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The product code(s) for this leaflet is: PLGB 13832/0088.
Amgevita HCF 20mg, 40mg and 80mg solution for injection in pre-filled syringe
AMGEVITA HCF 20 mg solution for injection in pre-filled syringe
AMGEVITA HCF 40 mg solution for injection in pre-filled syringe
AMGEVITA HCF 80 mg solution for injection in pre-filled syringe
adalimumab
1. What AMGEVITA is and what it is used for
2. What you need to know before you use AMGEVITA
3. How to use AMGEVITA
4. Possible side effects
5. How to store AMGEVITA
6. Contents of the pack and other information
AMGEVITA contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.
AMGEVITA is intended for the treatment of the inflammatory diseases described below:
The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, AMGEVITA decreases the process of inflammation in these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
AMGEVITA is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your rheumatoid arthritis.
AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
AMGEVITA slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Usually, AMGEVITA is used with methotrexate. If your doctor determines that methotrexate is inappropriate, AMGEVITA can be given alone.
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years and enthesitis-related arthritis in patients from 6 years. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
AMGEVITA is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your disease.
Psoriatic arthritis
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
AMGEVITA is used to treat psoriatic arthritis in adults. AMGEVITA slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Plaque psoriasis in adults and children
Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.
AMGEVITA is used to treat moderate to severe plaque psoriasis in adults. AMGEVITA is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.
AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. AMGEVITA can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given AMGEVITA.
Crohn’s disease in adults and children
Crohn’s disease is an inflammatory disease of the digestive tract.
AMGEVITA is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your Crohn’s disease.
Ulcerative colitis in adults and children
Ulcerative colitis is an inflammatory disease of the large intestine.
AMGEVITA is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis you may first be given other medicines. If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your disease.
Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
AMGEVITA is used to treat
This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). AMGEVITA works by reducing this inflammation.
Talk to your doctor or pharmacist before using AMGEVITA:
Allergic reactions
Infections
Tuberculosis
Travel / recurrent infection
Hepatitis B virus
Age over 65 years
Surgery or dental procedures
Demyelinating disease
Vaccinations
Heart failure
Fever, bruising, bleeding or looking pale
Cancer
Autoimmune diseases
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
AMGEVITA can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
You should not take AMGEVITA with medicines containing the active substances, anakinra or abatacept due to increased risk of serious infection. If you have questions, please ask your doctor.
AMGEVITA may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking AMGEVITA.
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
AMGEVITA is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.
In rheumatoid arthritis, methotrexate is continued while using AMGEVITA. If your doctor determines that methotrexate is inappropriate, AMGEVITA can be given alone.
If you have rheumatoid arthritis and you do not receive methotrexate with your AMGEVITA therapy, your doctor may decide to give 40 mg every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
The recommended dose of AMGEVITA is 20 mg every other week.
Children, adolescents and adults from 2 years of age weighing 30 kg or more
The recommended dose of AMGEVITA is 40 mg every other week.
Children, adolescents and adults with enthesitis-related arthritis
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
The recommended dose of AMGEVITA is 20 mg every other week.
Children, adolescents and adults from 6 years of age weighing 30 kg or more
The recommended dose of AMGEVITA is 40 mg every other week.
Adults with plaque psoriasis
The usual dose for adults with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject AMGEVITA for as long as your doctor has told you. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg
The recommended dose of AMGEVITA is an initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.
Children and adolescents from 4 to 17 years of age weighing 30 kg or more
The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor. It is recommended that you use an antiseptic wash daily on the affected areas.
Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
The recommended dose of AMGEVITA is an initial dose of 80 mg, followed by 40 mg every other week starting one week later. If you have an inadequate response to AMGEVITA 40 mg every other week, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
It is recommended that you use an antiseptic wash daily on the affected areas.
Adults with Crohn’s disease
The usual dose regimen for Crohn’s disease is 80 mg initially followed by 40 mg every other week two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg two weeks later, and thereafter as 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with Crohn's disease
Children and adolescents from 6 to 17 years of age weighing less than 40 kg
The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg followed by 40 mg two weeks later.
Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may increase the dose frequency to 20 mg every week.
Children and adolescents from 6 to 17 years of age weighing 40 kg or more
The usual dose regimen is 80 mg initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days) followed by 80 mg two weeks later.
Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Adults with ulcerative colitis
The usual AMGEVITA dose for adults with ulcerative colitis is 160 mg initially (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days) followed by 80 mg two weeks later, then 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents with ulcerative colitis
Children and adolescents from 6 years of age weighing less than 40 kg
The usual AMGEVITA dose is 80 mg initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.
Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.
Children and adolescents from 6 years of age weighing 40 kg or more
The usual AMGEVITA dose is 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days) initially, followed by 80 mg two weeks later. Thereafter the usual dose is 80 mg every other week.
Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject AMGEVITA for as long as your doctor has told you.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA. AMGEVITA can also be given alone.
Children and adolescents with chronic non-infectious uveitis from 2 years of age
Children and adolescents from 2 years of age weighing less than 30 kg
The usual dose of AMGEVITA is 20 mg every other week with methotrexate.
Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Children and adolescents from 2 years of age weighing 30 kg or more
The usual dose of AMGEVITA is 40 mg every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
AMGEVITA is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject AMGEVITA are provided in “Instructions for use” section.
If you accidentally inject AMGEVITA more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more. Always take the outer carton of this medicine with you, even if it is empty.
If you forget to give yourself an injection, you should inject the next dose of AMGEVITA as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
The decision to stop using AMGEVITA should be discussed with your doctor. Your symptoms may return upon discontinuation.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last AMGEVITA injection.
Tell your doctor immediately if you notice any of the following signs of allergic reaction or heart failure:
Tell your doctor as soon as possible if you notice any of the following:
The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1 000 people)
Not known (frequency cannot be estimated from available data)
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1 000 people)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original carton in order to protect from light.
A single AMGEVITA pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled syringe must be protected from light, and discarded if not used within the 14-day period.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
AMGEVITA is a clear and colourless to slightly yellow solution.
Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).
Each pack contains 1, 2 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).
Each pack contains 1, 2 or 3 single-use 80 mg pre-filled syringes (with orange plunger rod).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in June 2024.
Dosing:
Using your AMGEVITA pre-filled syringe:
Important: Keep the pre-filled syringe and sharps disposal container out of the sight and reach of children.
2a Grasp pre-filled syringe by the body and remove from the carton.
2b Wait 30 minutes for the pre-filled syringe to reach room temperature.
2c Gather and place the items for your injection on a clean, well-lit surface.
3a Inspect the medicine.
Important: If the medicine is cloudy, discoloured, or contains flakes or particles, call your doctor or healthcare provider.
3b Check the expiry date (EXP) and inspect the pre-filled syringe for damage.
Important: If the pre-filled syringe is medicine is damaged or expired, call your doctor or healthcare provider.
3c Inject in one of these locations.
Important: Avoid areas with scars, stretch marks, or where skin is tender, bruised, red or hard.
Important: Only remove the needle cap when you can inject right away (within 5 minutes) because the medicine can dry out.
4a Pull the needle cap straight off while holding the pre-filled syringe barrel.
4b Pinch the skin around the injection site before the injection.
4c Insert the needle into the pinched skin.
4d Slowly press the plunger rod down to the bottom of the pre-filled syringe to inject the medicine.
Important: Continue to pinch the skin until injection is complete
Important: Never put the needle cap back on.
5a Discard the used pre-filled syringe and needle cap in the sharps disposal container.
Do not recycle the pre-filled syringe or throw it into the household waste.
Important: Always keep the sharps disposal container out of the sight and reach of children.
5b Check injection site.