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Known Side Effects & Uses of Levemir Flexpen (Insulin Injection)

By Jemima Faith

Levemir FlexPen

There are a good number of diabetes control medications found in our pharmacies today. Most of these are alternative forms of insulin, which helps to replace the insulin deficiency that is evident in diabetes patients. However, most of these medicines are geared at controlling either type 1 or type 2 diabetes and not both. Insulin is the substance that helps the body to convert sugar into useable glucose and energy. If this fails, sugar accumulates in the system, which is often time toxic and fatal. Levemir Flexpen is the game changer in that it is approved for the treatment of both type 1 and type 2 diabetes. Levemir Flexpen is one of the few insulin products that closely resemble normal human insulin in all its structure and activities and only differ around its amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been bound to the amino acid B29. This insulin is produced following a recombinant DNA technology in Saccharomyces cerevisiae accompanied by chemical change. Levemir Flexpen is an injectable insulin solution main to be administered subcutaneously. Levemir Flexpen is more effective when it is used as part of the diabetes control program which also include good eating habits (eating less sugary diets) and exercise (to help burn out excess glucose).  

Levemir Flexpen is a long-acting diabetes therapeutic drug whose main functions are to stimulate the production of normal insulin in the pancreas and to replace insufficient amount of insulin in the body. It acts longer than regular insulin, offering a low, steady rate of insulin. Shorter-acting insulin product and Insulin detemir could both be used. Furthermore, it could as well be used alone or with other diabetes drugs (for instance exenatide and also metformin).

Levemir Flexpen insulin is recommended to be administered subcutaneously following either one daily dosage regimen (with the evening meal or at bedtime) or twice daily dosage regimen (morning and evening, 12 hours after the morning dose). Subjects may also be required to take a maintenance dose, following improvement with the initial dose. Such doses need to be adjusted according to metabolic needs, blood glucose assessments, and glycemic goals. For those moving from other insulin treatment to Levemir, insulin glargine and NPH insulin can be converted to a unit by unit basis. Close monitoring of blood glucose levels during the transition and in the initial weeks thereafter is essential. The dosage of Levemir Flexpen and frequency of short-acting insulin may need to be adjusted.

 Functioning and effectiveness of Levemir Flexpen

Levemir Flexpen is the brand name for insulin detemir, a form of insulin made following recombinant rDNA technology and use to control or lower blood glucose levels. It’s not approved for the treatment of diabetic ketoacidosis. In order to regular glucose, insulin detemir binds to insulin receptors. This then causes the lowering of blood glucose by enhancing cellular uptake of glucose into the skeletal muscle and adipose tissue and also decreases the amount of glucose from liver metabolism. Insulin also inhibits lipolysis (conversion of fats to glucose) in the adipocyte, inhibits proteolysis (conversion of proteins to glucose), and enhances protein synthesis. Levemir insulin is known to start working several hours after its administration and keeps working for as long as 24 hours, thus it’s a long-acting insulin. Levemir insulin is approved for the treatment of type 1 diabetes in adults and children who are older than two years and diabetes type 2 in adults only.

Patients should be trained and advised on self-management techniques such as the right way to administer the insulin, control of hypo- and hyperglycemia and glucose monitoring. They should be trained or educated on how to manage certain conditions like stress, emotional disturbance, or illness, missed dose, inadequate food intake, and the administration of an increased insulin dose. Patients should also be educated on the proper use of Levemir Flexpen. Let them know that, they have to press and hold down the dose button until the dose counter reads 0 and afterward, slowly count to 6 (with the button still down). Note that, when the counter reads 0, the recommended dose has not yet been administered until after 6 seconds.

In the event where the counter does not read 0 after continuously pressing the dose button, you should check the needle for blockage. Change the needle and repeat the process.  If the patient, however didn’t use a blocked needle, he should change the needle. Make sure patients know how to select the full dose needed.

In order to achieve maximum benefits from Levemir insulin, you should take it as advised by your healthcare provider and never miss any dose. You should not drive or operate heavy machinery and should not drink or take any un-prescribed drugs while on insulin therapy

Uses of Levemir Flexpen

Levemir is use mainly to improve glucose control (diabetes) in adults and children. Apart from this, other uses of Levemir Flexpen include; to improve glycemic control in patients with type 1 diabetes mellitus, to enhance glycemic control in patients with type 2 diabetes mellitus as well as to improve glycemic control in pediatric patients 2 years or older with type 1 diabetes mellitus.

This medicine may also be prescribed for purposes other than those discussed in this guide. You should ask your healthcare provider or pharmacist the various uses of Levemir insulin. Avoid using this insulin for conditions for which it was not prescribed and do not give it to other people even if they exhibit the same signs and symptoms that you have.

Before taking this medicine

Levemir is a safe drug though it also has some serious side effects. Thus, you should not take Levemir if you have ever had a history of a severe allergic reaction to insulin detemir, or if you are having an episode of low blood sugar (hypoglycemia). You should talk with your doctor about the best treatment for you if you have diabetes. This insulin should never administer to a child younger than 2 years of age and should not also be used to treat type 2 diabetes in children of any age.

You should make sure you inform your healthcare provider about your clinical history, especially if you ever have:

  • liver or kidney disease;
  • hypokalemia (low systemic levels of potassium)
  • diabetic ketoacidosis

To help your healthcare provider to safely prescribe this medicine for you, you should inform him of all the medicine (prescriptions, over the counter and herbal medicines) you might have taken or are taking including pioglitazone or rosiglitazone, and other oral diabetes medicines. These medicines, if taken with Levemir may increase your risk of serious heart problems.

You are advised to always visually inspect your flexpen for particulate matter and discoloration before any administration and should only be used when the suspension appears clear and colorless. Make sure your insulin is at room temperature before administration. You should never mix or dilute Levemir insulin with any other solution or insulin.

Inform your health care provider if you are pregnant, plan to become pregnant or are breastfeeding.

You should make sure you read through the medical guide or instruction leaflet that comes with this medicine and follow the advice and recommendations from your healthcare provider or pharmacist. If you have any doubt or problem with the dose measurement, or dose strength, you should ask your doctor. You should not change the type of insulin or dosage regimen unless your health care provider asked you to do so. You should regularly check your blood sugar/glucose levels. Ask your doctor about the safety and effectiveness of Levemir used during pregnancy or nursing.

Side effects of Levemir Flexpen

Levemir Flexpen is an effective medication against diabetes. However, Levemir Flexpen use may result in some adverse reaction in some people. These reactions may often be less sever, although there have been some reported cases of increased severity. For these reasons, we are going to group the various side effects of Levemir Flexpen based on their severity.

Major (Severe but Less Common) Side Effects of Levemir Flexpen

The following symptoms have been associated with severe side effects of Levemir Flexpen. If you suspect or notice any, you should discontinue the use of this drug promptly and get an emergency medical help.

  • confusion
  • cool, pale skin
  • fever
  • headache
  • leg cramps
  • constipation
  • irregular heartbeats
  • fluttering in your chest
  • increased thirst or urination
  • numbness or tingling
  • muscle weakness or limp feeling
  • Anxiety
  • blurred vision
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • chills
  • increased hunger
  • irritation
  • seizures
  • shakiness
  • itching

 

  • hives
  • hoarseness
  • cough
  • nausea
  •  joint pain
  • cold sweats
  • swelling of the eyelids, face, lips, hands, or feet
  • weight gain
  • tightness in the chest
  • nightmares
  • skin rash
  • slurred speech
  • stiffness or swelling
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • trouble breathing
  • unusual tiredness or weakness
  • depression

Minor Side Effects Levemir Flexpen

There are some less severe but more common side effects of insulin Levemir that may not need medical attention. These Levemir side effects are usually seen during the early treatment with this drug. They often disappear as the body become use to the drug. However, some of them may persist and thus requiring the help of a healthcare professional. Also, your health care provider may be able to advise you about the various methods you can use to prevent or reduce the frequency or severity of these side effects. Some of these Levemir side effects include:

  • discoloration of the skin
  • feeling of pressure
  • numbness
  • redness
  • hives
  • tenderness
  • tingling
  • infection
  • thickening or hollowing of the skin where you injected the medicine
  • Bleeding
  • inflammation
  • itching, mild skin rash lumps
  • Blistering
  • flu symptoms
  • swelling of the fingers, hands, feet, or lower legs
  • trouble breathing at rest
  • noisy, rattling breathing
  • weight gain
  • decrease in the amount of urine
  • redistribution or accumulation of body fat
  • cold symptoms such as stuffy nose, sneezing, sore throat
  •  scarring
  • soreness
  • stinging
  • Burning
  • ulceration
  • warmth at the injection site
  • Coldness
  • back and stomach pain

 

This may not be a comprehensive list of all the possible Levemir side effects. If you observe other effects not listed above, discuss it with your doctor or pharmacist. In the US -Call your physician for medical advice about side effects. You may report Levemir side effects to FDA at 1-800-FDA-1088.

Warnings and Precautions of Levemir Flexpen    

Sharing a Levemir FlexTouch

​Sharing and reused of a Levemir Flexpen between patients poses a risk for transmission of blood-borne pathogens. Thus, you should for no reason ever share yours even after you change the needle.

Dosage adjustment and monitoring

Since insulin Levemir work to control blood glucose, the follow-up of glucose is essential for every patient undergoing insulin treatment. Depending on your clinical record and response to therapy, changes to an insulin dosage regimen may be required. Such can only be done if there is proper follow up or medical supervision. Your response to treatment may also determine the need for changes the manufacturer, type, and approach of the administration or even the anti-diabetic drug used in combination with Levemir treatment. 

As with all medicines, the duration and effectiveness of action for Levemir may depends on the individual’s clinical record alongside the physical activity, local temperature, and local blood supply.

Fluid retention and heart failure 

Peroxisome proliferator-activated receptor (PPAR)-gamma agonists, such as Thiazolidinediones (TZDs) when used in combination with insulin, may cause dose-related fluid retention. Fluid retention has been a common cause of heart failure in such patients. For this reason, subjects undergoing insulin, such as Levemir therapy, in combination with a PPAR-gamma agonist should be monitored for signs and symptoms of heart failure. If the subjects develop symptoms of heart failure, discontinuation or dose reduction of the PPAR-gamma agonist must be considered. Also, symptoms of heart failure should be managed in line with the current standards of care.

Hypersensitivity and Allergic Reactions

Some subject treated with Levemir insulin may develop a severe, life-threatening, generalized allergic reaction, including anaphylaxis. Subjects with a history of any allergic reaction to any of the components of Levemir may be at higher risk of severe reactions.

Overdose of Levemir Flexpen

An excess of insulin relative to food intake, energy expenses, or the both of them, may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Moderate episodes of hypoglycemia can be treated with oral glucose. Caution must be taken when prescribing Levemir to balance the dosage, meal patterns, and exercise. More severe episodes with seizure, or neurologic impairment, coma may be treated with concentrated intravenous glucose, or intramuscular/subcutaneous glucagon. After visible clinical recovery from hypoglycemia, ongoing observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.

Half-life of Levemir Insulin

Plasma concentration/time profile of insulin is relatively constant over a period of 24 hours following subcutaneous injection of Levemir insulin with a maximum concentration reach between 6-8 hours. Following subcutaneous administration, Levemir insulin is said to have a terminal half-life (time taken for maximum plasma concentration of insulin to drop by half) of 5 to 7 hours. This estimate also depends on the dose of insulin use.

Storage and handling conditions of Levemir Flexpen

Unused (unopened) Levemir should be stored in the refrigerator between 2° and 8°C (36° to 46°F). You should not store in the freezer or directly adjacent to the refrigerator cooling component. Do not freeze and do not use Levemir Flexpenif it has been frozen.

Unused Levemir can be kept until the expiration date printed on the label if it is stored in a refrigerator. Put unused Levemir in the carton so that it stays clean and protected from light. If refrigeration is not possible, unused (unopened) Levemir can be preserved unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated Levemir should be thrown off 42 days after it is first kept out of the refrigerator, even if the Flexpen or vial still possesses insulin.

Vials (thesmall glass or plastic vessel or bottle, usually used in storing medication as capsules, liquids, or powders):

After initial use, vials should be stored in a refrigerator, and never to be kept in the freezer. If not possible to be kept in a refrigerator, the in-use vial can be kept unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Refrigerated Levemir vials should be thrown off 42 days after initial application. Unrefrigerated Levemir vials should be thrown off 42 days after they are first kept out of the refrigerator. Do not use this medicine if found to be expired. Dispose of all expired and unused drugs following safe environmental practices. Keep this medicine out of the reach of the children.

Use in specific populations

Pregnancy

There is a greater or increased risk of unwanted reactions, including miscarriages, birth defects, and other complications that are associated with pregnancy, in pregnancies complicated by hyperglycemia. Female diabetes patients should be advised to consult with their healthcare provider if they are pregnant or plan to become pregnant while administering Levemir. There was no significant increase in potential risk fetal abnormalities associated pregnancy use of Levemir with women with type I diabetes. However, the potential risk of undesired reactions in pregnancies complicated by diabetes (hyperglycemia) may be significant reduced with better eating lifestyle, and exercise before conception and throughout pregnancy. And due to the fact that insulin requirements may change throughout pregnancy and in the post-partum period, careful following up of glucose control is essential in pregnant women.

Nursing mothers

There is no verified evidence regarding the passing of Levemir into human milk, its effects on breastfeeding children, or its effects on the quantity or quality of milk produced. Due to the fact that many substances, including human insulin are passed into human milk, Levemir should be administered with caution to nursing women. However, the health and developmental benefits of breastfeeding infant should be taken into account along with the potential side effects on the breastfed child from Levemir and the mother’s clinical need for Levemir or from the underlying maternal condition. Women with diabetes who are breastfeeding could need adjustments of their insulin doses.

Pediatric use

The subcutaneous injections of Levemir Flexpen are said to be safe and effective in pediatric patients who are older than 6 years (but not in children younger than 6 years of age) with type 1 diabetes. Levemir has not been approved in pediatric patients with type 2 diabetes. When converting from other diabetes drug to Levemir, there is no need for dose adjustment for adults. The prescribed dose of Levemir must be inconsistent or in accordance with the pediatric patient’s clinical record and his metabolic needs. Frequent monitoring of blood glucose in adults is essential.

Geriatric use

There was no significant difference in the safety and effective between these patients and younger patients. However, clinical trials did not involve any significant number of diabetes subjects in this age group (older than 65 years) for any meaningful conclusion to be drawn. We cannot rule out the greater sensitivity of subjects in this age group of kidney and liver problems thus, Levemir should be prescribed with caution and usually starting with the lowest possible dose. Hypoglycemia may be difficult to identify in the elderly.

Renal impairment

There has been no contrary experience in the pharmacokinetics of insulin detemir between non-diabetic individuals with healthy volunteers and renal impairment. However, some researches with human insulin have shown increased circulating insulin concentrations in patients with renal impairment. Careful glucose following up and dose adjustments of insulin, including Levemir uses, may be necessary in patients with renal impairment.

Hepatic impairment

There have been lower systemic exposures to insulin detemir compared to healthy volunteers for non-diabetic individuals with severe hepatic impairment. However, a few research with human insulin have shown increased circulating insulin concentrations in patients with liver impairment. The keen glucose monitoring and dose adjustments of insulin, including Levemir Flexpen uses, may be necessary in patients with hepatic impairment.

A disclaimer: All information and content on this article are for information and educational purposes solely. The information should not be used for either diagnosis or treatment or both for health related disease or problem. Always seek the advice of a professional physician for medical diagnosis and treatment.

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