Levemir FlexPen

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

insulin detemir (rys)

Consumer Medicine Information

What is in this leaflet

What Levemir^® is used for

Before you use Levemir^® FlexPen^®

How to use Levemir^® FlexPen^®

While you are using Levemir^® FlexPen^®

Side effects

After using Levemir^® FlexPen^®

Product description

Further information

Instructions for Use

This leaflet answers some common questions about Levemir^® FlexPen^®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Levemir^® FlexPen^® against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor, diabetes education nurse or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Levemir^® is used for

The insulin detemir (rys), or "Levemir^®", in Levemir^® FlexPen^® is a long-acting insulin used to treat diabetes mellitus. It may be used in combination with oral antidiabetic medicines (diabetes tablets) or as add-on therapy to liraglutide (Victoza^®), which is used to treat type 2 diabetes mellitus in adults. Levemir^® can also be used with a meal-related short- or rapid-acting insulin such as NovoRapid^®.

Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed.

There are two types of diabetes mellitus:

Type 1 diabetes - also called juvenile onset diabetes

Type 2 diabetes - also called maturity onset diabetes.

Patients with type 1 diabetes always require insulin to control their blood sugar levels.

Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets.

Levemir^® lowers your blood sugar level after injection. The effect may last for up to 24 hours.

As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

FlexPen^® is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 60 units of Levemir^® in increments of 1 unit.

This medicine is not addictive.

Levemir^® FlexPen^® is available only with a doctor’s prescription.

Ask your doctor, diabetes education nurse or pharmacist if you have any questions about why this medicine has been prescribed for you.

Before you use Levemir^® FlexPen^®

When you must not use it

Do not use this medicine if:

1. you have an allergy to:

any medicine containing insulin

any of the ingredients listed in the 'Ingredients' section of this leaflet.

Some of the symptoms of an allergic reaction may include:

redness, swelling, rash and itching at the injection site

rash, itching or hives on the skin

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body.

2. you are experiencing low blood sugar levels (a “hypo”) when your dose is due.

If you have a lot of hypos discuss appropriate treatment with your doctor.

If you are not sure whether you should start using this medicine, talk to your doctor.

Do not use this medicine after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

kidney problems

liver problems

adrenal, pituitary or thyroid gland problems.

Tell your doctor if you are pregnant or plan to become pregnant.

Pregnancy may make managing your diabetes more difficult. Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breast-feeding or plan to breast-feed.

Your doctor can discuss with you the risks and benefits involved.

Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure.

If you have not told your doctor about any of the above, tell them before you start using this medicine.

Tell your doctor if you notice any skin changes at the injection site.

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see How to use Levemir^® FlexPen^®). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Levemir^® may interfere with each other and this may mean that your insulin dose has to change.

If you take any of the medicines listed below, your blood sugar level may fall (hypoglycaemia):

other medicines used for the treatment of diabetes

monoamine oxidase inhibitors (MAOI) - used for the treatment of depression

alpha blockers - used to treat high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate

non-selective beta blockers - used to treat high blood pressure and certain heart conditions which may also mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia

ACE inhibitors - used to treat high blood pressure, certain heart conditions or elevated protein/albumin in the urine

salicylates e.g. aspirin - used to relieve pain and lower fever

anabolic steroids - used to promote growth

sulphonamides - used to treat bacterial infections

quinine - used to treat malaria and relieve muscle cramps

quinidine - used to treat heart problems.

If you take any of the medicines below, your blood sugar level may rise (hyperglycaemia):

glucocorticoids (except when applied locally) - used to treat inflammatory conditions

oral contraceptives (“the pill”) - used for birth control

diuretics e.g. thiazides, frusemide or ethacrynic acid - used to treat high blood pressure or fluid retention (oedema)

thyroid hormones - used to treat malfunction of the thyroid gland

sympathomimetics - used to treat asthma

growth hormone - used to treat growth disorders.

danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and hereditary angioedema

oxymetholone - used to treat certain blood disorders

diazoxide - used to treat high blood pressure

nicotinic acid - used to treat high cholesterol levels in the blood

asparaginase - used to treat leukaemia and lymph gland tumours.

If you take the following medicines, your blood sugar level may rise or fall:

octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels

lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels.

Tell your doctor about any other medicines that you are taking.

This is very important. Your doctor will advise you if it is alright to keep taking them or if you should stop taking them.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Levemir^® FlexPen^®

Your doctor, diabetes education nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions.

They may differ from the information contained in this leaflet.

Any change in dose or type of insulin should be made cautiously and only under medical supervision.

If you change the type of insulin that you use, you may have to use more or less than before. This may happen with the first dose or over a period of time.

If you do not understand the instructions, ask your doctor, diabetes education nurse or pharmacist for help.

How much to use

Your doctor or diabetes education nurse will tell you how much of this medicine you need to use.

It is very important that you manage your diabetes carefully. Too much or too little insulin can cause serious effects.

When to use it

Levemir^® is either injected once or twice daily. If you require twice daily dosing, the evening dose can be administered either with the evening meal, at bedtime, or 12 hours after the morning dose. Your doctor will tell you when to inject your medicine.

How to use it

Inject Levemir^® under the skin (subcutaneous injection) as shown to you by your doctor or diabetes education nurse.

Never inject Levemir^® directly into a vein or muscle.

Levemir^® may be injected into your abdomen, thigh, buttock or upper arm.

Remember to change your injection site regularly as shown to you by your doctor or diabetes education nurse. This reduces the risk of developing lumps or skin pitting.

Do not use Levemir^® in insulin pumps.

Follow the detailed instructions on how to inject Levemir^® FlexPen^® in the instructions for use supplied with the product.

These instructions are also available via the following hyperlinks:

https://medsinfo.com.au/media/noilevfp

Checking your Levemir^® FlexPen^®:

Check your medicine before each preparation and injection. Make sure you are using the correct type of insulin.

Levemir^® is a clear colourless solution. Do not use this medicine if it is thickened, coloured, or has solid bits in it.

Read the instructions printed later in this leaflet carefully in order to prepare and handle your Levemir^® FlexPen^® correctly.

How long to use it

Do not stop using Levemir^® FlexPen^® unless your doctor tells you to.

If you use too much (overdose) - Hypoglycaemia

Your blood sugar level may become too low (you may experience hypoglycaemia or a “hypo”) if you:

use too much insulin

miss a meal

exercise more than usual

are ill.

The first symptoms of mild to moderate hypos can come on suddenly. They may include:

cold sweat, cool pale skin

fatigue, drowsiness, unusual tiredness and weakness

nervousness, anxious feeling, tremor, rapid heart beat

confusion, difficulty concentrating

excessive hunger

vision changes

headache, nausea.

Always carry some sugary food or fruit juice with you.

If you experience any of these symptoms of a hypo, immediately eat some sugary food or have a sugary drink, e.g. lollies, biscuits or fruit juice, and measure your blood sugar level.

Tell your relatives, friends, close workmates or carers that you have diabetes. It is important that they recognise the signs and symptoms of a hypo.

Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo.

If you lose consciousness, make sure they know:

to turn you on your side and get medical help immediately

not to give you anything to eat or drink.

This is because you could choke.

An injection of the hormone glucagon may speed up recovery from unconsciousness. This can be given by a relative, friend, workmate or carer who knows how to give it.

If glucagon is used, eat some sugary food or have a sugary drink as soon as you are conscious again.

If you do not feel better after this, contact your doctor, diabetes education nurse, or the closest hospital.

If you do not respond to glucagon treatment, you will have to be treated in a hospital.

See your doctor if you keep having hypo reactions, or if you have ever become unconscious after using insulin.

The amount or timing of insulin, food or exercise may need to be adjusted.

If a prolonged, severe hypo is not treated it can cause brain damage and death.

If you miss a dose - Hyperglycaemia

If you forget your insulin dose, check your blood sugar level and test your urine for ketones as soon as possible.

If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.

Do not use a double dose of your insulin.

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using it as you would normally.

Your blood sugar levels may become high (hyperglycaemia) if you:

miss doses of insulin or use less insulin than you need

have uncontrolled diabetes

exercise less than usual

eat more carbohydrates than usual

are ill or stressed.

High blood sugar levels over a long period of time can lead to too much acid in the blood (diabetic ketoacidosis).

Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms.

Symptoms of mild to moderate hyperglycaemia include:

drowsy feeling

flushed face

thirst, loss of appetite

fruity odour on the breath, dry mouth

blurred vision

passing larger amounts of urine than usual

getting up at night more often than usual to pass urine

high levels of glucose and acetone in the urine.

Symptoms of severe hyperglycaemia include:

heavy breathing

fast pulse

nausea, vomiting

dehydration

loss of consciousness.

Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.

Discuss any worries you may have about this with your doctor, diabetes education nurse or pharmacist.

While you are using Levemir^® FlexPen^®

Things you must do

Measure your blood sugar level regularly.

Make sure all friends, relatives, workmates and carers know that you have diabetes and are using insulin.

If your child has diabetes it is important to tell their carers.

Keep using your insulin even if you feel well.

It helps to control your condition, but does not cure it.

Tell your doctor if you often have hypos (low blood sugar levels).

Your doctor may need to adjust your insulin dose.

Always carry some sugary food or fruit juice with you.

If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice, and measure your blood sugar level.

Tell your doctor if you have trouble recognising the symptoms of hypos.

Under certain conditions, the early warning signs of hypos can be different or less obvious. Your doctor may need to adjust your insulin dose.

Make sure that you tell every doctor, dentist, pharmacist or other health care professional who is treating you that you have diabetes and are using insulin.

Tell your doctor, diabetes education nurse or pharmacist if you are travelling.

Ask them for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.

You may need to inject your insulin and eat your meals at different times because of time differences in and between countries.

You may not be able to get the same type of insulin in the country you are visiting.

Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.

Things you must not do

Do not stop using Levemir^® FlexPen^® unless your doctor tells you to.

Do not use this medicine if you think it has been frozen or exposed to excessive heat.

It will not work as well.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not share needles.

Things to be careful of

Be careful driving or operating machinery until you know how the insulin affects you.

If your blood sugar is low or high your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car:

if you have frequent hypos

if you find it hard to recognise hypos.

Tell your doctor if you drink alcohol.

Alcohol may mask the symptoms of hypos. If you are drinking alcohol your need for insulin may change, as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Tell your doctor if you are ill.

Illness, especially with nausea and vomiting, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should design an insulin plan for those times when you are sick.

Tell your doctor if you are exercising more than usual.

Exercise may lower your need for this medicine. Exercise may also speed up the effect of a dose of it, especially if the exercise involves the area of the injection site (e.g. the leg should not be used for injection prior to jogging or running).

Tell your doctor if your diet changes.

Insulin is essential to keep your blood sugar levels within acceptable limits. Regular meals and a balanced diet are important factors in the management of diabetes. It is important that you discuss a suitable diet plan with your doctor or diabetes team.

Smoking may increase the chance of complications with your diabetes.

Side effects

Tell your doctor, diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using Levemir^® FlexPen^®.

This medicine helps most people for whom it is prescribed, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor, diabetes education nurse or pharmacist to answer any questions you may have.

The most common side effect when using insulin is low blood sugar levels (a hypo).

Tell your doctor if you notice any of the following and they worry you:

hypos (mild to moderate)

pain, redness, swelling, hives, inflammation, bruising or itching at the injection site. Usually these symptoms disappear within a few weeks during continued use. If you have serious or continuing reactions, you may need to stop using Levemir^® and use another insulin.

a depression or thickening of the skin around the injection site (lipodystrophy). If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

when you first start your insulin treatment you may get visual problems or swollen hands and feet.

This list includes the more common side effects of your medicine. They are usually mild and short-lived.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

More severe symptoms of low blood sugar levels, including:

disorientation

seizures, fits or convulsions

loss of consciousness.

If a severe hypo is not treated, it can cause brain damage and death.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

skin rashes over a large part of the body

shortness of breath, wheezing

swelling of the face, lips or tongue

fast pulse

sweating.

This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Ask your doctor, diabetes education nurse or pharmacist to answer any questions you have.

After using Levemir^® FlexPen^®

Storage

Before opening:

Store Levemir^® FlexPen^® that are not being used between 2°C and 8°C in a refrigerator (not in or too near the freezer section or cooling element).

During use or when carried as a spare:

Store Levemir^® FlexPen^® that you are using, or that you are carrying as a spare up to 4 weeks below 30°C or between 2°C and 8°C in a refrigerator.

Discard Levemir^® FlexPen^® after 4 weeks even if there is still some medicine left in it.

The Levemir^® in Levemir^® FlexPen^® must not be frozen, or exposed to excessive heat or light. Protect the medicine in Levemir^® FlexPen^® from light by keeping the pen cap on when not in use.

Do not use Levemir^® after the expiry date which is stated on the FlexPen^® label and carton after 'Expiry'.

Never use Levemir^® FlexPen^® if the solution is not clear and colourless.

Keep out of the reach of children.

Disposal

Dispose of used needles safely into a sharps container.

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Levemir^® is a clear, colourless, aqueous solution for subcutaneous injection. Levemir^® FlexPen^® is a 3mL pre-filled glass cartridge contained in a dial-a-dose insulin pen.

Ingredients

Levemir^® contains insulin detemir (rys) 100 units per mL (100 U/mL) as the active ingredient. The abbreviation "rys" indicates the method of genetic engineering used to manufacture this insulin.

Levemir^® also contains the following inactive ingredients:

glycerol

phenol

metacresol

zinc acetate

sodium chloride

dibasic sodium phosphate dihydrate

sodium hydroxide

hydrochloric acid

water for injections

Sponsor

Levemir^® FlexPen^® is supplied in Australia by: