Amgevita

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  • Heiti vöru:
  • Amgevita
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Staðsetning

  • Fáanlegt í:
  • Amgevita
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Immunosuppressants,
  • Lækningarsvæði:
  • Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
  • Ábendingar:
  • Rheumatoid arthritis  AMGEVITA in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate., the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.,  AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMAR
  • Vörulýsing:
  • Revision: 5

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/004212
  • Leyfisdagur:
  • 20-03-2017
  • EMEA númer:
  • EMEA/H/C/004212
  • Síðasta uppfærsla:
  • 24-05-2019

Opinber matsskýrsla

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London E14 5EU

United Kingdom

An agency of the European Union

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+44 (0)20 3660 6000

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+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/196798/2017

EMEA/H/C/004212

EPAR summary for the public

Amgevita

adalimumab

This is a summary of the European public assessment report (EPAR) for Amgevita. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Amgevita.

For practical information about using Amgevita, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Amgevita and what is it used for?

Amgevita is a medicine that acts on the immune system and is used to treat the following conditions:

plaque psoriasis (a disease causing red, scaly patches on the skin)

psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)

rheumatoid arthritis (a disease causing inflammation of the joints)

axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing

spondylitis and when there is no damage on X-ray but clear signs of inflammation

Crohn’s disease (a disease causing inflammation of the gut)

ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)

polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases

causing inflammation in the joints)

hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses

(collections of pus) and scarring on the skin

non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

Amgevita

EMA/196798/2017

Page 2/4

Amgevita is mostly used in adults when their conditions are severe, moderately severe or getting

worse, or when patients cannot use other treatments. For detailed information on the use of Amgevita

in all conditions, including when it can be used in children, see the summary of product characteristics

(also part of the EPAR).

Amgevita contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that

Amgevita is highly similar to a biological medicine (also known as the ‘reference medicine’) that is

already authorised in the European Union (EU). The reference medicine for Amgevita is Humira. For

more information on biosimilar medicines, see the question-and-answer document here.

How is Amgevita used?

Amgevita can only be obtained with a prescription and treatment should be started and supervised by

specialist doctors experienced in the diagnosis and treatment of the conditions for which it is

authorised. Doctors treating uveitis should also take advice from doctors who have experience of using

Amgevita.

The medicine is available as a solution for injection under the skin in a pre-filled syringe or pen. The

dose depends on the condition to be treated and in children is usually calculated according to the

child’s weight and height. After the starting dose, Amgevita is most often given every two weeks, but it

may be given every week in certain situations. After training, patients or their carers may inject

Amgevita if their doctor considers it appropriate. Patients may be given other medicines during

treatment with Amgevita, such as methotrexate or corticosteroids (other anti‑inflammatory

medicines).

For information on the doses to be used for each condition and other information on the use of

Amgevita, see the package leaflet.

How does Amgevita work?

The active substance in Amgevita, adalimumab, is a monoclonal antibody (a type of protein) that has

been designed to recognise and attach to a chemical messenger in the body called tumour necrosis

factor (TNF). This messenger is involved in causing inflammation and is found at high levels in patients

with the diseases that Amgevita is used to treat. By attaching to TNF, adalimumab blocks its activity,

thereby reducing inflammation and other symptoms of the diseases.

What benefits of Amgevita have been shown in studies?

Extensive laboratory studies comparing Amgevita with Humira have shown that adalimumab in

Amgevita is highly similar to adalimumab in Humira in terms of chemical structure, purity and

biological activity.

Because Amgevita is a biosimilar medicine, the studies on effectiveness and safety carried out for

Humira do not all need to be repeated for Amgevita.

The medicine has been shown to have similar effects to Humira in one main study involving 526

patients with moderate to severe rheumatoid arthritis that had not responded adequately to

methotrexate, and in another main study in 350 patients with moderate to severe psoriasis.

In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom

score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of

those given Humira. In the psoriasis study, which looked at the degree of improvement after 16

Amgevita

EMA/196798/2017

Page 3/4

weeks, there was an 81% improvement in symptom score with Amgevita compared with an 83%

improvement with Humira.

What are the risks associated with Amgevita?

The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in

the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching,

bleeding, pain or swelling), headache and muscle and bone pain.

Amgevita and other medicines of its class may also affect the ability of the immune system to fight off

infections and cancer, and there have been some cases of serious infections and blood cancers in

patients using adalimumab.

Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of

bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the

immune system attacks the patient’s own tissues, causing inflammation and organ damage), and

Stevens-Johnson syndrome (a serious skin condition).

Amgevita must not be used in patients with active tuberculosis or other severe infections, or in

patients with moderate to severe heart failure (an inability of the heart to pump enough blood around

the body). For the full list of restrictions with Amgevita, see the package leaflet.

Why is Amgevita approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance

with EU requirements for biosimilar medicines, Amgevita has a highly similar structure, purity and

biological activity to Humira and is distributed in the body in the same way.

In addition, studies in rheumatoid arthritis and psoriasis have shown that the effects of the medicine

are equivalent to those of Humira in these conditions. All these data were considered sufficient to

conclude that Amgevita will behave in the same way as Humira in terms of effectiveness and safety in

its approved indications. Therefore, the CHMP’s view was that, as for Humira, the benefit outweighs

the identified risk. The Committee recommended that Amgevita be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Amgevita?

The company that markets Amgevita must provide educational packs for doctors who will prescribe the

medicine. These packs will include information on the safety of the medicine and an alert card to be

given to patients.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Amgevita have also been included in the summary of product characteristics and

the package leaflet.

Other information about Amgevita

The European Commission granted a marketing authorisation valid throughout the European Union for

Amgevita on 22 March 2017.

The full EPAR for Amgevita can be found on the Agency’s website:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

treatment with Amgevita, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

Amgevita

EMA/196798/2017

Page 4/4

This summary was last updated in 03-2017.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

AMGEVITA 20 mg solution for injection in pre-filled syringe

AMGEVITA 40 mg solution for injection in pre-filled syringe

adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

Your doctor will also give you a

Patient Reminder Card

, which contains important safety

information that you need to be aware of before you are given AMGEVITA and during

treatment with AMGEVITA. Keep this

Patient Reminder Card

with you.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet (see section 4).

What is in this leaflet

What AMGEVITA is and what it is used for

What you need to know before you use AMGEVITA

How to use AMGEVITA

Possible side effects

How to store AMGEVITA

Contents of the pack and other information

1.

What AMGEVITA is and what it is used for

AMGEVITA contains the active substance adalimumab.

AMGEVITA is intended for the treatment of the inflammatory diseases described below:

Rheumatoid arthritis

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Ankylosing spondylitis

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Psoriatic arthritis

Plaque psoriasis

Hidradenitis suppurativa

Crohn’s disease

Ulcerative colitis

Non-infectious uveitis

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.

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

Ulcerative colitis is an inflammatory disease of the bowel.

AMGEVITA is used to treat ulcerative colitis in adults. If you have ulcerative colitis 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.

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

Adults with non-infectious uveitis with inflammation affecting the back of the eye.

Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting

the front of the eye.

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.

2.

What you need to know before you use AMGEVITA

Do not use AMGEVITA:

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).

It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds,

feeling tired, dental problems.

if you have moderate or severe heart failure. It is important to tell your doctor if you have had

or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using AMGEVITA:

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash do not inject more AMGEVITA and contact your doctor immediately

since, in

rare cases, these reactions can be life threatening

If you have an infection, including long-term or localised infection (for example, leg ulcer)

consult your doctor before starting AMGEVITA. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving AMGEVITA treatment. This risk

may increase if your lung function is impaired. These infections may be serious and include

tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic

infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your

doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your

doctor may recommend temporary discontinuation of AMGEVITA.

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor

will check you for signs and symptoms of tuberculosis before starting AMGEVITA. This will

include a thorough medical evaluation including your medical history and appropriate screening

tests (for example chest x-ray and a tuberculin test). The conduct and results of these tests

should be recorded on your

Patient Reminder Card

. It is very important that you tell your

doctor if you have ever had tuberculosis, or if you have been in close contact with someone

who has had tuberculosis. Tuberculosis can develop during therapy even if you have received

preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight

loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your

doctor immediately.

Advise your doctor if you reside or travel in regions where fungal infections such as

histoplasmosis coccidioidomycosis or blastomycosis are endemic.

Advise your doctor if you have a history of recurrent infections or other conditions that increase

the risk of infections.

Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV

or if you think you might be at risk of contracting HBV. Your doctor should test you for HBV.

AMGEVITA can cause reactivation of HBV in people who carry this virus. In some rare cases,

especially if you are taking other medicines that suppress the immune system, reactivation of

HBV can be life-threatening.

If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.

You and your doctor should pay special attention to signs of infection while you are being

treated with AMGEVITA. It is important to tell your doctor if you get symptoms of infections,

such as fever, wounds, feeling tired or dental problems.

If you are about to undergo surgery or dental procedures please inform your doctor that you are

taking AMGEVITA. Your doctor may recommend temporary discontinuation of AMGEVITA.

If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide

if you should receive or continue to receive AMGEVITA. Tell your doctor immediately if you

experience symptoms like changes in your vision, weakness in your arms or legs or numbness

or tingling in any part of your body.

Certain vaccines may cause infections and should not be given while receiving AMGEVITA.

Please check with your doctor before you receive any vaccines. It is recommended that

children, if possible, be brought up to date with all immunisations in agreement with current

immunisation guidelines prior to initiating AMGEVITA therapy. If you received AMGEVITA

while you were pregnant, your baby may be at higher risk for getting such an infection for up to

approximately five months after the last dose you received during pregnancy. It is important

that you tell your baby's doctors and other health care professionals about your AMGEVITA

use during your pregnancy so they can decide when your baby should receive any vaccine.

If you have mild heart failure and you are being treated with AMGEVITA, your heart failure

status must be closely monitored by your doctor. It is important to tell your doctor if you have

had or have a serious heart condition. If you develop new or worsening symptoms of heart

failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor

immediately. Your doctor will decide if you should receive AMGEVITA.

In some patients the body may fail to produce enough of the blood cells that help your body

fight infections or help you to stop bleeding. If you develop a fever that does not go away,

bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may

decide to stop treatment.

There have been very rare cases of certain kinds of cancer in children and adult patients taking

adalimumab or other TNF blockers. People with more serious rheumatoid arthritis that have

had the disease for a long time may have a higher than average risk of getting lymphoma (a

cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone

marrow). If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers

may increase. On rare occasions, a specific and severe type of lymphoma has been observed in

patients taking adalimumab. Some of those patients were also treated with azathioprine or 6-

mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with

AMGEVITA. In addition, cases of non-melanoma skin cancer have been observed in patients

taking adalimumab. If new skin lesions appear during or after therapy or if existing lesions

change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung

disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF

blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor

whether treatment with a TNF blocker is appropriate for you.

On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome. Contact

your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness

occur.

The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex),

which may cause allergic reactions.

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.

Children and adolescents

Vaccinations: if possible children should be up to date with all vaccinations before using

AMGEVITA.

Do not give AMGEVITA to children with polyarticular juvenile idiopathic arthritis below the

age of 2 years.

Other medicines and AMGEVITA

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.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its

use for at least 5 months after the last AMGEVITA treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice about taking this medicine.

AMGEVITA should only be used during a pregnancy if needed.

According to a pregnancy study, there was no higher risk of birth defects when the mother had

received AMGEVITA during pregnancy compared with mothers with the same disease who did

not receive AMGEVITA.

AMGEVITA can be used during breast-feeding.

If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for

getting an infection.

It is important that you tell your baby’s doctors and other health care professionals about your

AMGEVITA use during your pregnancy before the baby receives any vaccine. For more

information on vaccines see the “Warnings and precautions” section.

Driving and using machines

AMGEVITA may have a minor influence on your ability to drive, cycle or use machines. Room

spinning sensation and vision disturbances may occur after taking AMGEVITA.

AMGEVITA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium-

free’.

3.

How to use AMGEVITA

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 (as two 40 mg injections in

one day), 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 dosage 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 (as four 40 mg

injections in one day or two 40 mg injections per day for two consecutive days), followed by an

80 mg dose (as two 40 mg injections in one day) 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 (as two 40

mg injections in one

day), 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 dosage to 40

mg every week or

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 (as two 40 mg injections in one day) 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 (as four 40 mg injections in one day or two 40 mg injections per

day for two consecutive days), followed by 80 mg (as two 40

mg injections in one day) two weeks

later, and thereafter as 40 mg every other week. Depending on your response, your doctor may

increase the dosage 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 (as two 40 mg injections in one day)

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 (as two 40 mg injections in one day) initially followed by 40 mg two

weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as

four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days)

followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may

increase the dosage 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 (as four 40 mg

injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg

(as two 40 mg injections in one day) two weeks later, then 40 mg every other week. Depending on

your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg

injections in one day), 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.

Method and route of administration

AMGEVITA is administered by injection under the skin (subcutaneous injection).

If you use more AMGEVITA than you should

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 use AMGEVITA

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.

If you stop using AMGEVITA

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.

4.

Possible side effects

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

severe rash, hives or other signs of allergic reaction;

swollen face, hands, feet;

trouble breathing, swallowing;

shortness of breath with exertion or upon lying down or swelling of the feet.

Tell your doctor as soon as possible if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;

feeling weak or tired;

coughing;

tingling;

numbness;

double vision;

arm or leg weakness;

a bump or open sore that doesn't heal;

signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,

paleness.

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)

injection site reactions (including pain, swelling, redness or itching);

respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);

headache;

abdominal pain;

nausea and vomiting;

rash;

musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza);

intestinal infections (including gastroenteritis);

skin infections (including cellulitis and shingles);

ear infections;

oral infections (including tooth infections and cold sores);

reproductive tract infections;

urinary tract infection;

fungal infections;

joint infections;

benign tumours;

skin cancer;

allergic reactions (including seasonal allergy);

dehydration;

mood swings (including depression);

anxiety;

difficulty sleeping;

sensation disorders such as tingling, prickling or numbness;

migraine;

nerve root compression (including low back pain and leg pain);

vision disturbances;

eye inflammation;

inflammation of the eye lid and eye swelling;

vertigo;

sensation of heart beating rapidly;

high blood pressure;

flushing;

haematoma;

cough;

asthma;

shortness of breath;

gastrointestinal bleeding;

dyspepsia (indigestion, bloating, heart burn);

acid reflux disease;

sicca syndrome (including dry eyes and dry mouth);

itching;

itchy rash;

bruising;

inflammation of the skin (such as eczema);

breaking of finger nails and toe nails;

increased sweating;

hair loss;

new onset or worsening of psoriasis;

muscle spasms;

blood in urine;

kidney problems;

chest pain;

oedema;

fever;

reduction in blood platelets which increases risk of bleeding or bruising;

impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when

resistance to disease is lowered);

neurological infections (including viral meningitis);

eye infections;

bacterial infections;

diverticulitis (inflammation and infection of the large intestine);

cancer;

cancer that affects the lymph system;

melanoma;

immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting

as sarcoidosis);

vasculitis (inflammation of blood vessels);

tremor;

neuropathy;

stroke;

hearing loss, buzzing;

sensation of heart beating irregularly such as skipped beats;

heart problems that can cause shortness of breath or ankle swelling;

heart attack;

a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;

lung diseases causing shortness of breath (including inflammation);

pulmonary embolism (blockage in an artery of the lung);

pleural effusion (abnormal collection of fluid in the pleural space);

inflammation of the pancreas which causes severe pain in the abdomen and back;

difficulty in swallowing;

facial oedema;

gallbladder inflammation, gallbladder stones;

fatty liver;

night sweats;

scar;

abnormal muscle breakdown;

systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other

organ systems);

sleep interruptions;

impotence;

inflammations.

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow);

severe allergic reaction with shock;

multiple sclerosis;

nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause

muscle weakness, abnormal sensations, tingling in the arms and upper body);

heart stops pumping;

pulmonary fibrosis (scarring of the lung);

intestinal perforation;

hepatitis;

reactivation of hepatitis B;

autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);

cutaneous vasculitis (inflammation of blood vessels in the skin);

Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);

facial oedema associated with allergic reactions;

erythema multiforme (inflammatory skin rash);

lupus-like syndrome;

angioedema (localised swelling of the skin);

lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);

Merkel cell carcinoma (a type of skin cancer);

liver failure;

worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle

weakness).

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)

low blood measurements for white blood cells;

low blood measurements for red blood cells;

increased lipids in the blood;

elevated liver enzymes.

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells;

low blood measurements for platelets;

increased uric acid in the blood;

abnormal blood measurements for sodium;

low blood measurements for calcium;

low blood measurements for phosphate;

high blood sugar;

high blood measurements for lactate dehydrogenase;

autoantibodies present in the blood;

low blood potassium.

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin measurement (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count.

Reporting of side effects

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 via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store AMGEVITA

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 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.

6.

Contents of the pack and other information

What AMGEVITA contains

The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in

0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.

The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and

water for injection.

What AMGEVITA looks like and contents of the pack

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, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology Ireland UC

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

s.a. Amgen n.v.

Tel/Tél: +32 (0)2 7752711

Lietuva

Amgen Switzerland AG Vilniaus filialas

Tel: +370 5 219 7474

България

Амджен България ЕООД

Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg

s.a. Amgen

Belgique/Belgien

Tel/Tél: +32 (0)2 7752711

Česká republika

Amgen s.r.o.

Tel: +420 221 773 500

Magyarország

Amgen Kft.

Tel.: +36 1 35 44 700

Danmark

Amgen, filial af Amgen AB, Sverige

Tlf: +45 39617500

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Eesti

Amgen Switzerland AG Vilniaus filialas

Tel: +372 586 09553

Norge

Amgen AB

Tel: +47 23308000

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Τηλ.: +30 210 3447000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

España

Amgen S.A.

Tel: +34 93 600 18 60

Polska

Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000

France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Portugal

Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220606

Hrvatska

Amgen d.o.o.

Tel: +385 (0)1 562 57 20

România

Amgen România SRL

Tel: +4021 527 3000

Ireland

Amgen Ireland Limited

Tel: +353 1 8527400

Slovenija

AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Amgen Slovakia s.r.o.

Tel: +421 2 321 114 49

Italia

Amgen S.r.l.

Tel: +39 02 6241121

Suomi/Finland

Orion Pharma

Puh/Tel: +358 10 4261

Kύπρος

C.A. Papaellinas Ltd

Τηλ.: +357 22741 741

Sverige

Amgen AB

Tel: +46 (0)8 6951100

Latvija

Amgen Switzerland AG Rīgas filiāle

Tel: +371 257 25888

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

Instructions for use:

AMGEVITA single use pre-filled syringe

For subcutaneous use

Guide to parts

Before use

After use

Plunger rod

Finger flange

Label and

expiration date

Syringe barrel

Medicine

Needle

cap on

Used plunger rod

Finger flange

Label and expiration

date

Used syringe barrel

Used needle

Needle cap off

Important:

Needle is inside

Important

Before you use an AMGEVITA pre-filled syringe, read this important information:

Using your AMGEVITA pre-filled syringe

It is important that you do not try to give the injection unless you or your caregiver has received

training.

Do not

use an AMGEVITA pre-filled syringe if it has been dropped on a hard surface. Part of

the AMGEVITA pre-filled syringe may be broken even if you cannot see the break. Use a new

AMGEVITA pre-filled syringe.

The needle cover of the AMGEVITA pre-filled syringe is made from dry natural rubber, which

contains latex. Tell your healthcare provider if you are allergic to latex.

Step 1: Prepare

A.

Remove the number of AMGEVITA pre-filled syringes you need from the package.

Grab the syringe

barrel to remove

the syringe from

the tray.

Place your finger or thumb on

edge of tray to secure it while

you remove the syringe.

Grab Here

Put the original package with any unused syringes back in the refrigerator.

For safety reasons:

Do not

grasp the plunger rod.

Do not

grasp the needle cap.

Do not

remove the needle cap until you are ready to inject.

Do not

remove the finger flange. This is part of the syringe.

For a more comfortable injection, leave the syringe at room temperature for

15 to 30

minutes before

injecting.

Do not

put the syringe back in the refrigerator once it has reached room temperature.

Do not

try to warm the syringe by using a heat source such as hot water or microwave.

Do not

leave the syringe in direct sunlight.

Do not

shake the syringe.

Important:

Always hold the pre-filled syringe by the syringe barrel.

B.

Inspect the AMGEVITA pre-filled syringe.

Syringe barrel

Label expiration

date

Plunger rod

Needle cap on

Medicine

Finger flange

Always hold the syringe by the syringe barrel.

Make sure the medicine in the syringe is clear and colourless to slightly yellow.

Do not

use the syringe if:

The medicine is cloudy or discoloured or contains flakes, or particles.

Any part appears cracked or broken.

The needle cap is missing or not securely attached.

The expiration date printed on the label has passed.

In all cases, use a new syringe.

C.

Gather all materials needed for your injection(s).

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place a new, pre-filled syringe.

You will also need these additional items, as they are not included in the carton:

Alcohol wipes

Cotton ball or gauze pad

Plaster

Sharps disposal container

D.

Prepare and clean your injection site(s).

Belly

Thigh

You can use:

Your thigh

Belly, except for a 2 inch (5 centimetres) area around your belly button

Clean your injection site with an alcohol wipe. Let your skin dry.

Do not

touch this area again before injecting.

If you want to use the same injection site, make sure it is not the same spot on the injection site

you used for a previous injection.

Do not

inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into

areas with scars or stretch marks.

If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin

patch or lesion.

Step 2: Get ready

E.

Pull the needle cap straight out and away from your body when you are ready to inject.

It is normal to see a drop of liquid at the end of the needle.

Do not

twist or bend the needle cap.

Do not

put the needle cap back onto the syringe.

Do not

remove the needle cap from the syringe until you are ready to inject.

Important:

Throw the needle cap into the sharps disposal container provided.

F.

Pinch your injection site to create a firm surface.

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres)

wide.

Important:

Keep the skin pinched while injecting.

Step 3: Inject

G.

Hold the pinch. With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.

Do not

place your finger on the plunger rod while inserting the needle.

H.

Using slow and constant pressure, push the plunger rod all the way down until it stops moving.

I.

When done, release your thumb, and gently lift the syringe off of your skin.

Step 4: Finish

J.

Discard the used syringe and the needle cap.

Do not

reuse the used syringe.

Do not

use any medicine that is left in the used syringe.

Put the used AMGEVITA syringe in a sharps disposal container immediately after use.

Do not

throw away (dispose of) the syringe in your household waste.

Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for

disposal.

Do not

recycle the syringe or sharps disposal container or throw them into the household waste.

Important:

Always keep the sharps disposal container out of the sight and reach of children.

K.

Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site.

Do not

rub the injection site.

Apply a plaster if needed.

Package leaflet: Information for the user

AMGEVITA 40 mg solution for injection in pre-filled pen

adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

Your doctor will also give you a

Patient Reminder Card

, which contains important safety

information that you need to be aware of before you are given AMGEVITA and during

treatment with AMGEVITA. Keep this

Patient Reminder Card

with you.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet (see section 4).

What is in this leaflet

What AMGEVITA is and what it is used for

What you need to know before you use AMGEVITA

How to use AMGEVITA

Possible side effects

How to store AMGEVITA

Contents of the pack and other information

1.

What AMGEVITA is and what it is used for

AMGEVITA contains the active substance adalimumab.

AMGEVITA is intended for the treatment of the inflammatory diseases described below:

Rheumatoid arthritis

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Ankylosing spondylitis

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Psoriatic arthritis

Plaque psoriasis

Hidradenitis suppurativa

Crohn’s disease

Ulcerative colitis

Non-infectious uveitis

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.

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

Ulcerative colitis is an inflammatory disease of the bowel.

AMGEVITA is used to treat ulcerative colitis in adults. If you have ulcerative colitis 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.

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

Adults with non-infectious uveitis with inflammation affecting the back of the eye.

Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting

the front of the eye.

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.

2.

What you need to know before you use AMGEVITA

Do not use AMGEVITA:

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).

It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds,

feeling tired, dental problems.

if you have moderate or severe heart failure. It is important to tell your doctor if you have had

or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using AMGEVITA:

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash do not inject more AMGEVITA and contact your doctor immediately since, in

rare cases, these reactions can be life threatening.

If you have an infection, including long-term or localised infection (for example, leg ulcer)

consult your doctor before starting AMGEVITA. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving AMGEVITA treatment. This risk

may increase if your lung function is impaired. These infections may be serious and include

tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic

infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your

doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your

doctor may recommend temporary discontinuation of AMGEVITA.

As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor

will check you for signs and symptoms of tuberculosis before starting AMGEVITA. This will

include a thorough medical evaluation including your medical history and appropriate screening

tests (for example chest x-ray and a tuberculin test). The conduct and results of these tests

should be recorded on your

Patient Reminder Card

. It is very important that you tell your

doctor if you have ever had tuberculosis, or if you have been in close contact with someone

who has had tuberculosis. Tuberculosis can develop during therapy even if you have received

preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight

loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your

doctor immediately.

Advise your doctor if you reside or travel in regions where fungal infections such as

histoplasmosis coccidioidomycosis or blastomycosis are endemic.

Advise your doctor if you have a history of recurrent infections or other conditions that increase

the risk of infections.

Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV

or if you think you might be at risk of contracting HBV. Your doctor should test you for HBV.

AMGEVITA can cause reactivation of HBV in people who carry this virus. In some rare cases,

especially if you are taking other medicines that suppress the immune system, reactivation of

HBV can be life-threatening.

If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.

You and your doctor should pay special attention to signs of infection while you are being

treated with AMGEVITA. It is important to tell your doctor if you get symptoms of infections,

such as fever, wounds, feeling tired or dental problems.

If you are about to undergo surgery or dental procedures please inform your doctor that you are

taking AMGEVITA. Your doctor may recommend temporary discontinuation of AMGEVITA.

If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide

if you should receive or continue to receive AMGEVITA. Tell your doctor immediately if you

experience symptoms like changes in your vision, weakness in your arms or legs or numbness

or tingling in any part of your body.

Certain vaccines may cause infections and should not be given while receiving AMGEVITA.

Please check with your doctor before you receive any vaccines. It is recommended that

children, if possible, be brought up to date with all immunisations in agreement with current

immunisation guidelines prior to initiating AMGEVITA therapy. If you received AMGEVITA

while you were pregnant, your baby may be at higher risk for getting such an infection for up to

approximately five months after the last dose you received during pregnancy. It is important

that you tell your baby's doctors and other health care professionals about your AMGEVITA

use during your pregnancy so they can decide when your baby should receive any vaccine.

If you have mild heart failure and you are being treated with AMGEVITA, your heart failure

status must be closely monitored by your doctor. It is important to tell your doctor if you have

had or have a serious heart condition. If you develop new or worsening symptoms of heart

failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor

immediately. Your doctor will decide if you should receive AMGEVITA.

In some patients the body may fail to produce enough of the blood cells that help your body

fight infections or help you to stop bleeding. If you develop a fever that does not go away,

bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may

decide to stop treatment.

There have been very rare cases of certain kinds of cancer in children and adult patients taking

adalimumab or other TNF blockers. People with more serious rheumatoid arthritis that have

had the disease for a long time may have a higher than average risk of getting lymphoma (a

cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone

marrow). If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers

may increase. On rare occasions, a specific and severe type of lymphoma has been observed in

patients taking adalimumab. Some of those patients were also treated with azathioprine or 6-

mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with

AMGEVITA. In addition, cases of non-melanoma skin cancer have been observed in patients

taking adalimumab. If new skin lesions appear during or after therapy or if existing lesions

change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma in patients with a specific type of lung

disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF

blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor

whether treatment with a TNF blocker is appropriate for you.

On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome. Contact

your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness

occur.

The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which

may cause allergic reactions.

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.

Children and adolescents

Vaccinations: if possible children should be up to date with all vaccinations before using

AMGEVITA.

Do not give AMGEVITA to children with polyarticular juvenile idiopathic arthritis below the

age of 2 years.

Other medicines and AMGEVITA

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.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its

use for at least 5 months after the last AMGEVITA treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice about taking this medicine.

AMGEVITA should only be used during a pregnancy if needed.

According to a pregnancy study, there was no higher risk of birth defects when the mother had

received AMGEVITA during pregnancy compared with mothers with the same disease who did

not receive AMGEVITA.

AMGEVITA can be used during breast-feeding.

If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for

getting an infection.

It is important that you tell your baby’s doctors and other health care professionals about your

AMGEVITA use during your pregnancy before the baby receives any vaccine. For more

information on vaccines see the “Warnings and precautions” section.

Driving and using machines

AMGEVITA may have a minor influence on your ability to drive, cycle or use machines. Room

spinning sensation and vision disturbances may occur after taking AMGEVITA.

AMGEVITA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodium-

free’.

3.

How to use AMGEVITA

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, 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, 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 (as two 40

mg injections in

one day), 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 dosage 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 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 (as four 40 mg

injections in one day or two 40 mg injections per day for two consecutive days), followed by an

80 mg dose (as two 40 mg injections in one day) 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 (as two 40

mg injections in one

day), 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 dosage to 40

mg every week or

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 (as two 40

mg injections in one day) 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 (as four 40 mg injections in one day or two 40 mg injections per

day for two consecutive days), followed by 80 mg (as two 40

mg injections in one day) two weeks

later, and thereafter as 40 mg every other week. Depending on your response, your doctor may

increase the dosage 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 (as two 40 mg injections in one day)

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.

The 40 mg pre-filled pen cannot be used for the 20 mg dose. An AMGEVITA 20 mg pre-filled

syringe

is however available for the 20 mg dose.

Children and adolescents from 6 to 17 years of age weighing 40 kg or more

The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two

weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as

four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days)

followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may

increase the dosage 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 (as four 40 mg

injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg

(as two 40 mg injections in one day) two weeks later, then 40 mg every other week. Depending on

your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg

injections in one day), 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.

The 40 mg pre-filled pen cannot be used for the 20 mg dose. An AMGEVITA 20 mg pre-filled

syringe

is however available for the 20 mg 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.

Method and route of administration

AMGEVITA is administered by injection under the skin (subcutaneous injection).

If you use more AMGEVITA than you should

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 use AMGEVITA

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.

If you stop using AMGEVITA

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.

4.

Possible side effects

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

severe rash, hives or other signs of allergic reaction;

swollen face, hands, feet;

trouble breathing, swallowing;

shortness of breath with exertion or upon lying down or swelling of the feet.

Tell your doctor as soon as possible if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;

feeling weak or tired;

coughing;

tingling;

numbness;

double vision;

arm or leg weakness;

a bump or open sore that doesn't heal;

signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,

paleness.

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)

injection site reactions (including pain, swelling, redness or itching);

respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);

headache;

abdominal pain;

nausea and vomiting;

rash;

musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza);

intestinal infections (including gastroenteritis);

skin infections (including cellulitis and shingles);

ear infections;

oral infections (including tooth infections and cold sores);

reproductive tract infections;

urinary tract infection;

fungal infections;

joint infections;

benign tumours;

skin cancer;

allergic reactions (including seasonal allergy);

dehydration;

mood swings (including depression);

anxiety;

difficulty sleeping;

sensation disorders such as tingling, prickling or numbness;

migraine;

nerve root compression (including low back pain and leg pain);

vision disturbances;

eye inflammation;

inflammation of the eye lid and eye swelling;

vertigo;

sensation of heart beating rapidly;

high blood pressure;

flushing;

haematoma;

cough;

asthma;

shortness of breath;

gastrointestinal bleeding;

dyspepsia (indigestion, bloating, heart burn);

acid reflux disease;

sicca syndrome (including dry eyes and dry mouth);

itching;

itchy rash;

bruising;

inflammation of the skin (such as eczema);

breaking of finger nails and toe nails;

increased sweating;

hair loss;

new onset or worsening of psoriasis;

muscle spasms;

blood in urine;

kidney problems;

chest pain;

oedema;

fever;

reduction in blood platelets which increases risk of bleeding or bruising;

impaired healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when

resistance to disease is lowered);

neurological infections (including viral meningitis);

eye infections;

bacterial infections;

diverticulitis (inflammation and infection of the large intestine);

cancer;

cancer that affects the lymph system;

melanoma;

immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting

as sarcoidosis);

vasculitis (inflammation of blood vessels);

tremor;

neuropathy;

stroke;

hearing loss, buzzing;

sensation of heart beating irregularly such as skipped beats;

heart problems that can cause shortness of breath or ankle swelling;

heart attack;

a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;

lung diseases causing shortness of breath (including inflammation);

pulmonary embolism (blockage in an artery of the lung);

pleural effusion (abnormal collection of fluid in the pleural space);

inflammation of the pancreas which causes severe pain in the abdomen and back;

difficulty in swallowing;

facial oedema;

gallbladder inflammation, gallbladder stones;

fatty liver;

night sweats;

scar;

abnormal muscle breakdown;

systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other

organ systems);

sleep interruptions;

impotence;

inflammations.

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow);

severe allergic reaction with shock;

multiple sclerosis;

nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause

muscle weakness, abnormal sensations, tingling in the arms and upper body);

heart stops pumping;

pulmonary fibrosis (scarring of the lung);

intestinal perforation;

hepatitis;

reactivation of hepatitis B;

autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);

cutaneous vasculitis (inflammation of blood vessels in the skin);

Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);

facial oedema associated with allergic reactions;

erythema multiforme (inflammatory skin rash);

lupus-like syndrome;

angioedema (localised swelling of the skin);

lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);

Merkel cell carcinoma (a type of skin cancer);

liver failure;

worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle

weakness).

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)

low blood measurements for white blood cells;

low blood measurements for red blood cells;

increased lipids in the blood;

elevated liver enzymes.

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells;

low blood measurements for platelets;

increased uric acid in the blood;

abnormal blood measurements for sodium;

low blood measurements for calcium;

low blood measurements for phosphate;

high blood sugar;

high blood measurements for lactate dehydrogenase;

autoantibodies present in the blood;

low blood potassium.

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin measurement (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count.

Reporting of side effects

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 via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store AMGEVITA

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 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 pen may be stored at temperatures up to a maximum of 25°C for a

period of up to 14 days. The pre-filled pen 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.

6.

Contents of the pack and other information

What AMGEVITA contains

The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in

0.8 mL of solution.

The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and

water for injection.

What AMGEVITA looks like and contents of the pack

AMGEVITA is a clear and colourless to slightly yellow solution.

Each pack contains 1, 2, 4 or 6 single use SureClick pre-filled pens.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer

Amgen Technology Ireland UC

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

s.a. Amgen n.v.

Tel/Tél: +32 (0)2 7752711

Lietuva

Amgen Switzerland AG Vilniaus filialas

Tel: +370 5 219 7474

България

Амджен България ЕООД

Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg

s.a. Amgen

Belgique/Belgien

Tel/Tél: +32 (0)2 7752711

Česká republika

Amgen s.r.o.

Tel: +420 221 773 500

Magyarország

Amgen Kft.

Tel.: +36 1 35 44 700

Danmark

Amgen, filial af Amgen AB, Sverige

Tlf: +45 39617500

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Eesti

Amgen Switzerland AG Vilniaus filialas

Tel: +372 586 09553

Norge

Amgen AB

Tel: +47 23308000

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Τηλ.: +30 210 3447000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

España

Amgen S.A.

Tel: +34 93 600 18 60

Polska

Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000

France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Portugal

Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220606

Hrvatska

Amgen d.o.o.

Tel: +385 (0)1 562 57 20

România

Amgen România SRL

Tel: +4021 527 3000

Ireland

Amgen Ireland Limited

Tel: +353 1 8527400

Slovenija

AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Amgen Slovakia s.r.o.

Tel: +421 2 321 114 49

Italia

Amgen S.r.l.

Tel: +39 02 6241121

Suomi/Finland

Orion Pharma

Puh/Tel: +358 10 4261

Kύπρος

C.A. Papaellinas Ltd

Τηλ.: +357 22741 741

Sverige

Amgen AB

Tel: +46 (0)8 6951100

Latvija

Amgen Switzerland AG Rīgas filiāle

Tel: +371 257 25888

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

Instructions for use:

AMGEVITA single use SureClick pre-filled pen

For subcutaneous use

Guide to parts

Before use

After use

Blue start button

Expiration date

Window

Medicine

Yellow cap on

Expiration date

Yellow window

(injection complete)

Yellow safety guard

Yellow cap off

Important:

Needle is inside

Important

Before you use an AMGEVITA pre-filled pen, read this important information:

Using your AMGEVITA pre-filled pen

It is important that you do not try to give the injection unless you or your caregiver has received

training.

Do not

use an AMGEVITA pre-filled pen if it has been dropped on a hard surface. Part of the

AMGEVITA pre-filled pen may be broken even if you cannot see the break. Use a new

AMGEVITA pre-filled pen.

The needle cover of the AMGEVITA pre-filled pen is made from dry natural rubber, which

contains latex. Tell your healthcare provider if you are allergic to latex.

Step 1: Prepare

A.

Remove one AMGEVITA pre-filled pen from the package.

Carefully lift the pre-filled pen straight up out of the box.

Put the original package with any unused pre-filled pens back in the refrigerator.

For a more comfortable injection, leave the pre-filled pen at room temperature for

15 to 30

minutes

before injecting.

Do not

put the pre-filled pen back in the refrigerator once it has reached room temperature.

Do not

try to warm the pre-filled pen by using a heat source such as hot water or microwave.

Do not

shake the pre-filled pen.

Do not

remove the yellow cap from the pre-filled pen yet.

B.

Inspect the AMGEVITA pre-filled pen.

Yellow cap on

Window

Medicine

Make sure the medicine in the window is clear and colourless to slightly yellow.

Do not

use the pre-filled pen if:

The medicine is cloudy or discoloured, or contains flakes or particles.

Any part appears cracked or broken.

The pre-filled pen has been dropped on a hard surface.

The yellow cap is missing or not securely attached.

The expiration date printed on the label has passed.

In all cases, use a new pre-filled pen.

C.

Gather all materials needed for your injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place a new, pre-filled pen.

You will also need these additional items, as they are not included in the carton:

Alcohol wipes

Cotton ball or gauze pad

Plaster

Sharps disposal container

D.

Prepare and clean your injection site.

Belly

Thigh

You can use:

Your thigh

Belly, except for a 2-inch (5 centimetre) area right around your belly button

Clean your injection site with an alcohol wipe. Let your skin dry.

Do not

touch this area again before injecting.

If you want to use the same injection site, make sure it is not the same spot on the injection site

you used for a previous injection.

Do not

inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into

areas with scars or stretch marks.

If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin

patch or lesion.

Step 2: Get ready

E.

Pull the yellow cap straight off when you are ready to inject.

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

Do not

twist or bend the yellow cap.

Do not

put the yellow cap back onto the pre-filled pen.

Do not

remove the yellow cap from the pre-filled pen until you are ready to inject.

F.

Stretch or pinch your injection site to create a firm surface.

Stretch method

Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area

about

2

inches (

5

centimetres) wide.

OR

Pinch method

Pinch the skin firmly between your thumb and fingers, creating an area about

2

inches (

5

centimetres)

wide.

Important:

Keep the skin stretched or pinched while injecting.

Step 3: Inject

G.

Hold the stretch or pinch. With the yellow cap off,

place

the pre-filled pen on your skin at

90 degrees.

Important:

Do not touch the blue start button yet.

H.

Firmly

push

the pre-filled pen down onto the skin until it stops moving.

Push down

Important:

You must push all the way down but do not touch the blue start button until you are

ready to inject.

I.

When you are ready to inject,

press

the blue start button.

“Click”

J.

Keep

pushing

down on your skin. Your injection could take about 10 seconds.

~10s

The window turns yellow

When the injection is done

Note:

After you remove the pre-filled pen from your

skin, the needle will be automatically covered.

Important:

When you remove the pre-filled pen, if the window has not turned yellow, or if it looks

like the medicine is still injecting, this means you have not received a full dose. Call your doctor

immediately.

“Click”

Step 4: Finish

K.

Discard the used pre-filled pen and the yellow cap.

Put the used pre-filled pen in a sharps disposal container immediately after use.

Do not

throw

away (dispose of) the pre-filled pen in your household waste.

Talk with your doctor or pharmacist about proper disposal. There may be local guidelines for

disposal.

Do not

reuse the pre-filled pen.

Do not

recycle the pre-filled pen or sharps disposal container or throw them into the household

waste.

Important:

Always keep the sharps disposal container out of the sight and reach of children.

L.

Examine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site.

Do not

rub the injection site.

Apply a plaster if needed.