Description
Description
The Levemir FlexTouch Pen is an insulin pen that contains insulin detemir as its active ingredient.
Levemir is a solution for subcutaneous use. Insulin detemir is a long-acting recombinant human insulin analog. Levemir is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29.
Levemir is not meant to treat insulin ketoacidosis. Do not take Levemir FlexTouch if you have an allergy to any of the ingredients contained in Levemir.
Levemir is also available in Penfill cartridges. Ensure you are ordering the correct FlexTouch, as they are available by many brands including: Fiasp, Tresiba and NovoLog.
Warnings and Precautions
Warnings and Precautions
Before taking Levemir, inform your doctor about all your medical conditions, including any pre-existing medical conditions such as heart, liver, or kidney issues. Let your doctor know if you are pregnant, planning on pregnancy, or breastfeeding. Also, discuss if you are taking any other medications, over-the-counter medications, vitamins, or herbal supplements.
Please do not share your FlexTouch pen with others as it may spread serious infections.
Do not skip meals when taking insulin.
It is important to rotate injection sites to avoid skin complications.
Do not inject into a muscle or vein.
Hypoglycemia is a common side effect for people with diabetes. Keep a sugary snack, juice, or pop (non-diet) glucose tablet available to avoid hypoglycemia.
Do not mix or dilute Levemir with any other solution or insulin. Do not administer using an insulin pump intravenously or intramuscularly as it may cause severe hypoglycemia.
Usage
Usage
Never share your insulin with others, even if you attach a new pen needle. Use a new pen needle for every injection.
Remove pen needles after injection and discard them into a sharps disposal container. Please do not place a new needle into the FlexPen unless you are ready to use it.
Review the patient instructions on how to perform a function check if your Levemir Flexpen is working correctly
Use a new needle for every injection to prevent infection.
Remove the needle after every use and do not store it to prevent contamination, leakage of insulin, or infection.
Do not modify your insulin regimen without consulting your doctor first.
Part of your insulin treatment should be checking your blood glucose levels regularly. Speak to your doctor or diabetes educator on how to do this.
A modification may be required to dosage if the patient has weight loss or gain, increased stress, changed diet, or became ill.
Administration
Administration
Levemir should only be administered subcutaneously. Do not administer Levemir intravenously or intramuscularly.
The intended duration of activity of Levemir is dependent on injection into subcutaneous tissue. Intravenous or intramuscular 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 pharmacokinetic or pharmacodynamic profile (e.g., the onset of action, time to peak effect) of Levemir and the mixed insulin may be altered unpredictably.
Dosing
Dosing
Levemir is a recombinant human insulin analog for once- or twice-daily subcutaneous administration. Patients treated with Levemir once daily should administer the dose with the evening meal or at bedtime. Patients who require twice-daily dosing can administer the evening dose with the evening meal, at rest, or 12 hours after the morning dose.
The dose of Levemir must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy. Patients adjusting the amount or timing of dosing with Levemir should only do so under medical supervision with appropriate glucose monitoring.
In patients with type 1 diabetes, Levemir must be used in a regimen with rapid-acting or short-acting insulin.
As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy.
Levemir can be injected subcutaneously in the thigh, abdominal wall, or upper arm.
As with all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered medications or meal patterns.
Side Effects
Side Effects
As with taking any insulin, side effects may occur.
Hypoglycemia (low blood sugar) may happen. Symptoms may include anxiety, mood changes, dizziness, sweating, confusion, headache, and irritability.
Hypoglycemia is a common side effect with most insulin treatments (including Levemir) and may be life-threatening if not treated.
Common side effects may include skin reactions at the site of injection may consist of itching and rashes, skin thickening or pitting at injection sites (lipodystrophy), weight gain, and swelling.
If you are experiencing any of the following side effects, get medical help immediately: trouble breathing, shortness of breath, rapid heartbeat, dizziness, confusion, drowsiness, sweating, and swelling of the face, throat, or tongue.
Drug Interactions
Drug Interactions
Several medications affect glucose metabolism and may require an insulin dose adjustment and particularly close monitoring.
The following are examples of medications that may increase the blood-glucose-lowering effect of insulins, including Levemir and, therefore, increase the susceptibility to hypoglycemia: oral antidiabetic medications, pramlintide acetate, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.
The following are examples of medications that may reduce the blood-glucose-lowering effect of insulins, including Levemir: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g., olanzapine and clozapine).
Beta-blockers, clonidine, lithium salts, and alcohol may either increase or decrease the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.
Overdose
Overdose
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.
More severe episodes with coma, seizure or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.
Pregnancy
Pregnancy
The background risk of birth defects, pregnancy loss, or other adverse events for all pregnancies is increased in pregnancies complicated by hyperglycemia. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking Levemir. A randomized controlled 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 studies in non-diabetic rats and rabbits that included concurrent human insulin control groups indicated that insulin detemir and human insulin had similar embryotoxicity and teratogenicity attributed to maternal hypoglycemia.
Storage
Storage
After initial use of the Levemir FlexTouch, it must not be stored in a refrigerator. Do not freeze the Levemir FlexTouch pen or use it if it has been frozen.
Keep your FlexTouch at room temperature, below 86°F (30°C) once in use. Unrefrigerated Levemir FlexTouch should be discarded after 42 days after it has been taken out of the refrigerator.
Keep in use FlexTouch away from sunlight and direct heat.
Disposing
Disposing
Speak to your pharmacist about how to properly dispose of medication. You can put pen and needles in an FDA-cleared sharps container after use. Do not dispose of medicine, pens, and needles in the household trash or down wastewater. If you do not have a sharps container, you can use a household container made from heavy-duty plastic, is puncture/leak-resistant, and label the container as hazardous waste.
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