Levemir

How does it work?

Levemir prefilled pens (FlexPen and InnoLet) and penfill cartridges (for use with NovoPens) contain the active ingredient insulin detemir. They are used to treat diabetes.

People with diabetes have a deficiency or absence of a hormone manufactured by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar (glucose) in the blood.

People with type one diabetes need to have injections of insulin to control the amount of glucose in their bloodstream. Insulin injections act as a replacement for natural insulin, and allow people with diabetes to achieve normal blood glucose levels.

Insulin injections work in the same way as natural insulin, by binding to insulin receptors on cells in the body. Insulin causes cells in the liver, muscle and fat tissue to increase their uptake of glucose from the bloodstream. It also decreases the production of glucose by the liver, and has various other effects that lower the amount of glucose in the blood.

The type of insulin in this medicine is called insulin detemir. This is known as a long acting insulin. It is injected under the skin, where it forms a reservoir of insulin that is released slowly over a period of up to 24 hours, depending on the dose. The injection can be given once or twice daily to give a background control of blood glucose levels throughout a 24 hour period. Insulin detemir is normally used in combination with a short acting insulin, which is given before meals to control the increase in blood glucose that happens after eating.

It is important to monitor your blood glucose regularly and adjust your insulin dose as required. Your doctor or diabetic team will explain how to do this. Keeping your blood glucose level as close to normal as possible, and not too high or too low, significantly reduces the risk of developing late-stage diabetic complications.

What is it used for?

Diabetes.

Warning!

Levemir must not be injected into a vein (intravenously).

People treating their diabetes with insulin should regularly check their blood sugar level. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist.

Your insulin requirements may increase when you are ill, especially if you have an infection or fever. Your insulin dose may also need adjusting during periods of emotional disturbance, or if you increase your physical activity or change your usual diet. Insulin requirements may be reduced if you have impaired kidney or liver function. Discuss this with your doctor or diabetes nurse to make sure you optimise control of your blood sugar.

Low blood sugar can often occur as a side effect of insulin therapy. This is more likely to happen if you suddenly do more exercise than normal, have your meals at irregular times, eat less than usual, or miss meals altogether. For this reason, it is important that you follow any dietary or exercise advice given to you by your doctor. You should also make sure you are aware of the symptoms of hypoglycaemia (these usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations) and what to do if you experience these symptoms. Discuss this with your GP, pharmacist or diabetes specialist. You should also be aware that if your blood sugar control is greatly improved, for example by intensified insulin treatment, your usual warning symptoms of low blood sugar may change.

Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinary. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor.

People with diabetes who are on insulin should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking.

Your insulin should only be changed on your doctor's advice. If you do transfer to a different insulin, eg different type (short, intermediate or long acting), different species (human or animal), different brand, or different strength of insulin, your doctor may need to alter your dose, and your warning symptoms of low blood sugar may be slightly different.

Each time you inject your insulin make sure you use a different site within the area you use. This helps to prevent the skin thickening and pitting, which can occur if the injection is repeatedly given in the same site.

This brand of insulin contains metacresol, which may cause allergic reactions.

Before opening, Levemir penfill cartridges, FlexPens and InnoLet pens should be stored in their outer cartons in a refrigerator at 2-8°C. Do not freeze. Make sure the containers do not directly touch the freezer compartment. Once in use the cartridges and pens should be kept outside the fridge, but must be kept below 30°C. You should keep the cap on FlexPens and InnoLet pens that are not in use to protect the insulin from light. Any unused medicine should be discarded six weeks after the first use. You may find it helpful to write the date of first use on the label.

People with diabetes who smoke normally need more insulin, as smoking reduces the amount of insulin that is absorbed into the blood from an injection under the skin. If you give up smoking, you may subsequently need a reduction in your insulin dose. Discuss this with your doctor. (If you are diabetic giving up smoking is one of the most important things you can do, because it will vastly reduce your risk of complications like heart disease and circulatory problems.)

The safety and efficacy of Levemir have not been studied in children under six years of age.

Use with caution in

Low blood albumin levels (hypoalbuminaemia).

Not to be used in

Low blood sugar levels .

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The manufacturer has not studied this type of insulin in pregnant women, and it should be used with caution. Blood sugar levels need to be maintained as stable as possible during pregnancy, and you should consult your diabetic specialist to discuss how to achieve this. Your insulin requirements are likely to decrease in the first trimester and subsequently increase in the second and third trimesters. Discuss this with your doctor.

The manufacturer has not studied the use of this type of insulin by breastfeeding mothers, and it should be used with caution. Seek medical advice from your doctor. Breastfeeding women may need a lower dose of insulin. Discuss this with your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Low blood glucose level (hypoglycaemia)

Redness, swelling, bruising or itching at the injection site

Skin thickening or pitting (lipodystrophy) if injection given too frequently into the same site

Excessive fluid retention in the body tissues, resulting in swelling (oedema)

Allergic reaction to active ingredient

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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