SUMMARY CMI

HUMALOG^®/HUMALOG^® MIX25/HUMALOG^® MIX50 cartridges

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.

1. Why am I using HUMALOG insulin?

HUMALOG insulins contain the active ingredient insulin lispro (rbe). HUMALOG insulins are used to reduce high blood sugar (glucose) levels in patients with diabetes. For more information, see Section 1. Why am I using HUMALOG insulin? in the full CMI.

2. What should I know before I use HUMALOG insulin?

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 insulin? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with HUMALOG insulins and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use HUMALOG insulin?

• Your doctor will tell you what dose of HUMALOG insulin you need to use each day.
• HUMALOG insulin cartridges can be used in a re-useable pen (HumaPen) or using a subcutaneous infusion pump.
• Do not inject HUMALOG MIX 25 or HUMALOG MIX50 directly into your veins (intravenously).

More instructions can be found in Section 4. How do I use HUMALOG insulin? in the full CMI.

5. What should I know while using HUMALOG insulin?

For more information, see Section 5. What should I know while using HUMALOG insulins? in the full CMI.

6. Are there any side effects?

The most common (and potentially the most severe) side effect of HUMALOG insulins 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.

FULL CMI

HUMALOG^®/HUMALOG^® MIX25/HUMALOG^® MIX50 cartridges

Active ingredient: insulin lispro (rbe)

Consumer Medicine Information (CMI)

This leaflet provides important information about using HUMALOG insulins. 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 insulins.

Where to find information in this leaflet:

1. Why am I using HUMALOG insulin?
2. What should I know before I use HUMALOG insulin?
3. What if I am taking other medicine?
4. How do I use HUMALOG insulin?
5. What should I know while using HUMALOG insulin?
6. Are there any side effects?
7. Product details

1. Why am I using HUMALOG insulin?

HUMALOG insulins contain the active ingredient insulin lispro (rbe).

There are 3 different types of HUMALOG insulins available in cartridges:

• HUMALOG
• HUMALOG MIX25
• HUMALOG MIX50

They all contain the same active ingredient but HUMALOG is a solution whereas HUMALOG MIX25 and HUMALOG MIX 50 are pre-mixed suspensions. Each will vary with how long they work in your body.

HUMALOG insulins are 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.

2. What should I know before I use HUMALOG insulin?

Warnings

Do not use HUMALOG insulins:

• 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).
• HUMALOG MIX25 and HUMALOG MIX50 should not be used intravenously.

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 insulin that you are prescribed.
• have or have had kidney or liver disease. This may affect the dose of HUMALOG insulin 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 insulin.
• 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 insulins are excreted in significant amounts in breast milk.

Children (under 18 years)

The use of HUMALOG MIX25 and HUMALOG MIX50 have not been studied in children under the age of 18.

3. What if I am taking other medicines?

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 insulin 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 insulin 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 insulins.

4. How do I use HUMALOG insulin?

How much to use

Your doctor will tell you what dose of HUMALOG insulin you need to use each day.

When to use HUMALOG insulin

• Your doctor will tell you when to use HUMALOG insulin.
• You should normally use HUMALOG insulins immediately (or up to 15 minutes) before a meal.
• When necessary, HUMALOG can be used within 20 minutes after the start of a meal. Do not use HUMALOG MIX 25 or HUMALOG MIX50 after the start of a meal.

How to use HUMALOG insulins

HUMALOG should be used by subcutaneous injection via a re-useable pen or insulin pump.

HUMALOG insulins in a re-useable pen

HUMALOG, HUMALOG MIX25 and HUMALOG MIX50 cartridges may be used with the HumaPen.

The manufacturer's instructions for the HumaPen delivery systems should be followed for loading the cartridge, attaching the needle, and administering the insulin injection.

Check your cartridge

1. Check the cartridge before using. Make sure you are using the correct cartridge. The solution of HUMALOG should be clear and colourless. The suspension in HUMALOG MIX25 and HUMALOG MIX50 cartridges should be white and cloudy or milky.

Prepare dose

1. Wash your hands.
2. HUMALOG MIX25 and HUMALOG MIX50 cartridges must be rolled between your palms ten times and inverted ten times until the contents are uniformly mixed. Do not shake as this may cause frothing which may interfere with the correct measurement of the dose.
3. Inspect the cartridge for uniform mixing and repeat the above steps if necessary.
4. Put the cartridge into the pen.
5. Attach a needle. Remove the outer needle shield. Do not throw it away.
6. Pull off the inner needle shield and throw it away.

Checking for insulin flow (Priming)

Always prime your pen before injecting a dose.

Priming may highlight a malfunction with the pen or needle. It also removes any air bubbles and ensures that you receive the correct dose.

1. Set the dose to 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. Priming is complete when a stream of insulin comes out of the needle. This is very important to ensure the correct dose is injected.
4. If a drop of insulin still does not appear, hold the pen with the needle facing upwards and away from your face. Attach a new needle. Repeat steps 1 - 3 again. If you are still unable to get insulin flowing out of the needle, do not use the pen. Return the pen to your doctor, diabetes educator or pharmacist to obtain a replacement pen.
5. Only after seeing a stream of insulin at the needle tip should you proceed to dial up your required dose. There may still be some small air bubbles left in the cartridge. These are harmless.
6. If the air bubble is too big, you should prime the pen again.

Injecting dose

HUMALOG insulins should be injected under the skin (subcutaneously). Your doctor or diabetes educator will show you how to properly inject HUMALOG.

Under no circumstances should HUMALOG MIX25 or HUMALOG MIX50 be injected intravenously (directly into your veins).

1. Dial your prescribed dose.
2. Choose a site for injection (abdomen or thighs). Use of injection sites should be rotated so that the same spot is not used more than once a month.
3. Stabilise the skin by spreading it or gently pinching up a large area of skin. Insert the needle as instructed by your doctor.
4. Press the knob. Count to 5 slowly before pulling the needle out.

After injecting

1. Release the skin and apply gentle pressure over the injection site for several seconds. Do not rub the area.
2. Using the outer needle cap, unscrew the needle and dispose of it safely into a sharps container. Do not re-use the needle.
3. Leave the cartridge in the pen until it needs to be replaced.

Further injections

• 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.
• 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.

HUMALOG in a subcutaneous infusion pump

HUMALOG may be given under the skin by means of an insulin infusion pump. HUMALOG MIX25 and HUMALOG MIX50 should never be used in a pump.

HUMALOG should never be mixed with any other insulin when used in a pump.

1. Use the type of pump system recommended by your doctor, read and follow the instructions that accompany your pump.
2. 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.
3. Be sure to use the correct reservoir and catheter for your pump.
4. When you are filling a new syringe, do not leave large air bubbles in either the syringe or the catheter.
5. Change the syringe and catheter at least every 48 hours (2 days).
6. Follow your doctor, nurse, diabetes educator, or pharmacist's advice about the basal infusion rate and the mealtime insulin boluses to be taken.
7. 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.
8. 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 the skin.

If you forget to use HUMALOG insulin

Test your blood sugar level as soon as possible.

If you use less HUMALOG insulin 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 insulin.

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

If you use too much HUMALOG insulin

Hypoglycaemia (low blood sugar) may occur if you have used more HUMALOG insulin 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, or
• go to the Emergency department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using HUMALOG insulin?

Things you should do

• Remind any doctor, dentist, pharmacist, and diabetes educator you visit that you are using HUMALOG insulin.
• Monitor your blood sugar levels regularly to ensure that your dose of HUMALOG insulin 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 insulin cartridges and your pen.
• 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 insulin.
• 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 insulin when you have hypoglycaemia (low blood sugar) as it will make it worse.
• Do not stop using HUMALOG insulin without first checking with your doctor.
• Do not change your insulin (dose or type) without first checking with your doctor.
• Do not give your HUMALOG insulin to anyone else, even if they have the same condition as you. Your doctor has prescribed HUMALOG insulin specifically for you.
• Do not mix HUMALOG insulin with any other animal or human insulin preparations.
• Do not share needles, cartridges, or pens.
• Do not re-use needles.
• Do not store your insulin pen with the needle attached. This will ensure that your insulin will not become contaminated, and prevent leakage, the re-entry of air, and potential needle clogs.
• Do not use HUMALOG insulin 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 MIX25 or HUMALOG MIX50 if the suspension is no longer cloudy white after gentle shaking or if it has solid pieces in it, as it may no longer be good to use.
• Do not use HUMALOG insulin if the cartridge appears frosted, as it may no longer be good to use.
• Do not use HUMALOG insulin 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 insulin
• 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 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 insulin 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 insulin 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).

• 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).

• heavy breathing
• fast pulse
• nausea, vomiting
• 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 insulin.

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 insulin 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 insulin 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 insulin 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 insulin or other antidiabetic medications.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how HUMALOG insulins affect 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 insulin that you are prescribed.

Looking after your medicine

• Keep your cartridges in a fridge between 2°C - 8°C. Do not freeze.
• When the cartridge has been inserted into the pen, the cartridge pen combination should not be kept in the fridge. You may keep the cartridges unrefrigerated (below 30°C) for up to 28 days while you are using them.
• Dispose of unrefrigerated cartridges after 28 days even if they still contain insulin.
• Do not store the cartridges in the bathroom or near a sink.
• Do not put the cartridges near heat or in the sun.
• Keep it where young children cannot reach it.

When to discard your medicine

Discard cartridges 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 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, pharmacist or diabetes educator where you can dispose of the container once it is full.

6. Are there any side effects?

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

Serious side effects

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.

7. Product details

HUMALOG insulins are only available with a doctor's prescription.

What HUMALOG insulins contain

Do not take this medicine if you are allergic to any of these ingredients.

What HUMALOG insulins look like

HUMALOG (AUST R 53466)

HUMALOG is available in 3 mL cartridges.

HUMALOG is a clear colourless solution.

HUMALOG MIX25 (AUST R 69163)

HUMALOG MIX25 is available in 3 mL cartridges.

HUMALOG MIX25 is a white and cloudy or milky suspension.

HUMALOG MIX50 (AUST R 69166)

HUMALOG MIX50 is available in 3 mL cartridges.

HUMALOG MIX50 is a white and cloudy or milky suspension.

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

®= Registered Trademark

This leaflet was prepared in October 2024.

vA10.0_Oct24

Published by MIMS December 2024

1 Name of Medicine

Insulin lispro (rbe).

2 Qualitative and Quantitative Composition

The Humalog range consists of three presentations:

Humalog.

Humalog Mix25.

Humalog Mix50.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients with type 1 (IDDM) and type 2 (NIDDM) diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

4.2 Dose and Method of Administration

Compared to regular insulin, Humalog takes effect more rapidly and has a shorter duration of activity (2 to 5 hours).

Adults.

Children.

General.

Instructions for use/ handling.

Humalog - use in continuous subcutaneous infusion pumps.

Humalog Mix25 and Humalog Mix50 cartridges.

Humalog Mix25 and Mix50 KwikPens.

4.3 Contraindications

Hypoglycaemia.
Hypersensitivity to insulin lispro or one of its excipients.
Humalog Mix25 and Humalog Mix50 should not be given intravenously.

4.4 Special Warnings and Precautions for Use

General.

Injection technique.

Subcutaneous insulin infusion pumps.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The physician should be consulted when using other medication in addition to insulin lispro (see Section 4.4 Special Warnings and Precautions for Use).
Insulin requirements may be increased by drugs with hyperglycaemic activity, such as oral contraceptives, corticosteroids, thyroid replacement therapy, isoniazid, phenothiazines, danazol or beta-2 stimulants (such as salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of drugs with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, aspirin), sulphonamides, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril and enalapril), angiotensin II receptor blockers, beta-blockers, octreotide and alcohol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The patient's ability to concentrate and to react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycaemia while driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Adverse Effects (Undesirable Effects)

The preclinical safety profile indicates that Humalog is safe in the chronic treatment of diabetes in humans. The safety profile of Humalog has been assessed in a series of preclinical studies. In in vitro tests, including binding to insulin receptor sites and effects on growing cells, Humalog behaved in a manner that closely resembled human insulin. Toxicology studies produced no significant toxicity findings. Most importantly, and like human insulin, Humalog did not produce proliferative effects or tumours in organs and tissues when given at very high subcutaneous doses in chronic toxicity tests.

Hypoglycaemia.

Allergic reactions.

Lipodystrophy.

Spontaneous data.

Reporting suspected adverse effects.

4.9 Overdose

Insulins have no specific overdose definitions because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin or insulin analogue relative to food intake and energy expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or saccharated products.
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is not available or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

See Section 5.1 Pharmacodynamic Properties.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form.

6.2 Incompatibilities

Humalog should not be mixed with any other animal or human insulin preparations. Humalog Mix25 or Humalog Mix50 should not be mixed with other insulins. See Section 4.2 Dose and Method of Administration.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Humalog preparations should be stored in a refrigerator between 2°C and 8°C. They should not be frozen or exposed to excessive heat or sunlight.
Humalog vials, cartridges and KwikPen prefilled pen delivery devices can be kept at ambient temperature below 30°C and away from direct heat and light for 28 days while in use. Humalog Mix25 and Humalog Mix50 cartridges can be kept at ambient temperature below 30°C and away from direct heat and light for 28 days while in use. The reusable cartridge pen combination should not be refrigerated.

6.5 Nature and Contents of Container

Humalog.

Humalog Mix25.

Humalog Mix50.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes