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

By Jemima Faith

Levemir FlexPenDescription of Levemir Flexpen?

Levemir (insulin detemir (DNA origin) injection) is a sterile solution of insulin detemir for use as a subcutaneous injection. Insulin detemir is a prolonge-acting (up to 24-hour duration of action) recombinant human insulin analog. Levemir is produced by a process that carries the expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical change. Insulin detemir is different from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been bound to the amino acid B29.

Insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps stop kidney damage, loss of limbs, nerve problems, sexual function problems and blindness. Proper management of diabetes may also reduce your risk of a heart attack or stroke.

Insulin detemir is a man-made product that is similar to human insulin. It substitutes the insulin that your body would obviously make. It acts longer than regular insulin, offering a low, steady rate of insulin. It works by assisting blood sugar (glucose) get into cells so your body can use it for energy. Insulin detemir could be used with a shorter-acting insulin product. It could also be used alone or with other diabetes drugs (for instance exenatide and also metformin).

 

Possible side effects of Levemir Flexpen

Tell your doctor, diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using Levemir Flexpen. This medicine helps most people for whom it is prescribed, but it may exhibit unwanted side effects in a few people. All drugs can have side effects. At times, they are serious, most of the time they are not. You may need medical therapy if you get some of the side effects Levemir Flexpen. Some of the side effects that can occur with insulin detemir may not need medical involvement. As your body adapts to the medicine during treatment, these side effects Levemir Flexpen may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects of Levemir Flexpen. If any of the following Levemir Flexpen side effects continue, are disturbed or if you have any questions about them, find out with your health care professional.

            The possible side effects of Levemir Flexpen include:

Signs of allergy: Local allergic reactions (redness, pain, inflammation, hives, bruising, itching and  swelling) at the injection position may occur. These usually vanish after a few weeks of taking your insulin. If they do not vanish, or if they spread throughout your body, call your doctor immediately.

Vision difficulties: When you first begin your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection decreases the risk of developing such skin changes. If you observe your skin pitting or thickening at the injection site, call your doctor or nurse. These manifestations can become more severe, or they may alter the absorption of your insulin, if you inject in the site.

Swollen joints: When you start taking insulin, water preservation may cause swelling around your ankles and other joints. Obviously, this soon disappears. If not, call your doctor.

Diabetic retinopathy (an eye disease related to diabetes, which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level enhances very fast, the retinopathy may get worse. Tell your doctor about this.

Intense neuropathy: (pain due to nerve havoc): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.

Injection site reactions: (such as irritation, redness, pain) as well as swelling of the hands/feet may occur. If any of these side effects Levemir Flexpen persist or worsen, inform your health care provider or doctor promptly. Recall 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. A handful of people taking this medication do not have serious side effects Levemir Flexpen. Tell your doctor right away if you have any serious side effects, including: symptoms of low potassium level in the blood like weakness.

This medication can cause low blood sugar (hypoglycemia). This may happen if you do not consume enough calories from food or if you do unusually heavy exercise. Signs of low blood sugar include sudden shaking, sweating, hunger, blurred vision, fast heartbeat, tingling hands/feet or dizziness. It is a good attitude to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable types of glucose, quickly elevate your blood sugar by eating a quick source of sugar such as honey, or candy, or drink fruit juice or non-diet soda, and table sugar. Call your doctor right away about the reaction and the uses of Levemir Flexpen. To help prevent low blood sugar, take meals on regular intervals, and do not skip meals. Cooperate with your doctor or pharmacist to find out what you should do if you miss a meal.

Signs of high blood sugar (hyperglycemia) include; drowsiness, thirst, increased urination, fruity breath odor confusion, rapid breathing, and flushing. If these symptoms happen, call your doctor right away. Your dosage may need to be raised. A very intense allergic reaction to this drug is rare. However, get medical aid right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling, rash (particularly of the face/tongue), intense dizziness, difficulty breathing.

This is not a complete list of possible Levemir Flexpen side effects. If you observe other effects not listed above, discuss with your doctor or pharmacist. In the US -Call your physician for medical advice about side effects. You may report Levemir Flexpen side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada-Call your physician for medical advice about Levemir Flexpen side effects. You may report side effects of Levemir Flexpen to Health Canada at 1-866-234-2345.

 

Warnings and Precautions of Levemir Flexpen           

i). Dosage adjustment and monitoring

Glucose monitoring is essential for all patients receiving insulin treatment. Changes to an insulin regimen have to be made cautiously and only under medical supervision. Changes in insulin effectiveness, manufacturer, type, or approach of administration may result in the need for a change in the insulin dose or an adjustment of concomitant anti-diabetic treatment. As with all insulin preparations, the duration of action for Levemir may vary in different individuals or at different times in the same individual and is dependent on several conditions, alongside the physical activity, local temperature, and local blood supply.

ii). Administration

Levemir should only be administered subcutaneously. Do not administer Levemir intravenously or intramuscularly. The intended time frame of activity of Levemir is dependent on injection into subcutaneous tissue. Intramuscular or intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. Do not use Levemir in insulin infusion pumps. Do not dilute or mix Levemir with any other insulin or solution. If Levemir is diluted or mixed, the pharmacodynamic or pharmacokinetic profile (for instance, onset of action, time to peak effect) of Levemir and the mixed insulin may be altered in an unpredictable manner.

iii). Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin therapy, including Levemir. The danger of hypoglycemia increases with intensive glycemic control. Patients must be taught to recognize and manage hypoglycemia. Severe hypoglycemia can result to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or demise. Severe hypoglycemia requiring the aid of another person or parenteral glucose infusion, or glucagon administration has been noticed in clinical trials with insulin, including trials with Levemir. The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors, for instance changes in food intake (e.g. proportion of food or timing of meals), exercise, and concomitant medications could also alter the risk of hypoglycemia. The prolonged effect of subcutaneous Levemir may delay recovery from hypoglycemia. As with all insulins, among the uses of Levemir Flexpen,   caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g. the pediatric patients and populations who fast or have erratic food intake). The patient's level to focus and react may be impaired as a result of hypoglycemia. This may present a danger in situations where these abilities are essentially important, such as driving or using other machinery. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as intense diabetes, diabetic neuropathy, use of medications like the beta-blockers, or intensified glycemic preservation. These situations may lead to severe hypoglycemia (and, possibly, loss of consciousness) in relations to the patient’s awareness of hypoglycemia.

iv). Hypersensitivity and allergic reactions

Intense, generalized allergy, life-threatening, including anaphylaxis, can occur with insulin products, including Levemir.

v). Renal Impairment

No difference was observed 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 Flexpen uses, may be necessary in patients with renal impairment.

vi). Hepatic Impairment

Non-diabetic individuals with severe hepatic impairment had lower systemic exposures to insulin detemir compared to healthy volunteers. However, some researches with human insulin have shown increased circulating insulin concentrations in patients with liver impairment. Careful glucose following up and dose adjustments of insulin, including Levemir Flexpen uses, may be necessary in patients with hepatic impairment.

vii). Drug interactions

Some medications may change insulin requirements and subsequently increase the risk for hypoglycemiaor hyperglycemia.

 

Uses of Levemir Flexpen

Levemir Flexpen uses are indicated to improve glycemic control in adults and children with diabetes mellitus. 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.

i). Important Limitations of use

Levemir Flexpen uses are not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting or rapid-acting insulin is the preferred treatment for this condition.

 

Dosage of Levemir Flexpen

i). Usual Adult Dose of Levemir for Diabetes Type 1:

Dosage of Levemir Flexpen should be individualized based on clinical response; this basal insulin should be used in regimens with short-acting insulin initial dose: One-third the total daily insulin requirement subcutaneously once a day or in divided doses twice a day. Once daily dosing should be administered with the evening meal or at bedtime; twice daily dosage of Levemir Flexpen should be given morning and evening; the evening dose may be taken with dinner, at bedtime, or 12 hours after the morning dosage of Flexpen. Maintenance dose: Adjust according to metabolic needs, blood glucose assessments, and glycemic goals. Conversion from Other Insulin Therapies: Insulin glargine and NPH insulin can be converted to a unit by unit basis; closely monitor blood glucose during the transition and in the initial weeks thereafter, the dosage of Levemir Flexpen and frequency of short-acting insulin may need to be adjusted.

ii). Usual Adult Dose of Levemir for Diabetes Type 2:

the dose should be individualized based on clinical response-Insulin-naive: Initial dose: 10 units (or 0.1 to 0.2 units/kg) subcutaneously in a day or in divided doses twice a day for patients inadequately controlled on a GLP-1 receptor agonist: Initial dose: 10 units subcutaneously once a day. Maintenance dose: Adjust according to metabolic needs, blood glucose assessment, and glycemic goals. Conversion from Other Insulin Treatments: Insulin glargine and NPH insulin can be converted to a unit by unit basis; however, some subjects may require more insulin detemir than NPH insulin.

 

iii). Usual Pediatric Dose of Levemir for Diabetes Type 1:

Age 2 years or older: Dose should be individualized based on clinical response; this basal insulin should be used in regimens with short-acting insulin. Initial dose: One-third the total daily insulin requirement subcutaneously once in a day or in divided doses twice a day. Once daily dosing should be administered with the evening meal or at bedtime; twice daily dosing should be given morning and evening; the evening dose may be taken with dinner, at bedtime, or 12 hours after the morning dose. Maintenance dose: Adjust according to metabolic needs, blood glucose assessments, and glycemic goals. Conversion from Other Insulin Therapies: Insulin glargine and NPH insulin can be converted on a unit to unit basis; closely monitor blood glucose during the transition and in the initial weeks henceforward, the dose and frequency of short-acting insulin may need to be adjusted.

 

Dosage Forms and Strengths of Levemir Flexpen

Levemir remedy for injection 100 Unit per mL is available as:

• 3 mL Levemir Flexpen

• 10 mL vial

 

Overdose of Levemir Flexpen

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

 

Storage conditions of LevemirFlexpen

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

Unused (unopened) 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 (the small 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.

Levemir Flexpen:

After initial use, the Levemir Flexpen must not be stored in a refrigerator and must not be stored with the needle intact. Preserve the opened (in use) Levemir Flexpen away from direct heat and light at room temperature, below 30°C (86°F). Unrefrigerated Levemir Flexpen should be discarded 42 days after they are first kept out of the refrigerator.

 

Use in specific populations

i). Pregnancy Category B

Risk Summary

The background risk of pregnancy loss, or other adverse events, birth defects, which exists for all pregnancies, may be increased in pregnancies complicated by hyperglycemia. Female patients should be advised to contact their physician if they intend to become, or if they become pregnant while administering Levemir. A randomized managed clinical trial of pregnant women with type I diabetes using Levemir during pregnancy did not show an increase in the risk of fetal abnormalities. Reproductive toxicology researches in non-diabetic rats and rabbits that included concurrent human insulin control groups indicated that insulin detemir and human insulin had similar effects regarding embryotoxicity and teratogenicity that were attributed to maternal hypoglycemia.

Clinical Considerations

The increased risk of adverse events in pregnancies complicated by hyperglycemia may be decreased with good glucose control before conception and throughout pregnancy. Because insulin requirements change throughout pregnancy and in the post-partum period, careful following up of glucose control is essential in pregnant women.

Human Data

In an, open-label, clinical research, women with type 1 diabetes who were (between weeks 8 and 12 of gestation) or intended to become pregnant were randomized 1:1 to Levemir (once or twice a day) or NPH insulin (once, twice or thrice a day). Insulin being part was administered before each meal. 152 women in the Levemir arm and 158 women in the NPH arm were or became pregnant during the research. (Total pregnant women = 310). Exactly one half of the study participants in each arm were randomized as pregnant and were exposed to NPH or to other insulins prior to conception and in the first 8 weeks of gestation. In the 310 pregnant women, the moderate glycosylated hemoglobin (HbA1c) was <7% in 10, 12, and 24 weeks of gestation in the two arms. In the intent-to-treat population, the ameliorated mean HbA1c (standard error) at gestational week 36 was 6.27% (0.053) in Levemir-treated patient (n=138) and 6.33% (0.052) in NPH-treated patients (n=145); the difference was not clinically significant.

ii). Nursing Mothers

It is unknown whether Levemir is excreted in human milk. Since many drugs, including human insulin, are passed in human milk, use caution when administering Levemir to a nursing woman. Women with diabetes who are lactating could require adjustments of their insulin doses.

iii). Pediatric Use

The pharmacokinetics, safety and effectiveness of subcutaneous injections of Levemir have been established in pediatric patients (age 6 to 17 years) with type 1 diabetes. Levemir has not been researched in pediatric patients younger than 6 years of age with type 1 diabetes. Levemir has not been researched in pediatric patients with type 2 diabetes. The dose recommended when converting to Levemir is the same as that described for adults. As in adults, the dosage of Levemir must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.

iv). Geriatric Use

In controlled clinical trials comparing Levemir to NPH insulin or insulin glargine, 64 of 1624 patients (3.9%) in the type 1 diabetes trials and 309 of 1082 patients (28.6%) in the type 2 diabetes trials were≥65 years. Approximations of 52 (7 type 1 and 45 type 2) patients (1.9%) were ≥75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but small sample illustrations, particularly for patients ≥65 years of age in the type 1 diabetes trials and for patients ≥75 years of age in all trials reduce conclusions. Greater sensitivity of some older persons cannot be ruled out. In aged patients with diabetes, the initial dosing, dose increases, and maintenance dosage should preserve to avoid hypoglycemia. Hypoglycemia may be difficult to identify in the elderly.

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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