Amgevita: detailed information

Package leaflet: Information for the user

AMGEVITA 20 mg solution for injection in pre-filled syringe, 40 mg solution for injection in pre-filled syringe

adalimumab
Please 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 give you a Patient Reminder Card containing important safety information you need to know before administration of AMGEVITA and during treatment with AMGEVITA. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What AMGEVITA is and what it is used for
What you need to know before using 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, a medicine that acts on the body's immune (defence) system.
AMGEVITA is indicated for the treatment of the following inflammatory diseases:

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Ankylosing spondylitis
Non-radiographic axial spondyloarthritis without evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

The active substance in AMGEVITA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
Adalimumab targets a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at higher concentrations in the inflammatory diseases listed above. By binding to TNFα, AMGEVITA reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
AMGEVITA is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, you may initially be given other disease-modifying drugs, such as methotrexate. If your response to these drugs is not satisfactory, you will be given AMGEVITA to treat rheumatoid arthritis.
AMGEVITA may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
AMGEVITA slows down the progression of joint cartilage and bone damage caused by the disease and improves physical function.
AMGEVITA is generally used in combination with methotrexate. If your doctor decides that treatment with methotrexate is not appropriate, AMGEVITA may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear during childhood.
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age and enthesitis-related arthritis in patients from 6 years of age. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If the response to these drugs is inadequate, AMGEVITA will be administered for the treatment of polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without evidence of ankylosing spondylitis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis without evidence of ankylosing spondylitis are inflammatory conditions of the spine.
AMGEVITA is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis without evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis without evidence of ankylosing spondylitis, you will first be given other medicines. If you do not achieve an adequate response with these medicines, you will be given AMGEVITA to reduce the signs and symptoms of the disease.

Psoriatic arthritis
Psoriatic arthritis is joint inflammation associated with psoriasis.
AMGEVITA is used to treat psoriatic arthritis in adults. AMGEVITA slows down joint cartilage and bone damage caused by the disease and improves physical function.

Plaque psoriasis in adults and children
Plaque psoriasis is a skin condition causing red, scaly and thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body's immune system leading to 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 not worked optimally or are not suitable.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease and is often painful. Symptoms may include painful nodules and abscesses (boils) that may drain pus. It most commonly affects specific skin areas such as the under-breast region, armpits, inner thighs, groin and buttocks. Scarring may also develop 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 often associated with this disease. You may initially be given other medicines. If you do not respond adequately to these medicines, you will be given AMGEVITA.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the gastrointestinal 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 adequately to these medicines, AMGEVITA will be administered to reduce signs and symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation 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 initially take other medicines. If you are unable to achieve an adequate response with these medicines, you will take AMGEVITA to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
AMGEVITA is used for the treatment of:

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 part of the eye.

This inflammation can lead to decreased vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). AMGEVITA works by reducing this inflammation.

2. What you should know before using AMGEVITA

Do not use AMGEVITA:

if you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
if you have a serious infection, including active tuberculosis, sepsis (blood infection), or other opportunistic infections (unusual infections associated with a weakened immune system) (see “Warnings and precautions”). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
if you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using AMGEVITA:
Allergic reactions

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer AMGEVITA again and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with AMGEVITA. If you are in any doubt, contact your doctor.
You may be more likely to get infections while being treated with AMGEVITA. This risk may increase if your lung function is impaired. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, or other opportunistic infections and sepsis, which may, in rare cases, be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may recommend temporarily stopping AMGEVITA.

Tuberculosis

Since cases of tuberculosis have occurred in patients treated with adalimumab, before starting therapy with AMGEVITA, your doctor will check whether you have signs or symptoms of tuberculosis. This will involve a detailed medical evaluation including your medical history and appropriate clinical tests (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has tuberculosis.
Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis.
Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after therapy.

Travel/recurrent infection

Inform your doctor if you live in or travel to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking AMGEVITA may cause reactivation of hepatitis B virus in people who are carriers of this virus. In some rare cases, especially if the patient is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus may be life-threatening.

Age over 65 years

If you are over 65 years of age, you may be more susceptible to infections while taking AMGEVITA. You and your doctor should pay particular attention to signs of infection while you are being treated with AMGEVITA. It is important to inform your doctor if you develop symptoms of infection such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

Before undergoing surgery or dental procedures, inform your doctor that you are taking AMGEVITA. Your doctor may recommend temporarily stopping AMGEVITA.

Demyelinating disease

If you have or develop a demyelinating disease such as multiple sclerosis, your doctor will decide whether you should start or continue treatment with AMGEVITA. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccinations

Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and may cause infections; these must not be given during treatment with AMGEVITA. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the vaccination schedule according to current vaccination guidelines before starting AMGEVITA therapy.
If you have taken AMGEVITA during pregnancy, the baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the pediatrician or other healthcare provider about your use of AMGEVITA during pregnancy so they can decide when the baby should receive any vaccinations.

Heart failure

If you have mild heart failure and are being treated with AMGEVITA, your doctor must carefully monitor your heart condition. It is important to inform your doctor if you have or have had heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking AMGEVITA.

Fever, bruising, bleeding, or pale appearance

In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or appear pale, contact your doctor immediately. Your doctor may decide to stop the treatment.

Cancer

In patients, both children and adults, treated with adalimumab or other anti-TNF medicines, some types of cancer have very rarely occurred. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow).
If you are taking AMGEVITA, your risk of developing lymphoma, leukemia, or other cancers may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also being treated with azathioprine or 6-mercaptopurine. Inform 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 treatment, or if existing lesions change in appearance, inform 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 anti-TNF medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNF medicine is appropriate.

Autoimmune diseases

Rarely, treatment with AMGEVITA may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

To improve the traceability of this medicine, your doctor or pharmacist should record the name and batch number of the product administered to you on your patient card. You may wish to note down these details in case you are asked for them in the future.
Children and adolescents

Vaccinations: if possible, children should have completed all recommended vaccinations before starting AMGEVITA.
Do not give AMGEVITA to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
Do not give AMGEVITA to children under 4 years of age with plaque psoriasis.
Do not give AMGEVITA to children under 6 years of age with Crohn’s disease or ulcerative colitis.

Other medicines and AMGEVITA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AMGEVITA may be taken together with methotrexate and other disease-modifying antirheumatic drugs (DMARDs) (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), steroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
AMGEVITA must not be taken at the same time as medicines containing anakinra or abatacept as active substances due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

You should use an effective contraceptive method to prevent pregnancy and continue using it for at least 5 months after your last dose of AMGEVITA.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice regarding the use of this medicine.
AMGEVITA should be used during pregnancy only if clearly needed.
According to a pregnancy study, no increased risk of birth defects was observed when mothers received AMGEVITA during pregnancy compared to mothers with the same condition who did not receive AMGEVITA.
AMGEVITA may be used during breastfeeding.
If you take AMGEVITA during pregnancy, the baby may have an increased risk of infection.
It is important that you inform the pediatrician or other healthcare provider about your use of AMGEVITA during pregnancy before the baby receives any vaccinations. For more information on vaccinations, see the section “Warnings and precautions”.

Driving and using machines
AMGEVITA may affect, although only to a minor extent, your ability to drive, ride a bicycle, or use machinery. After taking AMGEVITA, you may experience visual disturbances or a sensation that your surroundings are spinning (dizziness).

AMGEVITA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose and is therefore essentially “sodium-free”.

3. How to use AMGEVITA

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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). In adult patients with rheumatoid arthritis,
ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
and psoriatic arthritis, the usual dosage is 40 mg every other week, administered as a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with AMGEVITA.
If your doctor determines that methotrexate is not appropriate, AMGEVITA may be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with AMGEVITA,
your doctor may decide to prescribe you 40 mg weekly or 80 mg every other week.

Children, adolescents and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of AMGEVITA is 20 mg every other week.
Children, adolescents and adults aged 2 years and older, 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 aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of AMGEVITA is 20 mg every other week.
Children, adolescents and adults aged 6 years and older, 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 (via two 40 mg injections on the same day), followed by 40 mg every other week, starting the week after the initial dose. You must continue treatment with AMGEVITA for the duration prescribed by your doctor. Depending on the clinical response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with plaque psoriasis
Children and adolescents aged 4 to 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of AMGEVITA is an initial dose of 20 mg, followed by a dose of 20 mg the following week. Thereafter, the usual dose is 20 mg every other week.
Children and adolescents aged 4 to 17 years, weighing 30 kg or more
The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by a dose of 40 mg the following week. Thereafter, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa
The usual dose for hidradenitis suppurativa is an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. After another two weeks, continue with a dose of 40 mg weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash solution daily on affected areas.

Adolescents with hidradenitis suppurativa, aged 12 to 17 years, weighing 30 kg or more
The recommended dose of AMGEVITA is an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose. If the response to 40 mg of AMGEVITA every other week is inadequate, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on affected areas.

Adults with Crohn's disease
In Crohn's disease, the usual dose is initially 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later, and subsequently 40 mg every other week. Depending on the clinical response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with Crohn's disease
Children and adolescents aged 6 to 17 years, weighing less than 40 kg
Initially, the usual dosing regimen is 40 mg, followed by 20 mg two weeks later. If a more rapid response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg two weeks later.
Thereafter, the usual dose is 20 mg every other week. Depending on the child's response, your doctor may increase the frequency to 20 mg weekly.
Children and adolescents aged 6 to 17 years, weighing 40 kg or more
Initially, the usual dosing regimen is 80 mg (via two 40 mg injections on the same day), followed by 40 mg two weeks later. If a more rapid response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later.
Thereafter, the usual dose is 40 mg every other week. Depending on the child's response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Adults with ulcerative colitis
For adults with ulcerative colitis, the usual initial dose of AMGEVITA is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later, then 40 mg every other week. Depending on the clinical response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis
Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of AMGEVITA is 80 mg (via two 40 mg injections on the same day), followed by 40 mg (via a single 40 mg injection) after two weeks. Thereafter, the usual dose is 40 mg every other week.
Patients who turn 18 years old while receiving 40 mg every other week should continue the prescribed dose.
Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of AMGEVITA is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) after two weeks. Thereafter, the usual dose is 80 mg every other week.
Patients who turn 18 years old while receiving 80 mg every other week should continue the prescribed dose.

Adults with non-infectious uveitis
For adults with non-infectious uveitis, the usual dose is an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose. You must continue injecting AMGEVITA for the duration prescribed by your doctor.
In non-infectious uveitis, corticosteroids or other immunosuppressive medications may be continued during treatment with AMGEVITA. AMGEVITA may also be administered as monotherapy.

Children and adolescents with chronic non-infectious uveitis, aged 2 years and older
Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of AMGEVITA is 20 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 40 mg, which may be administered one week before starting the usual dosing regimen.
Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of AMGEVITA is 40 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg, which may be administered one week before starting the usual dosing regimen.

Method and route of administration
AMGEVITA is administered by subcutaneous injection (injection under the skin).
Detailed instructions on how to inject AMGEVITA are provided in the section “Instructions for use”.

If you use more AMGEVITA than you should
If you accidentally inject AMGEVITA more frequently than prescribed by your doctor or pharmacist, contact your doctor or pharmacist and inform them that you have taken more medicine than prescribed. Always keep the carton of this medicine, even if empty.

If you forget to use AMGEVITA
If you forget to give an injection, inject the next dose of AMGEVITA as soon as you remember. Then resume your regular dosing schedule.

If you stop using AMGEVITA
The decision to stop using AMGEVITA should be discussed with your doctor. Symptoms may return after stopping treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are mild to moderate in severity. However, some can be serious and require treatment. Side effects may occur up to 4 months after the last injection of AMGEVITA.

Contact your doctor immediately if you notice any of the following signs of an allergic reaction or heart failure:

severe rash, hives, or other signs of allergic reaction;
swelling of the face, hands, or feet;
difficulty breathing, difficulty swallowing;
shortness of breath during exertion or when lying down, or swelling of the feet.

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

signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
fatigue or weakness;
cough;
tingling;
numbness;
double vision;
weakness in arms or legs;
signs of skin cancer such as a lump or sore that does not heal;
signs and symptoms suggesting blood disorders (e.g. persistent fever, bruising, bleeding, paleness).

The symptoms described above may be signs of the following 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 colds, runny nose, sinus infection, and lung infection);
headache;
abdominal pain;
nausea and vomiting;
rash;
musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including sepsis and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and herpes zoster infection);
ear infections;
oral infections (including dental infections and cold sores);
reproductive organ infections;
urinary tract infections;
fungal infections;
joint infections;
benign tumours;
skin cancer;
allergic reactions (including seasonal allergies);
dehydration;
mood swings (including depression);
anxiety;
difficulty sleeping;
sensory disturbances such as tingling, stabbing sensations, or numbness;
migraine;
nerve root compression (including lower back pain and leg pain);
vision disorders;
eye inflammation;
eyelid inflammation and eye swelling;
dizziness (feeling dizzy or that the room is spinning);
sensation of rapid heartbeat;
high blood pressure;
redness;
bruising;
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloated stomach, heartburn);
acid reflux disorder;
dry syndrome (including dry eyes and dry mouth);
itching;
itchy rash;
bruising;
skin inflammation (such as eczema);
cracking of fingernails and toenails;
increased sweating;
hair loss;
onset or worsening of psoriasis;
muscle spasms;
blood in the urine;
kidney problems;
chest pain;
oedema;
fever;
reduced platelet count in the blood, increasing the risk of bleeding or bruising;
difficulty healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (including tuberculosis and other infections that occur when the immune system is weakened);
neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
cancer, including cancers affecting the lymphatic system (lymphoma) and melanoma (skin cancer);
immune system disorders that may affect the lungs, skin, and lymph nodes (most commonly presenting as sarcoidosis);
vasculitis (inflammation of blood vessels);
tremor;
neuropathy;
stroke;
hearing loss, ringing in the ears;
sensation of irregular heartbeat such as skipped beats;
heart problems that may cause shortness of breath or ankle swelling;
heart attack;
formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
lung diseases causing shortness of breath (including inflammation);
pulmonary embolism (blockage of a lung artery);
pleural effusion (abnormal fluid accumulation in the pleural space);
pancreatitis (inflammation of the pancreas) causing severe abdominal and back pain;
difficulty swallowing;
facial oedema;
gallbladder inflammation, gallstones;
fatty liver;
night sweats;
scarring;
abnormal muscle breakdown;
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
interrupted sleep;
impotence;
inflammations.

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

leukaemia (blood cancer of the bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
neurological disorders (such as optic neuritis and Guillain-Barré syndrome, which may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
cardiac arrest;
pulmonary fibrosis (scarring of the lungs);
intestinal perforation (a hole in the intestinal wall);
hepatitis (liver inflammation);
reactivation of hepatitis B;
autoimmune hepatitis (liver inflammation caused by the body’s own immune system);
cutaneous vasculitis (inflammation of blood vessels in the skin);
Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and rash with blisters);
facial oedema associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localized swelling of the skin);
lichenoid skin reaction (itchy red-purple rash).

Not known (frequency cannot be estimated from the available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma usually presents with purple lesions on the skin;
liver failure;
worsening of a condition called dermatomyositis (characterized by skin rash and muscle weakness);
weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and can only be detected through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low white blood cell count;
low red blood cell count;
increased blood lipids;
increased liver enzymes.

Common (may affect up to 1 in 10 people)

increased white blood cell count;
reduced platelet count;
increased blood uric acid;
abnormal blood sodium;
decreased blood calcium;
decreased blood phosphate;
increased blood glucose;
increased blood lactate dehydrogenase;
presence of autoantibodies in the blood;
decreased blood potassium.

Uncommon (may affect up to 1 in 100 people)

elevated blood bilirubin (liver blood test).

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

low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 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.
Keep in the original packaging to protect the medicine from light.
A single pre-filled syringe of AMGEVITA may be stored at temperatures up to a maximum of 25°C for a maximum period of 14 days. The pre-filled syringe must be protected from light and must be discarded if not used within the 14-day period.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 excipients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of AMGEVITA and contents of the pack
AMGEVITA is a clear, colourless to slightly yellow solution.
Each pack contains 1 single-use 20 mg pre-filled syringe (with a yellow plunger).
Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with a blue plunger).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
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 further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
s.a. Amgen n.v. Amgen Switzerland AG Vilniaus filialas
Tél/Tel: +32 (0)2 7752711 Tel: +370 5 219 7474

България Luxembourg/Luxemburg
Амджен България ЕООД s.a. Amgen
Тел.: +359 (0)2 424 7440 Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika Magyarország
Amgen s.r.o. Amgen Kft.
Tel: +420 221 773 500 Tel.: +36 1 35 44 700

Danmark Malta
Amgen, filial af Amgen AB, Sverige Amgen S.r.l.
Tlf: +45 39617500 Italy
Tel: +39 02 6241121

Deutschland Nederland
Amgen GmbH Amgen B.V.
Tel: +49 89 1490960 Tel: +31 (0)76 5732500

Eesti Norge
Amgen Switzerland AG Vilniaus filialas Amgen AB
Tel: +372 586 09553 Tlf: +47 23308000

Ελλάδα Österreich
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Amgen GmbH
Τηλ: +30 210 3447000 Tel: +43 (0)1 50 217

España Polska
Amgen S.A. Amgen Biotechnologia Sp. z o.o.
Tel: +34 93 600 18 60 Tel.: +48 22 581 3000

France Portugal
Amgen S.A.S. Amgen Biofarmacêutica, Lda.
Tél: +33 (0)9 69 363 363 Tel: +351 21 4220606

Hrvatska România
Amgen d.o.o. Amgen România SRL
Tel: +385 (0)1 562 57 20 Tel: +4021 527 3000

Ireland Slovenija
Amgen Ireland Limited AMGEN zdravila d.o.o.
Tel: +353 1 8527400 Tel: +386 (0)1 585 1767

Ísland Slovenská republika
Vistor hf. Amgen Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 321 114 49

Italia Suomi/Finland
Amgen S.r.l. Amgen AB, sivuliike Suomessa/Amgen AB, filial
Tel: +39 02 6241121 i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος Sverige
C.A. Papaellinas Ltd Amgen AB
Τηλ: +357 22741 741 Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for use:

AMGEVITA, pre-filled single-use syringe

For subcutaneous use

Parts Guide
Before use	After use
Piston Flange Label and expiration date Syringe barrel Medication Needle cap inserted	Used piston Flange Label and expiration date Used syringe barrel Used needle Needle cap removed
Important: The needle is inside

Important
Before using a pre-filled syringe of AMGEVITA, read these instructions:
Use of AMGEVITA pre-filled syringes

It is important not to attempt to perform the injection yourself unless you or the person assisting you has been properly trained.
Do not use a pre-filled syringe of AMGEVITA if it has fallen on a hard surface. Some parts of the AMGEVITA pre-filled syringe may have broken even if the damage is not visible to you. Use a new AMGEVITA pre-filled syringe.

Step 1: Preparation

A.	Remove from the packaging the number of AMGEVITA pre-filled syringes you need.
To remove the syringe from the tray, hold it by the barrel. While removing the syringe, keep the edge of the tray steady with your index finger or thumb. Hold here. Store unused syringes in the refrigerator. For safety: ● Do not grasp the plunger. ● Do not grasp the needle cap. ● Do not remove the needle cap until you are ready to administer the injection. ● Do not remove the flange. It is an integral part of the syringe. For more comfortable injection, allow the syringe to reach room temperature for 15–30 minutes before administering the injection. ● Do not return the syringe to the refrigerator once it has reached room temperature. ● Do not attempt to warm the syringe using heat sources such as hot water or microwave. ● Do not expose the syringe to direct sunlight. ● Never shake the syringe. Important: Always hold the pre-filled syringe by the barrel of the syringe.
B.	Inspect the AMGEVITA pre-filled syringe.
Syringe barrel Expiry date on label Plunger Needle cap in place Medication Flange Always hold the syringe by the barrel. Ensure that the medication in the syringe is clear and colorless to slightly yellow. ● Do not use the syringe if: -The medication is cloudy, discolored, or contains flakes or particles. -Any part is cracked or broken. -The needle cap is missing or not securely attached. -The expiry date on the label has passed. In any of these cases, use a new syringe.
C.	Gather all necessary items to administer the injection(s).
Wash hands thoroughly with soap and water. On a clean, well-lit surface, place a new pre-filled syringe. Other necessary items not included in the package: ● Alcohol swabs ● Cotton balls or gauze pads ● Adhesive bandage ● Sharps disposal container
D.	Prepare and clean the injection site(s).
Abdomen Thigh You may use: ● The thigh ● The abdomen, except for the area within 5 centimeters around the navel Clean the injection site with an alcohol swab. Allow the skin to dry. ● Do not touch the disinfected area again before administering the injection. ● If it is necessary to use the same injection site, ensure that the injection is not administered at the exact same spot as the previous time. -Do not administer the injection in areas where the skin is tender or shows bruising, redness, or hardening. Avoid injecting into areas with scars or stretch marks. ● In case of psoriasis, avoid injecting directly into raised, thickened, red, scaly skin areas or into a lesion.

Step 2: Preparation for Injection

E.	When ready to administer the injection, firmly remove the needle cap, keeping it away from the body.
It is normal to see a drop of liquid at the tip of the needle. ● Do not twist or bend the needle cap. ● Do not reattach the needle cap to the syringe. ● Do not remove the needle cap from the syringe until ready to administer the injection. Important: Dispose of the needle cap in the sharps container provided.
F.	Create a skin fold to form a safe injection surface.
Firmly grasp a section of skin with the thumb and fingers, creating a fold approximately 5 centimeters wide. Important: Hold the skin fold firmly throughout the injection.

Step 3: Injection

G.	Hold the skinfold. With the needle cap removed, insert the syringe into the skin at an angle between 45 and 90 degrees.
During needle insertion, do not hold the plunger.
H.	Push the plunger all the way in with slow and steady pressure until it no longer moves.

I.	Once completed, release the thumb from the plunger and gently remove the syringe from the skin.

Step 4: Final Procedures

J.	Dispose of the used syringe and the needle cap.
Do not reuse the used syringe. ● Do not use any remaining medicine left in the used syringe. ● Place the AMGEVITA syringe immediately into a sharps disposal container after use. Do not dispose of (throw away) the syringe in household waste. ● Discuss appropriate disposal methods with your doctor or pharmacist. Local guidelines may apply. ● Do not recycle the syringe or the sharps disposal container, and do not dispose of them in household waste. Important: Always keep the sharps disposal container out of the sight and reach of children.
K.	Examine the injection site.
If you see blood, press a cotton ball or gauze firmly over the area. Do not rub the injection site. Apply a bandage if needed.

Package leaflet: information for the user

AMGEVITA 40 mg solution for injection in pre-filled pen

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
Your doctor will provide you with a Patient Reminder Card containing important safety information you need to know before and during treatment with AMGEVITA. Keep this Patient Reminder Card.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What AMGEVITA is and what it is used for
What you need to know before using 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, a medicine that acts on the body's immune (defence) system.
AMGEVITA is indicated for the treatment of the following inflammatory diseases:

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Ankylosing spondylitis
Non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn's disease
Ulcerative colitis
Non-infectious uveitis

The active substance in AMGEVITA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that bind 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 higher concentrations in the inflammatory diseases listed above. By binding to TNFα, AMGEVITA reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear during childhood.
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age and enthesitis-related arthritis in patients from 6 years of age. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If the response to these drugs is not adequate, you will be given AMGEVITA to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory conditions of the spine.
AMGEVITA is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If you do not achieve an adequate response with these medicines, you will be given AMGEVITA to reduce the signs and symptoms of the disease.

Plaque psoriasis in adults and children
Plaque psoriasis is a skin condition that causes red, scaly, hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to break, thicken or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body's immune system leading 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 phototherapy have not worked optimally or are not indicated.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease and is often painful. Symptoms may include painful nodules and abscesses (boils) that may drain pus. It most commonly affects specific skin areas such as the submammary region, armpits, inner thighs, groin and buttocks. Scarring may also develop 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 often associated with this disease. You may initially receive other medicines. If you do not respond sufficiently to these medicines, you will be given AMGEVITA.

Crohn's disease in adults and children
Crohn's disease is an inflammation of the gastrointestinal 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 adequately to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of Crohn's disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation 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 initially take other medicines. If you do not achieve an adequate response with these medicines, you will take AMGEVITA to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
AMGEVITA is used for the treatment of:

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 part of the eye.

This inflammation can lead to decreased vision and/or the presence of floaters in the eye (black spots or fine lines moving across the visual field). AMGEVITA works by reducing this inflammation.

2. What you need to know before using AMGEVITA

Do not use AMGEVITA:

if you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
if you have a serious infection, including active tuberculosis, sepsis (blood infection), or other opportunistic infections (unusual infections associated with a weakened immune system) (see "Warnings and precautions"). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
if you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using AMGEVITA:
Allergic reactions

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling, or rash, do not administer AMGEVITA again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infections

If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with AMGEVITA. If you are unsure, contact your doctor.
You may be more likely to get infections while being treated with AMGEVITA. This risk may increase if your lung function is impaired. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, or other opportunistic infections and sepsis, which may, in rare cases, be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may recommend temporarily stopping AMGEVITA.

Tuberculosis

Since cases of tuberculosis have occurred in patients treated with adalimumab, before starting therapy with AMGEVITA, your doctor will check whether you have signs or symptoms of tuberculosis. This will involve a detailed medical evaluation including your medical history and appropriate clinical tests (e.g., a chest X-ray and tuberculin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with people who have tuberculosis.
Tuberculosis may develop during treatment even if you have received preventive treatment for tuberculosis.
Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after treatment.

Travel/recurrent infection

Inform your doctor if you live in or travel to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B infection. Taking AMGEVITA may cause reactivation of hepatitis B virus in people who are carriers of this virus. In some rare cases, especially if the patient is also receiving other medicines that suppress the immune system, reactivation of hepatitis B virus may be life-threatening.

Age over 65 years

If you are over 65 years of age, you may be more susceptible to infections while taking AMGEVITA. You and your doctor should pay particular attention to signs of infection while you are being treated with AMGEVITA. It is important to inform your doctor if you develop symptoms of infections such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedures

Before undergoing surgery or dental procedures, inform your doctor that you are taking AMGEVITA. Your doctor may recommend temporarily stopping AMGEVITA.

Demyelinating disease

If you have or develop a demyelinating disease such as multiple sclerosis, your doctor will decide whether to start or continue treatment with AMGEVITA. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling affecting any part of your body.

Vaccinations

Certain vaccines contain live but weakened forms of bacteria or viruses that cause diseases and may cause infections; these should not be given during treatment with AMGEVITA. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the vaccination schedule according to current vaccination guidelines before starting AMGEVITA therapy.
If you have taken AMGEVITA during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the pediatrician or other healthcare provider about your use of AMGEVITA during pregnancy, so they can determine when your baby should receive any vaccinations.

Heart failure

If you have mild heart failure and are being treated with AMGEVITA, your doctor will need to carefully monitor your heart condition. It is important to inform your doctor if you have or have had heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking AMGEVITA.

Fever, bruising, bleeding, or pale appearance

In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or look pale, contact your doctor immediately. Your doctor may decide to stop the treatment.

Cancer

In patients, both children and adults, treated with adalimumab or other anti-TNF medicines, some types of cancer have very rarely occurred. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow).
If you are taking AMGEVITA, your risk of developing lymphoma, leukemia, or other cancers may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving azathioprine or 6-mercaptopurine. Inform 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 treatment, or if the appearance of existing lesions changes, inform your doctor.
Cases of cancers other than lymphoma have been reported in patients with a specific lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNF medicine is appropriate.

Autoimmune diseases

Rarely, treatment with AMGEVITA may lead to the development of a lupus-like syndrome. Inform your doctor if you develop symptoms such as persistent unexplained skin rash, fever, joint pain, or fatigue.

To improve traceability of this medicine, your doctor or pharmacist should record the name and batch number of the product administered to you on your patient card. You may wish to note down these details in case you are asked for them in the future.
Children and adolescents

Vaccinations: if possible, children should have completed all recommended vaccinations before starting AMGEVITA.
Do not give AMGEVITA to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
Do not give AMGEVITA to children under 4 years of age with plaque psoriasis.
Do not give AMGEVITA to children under 6 years of age with Crohn's disease or ulcerative colitis.

Other medicines and AMGEVITA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AMGEVITA may be taken together with methotrexate and other disease-modifying antirheumatic drugs (DMARDs) such as sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts, as well as steroids or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
AMGEVITA must not be taken together with medicines containing anakinra or abatacept as active ingredients due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

You should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last dose of AMGEVITA.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
AMGEVITA should be used during pregnancy only if clearly needed.
According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received AMGEVITA during pregnancy compared to babies whose mothers had the same condition but did not receive AMGEVITA.
AMGEVITA may be used during breastfeeding.
If you take AMGEVITA during pregnancy, your baby may have an increased risk of infection.
It is important that you inform the pediatrician or other healthcare provider about your use of AMGEVITA during pregnancy before your baby receives any vaccinations. For more information on vaccinations, see the section "Warnings and precautions".

AMGEVITA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose and is therefore essentially "sodium-free".