Insulin detemir (Subcutaneous route)
- Levemir Flexpen
- Levemir FlexTouch
Insulin, Long Acting
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin detemir in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
- Thioctic Acid
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.
- Methylene Blue
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.
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.
Proper Use of This Medicine:
A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.
Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
Each package of insulin detemir contains a patient information sheet. Read this sheet carefully before beginning treatment and each time you refill for any new information, and make sure you understand:
- How to prepare the medicine.
- How to inject the medicine.
- How to dispose of syringes, needles, and injection devices.
This medicine may be given one or two times a day. It may be taken with the evening meal or at bedtime for once-a-day dosing, or taken 12 hours after the morning dose for twice-a-day dosing.
It is best to use a different place on the body for each injection (eg, abdomen or stomach, thigh, upper arm). If you have questions about this, contact a member of your health care team.
Follow carefully special instructions your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
The insulin solution should look clear and colorless. Do not use this medicine if it is cloudy or thickened.
Do not dilute or mix insulin detemir with any other insulins or solutions. This may cause the medicine to not work properly.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For type 1 diabetes:
- Adults, teenagers, and children 2 years of age and older—The dose is based on your blood sugar and must be determined by your doctor.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For type 2 diabetes:
- Adults—The dose is based on your blood sugar and must be determined by your doctor.
- Children—Use and dose must be determined by your doctor.
- For type 1 diabetes:
Call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store unused vials or pens in the refrigerator. Do not freeze. The expiration date on the insulin package tells you how long you can keep the medicine in the refrigerator. Throw the medicine away after the expiration date has passed.
You may also store the vials or pens (opened or unopened) at room temperature for up to 42 days. These should be kept as cool as possible and away from direct heat and light.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- Incidence not known
- blurred vision
- cold sweats
- cool, pale skin
- difficulty swallowing
- fast heartbeat
- increased hunger
- joint pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- skin rash
- slurred speech
- stiffness or swelling
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble breathing
- unusual tiredness or weakness
- Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- decrease in the amount of urine
- noisy, rattling breathing
- redistribution or accumulation of body fat
- swelling of the fingers, hands, feet, or lower legs
- trouble breathing at rest
- weight gain
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017