Active ingredient(s): adalimumab (ada-lim-u-mab)
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?
2. What should I know before I use AMGEVITA?
3. What if I am taking other medicines?
4. How do I use AMGEVITA?
5. What should I know while using AMGEVITA?
6. Are there any side effects?
7. Product details
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).
*For 160 mg and 80 mg doses, please also see Special dosing instructions (at the end of Section 4).
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
| Less serious side effects | What to do |
Injection site:
Lungs and upper airways:
Ears, eyes, and mouth:
Brain and nerves:
Gut and digestion:
Skin and nails:
Blood:
Body as a whole:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
More serious side effects
| More serious side effects | What to do |
Signs of tuberculosis:
Signs of an infection, such as:
Signs of problems with your nervous system, such as:
Signs suggesting a blood clot, such as:
| Speak to your doctor as soon as possible if you notice any of these more serious side effects. |
Very serious side effects
| Very serious side effects | What to do |
Signs of an allergic reaction, such as:
Signs of heart failure, such as:
Signs suggesting a blood disorder, such as:
| Call your doctor urgently or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 AMGEVITA contains
| Active ingredient (main ingredient) |
|
| Other ingredients (inactive ingredients) |
|
| Potential allergens | 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 |
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
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