Insulin Lispro (rbe)
Consumer Medicine Information
What is in this leaflet
This leaflet is designed to provide you with answers to some common questions about
these medicines. It does not contain all the available information and does not take
the place of talking with your doctor.
The information in this leaflet was last updated on the date shown on the final page.
More recent information on this medicine may be available. Make sure you speak to
your pharmacist, nurse or doctor to obtain the most up to date information on this
medicine. You can also download the most up to date leaflet from www.lilly.com.au.
The updated leaflet may contain important information about HUMALOG and its use that
you should be aware of.
All medicines have risks and benefits. Your doctor has more information about these
medicines than is contained in this leaflet. Also, your doctor has had the benefit
of taking a full and detailed history from you and is in the best position to make
an expert judgement to meet your individual needs.
If you have any concerns about using these medicines, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What the HUMALOG insulins are used for
HUMALOG insulins are used to reduce high blood sugar (glucose) levels in insulin dependent
diabetic patients. Diabetes is a condition in which your pancreas does not produce
enough insulin to control your blood sugar level. Extra insulin is therefore needed.
There are two types of diabetes mellitus:
Type 1 diabetes - also called Insulin Dependent Diabetes Mellitus (IDDM). Patients
with type 1 diabetes always need insulin to control their blood sugar levels.
Type 2 diabetes - also called Non insulin dependent diabetes mellitus (NIDDM). Some
patients with type 2 diabetes may also need insulin after initial treatment with diet,
exercise and tablets.
HUMALOG insulins are insulin lispro, which works more quickly than soluble human insulin
because the insulin molecule has been changed slightly.
HUMALOG MIX25 is 25% insulin lispro and 75% insulin lispro protamine sulfate suspension.
This means that the action of HUMALOG MIX25 is prolonged.
HUMALOG MIX50 is 50% insulin lispro and 50% insulin lispro protamine suspension. This
means that the action of HUMALOG MIX50 is prolonged.
The duration of effect of HUMALOG insulins varies in each individual and also depends
on dose, site of injection, blood supply, body temperature and physical activity.
This medicine is available only with a doctor's prescription.
Before using HUMALOG insulins
Tell your doctor if you have any of the following conditions or if you have ever experienced
any of these conditions.
When you must not use the HUMALOG insulins
Do not use/inject HUMALOG insulins:
if you have had an allergic reaction to HUMALOG, HUMALOG MIX25 or HUMALOG MIX50, or
to any of the ingredients listed at the end of this leaflet (see 'Product Description').
Signs of an allergic reaction include redness, swelling and itching at the injection
site, rash, shortness of breath, fast pulse or sweating.
if the packaging is torn or shows signs of tampering.
if you are experiencing low blood sugar (hypoglycaemia).
if HUMALOG solution is cloudy, thickened, coloured or has solid pieces in it.
if HUMALOG MIX25 or HUMALOG MIX50 suspension is no longer cloudy white after gentle
shaking or if it has solid pieces in it.
if the cartridge appears frosted.
This can occur when solid white particles stick to the bottom and walls.
if the expiry date (EXP) on the pack has passed.
HUMALOG MIX25 or HUMALOG MIX50 should not be given intravenously.
The use of HUMALOG MIX25 and HUMALOG MIX50 has not been studied in children under
the age of 18.
HUMALOG MIX25 or HUMALOG MIX50 should not be used in an insulin infusion pump.
If you are not sure whether you should start using HUMALOG insulins, talk to your
doctor or pharmacist.
Before you start using HUMALOG insulins
You must tell your doctor:
if you have had an allergic reaction to any medicine which you have used previously
to treat your current condition.
if you have or have had any medical conditions, especially kidney, liver or heart
if you experience fluid retention especially in the hands, ankles or feet.
if you are pregnant or intend 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.
if you are breast-feeding or plan to breast-feed.
It is not known if HUMALOG is excreted in significant amounts in breast milk.
if you often have hypoglycaemia (low blood sugar) or if you have trouble recognising
the symptoms of hypoglycaemia.
Under certain conditions the early warning signs of hypoglycaemia can be different
or less pronounced.
if you drink alcohol.
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.
if you are exercising more than usual.
Exercise may lower your need for insulin. Exercise may also speed up the effect of
an insulin dose, especially if the exercise involves the area of injection site (e.g.
the leg should not be used for injection just prior to running). Discuss with your
doctor how much insulin you should use if you are exercising.
if your diet changes.
Changes in diet may cause your insulin needs to change.
Tell your doctor about these things before you use HUMALOG insulins.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way your HUMALOG insulin works. These include:
oral antidiabetic medicines
medicines that affect your metabolism (corticosteroids such as prednisone, cortisone)
medicines used for oral contraception
medicines used in thyroid replacement therapy
certain antibiotics used to treat tuberculosis, such as isoniazid
medicines such as aspirin or other salicylates
certain medicines used to treat depression
certain medicines used to treat asthma, such as salbutamol or terbutaline
medicines used to treat high blood pressure or other heart conditions
certain medicines used to treat people with growth disorders and tumours, such as
medicines used to treat hormone-related disorders, such as danazol
thiazolidinediones (TZDs), also used to treat type 2 diabetes; when used with insulin
there may be an increased risk of fluid retention and heart disease.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while using HUMALOG insulins.
Tell your doctor about these medicines before you use HUMALOG insulins.
How to use HUMALOG insulins
Follow all directions given to you by your doctor or pharmacist carefully.
These may differ from the information contained in this leaflet.
Your doctor may tell you to use HUMALOG with a longer acting human insulin such as
HUMULIN NPH. A Consumer Medicine Information leaflet is also available for this product,
ask your pharmacist.
More frequent monitoring of your blood sugar level is recommended when changing insulin
dose or type.
There may be a delay in the effect of HUMALOG when it is mixed with HUMULIN NPH, compared
to HUMALOG and HUMULIN NPH being injected separately.
HUMALOG should not be mixed with any other animal or human insulin preparations.
How much to use
Your doctor will tell you how much insulin you need to use each day.
Your doctor will tell you the type of HUMALOG that is best suited to you.
Do not change your insulin unless your doctor tells you to. Be very careful if you
do change insulin.
If you change the type of insulin that you use (for example from human insulin to
HUMALOG), you may have to take more or less than before. This may happen with the
first injection or it may be a gradual change over several weeks or months.
How to use HUMALOG in a re-usable pen
Inject HUMALOG, HUMALOG MIX25 or HUMALOG MIX50 under the skin. Under no circumstances
should HUMALOG MIX25 or HUMALOG MIX50 be given intravenously.
Follow the steps below.
Preparing a dose
1. Check your cartridge. The solution of HUMALOG should be clear and colourless. The
suspension in HUMALOG MIX25, HUMALOG MIX50 cartridges should be white and cloudy or
2. HUMALOG MIX25 and HUMALOG MIX50 cartridges must be rolled between the palms ten times
and inverted ten times until the contents are uniformly mixed. Do not shake vigorously
as this may cause frothing which may interfere with the correct measurement of the
3. Inspect the cartridge for uniform mixing and repeat the above steps if necessary.
If HUMALOG MIX25 or HUMALOG MIX50 cartridges appear "frosted", please return to the
place of purchase for exchange. This can occur when solid white particles stick to
the bottom and walls.
Check your cartridge before each injection.
The manufacturer's instructions for the HumaPen delivery systems should be followed
for loading the cartridge, attaching the needle and administering the insulin injection.
5. Put the cartridge into the pen.
HUMALOG, HUMALOG MIX25 and HUMALOG MIX50 3 mL cartridges are only for use with the
Check for insulin flow (Priming)
1. Set the dose to 1 or 2 units.
2. Hold the pen with the needle pointing up and tap the side of the pen so that any bubbles
float to the top.
3. With the pen still pointing up, press the injection button. Do this until a stream
of insulin comes out of the needle. This is very important to ensure the correct dose
4. Only after seeing a stream of insulin at the needle tip can you proceed to dial up
your required dose. There may still be some small air bubbles left in the cartridge.
These are harmless, but if the air bubble is too big, it may make the dose of your
injection less accurate.
Injecting a dose
2. Choose a site for injection. Use of injection sites should be rotated so that the
same site is not used more than approximately once a month
3. Remove outer needle cap.
4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle
as instructed by your doctor.
5. Press the knob. Count to 5 slowly before pulling the needle out.
6. Pull the needle out and apply gentle pressure over the injection site for several
seconds. Do not rub the area.
7. Using the outer needle cap, unscrew the needle and dispose of it safely. Do not reuse
the needle. NEEDLES, CARTRIDGES or PENS MUST NOT BE SHARED.
8. Leave the cartridge in the pen.
1. Check your cartridge before each injection. Ensure HUMALOG MIX25 contents are uniformly
mixed, as described in 'Preparing a Dose'.
2. Before every injection, check for insulin flow. Do this by dialling 1 or 2 units and
pressing the injection button with the pen pointing up. Do this until a stream of
insulin comes out of the needle.
3. Stop using the cartridge if the leading edge of the plunger has gone to, or beyond,
the left side of the gauge on the side of the cartridge.
4. You can see how much insulin is left by looking at the gauge on the side of the cartridge.
The scale on the cartridge shows how many units you have left. If there is not enough
for your dose, change the cartridge.
Do not mix any other insulin in your cartridge. Once the cartridge is empty, do not
use it again.
When to use it
Your doctor will tell you when to use your HUMALOG insulin.
You should normally use HUMALOG, HUMALOG MIX25 or HUMALOG MIX50 immediately (or up
to 15 minutes) before a meal. When necessary, HUMALOG can be used soon after a meal.
When HUMALOG is given after a meal, it must be within 20 minutes of the start of the
How to use HUMALOG in a subcutaneous infusion pump
1. HUMALOG may be given under the skin by means of an insulin infusion pump. Use the
type of pump system recommended by your doctor, read and follow the instructions that
accompany your pump.
2. HUMALOG should never be mixed with any other insulin when used in a pump.
3. HUMALOG MIX25 and HUMALOG MIX50 should never be used in a pump.
4. Before inserting the needle, wash your hands and the skin where the needle is to be
inserted so as to prevent infection at the infusion site.
5. When you are filling a new syringe, be certain not to leave large air bubbles in either
the syringe or the catheter.
6. Change the syringe and catheter after a maximum of 2 days' usage.
7. Follow your doctor, nurse or pharmacists advice about the basal infusion rate and
the mealtime insulin boluses to be taken.
8. To get the benefit of insulin infusion, and to detect possible malfunction of the
insulin pump, you should measure your blood sugar levels regularly.
What to do in case of infusion pump system failure
In case of infusion pump system failure, you should always carry a spare cartridge
of HUMALOG and a pen, or an alternative insulin delivery system, for injection under
How long do I use it
Do not stop using your HUMALOG insulin just because you feel better. It is important
that you do not stop using your HUMALOG insulin unless your doctor tells you.
If you inject too much
Low blood sugar (hypoglycaemia) is the most likely reaction if you have injected more
insulin than you need. Symptoms of mild to moderate hypoglycaemia can include:
tremor, unsteady movement
depressive mood, anxiety
irritability, personality change
inability to concentrate
increased heart rate or irregular heart beat
tingling in the hands/feet/lips or tongue
Recognising these mild to moderate hypoglycaemic symptoms early may allow you to take
the necessary steps to avoid more serious hypoglycaemia. Symptoms of severe hypoglycaemia
If you experience symptoms of low blood sugar, eat some sugary food or drink, such
as jelly beans, orange juice or glucose tablets.
If you do not feel better after eating/drinking some sugary food or drink, contact
your doctor or go to the Emergency Department at your nearest hospital.
While you are using HUMALOG insulins
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are using
HUMALOG or HUMALOG MIX25, HUMALOG MIX50.
While you are using HUMALOG insulins, tell your doctor or pharmacist before you start
any new medicine.
If you become pregnant while using HUMALOG insulins tell your doctor.
Always carry a supply of your HUMALOG insulin cartridges and your pen with you.
Always carry something to show you have diabetes.
Always carry glucose or sugary foods with you.
Always check for insulin flow before injecting a dose.
Immediately after an injection, remove the needle from the pen.
This will ensure sterility and prevent leakage, re-entry of air and potential needle
Things you must not do
Do not stop using your HUMALOG insulin without first checking with your doctor.
Do not give your HUMALOG insulin to anyone else, even if they have the same condition
Your doctor has prescribed your HUMALOG insulin specifically for you.
Do not share needles, cartridges or pens.
Do not reuse needles.
Do not inject HUMALOG MIX25 or HUMALOG MIX 50 directly into a vein (intravenously).
Things to be careful of
if you become ill
if you are exercising more than usual
if your diet changes.
You should learn to recognise your own symptoms of hypoglycaemia (low blood sugar).
You can then take the appropriate action, when necessary. If you are having problems
recognising these symptoms, frequent monitoring of your blood sugar level is recommended.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using any of the HUMALOG insulins.
Like other medicines, HUMALOG insulins may cause some unwanted side effects. These
are likely to vary from patient to patient. Some side effects may be related to the
dose of your insulin so it is important that you never exceed the stated dose.
Tell your doctor as soon as possible about any unwanted effects.
Your doctor may then decide to adjust the dose of insulin you are using.
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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following side effects:
1. Hypoglycaemia - The most common unwanted effect when using insulin, including HUMALOG
insulins, is low blood sugar (hypoglycaemia).
If untreated, severe hypoglycaemia may lead to unconsciousness and, in extreme cases,
If you experience symptoms of low blood sugar (hypoglycaemia), eat some sugary food
or drink, such as jelly beans, orange juice or glucose tablets.
If you do not feel better after eating/drinking some sugary food or drink, contact
your doctor or go to the Emergency Department at your nearest hospital.
2. Local Allergy - Some patients occasionally experience redness, swelling and itching
at the injection site. Sometimes this local allergy may be due to factors other than
your insulin, such as irritants in the skin cleansing agent or poor injection technique.
If you have local allergic reactions while using HUMALOG insulins contact your doctor.
3. Generalised Allergy - Generalised allergy is less common, but can be more serious
than local allergies. Symptoms of generalised allergy include: rash over the whole
body, shortness of breath, wheezing, reduction in blood pressure, fast pulse or sweating.
Severe cases of generalised allergy may be life threatening.
If you think you are having a generalised allergic reaction to any HUMALOG insulin,
tell a doctor immediately or go to the Emergency Department at your nearest hospital.
4. Lipodystrophy - A depression in the skin or an enlargement or thickening of the tissue
can develop at the injection site.
Tell your doctor if you notice these symptoms.
A change in the way you inject and rotating the injection site may help relieve these
5. Oedema - Fluid retention, particularly in the ankles, feet and hands.
Tell your doctor if you notice anything unusual or if you are concerned about any
aspect of your health, even if you think the problems are not connected with this
medicine and are not referred to in this leaflet.
After using HUMALOG insulins
Keep your cartridges in a fridge between 2°C - 8°C. Do not freeze any of these HUMALOG
You may keep the cartridges below 30°C for up to 28 days while you are using them.
Do not put your cartridges near heat or in the sun. When the cartridge has been inserted
into the pen, the cartridge pen combination should not be put in the fridge.
Do not use a cartridge after the expiry date (month, year) stamped on the label.
All medicines should be kept where young children cannot reach them.
If your doctor tells you to stop using HUMALOG insulins or you find your cartridges
have passed their expiry date, please return any leftover cartridges to your pharmacist.
Empty cartridges and needles should be disposed of in a sharps container or similar
puncture proof container composed of hard plastic or glass.
Ask your doctor, nurse or pharmacist where you can dispose of the container once it
What it looks like
HUMALOG is available in 3 mL cartridges, in a maroon carton.
HUMALOG is a clear colourless solution.
HUMALOG MIX25 is available in 3 mL cartridges, in a yellow carton.
The suspension in HUMALOG MIX25 cartridges is white and cloudy or milky.
HUMALOG MIX50 is available in 3 mL cartridges, in a red carton.
The suspension in HUMALOG MIX50 cartridges is white and cloudy or milky.
All cartridges in the HUMALOG range contain 100 units of insulin lispro per mL.
HUMALOG also contains metacresol, glycerol, dibasic sodium phosphate heptahydrate,
zinc oxide and water for injection.
HUMALOG MIX25 and HUMALOG MIX50 also contain metacresol, phenol, glycerol, dibasic
sodium phosphate heptahydrate, protamine sulfate, zinc oxide and water for injection.
Supplied in Australia by:
Eli Lilly Australia Pty. Limited
112 Wharf Road
WEST RYDE NSW 2114
Supplied in New Zealand by:
Eli Lilly and Company (NZ) Limited
PO Box 109 197
Australian Registration Numbers:
HUMALOG Cartridges -AUST R 53466
HUMALOG MIX25 Cartridges - AUST R 69163
HUMALOG MIX50 Cartridges - AUST R 69166
You can get more information about diabetes and insulin from:
freecall helpline 1300 136 588
Diabetes New Zealand
tollfree helpline 0800 DIABETES (0800 342 238)
This leaflet was revised in December 2020.
vA10.0_Dec20 supersedes vA9.0_Aug20