Levemir FlexTouch

Contraindications

Systemic allergic reactions

During episodes of hypoglycemia

Cautions

Never share pen between patients even if needle is changed

Long-acting insulin; do not use for circumstances that require rapid-acting insulin

Use with caution in patients with decreased insulin requirements, including those with diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, or hepatic impairment

Rapid changes in serum glucose may induce symptoms of hypoglycemia

Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function, because of risk for prolonged hypoglycemia

May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium  

Use with caution in patients with increased insulin requirements, including those with fever, hyperthyroidism, trauma, or infection or who have undergone surgery

Pregnancy, lactation

Lower dose when used in combination with a GLP-1 receptor agonist to minimize the risk of hypoglycemia

Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones

Mechanism of Action

Regulates glucose metabolism

Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

Absorption

Bioavailability: 60% SC; well absorbed

Onset: 3-4 hr

Peak onset: 6-8 hr (not pronounced; released at constant rate over 24 hr)

Duration: Up to 24 hr (range 5.7-23.2 hr)

Distribution

Protein bound: 98% bound to albumin

Vd: 0.1 L/kg

Elimination

Half-life elimination: 5-7 hr (dose dependent)

Excretion: Urine

Insulin detemir is a man-made form of insulin, a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin detemir is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin detemir is used to treat type 2 diabetes in adults.

Insulin detemir is also used to treat type 1 diabetes in adults and children who are at least 2 years old.

Insulin detemir may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).

Many other drugs can potentially interfere with the effects of insulin detemir. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. An insulin overdose can cause life-threatening hypoglycemia. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Be sure your family and close friends know how to help you in an emergency.

You should not use this medication if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).

To make sure you can safely take insulin detemir, tell your doctor if you have liver or kidney disease, or if you are taking any other medications.

FDA pregnancy category B. Insulin detemir is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin detemir passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not change the brand of insulin detemir or syringe you are using without first talking to your doctor or pharmacist.

Avoid drinking alcohol. It can lower your blood sugar.

Tell your doctor about all other medications you use, especially other diabetes medications such as:

• exenatide (Byetta, Bydureon);
• liraglutide (Victoza); or
• any oral (taken by mouth) diabetes medications, especially metformin (Glucophage, Actoplus Met, Avandamet, Glucovance, Janumet, Jentadueto, Kombiglyze, Metaglip, or Prandimet).

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• asthma medication;
• cholesterol-lowering medication;
• heart or blood pressure medication, including a diuretic (water pill);
• medicine to treat depression or psychiatric disorders;
• steroid medication;
• sulfa drugs; or
• thyroid replacement medication.

This list is not complete and there are many other drugs that can increase or decrease the effects of insulin detemir on lowering your blood sugar. Tell your doctor about all medications you use; prescription and over the counter drugs, vitamins, minerals, or herbal products. Do not start using a new medication without telling your doctor.

Insulin detemir is a long-acting type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus, your body cannot make enough insulin or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

Insulin detemir is a long-acting insulin that works slowly over 24 hours. You may have to use insulin detemir in combination with another type of insulin or with oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin detemir to treat type 1 diabetes in children 2 years of age and older. However, safety and efficacy of insulin detemir have not been established to treat type 1 diabetes in children younger than 2 years of age or to treat type 2 diabetes in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin detemir in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Lanreotide
• Levofloxacin
• Liraglutide
• Lomefloxacin
• Metreleptin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Pioglitazone
• Pramlintide
• Prulifloxacin
• Rosiglitazone
• Rufloxacin
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Furazolidone
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis—Should not be used in patients with this condition.

• Emotional disturbances or
• Illness or
• Stress—These conditions increase blood sugar and may increase the amount of insulin or insulin detemir you need.

• Hypoglycemia (low blood sugar)—If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Kidney disease or
• Liver disease—Effects of insulin detemir may be increased or decreased. Your doctor may need to change your insulin dose.

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood tests will be needed to check unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may increase or decrease your blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking insulin detemir unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency: There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin detemir and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, shortness of breath, swelling of the face, tongue, and throat, trouble with breathing, or chest pain after you receive the medicine.

You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject insulin detemir into a skin area that is red, swollen, or itchy.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Too much insulin detemir can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin detemir with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drinks, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

You may feel dizzy or have trouble in paying attention if you have low blood sugar. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.