Abasaglar 100 units-in-mL Solution for Injection in Pre-filled Pen - Consumer Medicine Information
|Manufacture:||Eli Lilly and Company|
|Ingredients:||insulin glargine,zinc oxide, metacresol, glycerol, sodium hydroxide, hydrochloric acid and water for injections.|
What Abasaglar is and What it is Used For
Abasaglar is a solution for injection containing insulin glargine. Insulin glargine is a modified insulin, very similar to human insulin.
Abasaglar is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.
What You Need to Know Before You Use Abasaglar
Do not Use Abasaglar
If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in Contents of the pack and other information).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Abasaglar.
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Before travelling consult your doctor. You may need to talk about:
- the availability of your insulin in the country you are visiting,
- supplies of insulin, syringes etc.
- correct storage of your insulin while travelling,
- timing of meals and insulin administration while travelling,
- the possible effects of changing to different time zones,
- possible new health risks in the countries to be visited,
- what you should do in emergency situations when you feel unwell or become ill.
Illnesses and injuries
In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):
- If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
- If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
In most cases you will need a doctor. Make sure that you contact a doctor early.
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).
Other Medicines and Abasaglar
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, have recently taken or might take any other medicines. 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
- all other medicines to treat diabetes,
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),
- disopyramide (used to treat certain heart conditions),
- fluoxetine (used to treat depression),
- fibrates (used to lower high levels of blood lipids),
- monoamine oxidase (MAO) inhibitors (used to treat depression),
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
- somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone),
- sulphonamide antibiotics.
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include
- corticosteroids (such as "cortisone" used to treat inflammation),
- danazol (medicine acting on ovulation),
- diazoxide (used to treat high blood pressure),
- diuretics (used to treat high blood pressure or excessive fluid retention),
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
- isoniazid (used to treat tuberculosis),
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
- phenothiazine derivatives (used to treat psychiatric disorders),
- somatropin (growth hormone),
- sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),
- thyroid hormones (used to treat thyroid gland disorders),
- atypical antipsychotic medicines (such as clozapine, olanzapine),
- protease inhibitors (used to treat HIV).
Your blood sugar level may either rise or fall if you take
- beta-blockers (used to treat high blood pressure),
- clonidine (used to treat high blood pressure),
- lithium salts (used to treat psychiatric disorders).
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.
Abasaglar With Alcohol
Your blood sugar levels may either rise or fall if you drink alcohol.
Pregnancy and Breast-feeding
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. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Driving and Using Machines
Your ability to concentrate or react may be reduced if:
- you have hypoglycaemia (low blood sugar levels),
- you have hyperglycaemia (high blood sugar levels),
- you have problems with your sight.
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:
- you have frequent episodes of hypoglycaemia,
- the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.
Important Information About Some of the Ingredients of Abasaglar
This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially ‘sodium-free’.
How to Use Abasaglar
Always use this medicine exactly as you doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 Abasaglar per day you will need and at what time,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- tell you when you may need to inject a higher or lower dose of Abasaglar.
Abasaglar is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
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.
Use in Children and Adolescents
Abasaglar can be used in adolescents and children aged 2 years and above. There is no experience with the use of Abasaglar in children below the age of 2 years.
Frequency of Administration
You need one injection of Abasaglar every day, at the same time of the day.
Method of Administration
Abasaglar is injected under the skin. Do NOT inject Abasaglar in a vein, since this will change its action and may cause hypoglycaemia.
Your doctor will show you in which area of the skin you should inject Abasaglar. With each injection, change the puncture site within the particular area of skin that you are using.
How to Handle Abasaglar KwikPen
Abasaglar KwikPen is a pre-filled disposable pen containing insulin glargine.
Read carefully the "Abasaglar KwikPen Instructions for Use" included with this package leaflet. You must use the pen as described in these Instructions for Use.
A new needle must be attached before each use. Only use needles that are compatible for use with Abasaglar KwikPen (see Abasaglar KwikPen Instructions for Use).
A safety test must be performed before each injection.
Look at the cartridge before you use the pen. Do not use Abasaglar KwikPen if you notice particles in it. Only use Abasaglar KwikPen if the solution is clear, colourless and water-like. Do not shake or mix it before use.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with Abasaglar KwikPen, consult your doctor, pharmacist or nurse.
Empty pens must not be re-filled and must be properly discarded.
Do not use Abasaglar KwikPen if it is damaged or not working properly, it has to be discarded and a new KwikPen has to be used.
If you use more Abasaglar than you should
- If you have injected too much Abasaglar, your blood sugar level may become too low (hypoglycaemia). 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 forget to use Abasaglar
- If you have missed a dose of Abasaglar or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
- Do not take a double dose to make up for a forgotten dose.
If you stop using Abasaglar
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 Abasaglar without speaking to a doctor, who will tell you what needs to be done.
You must always check the insulin label before each injection to avoid mix-ups between Abasaglar and other insulins.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible Side Effects
Like all medicines, this medicine 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 heartbeat and sweating. These could be symptoms of severe allergic reactions to insulins and may become life threatening.
Very common side effects (may affect more than 1 in 10 people)
As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.
Common side effects (may affect up to 1 in 10 people)
- Skin changes at the injection site
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy) or thicken (lipohypertrophy). Thickening of fatty tissue may occur in 1 to 2 % of patients while shrinking may occur uncommonly. 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.
- Skin and allergic reactions
3 to 4 % of patients may experience reactions at the injection site (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.
Rare side effects (may affect up to 1 in 1,000 people)
- Severe allergic reactions to insulins
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 heartbeat and sweating. These could be symptoms of severe allergic reactions toinsulins and may become life-threatening.
- 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.
- General disorders
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
Very rare side-effects (may affect up to 1 in 10,000 people)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Other side effects with frequency not known (frequency cannot be estimated from available data) Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Rarely, this may require a change to your insulin dose.
Use in Children and Adolescents
In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
Clinical study safety data are not available for children under 2 years.
Reporting of Side Effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website:www.hpra.ie, e-mail:email@example.com, Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal, United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Abasaglar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. 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 Abasaglar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
Pre-filled pens in use or carried as a spare may be stored for a maximum of 28 days up to 30 °C and away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use it after this time period. The pen cap must be put back on the pen after each injection in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the Pack and Other Information
What Abasaglar Contains
- The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
- The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see Important information about some of the ingredients of Abasaglar), hydrochloric acid and water for injections.
What Abasaglar Looks Like and Contents of the Pack
Abasaglar 100 units/mL solution for injection in a pre-filled pen, KwikPen, is a clear and colourless solution.
Each pen contains 3 mL of solution for injection (equivalent to 300 units). Packs of 1, 2, 5 and a multipack with 2 x 5 pre-filled pens of 3 mL are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Eli Lilly Regional Operations GmbH., Kölblgasse 8-10, 1030, Vienna, Austria.
Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600