| Active substance(s) | insulin glulisine |
| Country of admission | gb |
| Marketing authorisation holder | Sanofi-Aventis Deutschland GmbH |
| ATC Code | A10AB06 |
| Pharmacological groups | Insulins and analogues |
Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Special patient groups
If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Travel
Before travelling consult your doctor. You may need to talk about
Illnesses and injuries
In the following situations, the management of your diabetes may require extra care:
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. 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 medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Your blood sugar level may either rise or fall if you take:
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Your blood sugar levels may either rise or fall if you drink alcohol.
Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
There are no adequate data on the use of Apidra in pregnant women.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Your ability to concentrate or react may be reduced if:
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machines).
You should contact your doctor for advice on driving if:
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ?sodium-free?.
Apidra contains metacresol, which may cause allergic reactions.
Dose
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Always use Apidra exactly as your doctor has told you. You should check with your doctor if you are not sure.
Apidra is a short-acting insulin. Your doctor may tell you to use it in combination with an intermediate, long acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.
Method of administration
Apidra is injected under the skin (subcutaneously).
Your doctor will show you in which area of the skin you should inject Apidra. Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be slightly quicker if the insulin is injected into your abdomen. As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Frequency of administration
Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Instructions for proper use
OptiSet is a pre-filled disposable pen containing insulin glulisine.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Before use always attach a new needle, and perform a safety test. Only use needles that have been approved for use with OptiSet.
Look at the cartridge sealed in the disposable pen injector before you use it. Only use it if the solution is clear, colourless and has no visible particles in it. Do not shake or mix it before use.
Always use a new penif you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with OptiSet, please refer to the Questions and Answers section of the attached OptiSet Instructions for use, or have it checked by your doctor or pharmacist.
Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
If you stop usingApidra
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
You must always check the insulin label before each injection to avoid medication mix-ups between Apidra and other insulins.
Like all medicines, Apidra can cause side effects, although not everybody gets them.
Hypoglycaemia (low blood sugar) can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately.
If you experience the following symptoms, contact your doctor immediately:
large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. They could be symptoms of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
Very common reported side effects
- Hypoglycaemia
Hypoglycaemia (low blood sugars) means that there is not enough sugar in the blood. See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
Common reported side effects
- Skin and allergic reactions
Reactions at the injection site may occur (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.
Uncommon reported side effects
- Systemic allergic reactions
Generalised allergy to insulin. Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe cases of generalised reactions, including anaphylactic reaction, may be life-threatening.
Rare reported side effect
- Skin changes at the injection site (lipodystrophy)
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that you inject in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
Other side effects (frequency not known) include:- Hyperglycaemia (high blood sugars) means there is too much sugar in the blood If your blood sugar level is too high, this tells you that you could have needed more insulin than you injected. See the box at the end of this leaflet for further information.
- Eye reactions
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Apidra after the expiry date, which is stated on the carton and on the label of the cartridge. The expiry date refers to the last day of that month.
Not in-use pens
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not put the pre-filled pen next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
In-use pens
In use pre-filled pens may be stored for a maximum of 4 weeks below 25°C, away from direct heat or direct light and must not be stored in the refrigerator. Do not use it after this time period.
Do not use Apidra if it does not appear clear and colourless.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Apidra 100 Units/ml, solution for injection in a pre-filled pen, OptiSet. It is a clear, colourless, aqueous solution with no particles visible.
Each pen contains 3 ml solution, equivalent to 300 Units. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany.
Manufacturer:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, D-65926 Frankfurt
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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Tel: +370 5 2755224
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are a person with diabetes.
Why does hyperglycaemia occur?
Examples include:
Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
What should you do if you experience hyperglycaemia?Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Why does hypoglycaemia occur?
Examples include:
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions and loss of consciousness.
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if:
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
OPTISET INSTRUCTIONS FOR USE
OptiSet is a pre-filled pen for the injection of insulin. Doses from 2 to 40 units can be set in steps of 2 units. Each pen contains multiple doses.
Talk with your healthcare professional about proper injection technique before using OptiSet.
Read these instructions carefully before using your OptiSet. If you are not able to follow all the instructions completely on your own, use OptiSet only if you have help from a person who is able to follow the instructions. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
If you have any questions about OptiSet or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
Keep this leaflet for future reference each time you use OptiSet.
Schematic diagram of the pen
New information for use: - Name of the insulin is printed on the pen
- Dosage selector can only be turned in one direction
Important information for use of OptiSet:
Always attach a new needle before each use. Only use needles that have been approved for use with OptiSet. Always perform the safety test before each injection see Step 3. If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer. The dosage selector can only be turned in one direction. Never turn the dosage selector i.e. never change the dose after injection button has been pulled out. This pen is only for your use. Do not share it with anyone else. If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. Never use OptiSet if it is damaged or if you are not sure that it is working properly. Always have a spare OptiSet in case your OptiSet is lost or damaged.
Step 1. Check the insulin
C. Check the appearance of your insulin. Apidra is a clear insulin. Do not use this OptiSet if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle
Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
Before use of needle, carefully read the ?Instructions for use? accompanying the needles. Please note: The needles shown are for illustrative purposes only.
depending on the needle type).
- If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or damage the needle.
Step 3. Perform a safety test
Always perform the safety test before each injection. This ensures that you get an accurate dose by: - making sure that pen and needle work properly
- removing air bubbles
If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.
B. Select the dose for the Safety Test. New and unused OptiSet a dose of 8 units is already preset by the manufacturer for the first safety test. In-use OptiSet select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2. The dosage selector will only turn in one direction.
C. Pull out the injection button completely in order to load the dose. Never turn the dosage selector after injection button has been pulled out.
D. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it. keep
F. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
G. Press the injection button all the way in. Check if insulin comes out of the needle tip.
You may have to perform the safety test several times before insulin is seen.
- If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
- If still no insulin comes out, the needle may be blocked. Change the needle and try again. - If no insulin comes out after changing the needle, your OptiSet may be damaged. Do not use this OptiSet.
Step 4. Select the dose
You can set the dose in steps of 2 units, from a minimum of 2 units to a maximum of 40 units. If you need a dose greater than 40 units, you should give it as two or more injections.
The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet. This scale must not be used to set the insulin dose.
If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
If you turned past your dose,
- and you have not yet pulled the injection button, you can keep turning forward till you reach your dose again,
- and you have already pulled the injection button out, you must discard the dose that has been loaded before you turn the dosage selector again.
Step 5. Load the dose
amount of insulin that is left in the reservoir.
- The injection button must be held out under tension during this check.
- The last thick line visible on the injection button shows the amount of insulin loaded. When the injection button is held out only the top part of this thick line can be seen.
- In this example, 12 units are loaded.
In this case what should you do:
- either you can inject what is remaining in the pen and complete your dose with a new OptiSet. - or use a new OptiSet for your full dose.
Step 6. Inject the dose
C. Deliver the dose by pressing the injection button in all the way. A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
D. Keep the injection button pressed in and slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin have been used.
Step 7. Remove and discard the needle
Always remove the needle after each injection and store OptiSet without a needle attached. This helps prevent:
- Contamination and/or infection
- Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
reduce the risk of accidental needle injury, never replace the inner needle cap.
Please check Section 5 - How to store Apidra- of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature. Cold insulin is more painful to inject.
Discard your used OptiSet as required by your local regulations.
Protect your Optiset from dust and dirt.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your OptiSet is designed to work accurately and safely. It should be handled with care. Avoid situations where OptiSet might be damaged. If you are concerned that your OptiSet may be damaged, discard it and use a new one.
Wrong dose selected. Follow the instructions in Step 4 to select the correct dose. Dose has been selected and the injection button has been pulled out and pressed in again without a needle attached. 1. Attach a new needle. 2. Press the injection button completely in and discard the insulin. 3. Perform the safety test. If the safety test is successful OptiSet is ready for use. If test is not successful, the pen might be damaged. Use a new OptiSet. If in any doubt whether the pen is working correctly use a new OptiSet. The dosage selector does not turn. You are turning in the wrong direction. The dosage selector can only be turned forward. You are turning forward while the injection button is pulled out. Press the injection button in completely to discard the dose and select again. The amount indicated on the injection button is higher than the dose selected. Difference is 2 units. Discard insulin, then set your dose and check again. If the same error occurs again, OptiSet may be damaged, use a new OptiSet. Difference is more than 2 units OptiSet is damaged, use a new OptiSet. The amount indicated on the injection button is lower than the dose required There is not enough insulin in the reservoir. You can do one of the following inject the amount indicated on the injection button from this OptiSet and then inject the remaining dose using a new OptiSet, or inject the entire dose using a new OptiSet. The injection button cannot be pressed in. 1. Make sure you pulled out the injection button completely. 2. Attach a new needle. 3. Press the injection button completely in to discard the insulin. Perform the safety test. You dont hear clicking OptiSet is damaged, use a new OptiSet. while injecting.
Insulin is leaking from the pen. Needle may have been attached imprecisely e.g. at a slant. Remove needle and replace with a new needle attaching it on straight see Step 2. Perform the safety test see Step 3. Air bubbles are present in the reservoir. Small amounts of air may be present in the needle and insulin reservoir during normal use. You must remove this air by performing the safety test see Step 3. The tiny air bubbles in the insulin reservoir that do not move with tapping will not interfere with the injection and dosage. Do not force it. Do not try to repair or use tools on it. OptiSet is damaged or is not working properly. Use a new OptiSet. OptiSet has been dropped or subjected to impact. If in any doubt whether the pen is working correctly use a new OptiSet.
Last updated on 24.08.2022
The following drugs also contain the active ingredient insulin glulisine. Consult your doctor about a possible substitute for Apidra 100 Units/ml solution for injection in a pre-filledpen
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