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 AMGEVITA?
AMGEVITA pre-filled syringes and pre-filled SureClick® pens contain the active ingredient adalimumab. AMGEVITA is used to treat various
inflammatory conditions.
2. What should I know before I use AMGEVITA?
Read this leaflet carefully before you use AMGEVITA and keep it with the medicine.
Check the list of ingredients at the end of the CMI. Do not use AMGEVITA if you have
ever had an allergic reaction to any of the ingredients.
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.
3. What if I am taking other medicines?
Some medicines may interfere with AMGEVITA and affect how it works. AMGEVITA may interfere
with other medicines and how they work.
4. How do I use AMGEVITA?
AMGEVITA is injected under the skin (subcutaneous).
5. What should I know while using AMGEVITA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using AMGEVITA.
Keep all your appointments, including those for blood tests.
Tell your doctor if you develop an infection or you notice new or changed spots on
your skin.
Talk to 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 AMGEVITA suddenly 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 AMGEVITA affects
you.
The effects on your ability to drive or use machines whilst taking AMGEVITA are not
known.
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Drinking alcohol
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There is no information on the effects of taking AMGEVITA with alcohol.
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Looking after your medicine
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Store AMGEVITA in the refrigerator (2°C to 8°C). Do not freeze.
Keep AMGEVITA pens or syringes in the original 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(s):
adalimumab (ada-lim-u-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using AMGEVITA. 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 AMGEVITA.
Where to find information in this leaflet:
1. Why am I using AMGEVITA?
AMGEVITA contains the active ingredient adalimumab. AMGEVITA is a biosimilar medicine. It has been assessed to be as safe and effective
as the reference product and provides the same health outcomes.
AMGEVITA is used to treat any of the following inflammatory conditions (listed in
alphabetical order):
Ankylosing spondylitis
Crohn’s disease in adults and children aged 6 years and over
Enthesitis-related arthritis
Hidradenitis suppurativa in adults and adolescents aged 12 years and over
Polyarticular juvenile idiopathic arthritis
Psoriasis in adults and children aged 4 years and over
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis, and
Uveitis.
2. What should I know before I use AMGEVITA?
Warnings
Do not use AMGEVITA if any of the following apply:
You are allergic to adalimumab or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use it.
You have a severe infection such as sepsis (a serious infection of the blood), tuberculosis
(a serious infection of the lungs caused by bacteria), or other severe infection,
caused by a virus, fungus, parasite or bacteria.
You have heart failure considered by your doctor to be moderate or severe.
Check with your doctor if you have:
Any vaccinations scheduled
Any surgery planned
A lung disease called chronic obstructive pulmonary disease (COPD)
A disease that affects the insulating layer of the nerves, e.g. multiple sclerosis
(MS)
Current 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
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.
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
An infection caused by a fungus, or you have lived or travelled in countries where
fungal infections are common
Uveitis, where the middle layer of the eyeball is inflamed
Allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash
A blood disorder
Low resistance to disease
A heart condition
Cancer or autoimmune disease
Kidney problems
Liver problems
Psoriasis (a skin disease that produces patches of thickened, scaly skin that is not
contagious)
Phototherapy, also known as light therapy, for psoriasis.
Check with your doctor if 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
Make sure your doctor knows if you are pregnant or intend to become pregnant. AMGEVITA
should only be used in pregnancy if clearly needed.
If you use AMGEVITA 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 AMGEVITA injection.
Tell your baby’s doctors if you have taken AMGEVITA while you are pregnant, especially
before your baby receives any vaccinations.
Breastfeeding
Make sure your doctor knows if you are breastfeeding or intend to breastfeed.
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 AMGEVITA
treatment.
Treatment of Crohn’s disease in children should be supported by good nutrition to
allow appropriate growth.
The long-term effects of AMGEVITA 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 AMGEVITA.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other:
medicines
vitamins or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines may interfere with AMGEVITA and affect how it works.
Do not take AMGEVITA 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 cryopyrin.
Medicines that may
increase
the risk of infections when taken with AMGEVITA include:
anakinra
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).
AMGEVITA may affect how other medicines that you take work.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect AMGEVITA.
4. How do I use AMGEVITA?
How much to use
Doses for each condition are given in the following text (in alphabetic order).
Ankylosing spondylitis in adults
Inject one 40 mg dose every fortnight.
Crohn’s disease 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 the maintenance dose to 40 mg every week, or 80 mg* every fortnight, depending on your response.
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.
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.
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.
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 80 mg every fortnight from day 29 (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.
Use an antiseptic face wash on the affected areas.
Polyarticular juvenile idiopathic 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.
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.
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).
Psoriatic arthritis in adults
Inject one 40 mg dose every fortnight.
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.
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.
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).
Special dosing instructions
80 mg dose can be given as two 40 mg injections in 1 day.
160 mg dose can be given as either of the following:
four 40 mg injections in 1 day, or
two 40 mg injections per day over 2 consecutive days.
Some patients may need to use AMGEVITA and take other medicines. Your doctor will
tell you which medicines to take, how to take them, and how long to take them.
How to use AMGEVITA
Read the
Instructions for Use
that are supplied in the pack, with the product, before preparing and using an AMGEVITA
injection.
AMGEVITA is injected under the skin (subcutaneous). An injection should not be attempted
until proper training has been received on the correct injection technique.
AMGEVITA can be injected by the patient, or by someone else, such as a family member,
friend or carer.
Do not mix the solution for injection with any other medicine.
If you forget to use AMGEVITA
It is important that you use your medicine as prescribed by your doctor.
If you miss your dose at the usual time, inject AMGEVITA 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 AMGEVITA
If you think that you have used too much AMGEVITA, you may need urgent medical attention.
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 are no signs of discomfort or poisoning.
Always take the outer carton of the medicine with you.
5. What should I know while using AMGEVITA?
Things you should do
AMGEVITA should be used regularly, as prescribed by your doctor.
Follow all instructions given to you and use AMGEVITA until your doctor tells you
to stop.
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.
Check with your doctor before you receive any vaccines.
Remind any healthcare professional you visit that you are using AMGEVITA, 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 AMGEVITA.
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 AMGEVITA
affects you.
Drinking alcohol
There is no information on the use of alcohol with AMGEVITA.
Looking after your medicine
Follow the instructions on the AMGEVITA carton for instructions on how to take care
of your medicine properly.
Keep AMGEVITA in a refrigerator (at 2°C to 8°C). Do not freeze. Keep it in the carton
protected from light.
Keep it where children cannot reach it.
When necessary, AMGEVITA may be stored at room temperature (25°C) for a maximum of
14 days, protected from light.
Once removed from the refrigerator, each pen or syringe must be used within 14 days
or discarded, even if it has been returned to the refrigerator.
When to discard your medicine
After injecting AMGEVITA, immediately throw away the used syringe or pen into a special
sharps container.
Discard any AMGEVITA that has been removed from the refrigerator for more than 14
days.
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, take it to any pharmacy for safe disposal.
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
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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
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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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Lungs and upper airways:
cold
flu
runny nose
cough
sore throat
sinus infection
asthma or worsening of asthma
bronchitis, pneumonia (congestion on the chest)
Ears, eyes, and mouth:
ear pain
pain, redness or swelling of the eye or eye lid
changes in vision
mouth ulcers
gum pain
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 less serious side effects and they worry
you.
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More serious side effects
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More serious side effects
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What to do
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Signs of tuberculosis:
persistent cough
weight loss
listlessness (lack of energy)
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 notice any of these more serious side
effects.
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Very serious side effects
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Serious side effects
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What to do
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Signs of an allergic reaction, such as:
chest tightness
shortness of breath, wheezing or difficulty breathing
swelling of the face lips, tongue or other parts of the body
hives itching or skin 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 very easily
paleness.
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Call your doctor urgently 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.
7. Product details
This medicine is only available with a doctor's prescription.
What AMGEVITA contains
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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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glacial acetic acid (E260)
polysorbate 80 (E433)
sodium hydroxide (E524)
sucrose
water for Injection
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Potential allergens
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The needle cover of the pre-filled pen contains dry natural rubber (latex).
The needle cover of the pre-filled syringe does not contain latex
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Do not take this medicine if you are allergic to any of these ingredients.
What AMGEVITA looks like
AMGEVITA is a clear, colourless, sterile solution containing:
adalimumab 20 mg in 0.4 mL solution in a pre-filled syringe (AUST R 278702)
adalimumab 40 mg in 0.8 mL solution in a pre-filled syringe (AUST R 278701)
adalimumab 40 mg in 0.8 mL solution in a pre-filled SureClick® pen (AUST R 273536).
Pre-filled syringes and pens are available in pack containing:
1 syringe, or
2 syringes, or
2 SureClick® pens.
Who distributes AMGEVITA
Amgen Australia Pty Ltd
Level 11, 10 Carrington Street,
Sydney NSW 2000
Ph: 1800 803 638
www.amgenmedinfo.com.au
AMGEVITA® and SureClick® are registered trademarks of Amgen.
Version information
This leaflet was prepared in June 2022.
Version 4