Levemir

Generic name: Insulin detemir [rDNA origin]

What is Levemir?

Levemir is used once or twice daily for the treatment of adults or children with diabetes mellitus type 1, or adults with diabetes mellitus type 2 who require long-acting insulin to control their high blood sugar levels.

What is the most important information I should know about Levemir?

Do not make any changes with your insulin dose unless you have talked to your doctor. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your doctor about adjusting your insulin dose and before engaging in any new activity (such as a new exercise regimen or diet plan). Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.

Take Levemir exactly as prescribed. Do not miss any doses. Contact your doctor if you missed a dose.

Do not use Levemir with an insulin infusion pump. Do NOT dilute Levemir Cartridges or mix it with other insulin.

Consuming alcohol, including beer and wine, may increase and lengthen the risk of hypoglycemia (overly low blood sugar) when you take Levemir. Do not drink alcohol without discussing it first with your doctor.

Be careful when you drive a car or operate machinery until you know how you respond to Levemir. Your ability to concentrate or react may be reduced if you have hypoglycemia. Ask your doctor if you should drive if you have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia.

Tell your doctor or dentist that you take Levemir before you receive any medical or dental care, emergency care, or surgery. Carry an ID card at all times that says you have diabetes.

An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Lab tests, including fasting blood glucose levels or hemoglobin A_1c, may be performed while you use Levemir. Be sure to keep all doctor and lab appointments.

Who should not take Levemir?

Do not take Levemir if you are allergic to any of its ingredients.

What should I tell my doctor before I take the first dose of Levemir?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking to avoid a possible interaction with Levemir. Also talk with your doctor about your complete medical history, especially if you have nerve problems, thyroid problems, adrenal gland problems, pituitary problems, diabetic ketoacidosis, use 3 or more injections daily, are fasting, have high blood sodium levels, are on a low-salt diet, or have kidney or liver problems.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Doses of insulin are measured in units. Levemir is available as a U-100 insulin. One milliliter (mL) of U-100 contains 100 units of insulin detemir. (1 mL = 1 cc). Only U-100 type syringes should be used for injection to ensure proper dosing.

Adults and children 6 to 17 years: The usual dosage of Levemir is taken once or twice a day. If it is prescribed once daily, it should be taken with either your morning or evening meal. If Levemir is prescribed twice-daily, then take a morning dose, and then an evening dose may be taken either 12 hours after the morning dose, with your evening meal, or at bedtime. The dose of Levemir should be adjusted according to measurements of sugar in your blood.

How should I take Levemir?

Inspect Levemir visually prior to administration and only use if the solution appears clear, odorless, and colorless.

Use the proper injection technique taught to you by your doctor. Refer to the package insert that accompanies Levemir for detailed instructions.

Inject Levemir deep under the skin, NOT into a vein or muscle. Injection sites within an injection area (abdomen, thigh, upper arm) must be rotated from one injection to the next Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.

Levemir should not be mixed or diluted with any other insulin preparations.

Follow your doctor's instructions about monitoring your blood sugar. Do not make any changes with your insulin unless you have talked to your doctor. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your doctor about how to adjust your insulin dose. If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.

It is important that you use a new needle for each injection. After each injection, remove the needle without recapping and dispose of it in a puncture-resistant container.

What should I avoid while taking Levemir?

Do not inject Levemir in the same place twice; rotate injection sites. Do not mix this insulin with any other insulin, and should only be used if the solution is clear and colorless.

Do NOT take more than the recommended dose, use more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor. Do not miss a Levemir dose.

Consuming alcohol, including beer and wine, may increase and lengthen the risk of hypoglycemia (too low blood sugar) when you take Levemir. Be careful when you drive a car or operate machinery until you know how you react to Levemir. Your ability to concentrate or react may be reduced if you have hypoglycemia. Ask your doctor if you should drive if you have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia. Exercise or activity level may change the way your body uses insulin. Check with your doctor before you start an exercise program because your dose may need to be changed.

What are possible food and drug interactions associated with Levemir?

If Levemir is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Levemir with the following: ACE inhibitors, antidiabetic drugs (oral), beta-blockers, clonidine, corticosteroids, danazol, disopyramide, diuretics, estrogens, fibrates, fluoxetine, guanethidine, isoniazid, MAO inhibitors, phenothiazine derivatives, progestogens (eg, in oral contraceptives), propoxyphene, reserpine, salicylates, somatostatin analog (eg, octreotide), somatropin, sulfonamide antibiotics, sympathomimetic agents (eg, epinephrine, albuterol, terbutaline), thyroid hormones

What are the possible side effects of Levemir?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: allergic reactions/injection site reactions, low blood sugar (hypoglycemia), rash, weight gain

Hyperglycemia (high blood sugar) is a common side effect. It also occurs when there is a conflict between the amount of carbohydrates (source of glucose) from your food, the amount of glucose used by your body, and the amount and timing of insulin dosing. Speak to your doctor about the warning signs of hypoglycemia.

Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

In patients with type 1 or insulin-dependent diabetes, long-lasting hyperglycemia can cause diabetic ketoacidosis (DKA). The first symptoms of DKA usually come on slowly, over a period of hours or days, and include feeling drowsy, flushed face, thirst, loss of appetite, and fruity odor on the breath. With DKA, urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, long-lasting hyperglycemia or DKA can lead to nausea, vomiting, stomach pains, dehydration, loss of consciousness, or even death. Therefore, it is important that you obtain medical help right away.

What should I do if I miss a dose of Levemir?

It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Can I receive Levemir if I am pregnant or breastfeeding?

Before taking Levemir, talk to your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. There is a risk of Levemir causing harm to your unborn baby, or passing through your breast milk.

How should I store Levemir?

Unopened vials and PenFill cartridges: Store unopened vials and PenFill cartridges in a refrigerator (36°F to 46°F; 2°C to 8°C) but not in the freezer. Do not use Levemir if it has been frozen. Keep unopened Levemir vials and PenFill cartridges in the carton so they will stay clean and protected from light because the product is light sensitive.

Punctured vials: After initial use, the punctured vials should be stored in a refrigerator but not in a freezer. If refrigeration is not possible, the vial that you are currently using can be kept at room temperature up to 42 days, as long as it is kept below 30°C [86°F]. Throw away un-refrigerated vials after 42 days from the first use, even if they still contain insulin.

Punctured cartridges: After initial use (the rubber membrane has been punctured), do not refrigerate the punctured Levemir PenFill cartridges. However, keep them as cool as possible (below 30°C [86°F]). The PenFill cartridge that you are currently using can be kept at room temperature up to 42 days, as long as they are kept below 30°C [86°F]. Throw away unrefrigerated disposable Levemir PenFill cartridges after 42 days from the cartridges first use, even if it still contains Levemir.

Keep all disposable PenFill® cartridges and vials away from direct heat and sunlight.