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 Humira?
Humira contains the active ingredient adalimumab. Humira is used to treat various
inflammatory conditions.
2. What should I know before I use Humira?
Check the list of ingredients at the end of the CMI. Do not use Humira if you have
ever had an allergic reaction to any of them.
Talk to your doctor before you take this medicine if he/she is not aware that you
have any other medical conditions, take any other medicines, or are pregnant or plan
to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Humira and affect how it works, or Humira may interfere
with other medicines and affect how they work.
4. How do I use Humira?
Humira is injected under the skin (subcutaneous).
5. What should I know while using Humira?
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Things you should do
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Remind any doctor or dentist or pharmacist you visit that you are using Humira.
Keep all your appointments, including for blood tests.
Tell your doctor if you develop an infection or you notice new or changed spots on
your skin.
Tell your doctor if you are scheduled for any vaccines.
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Things you should not do
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Do not stop using this medicine or change the dose unless your doctor tells you to.
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Driving or using machines
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Be careful before you drive or use any machines until you know how Humira affects
you. The effects on your ability to drive or use machines whilst taking Humira are
not known.
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Drinking alcohol
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There is no information on the effects of taking Humira with alcohol
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Looking after your medicine
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Store Humira in the refrigerator (2 °C to 8 °C). Do not freeze.
Keep pens or syringes in the pack to protect your medicine from light.
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6. Are there any side effects?
Side effects that require urgent medical attention include: Signs of an allergic reaction,
such as chest tightness, difficulty breathing, swelling of face lips and tongue, rash;
signs of heart failure, such as shortness of breath on exertion or lying down, swelling
of the feet; signs suggesting a blood disorder, such as persistent fever, bruising,
bleeding, paleness.
Active ingredient:
adalimumab (rch) (a-da-li-mue-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Humira. 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 Humira.
Where to find information in this leaflet:
1. Why am I using Humira?
Humira contains the active ingredient adalimumab.
Humira is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,
enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s
disease in adults and children aged 6 years and over, ulcerative colitis, psoriasis
in adults and children aged 4 years and over, hidradenitis suppurativa in adults and
adolescents aged 12 years and over, and uveitis.
2. What should I know before I use Humira?
Warnings
Do not use Humira if:
1. you are allergic to adalimumab, or any of the ingredients listed at the end of this
document
2. you have a severe infection such as sepsis (a serious infection of the blood) or tuberculosis
(a serious infection of the lungs caused by bacteria), or other severe infection caused
by a virus, fungus, parasite or bacteria
3. you have heart failure considered by your doctor to be moderate or severe.
Check with your doctor if you:
have or have had an infection that does not go away or keeps coming back, this can
include leg ulcers
you have ever had tuberculosis, or you have been in close contact with someone who
has tuberculosis. Tuberculosis can develop during therapy even if you have received
treatment for the prevention of tuberculosis.
you currently have active hepatitis B, have ever had hepatitis B, are a carrier of
the hepatitis B virus or you think you may be at risk of contracting hepatitis B
you have or have had an infection caused by a fungus, or you have lived or travelled
in countries where fungal infections are common
you have or have had uveitis, where the middle layer of the eyeball is inflamed
you have or have had allergic reactions such as chest tightness, wheezing, dizziness,
swelling or rash
you have a disease that affects the insulating layer of the nerves, e.g. multiple
sclerosis (MS)
you have or have had a blood disorder
you have or have had low resistance to disease
you have or have had a heart condition
you have or have had cancer or autoimmune disease
you have a lung disease called chronic obstructive pulmonary disease (COPD)
you have or have had kidney or liver problems
you have any vaccinations scheduled
you have or have had psoriasis (a skin disease that produces patches of thickened,
scaly skin that is not contagious)
you have had phototherapy, also known as light therapy, for psoriasis
you have any surgery planned
you take any medicines for any other condition.
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
Make sure your doctor is aware that you are pregnant or plan to become pregnant. Humira
should only be used in pregnancy if clearly needed.
If you use Humira during pregnancy your baby may have a higher risk of getting an
infection.
You should consider the use of effective contraception to prevent pregnancy and continue
its use for at least 5 months after the last Humira injection.
Tell your baby’s doctors if you have taken Humira while you are pregnant, especially
before your baby receives any vaccinations.
Make sure your doctor is aware that you are breastfeeding, or you plan to do so.
Use in children
Wherever possible, it is recommended that children are up to date with all vaccinations,
according to current immunisation guidelines, before they are started on Humira treatment.
Treatment of Crohn’s disease in children should be supported by good nutrition to
allow appropriate growth.
The long-term effects of Humira on the growth and development of children is not known.
Use in the elderly
If you are over 65, you may be more likely to get an infection while taking Humira.
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.
Some medicines may interfere with Humira and affect how it works, while Humira may
affect how other medicines work.
Do not take Humira if you are taking the following medicine:
anakinra, a medicine used to treat rheumatoid arthritis, juvenile idiopathic arthritis
and conditions associated with a defect in a protein called cryoprin.
Medicines that may
increase
the risk of infection when taken with Humira include:
anakinra, a medicine used to treat rheumatoid arthritis, juvenile idiopathic arthritis
and conditions associated with a defect in a protein called cryoprin
abatacept, a medicine used to treat rheumatoid arthritis, polyarticular juvenile idiopathic
arthritis, psoriatic arthritis
azathioprine, a medicine used for suppressing the immune system to treat various conditions
6-mercaptopurine, a medicine used to treat certain types of leukaemia, a blood disorder.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Humira.
4. How do I use Humira?
How much to use
Rheumatoid arthritis in adults
Inject one 40 mg dose every fortnight.
If you are not taking methotrexate, your doctor may change this dose to 40 mg every week, or 80
mg every fortnight, depending on your response.
Psoriatic arthritis and ankylosing spondylitis in adults
Inject one 40 mg dose every fortnight.
Crohn’s disease and ulcerative colitis in adults
Inject 160 mg on day 1, followed by 80 mg on day 15 and 40 mg on day 29. Then, continue
to inject 40 mg every fortnight (maintenance dose).
Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight,
depending on your response.
(See Special dosing instructions at the end of this section.)
Psoriasis in adults
Inject 80 mg on day 1, followed by 40 mg on day 8 and 40 mg on day 22. Then, continue
to inject 40 mg every fortnight (maintenance dose).
Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight,
depending on your response.
(See Special dosing instructions at the end of this section.)
Uveitis in adults
Inject 80 mg on day 1, followed by 40 mg on day 8 and 40 mg on day 22. Then continue
to inject 40 mg every fortnight (maintenance dose).
(See Special dosing instructions at the end of this section.)
Hidradenitis suppurativa in adults
Inject 160 mg on day 1, followed by 80 mg on day 15. Then continue to inject 40 mg
every week or 80mg every fortnight from day 29 (maintenance dose).
(See Special dosing instructions at the end of this section.)
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
If the patient’s body weight is at least 30 kg, inject one 40 mg dose every fortnight.
If the patient’s body weight is between 10 and 30 kg, inject one 20 mg dose every
fortnight.
Crohn’s disease in children
If the patient’s body weight is at least 40 kg, inject 160 mg on day 1, followed by
80 mg on day 15 and 40 mg on day 29. Then, continue to inject 40 mg every fortnight
(maintenance dose).
Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight,
depending on your response.
(See Special dosing instructions at the end of this section.)
If the patient’s body weight is less than 40 kg, inject 80 mg on day 1, followed by
40 mg on day 15, and 20 mg on day 29. Then, continue to inject 20 mg every fortnight.
Your doctor may change this maintenance dose to 20 mg every week, depending on your
response.
(See Special dosing instructions at the end of this section.)
Psoriasis in children
If the patient’s body weight is at least 40 kg, inject 40 mg on day 1, followed by
40 mg on day 8 and 40 mg on day 22. Then continue to inject 40 mg every fortnight
(maintenance dose).
If the patient’s body weight is less than 40 kg, inject 20 mg on day 1, inject 20
mg on day 8, then 20 mg on day 22. Then continue to inject 20 mg every fortnight (maintenance
dose).
Hidradenitis suppurativa (HS) in adolescents
Inject 80 mg on day 1, followed by 40 mg on day 8, and 40 mg on day 22. Then continue
to inject 40 mg every fortnight (maintenance dose)
Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight
depending on your response.
(See Special dosing instructions at the end of this section.)
Use an antiseptic face wash on the affected areas.
Special dosing instructions
When a dose of 160 mg is required, this can be given as two 80 mg OR four 40 mg injections
in one day, or one 80 mg or two 40 mg injections per day over two consecutive days.
When a dose of 80 mg is required, this can be given as one 80 mg injection or two
40 mg injections in one day.
In some instances, Humira needs to be taken with other medicines. Your doctor will
let you know which medicines, how to take them and how long to take them.
Follow all instructions given to you and use Humira until your doctor tells you to
stop.
How to use Humira
Humira is injected under the skin (sub-cutaneous injection).
It can be injected by the patient, or by someone else, such as a family member, friend
or carer.
An injection should not be attempted until proper training has been received on the
correct injection technique.
Do not mix the injection with any other medicine.
Read the instructions for preparing and giving a Humira injection that are supplied
with the product. These instructions are also available via the following hyperlinks:
Humira syringe:
Humira 40mg/0.8mL pen:
Humira 40mg/0.4mL pen:
Humira 80mg/0.8mL pen:
If you forget to inject Humira
It is important that you use your medicine as prescribed by your doctor.
If you miss your dose at the usual time, inject Humira as soon as you remember, and
continue injecting the next dose at the usual time on your scheduled day.
Do not take a double dose to make up for the dose you missed.
If you inject too much Humira
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.
5. What should I know while using Humira?
Things you should do
Keep all your doctor’s appointments so your progress can be tracked.
Keep your appointments for blood tests. Some side effects are seen in blood results
before you have any symptoms.
Remind any doctor, dentist or pharmacist you visit that you are using Humira, especially
if you are scheduled for surgery or to receive any live vaccines (e.g. Bacille Calmette-Guerin
or oral polio vaccine).
Call your doctor straight away if you:
get symptoms of an infection, such as a fever, skin sores, feeling tired, any problems
with your teeth or gums or pain when passing urine or blood in your urine.
become pregnant while using Humira.
notice new skin lesions (skin spots or sores), or if existing lesions change appearance.
Things you should not do
Do not stop using this medicine or change the dose without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Humira
affects you.
Drinking alcohol
There is no information on the use of alcohol with Humira.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Keep Humira in the carton protected from light.
Keep Humira in a refrigerator (at 2°C to 8°C). Do not freeze.
Keep it where young children cannot reach it.
When to discard your medicine
When necessary, a single Humira pen or syringe may be stored at room temperature (25°C)
for a maximum of 14 days, protected from light.
Once removed from the refrigerator, the pen or syringe must be used within 14 days
or discarded, even if it has been returned to the refrigerator.
After injecting Humira, immediately throw away the used pen or syringe in a special
sharps container as instructed by your doctor, nurse or pharmacist.
Getting rid of any unwanted medicine
If your doctor advises that you no longer need to use this medicine or it is out of
date, follow local guidelines for safe disposal.
6. Are there any side effects?
All medicines can have 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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Injection site:
pain
swelling
redness
itching
Lungs and upper airways
cold
flu
runny nose
cough
sore throat
sinus infection
asthma or worsening asthma
bronchitis or pneumonia (congestions on the chest)
Ears, eyes and mouth
pain in the ear
pain, redness or swelling of the eye or eye lid
changes to vision
mouth ulcers
pain in the gums
excessive bleeding from the gums
Brain and nerves
headache or migraine
dizziness
muscle weakness
muscle, bone or joint pain
numbness
difficulty balancing
Gut and digestion
nausea
vomiting
tummy pain
reflux or heartburn
Skin and nails
rash
itching
redness
scaly skin patches
problems with your fingernails or toenails
hair loss
cold sore blisters
chicken pox.
Blood
bleeding
bruising more easily than usual
Body as a whole
tiredness
chest pain
lack of energy
increased heart rate
feeling overwhelmed or sad, lacking motivation (depression)
feeling especially fearful or worried (anxiety)
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Speak to your doctor if you have any of these 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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Signs of tuberculosis, such as:
persistent cough
weight loss
listlessness
fever.
Signs of an infection, such as:
fever
lack of energy
skin bump or sore that doesn’t heal
problems with your teeth or gums
pain when passing urine or blood in the urine.
Signs of problems with your nervous system, such as:
numbness
tingling throughout your body
arm or leg weakness
double or blurred vision.
Signs suggesting a blood clot, such as:
swelling, tenderness, redness and a warm feeling of an area of the arm or leg
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Speak to your doctor as soon as possible if you have any of these side effects.
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Very 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
This medicine is only available with a doctor's prescription.
What Humira contains
Humira 40 mg in 0.8 mL; 20 mg in 0.4 mL
Humira is a clear, colourless, sterile solution containing:
40 mg adalimumab in 0.8 mL solution in a prefilled pen (AUST R 199410)
40 mg adalimumab in 0.8 mL solution in a prefilled syringe (AUST R 199412)
20 mg adalimumab in 0.4 mL solution in a prefilled syringe (AUST R 199411)
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Active ingredient
(main ingredient)
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adalimumab
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Other ingredients
(inactive ingredients)
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mannitol
citric acid monohydrate
sodium citrate dihydrate
monobasic sodium phosphate dihydrate
dibasic sodium phosphate dihydrate
sodium chloride
Polysorbate 80
Water for injections
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Humira 80 mg in 0.8mL; 40 mg in 0.4 mL,
20 mg in 0.2 mL
Humira is a clear, colourless, sterile solution containing:
80 mg adalimumab in 0.8 mL solution in a prefilled pen (AUST R 285904)
80 mg adalimumab in 0.8 mL solution in a prefilled syringe (AUST R 292934)
40 mg adalimumab in 0.4 mL solution in a prefilled pen (AUST R 281509)
40 mg adalimumab in 0.4 mL solution in a prefilled syringe (AUST R 281470)
20 mg adalimumab in 0.2 mL solution in a prefilled syringe (AUST R 289104).
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Active ingredient
(main ingredient)
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adalimumab
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Other ingredients
(inactive ingredients)
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mannitol
Polysorbate 80
Water for injections
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What Humira looks like
Prefilled pens and prefilled syringes are available for patient use in packs of 1,2,
4 or 6 units with alcohol pads, although not all presentations may be available or
marketed in all pack sizes.
Who distributes Humira?
Humira is distributed in Australia by:
AbbVie Pty Ltd
ABN 48 156 384 262
241 O'Riordan Street
Mascot NSW 2020
This leaflet was prepared in April 2022.
Version 2