulin brand or type can cause dangerously high or low blood sugar.

Always keep an extra supply of insulin, syringes, and needles on hand.

Wear a Medic Alert bracelet or necklace and/or carry an identification card with your name and address, condition, medication, and prescriber's name and address.

If you develop a cold, diarrhea, vomiting, or other infection or illness, you should contact your health care professional or prescriber. 'Sick-days' may require changes to your insulin dosage. Or your illness may need to be evaluated. Ask your health care professional or prescriber what you should do if you become ill. Do not stop taking your insulin; check with your health care professional or prescriber for advice.

If you are a long time smoker and suddenly stop, you may need a change in insulin dose. Talk to your health care professional or prescriber first.

Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.

If you are going to have surgery, make sure you tell the health care professionals that you take insulin.

What side effects may I notice from receiving Insulin Glargine?

Learn how and when you should monitor your blood sugar, and what you should do if high or low blood sugar occurs. Side effects that you should report to your health care professional or prescriber as soon as possible:

Symptoms of hypoglycemia (low blood glucose):
• anxiety or nervousness, confusion, difficulty concentrating, hunger, pale skin, nausea, fatigue, sweating, headache, palpitations, numbness of the mouth, tingling in the fingers, tremors, muscle weakness, blurred vision, cold sensations, uncontrolled yawning, irritability, rapid heartbeat, shallow breathing, and loss of consciousness. You should learn to recognize your own symptoms of hypoglycemia. Your symptoms may be different than others. If you are uncertain about your symptoms of hypoglycemia, check your blood sugar often to help you learn to recognize the symptoms. Hypoglycemia may cause you to not be aware of your actions or surroundings if it is severe, so you should let others know what to do if you cannot help yourself in a severe reaction. Your health care professional or prescriber will teach you how to treat hypoglycemia. Always carry a quick source of sugar such as candies or glucose tablets with you.

Symptoms of high blood sugar (hyperglycemia):
• dizziness, dry mouth, flushed dry-skin, fruit-like breath odor, loss of appetite, nausea, stomach ache, unusual thirst, frequent passing of urine

Insulin also can cause rare but serious allergic reactions in some patients, including:
• severe skin rash and itching (hives)
• difficulty breathing

Side effects that usually do not require medical attention (report to your health care professional or prescriber if they continue or are bothersome):
• increase or decrease in fatty tissue under the skin, through overuse of a particular injection site
• itching, burning, swelling, or rash at the injection site

Where can I keep my medicine?

Keep out of the reach of children.

Store unopened insulin vials in a refrigerator between 2—8 degrees C (36—46 degrees F). Do not freeze or use if the insulin has been frozen. Opened vials (vials currently in use) may be stored in the refrigerator or at room temperature, at approximately 25 degrees C (77 degrees F) or cooler. Keeping your insulin at room temperature decreases the amount of pain during injection. Once opened, your insulin can be used for 28 days. After 28 days, the vial of insulin should be thrown away.

Store unopened pen-injector cartridges in a refrigerator between 2—8 degrees C (36—46 degrees F.) Do not freeze or use if the insulin has been frozen. Insulin cartridges inserted into the OptiClik™ system should be kept at room temperature, approximately 25 degrees C (77 degrees F) or cooler. Do not store in the refrigerator. Once inserted into the OptiClik™ system, the insulin can be used for 28 days. After 28 days, the cartridge of insulin should be thrown away.

Protect from light and excessive heat. Throw away any unused medicine after the expiration date or after the specified time for room temperature storage has passed.

Last updated: 11/1/2004 9:43:00 AM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Wikipedia: Insulin glargine
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Home > Library > Miscellaneous > Wikipedia
Insulin glargine
Systematic (IUPAC) name
Recombinant human insulin
Identifiers
CAS number 160337-95-1
ATC code A10AE04
PubChem  ?
DrugBank BTD00045
Chemical data
Formula C267H408N72O77S6 
Mol. mass 6063 g/mol
Pharmacokinetic data
Bioavailability  ?
Metabolism  ?
Half life  ?
Excretion  ?
Therapeutic considerations
Pregnancy cat.

C(US)
Legal status

POM(UK) ℞-only(US)
Routes Subcutaneous

Insulin glargine, marketed by Sanofi-Aventis under the name Lantus, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. Its advantage is that it has a duration of action of 24 hours, with a "less peaked" profile than NPH. Thus, it more closely resembles the basal insulin secretion of the normal pancreatic beta cells. Sometimes, in type 2 diabetes and in combination with a short acting sulfonylurea (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin—Type 1 diabetes, depleted type two (in some cases) or latent autoimmune diabetes of adults in late stage—Lantus needs the support of fast acting insulin taken with food to reduce the effect of prandially derived glucose. It is fasting glucose elevation which more significantly affects HbA1c and thus determines the progression of the long-term complications of diabetes mellitus[citation needed].

Contents

Benefit

For most patients, the peakless profile of Lantus also enables the dose to be higher than standard NPH insulin. Because standard NPH is normally administered at night, its peak of action tends to coincide with the lower serum glucose levels associated with nocturnal metabolism. This can induce nocturnal hypoglycaemia. Lantus offers the benefit of a more consistent pharmacological dynamic without nocturnal hypoglycaemia. The result of this is a patient who feels more confident and more comfortable with a lower pre-bed and pre-breakfast capillary glucose level.

Pharmacological specifications

Mechanism of action (pharmacodynamics)

glargine vs. NPH insulin

Insulin glargine have substitution of glycine for asparagine at A21 and two arginines added to the carboxy terminal of B chain. This allows insulin glargine to form a precipitate (hexamer) when injected subcutaneously into the patient. It can achieve a peakless level for at least 24 hours.

Acceptance and repartition in the body (pharmacokinetic)

Lantus is formulated at an acidic pH 4, where it is completely water soluble. After subcutaneous injection of the acidic solute ( which can cause discomfort and a stinging sensation and can be mitigated with the use of the I-port ), the body, at pH 7, slowly neutralizes the solution, causing insulin microcrystals to gradually precipitate from the insulin glargine solution, which then release insulin in biologically active form. This gradual process ensures that small amounts of Lantus are released into the body continuously, giving an almost peakless profile.

Usage

Mixing with other insulin preparations

Unlike some other longer-acting insulins, Lantus must not be diluted or mixed with other insulin or solution in the same syringe.[1]

Other information

Development

The development of Lantus was conducted at Sanofi-Aventis's biotechnology competence center in Frankfurt-Höchst. Sanofi supplies the product to over 100 countries and more than 3,5 million patients worldwide. This makes Lantus Germany's largest and most important export pharmaceutical product. Sanofi-Aventis increased its turn-over with Lantus around 28% to 2,45 Billion €, therefrom 130 Million € in Germany, where approx. 1,8 Mio. diabetics applied this preparation. In 2007 Lantus ranked place 15 on top-selling pharmaceutical products in Germany.

The investment in the production of Lantus and insulin-pen-manufacturing at the location Frankfurt-Höchst lied at 700 Mio. €. In 2008 a new manufacturing plant was established for further insulin-pen with an investment sum of 150 Mio. €. At Sanofi-Aventis the production of Lantus created 3000 jobs in Berlin and Frankfurt-Höchst.

On June 9, 2000 the European Commission approbated Sanofi-Aventis Germany Ltd. the launching of Lantus® in the entire European Union. The admission was prolonged on June 9, 2005.[2]

Advantages

International clinical studies have confirmed the advantages of insulin glargine in the treatment of heavy hypoglycaemia compared to standard NPH insulin. Glargine reduces the risk of severe nocturnal hypoglycaemia. Extensive clinical studies (ACCORD) have confirmed the higher risk of mortality with higher incidence of severe hypoglycaemia.[3][4] Other systematic reviews corroborate the results of benefit of insulin glargine regarding lower incidence of severe hypoglycaemia.[5]

On June 13, 2009, Diabetologia, the journal of European Association for the Study of Diabetes (EASD), published the results of a 5 year long-term randomized controlled trial. During the study no other safety issues, such as unexpected adverse events for either insulin emerged. However, insulin glargine was associated with a lower incidence of severe hypoglycaemia compared with NPH insulin.[6]

Possible cancer link

On June 26, 2009, Diabetologia published the results of four large-scale registry studies from Scotland, Sweden, UK and Germany. The German study, of around 127,000 insulin-treated patients from an insurance database, suggested a possible link between insulin glargine (Lantus) and increased risk of developing cancer.[7] The risk of cancer was dose-dependent, with those taking higher doses of Lantus apparently at increased risk[8]. Whilst the authors stressed the limitations of the study and recommended that patients prescribed Lantus continue to take the drug, the results led to the EASD making "an urgent call for more research into a possible link between use of insulin glargine (an insulin analogue, brand name Lantus) and increased risk of cancer."[9]

The European Medicines Agency (EMEA) responded, stating that the results of the four studies were inconsistent, and that a relationship between insulin glargine and cancer could neither be confirmed nor excluded.[10] They announced that they would undertake further detailed assessment of the studies’ results and any other relevant information, including several potential confounding factors that had not been fully taken into account by the studies. Patients being treated with insulin glargine were advised to continue their treatment as normal. [10] The following month, the EMEA reported back, concluding that "the available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.”[11]

The American Diabetes Association (ADA) also responded to the Diabetologia report, describing the published registry studies as “conflicting and confusing” and “inconclusive”. They advised patients against discontinuing Lantus and warned against "over-reaction".[12]

References

  1. ^ American Diabetes Association. (2003). Position statement: Insulin administration. Diabetes Care 26(Suppl. 1), 121–124
  2. ^ EPAR Lantus, German summary of admission report of EMEA (PDF)
  3. ^ [1], Action to Control Cardiovascular Risk in Diabetes (ACCORD), Trial , June 6, 2008
  4. ^ [2], Effects of Intensive Glucose Lowering in Type 2 Diabetes
  5. ^ Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H (February 2009). "Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis". CMAJ 180 (4): 385–97. doi:10.1503/cmaj.081041. PMID 19221352. PMC 2638025. http://www.cmaj.ca/cgi/pmidlookup?view=long&pmid=19221352. 
  6. ^ Rosenstock J, Fonseca V, McGill JB, Riddle M, Hallé JP, Hramiak I, Johnston P, Davis M. (13 June 2009). "Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study". Diabetologia. PMID 19526210. http://www.springerlink.com/content/c4352jj00640558p/fulltext.pdf. 
  7. ^ Hemkens LG et al (26 June 2009). "Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study". Diabetologia. PMID 19565214. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=19565214. 
  8. ^ http://webcast.easd.org/press/glargine/transcript.htm
  9. ^ http://www.diabetologia-journal.org/cancer.html
  10. ^ a b [3]European Medicines Agency update on safety of insulin glargine, June 29, 2009
  11. ^ [4] European Medicines Agency update on safety of insulin glargine, July 23, 2009
  12. ^ [5] Statement from the American Diabetes Association Related to Studies Published in 'Diabetologia', June 26, 2009

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