HUMALOG® vial
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
HUMALOG contains the active ingredient insulin lispro (rbe). HUMALOG is used to reduce high blood sugar (glucose) levels in patients with diabetes. For more information, see Section 1. Why am I using HUMALOG? in the full CMI.
Do not use if you have ever had an allergic reaction to insulin lispro or any of the
ingredients listed at the end of the CMI or when you have low blood sugar.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use HUMALOG? in the full CMI.
Some medicines may interfere with HUMALOG and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor will tell you what dose of HUMALOG insulin you need to use each day.
More instructions can be found in Section 4. How do I use HUMALOG? in the full CMI.
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Things you should do
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Remind any doctor, dentist, pharmacist, and diabetes educator you visit that you are
using HUMALOG.
Monitor your blood sugar levels regularly.
Always carry some glucose or sugary foods with you in case you get low blood sugar.
Tell your doctor if you become pregnant or start breastfeeding while using HUMALOG.
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Things you should not do
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Do not stop using or change your dose of HUMALOG without first checking with your
doctor.
Do not use HUMALOG when you have low blood sugar as it will make it worse.
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Driving or using machines
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Low blood sugar may impair your ability to concentrate or react while driving. Do
not drive if you feel like your blood sugar levels are low.
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Drinking alcohol
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Tell your doctor if you drink alcohol. Alcohol may mask the symptoms of low blood
sugar.
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Looking after your medicine
|
Keep your vials in a fridge between 2°C - 8°C. Do not freeze.
You may keep the vials below 30°C for up to 28 days while using them. Dispose after
28 days.
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For more information, see Section 5. What should I know while using HUMALOG? in the full CMI.
The most common (and potentially the most severe) side effect of HUMALOG is low blood
sugar.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
HUMALOG® vial
Active ingredient:
insulin lispro (rbe)
Consumer Medicine Information (CMI)
This leaflet provides important information about using HUMALOG. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using HUMALOG.
Where to find information in this leaflet:
HUMALOG contains the active ingredient insulin lispro (rbe).
HUMALOG is used to reduce high blood sugar (glucose) levels in patients with diabetes.
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:
Type 1 diabetes - patients with type 1 diabetes always need insulin to control their blood sugar levels.
Type 2 diabetes - some patients with type 2 diabetes may also need insulin after initial treatment
with diet, exercise, and tablets.
Do not use HUMALOG:
if you are allergic to insulin lispro, or any of the ingredients listed at the end
of this leaflet. Always check the ingredients to make sure you can use this medicine.
when you have hypoglycaemia (low blood sugar).
Check with your doctor if you:
have had an allergic reaction to any medicine which you have used previously to treat
diabetes.
are using, or have used, another type or brand of insulin. This may affect the dose
of HUMALOG that you are prescribed.
have or have had kidney or liver disease. This may affect the dose of HUMALOG that
you are prescribed.
have or have had heart disease and are also taking thiazolidinediones a type of medicine
used to treat type 2 diabetes (such as pioglitazone, rosiglitazone). You may be more
at risk to develop fluid retention (oedema) especially in the hands, ankles, or feet,
or heart failure while using HUMALOG.
are taking any other medications.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Pregnancy may make managing diabetes more difficult. Insulin needs usually decrease
during the first three months of pregnancy and increase during the last six months.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if HUMALOG is excreted in significant amounts in breast milk.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
You may need a
lower dose
of HUMALOG if you are also taking any of the following medicines:
other medicines that treat diabetes
aspirin or other salicylates
a group of antibiotics, known as sulfonamides, used to treat infections
certain medicines used to treat depression, such as monoamine oxidase inhibitors
certain medicines used to treat high blood pressure or other heart conditions, such
as captopril, enalapril, angiotensin II receptor blockers, and beta blockers
certain medicines used to treat people with growth disorders and tumours, such as
octreotide.
You may need a
higher dose
of HUMALOG if you are also taking any of the following medicines:
medicines used for oral contraception ('the pill')
medicines that affect your metabolism (corticosteroids such as prednisone and cortisone)
medicines used in thyroid replacement therapy
certain antibiotics used to treat tuberculosis, such as isoniazid
certain medicines used to treat asthma, such as salbutamol or terbutaline
certain medicines used to treat schizophrenia, bipolar disorder, or nausea and vomiting,
such as phenothiazines
certain medicines used to treat hormone-related disorders, such as danazol.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins,
or supplements you are taking and if these affect HUMALOG.
When to use HUMALOG
Your doctor will tell you when to use HUMALOG.
You should normally use HUMALOG immediately (or up to 15 minutes) before
a meal.
When necessary, HUMALOG can be used within 20 minutes
after
the start of a meal.
How to use HUMALOG
HUMALOG should be used by subcutaneous injection via a syringe or insulin pump. In
some cases, it may be given intravenously. Your doctor will advise on which option
may be best for you.
HUMALOG in a syringe
Check your vial
1. Check the vial before using. HUMALOG solution should be clear and colourless.
Prepare dose
1. Wash your hands.
2. If using a new HUMALOG vial, flip off the protective plastic cap but do not remove the rubber stopper.
3. Remove the needle cap/shield and draw air into the syringe that is equal to or slightly greater than the dose to be injected.
4. Put the needle through the rubber stopper and inject air into the HUMALOG vial. Do not remove the needle.
5. Hold the HUMALOG vial and syringe firmly in one hand and turn upside down.
6. Check the tip of the needle is in the insulin solution and withdraw the correct dose into the syringe.
7. Check the syringe for air bubbles before removing the needle from the vial, as these will reduce the amount of insulin in the syringe. If bubbles are present, keep holding the syringe vertically and tap its side until the bubbles float to the top. Push them out with the syringe plunger and withdraw the correct dose.
8. Remove the needle from the vial.
Injecting dose
HUMALOG should be injected under the skin (subcutaneously). Your doctor or diabetes
educator will show you how to properly inject HUMALOG.
1. Choose your injection site (abdomen or thighs). Use of injection sites should be rotated so that the same spot is not used more than once a month.
2. Stabilise the skin by spreading it or gently pinching up a large area of skin. Insert the needle as instructed by your doctor.
3. Push down on the plunger as far as it will go to inject your dose.
4. Slowly count to 5 before pulling the needle out.
5. Release the skin and apply gentle pressure over the injection site for several seconds. Do not rub the area.
After injecting
1. Dispose of your used needles, and syringes safely into a sharps container.
HUMALOG in a subcutaneous infusion pump
Use the type of pump system recommended by your doctor, read and follow the instructions
that accompany your pump.
HUMALOG should
never
be mixed with any other insulin when used in a pump.
1. Before inserting the needle, wash your hands and the skin where the needle is to be inserted. This will help prevent infection at the infusion site.
2. Be sure to use the correct reservoir and catheter for your pump.
3. When you are filling a new syringe, do not leave large air bubbles in either the syringe or the catheter.
4. Change the syringe and catheter at least every 48 hours (2 days).
5. Follow your doctor, nurse, diabetes educator, or pharmacist's advice about the basal infusion rate and the mealtime insulin boluses to be taken.
6. Measure blood sugar levels regularly. This will help check that your insulin pump is working correctly for you, and to detect possible malfunction of the insulin pump.
7. In case of infusion pump system failure, you should always carry a spare vial of HUMALOG and a syringe, or an alternative insulin delivery system for injection under the skin.
If you forget to use HUMALOG
Test your blood sugar level as soon as possible.
If you use less HUMALOG than you need, a high blood sugar level (hyperglycaemia) may
occur.
Use it as soon as you remember, and then go back to using it as you would normally. Do not use a double dose of HUMALOG.
If you are unsure, talk with your doctor, diabetes educator, or pharmacist.
If you use too much HUMALOG
Hypoglycaemia (low blood sugar) may occur if you have used more HUMALOG than you need.
Check your blood sugar.
If your blood sugar is low (mild hypoglycaemia) eat glucose tablets, sugar or drink
a sugary drink. Then eat fruit, biscuits, or a sandwich. This will often resolve mild
hypoglycaemia or a minor insulin overdose.
If you get worse and your breathing is shallow and your skin gets pale, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling Australia: 13 11 26 / New Zealand: 0800 764 766), or
contact your doctor,
go to the Emergency department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Remind any doctor, dentist, pharmacist, and diabetes educator you visit that you are
using HUMALOG.
Monitor your blood sugar levels regularly to ensure that your dose of HUMALOG is appropriate.
More frequent monitoring is recommended when changing insulin dose or type, or when
you start taking a new medicine.
Always carry a supply of HUMALOG vials and syringes.
Always carry something to show you have diabetes.
Always carry glucose or sugary foods in case you develop hypoglycaemia (low blood
sugar).
Tell your doctor
if you become pregnant or start breastfeeding while using HUMALOG.
if you notice changes to your eyesight. This may be a sign that your diabetes is not
being controlled appropriately.
Tell your doctor pharmacist, or diabetes educator if you plan to travel. You may need
to carry a letter explaining why you are taking injecting devices with you. Your doctor,
pharmacist, or diabetes educator can provide you with some helpful information.
Things you should not do
Do not use HUMALOG when you have hypoglycaemia (low blood sugar) as it will make it
worse.
Do not stop using HUMALOG without first checking with your doctor.
Do not change your insulin (dose or type) without first checking with your doctor.
Do not mix HUMALOG with any other animal or human insulin preparations.
Do not give your HUMALOG to anyone else, even if they have the same condition as you.
Your doctor has prescribed HUMALOG specifically for you.
Do not share needles, vials, or syringes.
Do not re-use needles or syringes.
Do not use HUMALOG if the packaging is torn or shows signs of tampering.
Do not use HUMALOG if the solution is cloudy, thickened, coloured, or has solid pieces
in it, as it may no longer be good to use.
Do not use HUMALOG if the vial appears frosted, as it may no longer be good to use.
Do not use HUMALOG if you think it has been frozen or exposed to excessive heat. It
will not work as well.
Hypoglycaemia (low blood sugar)
Your blood sugar level may become too low if you:
use too much HUMALOG
exercise too much or excessively
delay eating meals or snacks
eat too little food
are ill.
Symptoms of mild to moderate
hypoglycaemia can come on suddenly, and they may include:
weakness, trembling or shaking
sweating
light headedness/headache
lack of concentration
behaviour change
dizziness
tearfulness/crying
irritability
numbness around the lips/fingers
hunger
Tell your doctor if you have trouble recognising these symptoms, if you often have
hypoglycaemia or if you have ever become unconscious after using insulin. More frequent monitoring of your blood sugar level may be recommended, or your dose
of HUMALOG may need to be changed.
Recognising these mild to moderate symptoms early may allow you to take the necessary
steps to avoid more serious hypoglycaemia.
Always carry some sugary food or drink with you.
If you experience symptoms of mild to moderate hypoglycaemia, immediately eat some
sugary food or drink, such as jelly beans, fruit 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.
Tell your relatives, friends, close workmates, or carers that you have diabetes.
It is important that they also recognise the signs and symptoms of hypoglycaemia.
Make sure they know to give you some sugary food or drink for mild to moderate symptoms
of hypoglycaemia.
Severe
symptoms of hypoglycaemia may include:
disorientation
seizures, fits, or convulsions
loss of consciousness.
If you lose consciousness, make sure your relatives, friends, close workmates, or
carers know:
to turn you on your side and get medical help immediately.
not to give you anything to eat or drink to avoid choking.
Severe hypoglycaemia can lead to unconsciousness and in extreme cases death if not
treated.
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, have some sugary food or drink as soon as you are conscious again.
Hyperglycaemia (high blood sugar)
Your blood sugar levels may become too high if:
you miss doses of HUMALOG or use less than you need
you have uncontrolled diabetes
you exercise less than usual
you eat more carbohydrates than usual
you are ill or stressed
your insulin pump is not working correctly.
Contact your doctor if your blood sugar level is too high and you experience any of
the following symptoms. High blood sugar levels over a long period of time can lead to too much acid in
the blood (diabetic ketoacidosis).
Symptoms of mild to moderate hyperglycaemia may include:
drowsiness
flushed face
thirst, loss of appetite
fruity odour on the breath
blurred vision
passing larger amounts of urine than usual
getting up at night more often than usual to pass urine
nausea and vomiting.
Contact your doctor or the Emergency Department immediately if your blood sugar level
is too high and you experience any of the following
severe
symptoms: Severe hyperglycaemia can lead to unconsciousness and in extreme cases death (if
left untreated).
Symptoms of severe hyperglycaemia:
heavy breathing
fast pulse
nausea and vomiting where you cannot keep any fluids down (leading to dehydration)
loss of consciousness.
Illness
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.
Emotional disturbances
Tell your doctor if you are feeling particularly excited, upset, or stressed.
Emotional disturbances may impact your dose of HUMALOG.
Exercise
Exercise may lower your need for insulin. Exercise may also make insulin work more
quickly, especially if the exercise involves the area around the injection site (e.g.,
the leg should not be used as an injection site prior to jogging or running).
Tell your doctor if you are exercising more than usual, as your dose of HUMALOG may
need to change.
Diet
Changes to your diet may cause your insulin needs to change.
Tell your doctor before making any significant changes to your diet (e.g., removing
carbohydrates).
Injection site
If you inject HUMALOG in 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).
To help prevent these skin changes, do not use the same place for injection more often than once a month.
HUMALOG may not work very well if you inject into a lumpy, shrunken, or thickened
area. Avoid injecting into these areas.
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 measure your blood sugar more frequently, and to adjust
your dose of HUMALOG or other antidiabetic medications.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how HUMALOG
affects you.
Do not drive if you feel like your blood sugar level is low.
Hypoglycaemia (low blood sugar) may impair your ability to concentrate or react while
driving.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypoglycaemia (low blood sugar) and make it more
difficult to recognise them.
Alcohol may also affect the dose of HUMALOG that you are prescribed.
Looking after your medicine
Keep your vials in a fridge between 2°C - 8°C. Do not freeze.
While in use, you may keep the vials unrefrigerated (below 30°C) for up to 28 days.
If they are only used occasionally, keep them refrigerated.
Dispose of unrefrigerated vials after 28 days even if they still contain insulin.
Do not store the vials in the bathroom or near a sink.
Do not put the vials near heat or in the sun.
Keep it where young children cannot reach it.
When to discard your medicine
Discard vials after the expiry date (month, year) stamped on the label has passed.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Empty vials, needles, and syringes should be disposed of in a sharps container or
similar puncture proof container composed of hard plastic or glass.
Ask your doctor, nurse, pharmacist or diabetes educator where you can dispose of the
container once it is full.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Blood sugar related:
Mild to moderate hypoglycaemia (low blood sugar), symptoms may include:
weakness, trembling or shaking
sweating
light headedness/headache
lack of concentration
behaviour change
dizziness
tearfulness/crying
irritability
numbness around the lips/fingers
hunger.
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Immediately eat some sugary food or drink, such as jelly beans, fruit 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.
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Allergy related:
Local allergy, symptoms may include redness, swelling and itching around the injection site. These
symptoms generally resolve within days to a few weeks of continued use.
Skin related:
Lipodystrophy, symptoms may include a depression in the skin or an enlargement or thickening of
the tissue around the injection site.
A change in injection technique may help resolve the problem.
General:
Oedema (fluid retention), particularly in the ankles, feet and hands.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Blood sugar related:
Severe hypoglycaemia (low blood sugar), symptoms may include:
disorientation
seizures, fits, or convulsions
loss of consciousness.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
If you lose consciousness, caregivers should turn you on your side and get medical
help immediately. They should not give you anything to eat or drink to avoid choking.
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Allergy related:
Generalised allergy, symptoms may include:
rash over a large part of the body
shortness of breath
wheezing
low blood pressure
swelling of the face, lips, or tongue
fast pulse
sweating.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
HUMALOG is only available with a doctor's prescription.
What HUMALOG contains
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Active ingredient
(main ingredient)
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insulin lispro (100 units per mL)
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate heptahydrate
glycerol
hydrochloric acid
metacresol
sodium hydroxide
water for injection
zinc oxide
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Do not take this medicine if you are allergic to any of these ingredients.
What HUMALOG looks like
HUMALOG (AUST R 53488)
HUMALOG is available in 10 mL multi-dose rubber-stoppered vials.
HUMALOG is a clear colourless solution.
Who distributes HUMALOG insulins?
Supplied in Australia by:
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street
SYDNEY NSW 2000
Supplied in New Zealand by:
Eli Lilly and Company (NZ) Limited
PO Box 109 197
Newmarket
Auckland 1149
This leaflet was prepared in October 2024.
vA8.0_Oct24
®= Registered Trademark
