40 mg solution for injection in pre-filled pen 
adalimumab

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

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • Your doctor will also give you a Patient Card, which contains important safety information that you must be aware of before AMGEVITA is given to you and during treatment with AMGEVITA. Keep this Patient Card.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to 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).

In this leaflet you will find information about: 
1. What AMGEVITA is and what it is used for 
2. What you need to know before using AMGEVITA 
3. How to use AMGEVITA 
4. Possible side effects 
5. How to store AMGEVITA 
6. Contents of the packaging 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 ( rheumatoid arthritis )
  • Polyarticular juvenile idiopathic arthritis (rheumatoid arthritis)
  • Enthesitis-related arthritis (muscle, tendon attachment, and joint inflammation)
  • Ankylosing spondylitis (a rheumatic disease with inflammation of the joints of the spine)
  • Axial spondylarthritis without radiographic signs of ankylosing spondylitis(a rheumatic disease with inflammation of the shoulder)
  • Psoriatic arthritis
  • Plaque psoriasis
  • Hidradenitis suppurativa ( inflammation of the skin)
  • Crohn’s disease ( inflammation of the intestines)
  • Ulcerative colitis ( inflammation of the colon)
  • Non- infectious uveitis ( uveitis without infection, inflammation of the eye)

The active substance 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 tumor necrosis factor (TNFα), which is involved in the immune system and is found in elevated levels in the inflammatory diseases listed above. By binding to TNFα, AMGEVITA can reduce the inflammatory process 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 severely active rheumatoid arthritis, you will usually first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, your doctor may prescribe AMGEVITA to treat your rheumatoid arthritis.

AMGEVITA can also be used to treat severe, active, and progressive (progressive) rheumatoid arthritis not previously treated with methotrexate.

AMGEVITA slows down the destruction of cartilage and skeleton in the joints caused by the disease and can therefore increase your ability to perform daily activities.

AMGEVITA is commonly used with methotrexate. If your doctor decides 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 2 years of age and older and enthesitis-related arthritis in patients 6 years of age and older. You may first be given other disease-modifying drugs, such as methotrexate. If these medicines do not help enough, you will receive AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and axial spondylarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic signs of ankylosing spondylitis are inflammatory diseases of the spine.

AMGEVITA is used to treat ankylosing spondylitis and axial spondylitis without radiographic changes in ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondylarthritis without radiographic signs of ankylosing spondylitis, you will first be given other medicines. If these medicines do not help enough, you will receive AMGEVITA to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints that is due to the disease psoriasis.

AMGEVITA is used to treat psoriatic arthritis in adults. AMGEVITA slows down the damage to cartilage and bone in the joint caused by the disease, and to improve physical function.

Plaque psoriasis in adults and children

Plaque psoriasis is a disease that causes red, flaky, and dry plaques on the skin covered by silvery scales. Plaque psoriasis can also involve the nails, which can then crumble, become thicker and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a disorder in the body’s immune system that leads 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 4–17 years for whom local treatment and light therapy have not worked or are not appropriate.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. The symptoms can be sore nodules (lumps) and abscesses (boils) that can leak anywhere. The disease usually affects specific areas of the skin, e.g. under the breasts, armpits, inner thighs, groin, and buttocks. Scarring can also occur in the affected areas.

AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. AMGEVITA can reduce the number of lumps and boils you have as well as the pain that is often associated with the disease. You may be given other medicines first. If you do not respond adequately to these medicines, you will receive AMGEVITA.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the digestive system.

AMGEVITA is used to treat Crohn’s disease in adults and children 6-17 years of age. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not help enough, you will receive AMGEVITA to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory bowel disease.

AMGEVITA is used to treat ulcerative colitis in adults. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not help enough, you will receive AMGEVITA to reduce the signs and symptoms of your disease.

Uveitis without infection in adults and children

Uveitis without infection is an inflammatory disease that affects certain parts of the eye. AMGEVITA is used to treat

  • Adults with uveitis without infection where inflammation affects the back of the eye.
  • Children from 2 years of age with chronic uveitis without infection where inflammation affects the front of the eye.

Inflammation can lead to impaired vision and/or the presence of floaters in the eye (black dots or striped lines moving across the field of vision). 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 any of the other ingredients of this medicine (listed in section 6).
  • If you have a serious infection, including tuberculosis (see “Warnings and Precautions”). It is important that you tell your doctor if you have symptoms of infection, e.g. fever, sores, tiredness, dental problems.
  • If you have moderate or severe heart failure. It is important to tell your doctor if you have or have had a serious heart condition (see “Warnings and Precautions”).

Warnings and cautions

Talk to your doctor or pharmacist before using AMGEVITA:

  • If you get allergic reactions with symptoms such as tightness of the chest, wheezing, dizziness, swelling or rash, stop injecting AMGEVITA and contact your doctor immediately, as these reactions can be life-threatening in rare cases.
  • If you have any infection, including chronic infections or local infections (eg leg ulcers), you must consult your doctor before starting AMGEVITA. If you are not sure, talk to your doctor.
  • You may get infections more easily while you are being treated with AMGEVITA. This risk may increase if you have impaired lung function. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis which in rare cases can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, sores, tiredness, or dental problems. Your doctor may advise you to temporarily stop using AMGEVITA.
  • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will examine you for signs and symptoms of tuberculosis before starting treatment with AMGEVITA. This includes a comprehensive medical history and appropriate screening tests (eg, lung X-ray and a tuberculin test). The performance and results of these tests should be indicated on your patient 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 treatment even if you have received preventive treatment for tuberculosis. About symptoms of tuberculosis (persistent cough, weight loss, lethargy, mild fever), or if any other infection occurs during or after treatment, you must tell your doctor immediately.
  • Tell your doctor if you live or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are constantly present (endemic).
  • Tell your doctor if you have previously had problems with recurrent infections or other ailments that increase the risk of infection.
  • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you are at risk of getting HBV. Your doctor should test you for Hepatitis B. AMGEVITA may cause reactivation of HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that inhibit the immune system, reactivation of HBV can be life-threatening.
  • If you are over 65 years of age, you may be more susceptible to infections when using AMGEVITA. You and your doctor should pay special attention to signs of infection when you are treated with AMGEVITA. It is important to tell your doctor if you get symptoms of infection, such as fever, sores, tiredness, or dental problems.
  • If you are about to have an operation or a dental procedure, tell your doctor that you are taking AMGEVITA. Your doctor may advise you to temporarily stop using AMGEVITA.
  • If you have or develop a demyelinating disease such as multiple sclerosis (MS), your doctor will assess whether you can or should continue to be treated with AMGEVITA. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness in the arms or legs, or numbness or tingling anywhere on the body.
  • Some vaccines can cause infections and should not be given during treatment with AMGEVITA. Check with your doctor before getting vaccinated. It is recommended that children, if possible, be vaccinated according to current guidelines for general vaccination before starting treatment with AMGEVITA. If you have received AMGEVITA during your pregnancy, your newborn baby may be at increased risk of getting such an infection for up to five months after the last dose you received during pregnancy. It is important that you tell your pediatrician and other healthcare professionals that you used AMGEVITA during your pregnancy so that they can decide when your newborn baby should be vaccinated.
  • If you have mild heart failure and are being treated with AMGEVITA, your heart problems must be closely monitored by your doctor. It is important to tell your doctor if you have or have had a serious heart condition. If you develop new symptoms or if your symptoms of heart failure worsen (such as shortness of breath or swollen feet), you must contact your doctor immediately. Your doctor will decide if you should receive AMGEVITA.
  • In some patients, the body is unable to produce enough blood cells to help your body fight infections or stop bleeding. If you have a fever that does not go down, bruises or bleeds easily, or looks very pale, you should call your doctor immediately. Your doctor may then decide to stop treatment.
  • Very rare cases of certain cancers have occurred in children and adults treated with adalimumab or other TNF- blockers. Patients with more severe rheumatoid arthritis who have had the disease for a long time may have an increased risk of developing lymphoma (cancer that affects the lymphatic system ) and leukemia(cancer that affects the blood and bone marrow ). If you are being treated with AMGEVITA, the risk of developing lymphoma, leukemia, or another type of cancer may increase. On rare occasions have a specific and severe type of lymphoma observed in patients taking adalimumab. Some of these patients were also treated with azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA. Cases of non-melanoma skin cancer have also been reported in patients treated with adalimumab. If new skin ulcers occur during or after treatment or if existing skin ulcers change appearance, tell your doctor.
  • There have been cancers other than lymphoma, in those patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) and who are being treated with other TNF blockers. If you have COPD or are a heavy smoker, discuss with your doctor whether it is appropriate to treat you with TNF- blockers.
  • In rare cases, treatment with AMGEVITA may produce a lupus-like syndrome. Contact your doctor if symptoms such as persistent, unexplained rash, fever, joint pain, or fatigue occur.

The needle cover of the pre-filled pen is made of dry natural rubber (a latex derivative), which can cause allergic reactions.

To make it easier to trace this medicine, your doctor or pharmacist should note in your patient record the name and number of the medicine you have been given. You may also want to take note of this information to have on hand if you are ever asked about this information.

Children and young people

  • Vaccinations: if possible, your child should have received all vaccinations before using AMGEVITA.
  • Do not give AMGEVITA to children under 2 years of age with polyarticular juvenile idiopathic arthritis.

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 with methotrexate or certain disease-modifying anti-rheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and gold preparations for injection ), steroids, or painkillers, including non-steroidal anti-inflammatory drugs ( NSAIDs ).

You should not use AMGEVITA with medicines containing active substances, anakinra, or abatacept due to the increased risk of serious infections. If you have any further questions, ask your doctor.

Pregnancy and breastfeeding

  • You should consider using adequate contraception to prevent pregnancy while using AMGEVITA and continue to use it for at least 5 months after the last treatment with AMGEVITA.
  • If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
  • AMGEVITA should only be used during pregnancy if necessary.
  • According to a pregnancy study, there was no increased risk of birth defects when the mother had received AMGEVITA during pregnancy compared to mothers with the same disease who had not used AMGEVITA.
  • Breastfeeding can be used during breastfeeding.
  • If you get AMGEVITA during your pregnancy, your newborn baby may be at increased risk of getting an infection.
  • It is important that you tell your pediatrician and other healthcare professionals that you used AMGEVITA during your pregnancy before vaccinating your newborn baby. (For more information on vaccines, see the section “Warnings and Precautions”).

Driving and using machines

AMGEVITA may have a slight effect on your ability to drive, cycle, or use machines. A feeling of dizziness and visual disturbances may occur when AMGEVITA is used.

AMGEVITA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0.8 ml dose; is next to “sodium-free”.

3. How to use AMGEVITA

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondylarthritis 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 spondylarthritis without radiographic evidence of ankylosing spondylitis, and pre-patients with psoriatic arthritis is 40 mg given every two weeks as a single dose.

In rheumatoid arthritis, methotrexate is used with AMGEVITA. If your doctor decides that methotrexate is not suitable, AMGEVITA can be used alone.

If you have rheumatoid arthritis and you are not receiving methotrexate with AMGEVITA, your doctor may decide to give you 40 mg every week or 80 mg every two weeks.

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 two weeks. 

Children, adolescents, and adults with arthritis-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 two weeks.

Adults with plaque psoriasis

The usual dose for adults with plaque psoriasis is a starting dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every two weeks and starting one week after the starting dose. You should continue to inject AMGEVITA for as long as your doctor prescribes it. Depending on how you respond to treatment, your doctor may increase the dosage one to 40 mg every week or 80 mg every two weeks.

Children and adolescents with plaque psoriasis

Children and adolescents 4 – 17 years old weighing 30 kg or more

The recommended dose of AMGEVITA is a starting dose of 40 mg followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every two weeks.

Adults with hidradenitis suppurativa

The usual dose for hidradenitis suppurativa is a starting dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day two days in a row), followed by 80 mg (as two 40 mg injections in one day ) two weeks later. After a further two weeks, treatment is continued 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 a bactericidal solution daily on the affected areas.

Adolescents with hidradenitis suppurativa 12–17 years who weigh 30 kg or more

The recommended dose of AMGEVITA is a starting dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg every two weeks starting one week later. If you do not respond enough to AMGEVITA 40 mg every two weeks, your doctor may increase the dose to 40 mg every week or 80 mg every two weeks.

It is recommended that you use a bactericidal solution on the affected areas daily.

Adults with Crohn’s disease

The usual dosage 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 improvement is necessary, your doctor may give you a starting dose of 160 mg week 0 (as four 40 mg injections in one day or two 40 mg injections per day two days in a row), followed by 80 mg (as two 40 mg injections in one day) two weeks later and then 40 mg every two weeks. Depending on how you respond, your doctor may increase the dosage by one to 40 mg every week or 80 mg every two weeks.

Children and adolescents with Crohn’s disease

Children and adolescents 6 – 17 years old weighing less than 40 kg

The usual dose is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a starting 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 two weeks. Depending on how your child reacts, your child’s doctor may increase the dosage by one to 20 mg each week.

The 40 mg pre-filled pen cannot be used to deliver a 20 mg dose. However, a 20 mg pre-filled AMGEVITA syringe is available to give a dose of 20 mg.

Children and adolescents 6 – 17 years weighing 40 kg or more

The usual dose 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 child’s doctor may prescribe a starting 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). day) two weeks later.

Thereafter, the usual dose is 40 mg every two weeks. Depending on how your child reacts, your child’s doctor may increase the dosage by one to 40 mg every week or 80 mg every two weeks.

Adults with ulcerative colitis

The usual dose of AMGEVITA for adults with ulcerative colitis is initially 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 and then 40 mg every other week. Depending on how you respond, your doctor may increase the dose one to 40 mg every week or 80 mg every two weeks.

Adults with uveitis without infection

The usual dose for adults with uveitis without infection is a starting dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg every two weeks starting one week after the starting dose. You should continue to inject AMGEVITA for as long as your doctor prescribes it.

In uveitis without infection, corticosteroids, or other drugs that affect the immune system, may continue to be taken during treatment with AMGEVITA. AMGEVITA can also be given alone.

Children and adolescents from 2 years of age with chronic uveitis without infection

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of AMGEVITA is 20 mg every two weeks with methotrexate.

Doctors may also prescribe a starting dose of 40 mg given one week before starting the usual dose.

The 40 mg pre-filled pen cannot be used to deliver a 20 mg dose. However, a 20 mg pre-filled AMGEVITA syringe is available to give a dose of 20 mg.

Children and adolescents from 2 years of age weighing 30 kg or more

The usual dose of AMGEVITA is 40 mg every two weeks with methotrexate.

Doctors may also prescribe an initial dose of 80 mg given one week before starting the usual dose.

Method of administration and route of administration

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

If you use more AMGEVITA than you should

If you happen to inject AMGEVITA more often than your doctor or pharmacist has prescribed, contact your doctor or pharmacist and tell them that you have taken too much. Always carry 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, take a dose of AMGEVITA as soon as you remember. Then take your next dose on a specific day that you would have done if you had not missed a dose

If you stop using AMGEVITA

The decision to stop using AMGEVITA should be discussed with your doctor. Your symptoms may return when treatment is stopped.

If you have any further questions on the use of this product, 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 up to 4 months after the last AMGEVITA injection.

Tell your doctor immediately if you notice any of the following

  • severe itching, hives, or other signs of an allergic reaction;
  • swollen face, swollen hands, feet;
  • strained breathing, difficulty swallowing;
  • shortness of breath during exertion or when lying down or if the feet swell.

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

  • signs of infection such as fever, nausea, sores, dental problems, burning sensation when urinating;
  • feeling weak or tired;
  • cough;
  • knitting;
  • loss of sensation;
  • double vision;
  • arm or leg weakness;
  • a bump or open wound that does not heal;
  • signs and symptoms of blood diseases such as prolonged fever, bruising, bleeding, pallor.

The symptoms described above may be signs of side effects described below that have been observed with the use of adalimumab.

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

  • injection site reactions (including pain, swelling, redness, or itching );
  • respiratory infections (including colds, runny nose, sinusitis, pneumonia );
  • headache;
  • abdominal pain;
  • nausea and vomiting;
  • rash;
  • musculoskeletal pain.

Common (may affect up to 1 in 10 people)

  • serious infection (including sepsis and influenza );
  • infection is in the intestines (including gastroenteritis );
  • skin infections (including cellulite and shingles );
  • ear infections;
  • oral infections (including dental infections and herpes on the lips);
  • infection is in the genitals;
  • urinary tract infections;
  • fungal infections;
  • joint infections;
  • benign tumors;
  • skin cancer;
  • allergic reactions (including seasonal allergy);
  • dehydration;
  • mood swings (including depression);
  • concern;
  • problems sleeping;
  • sensory disturbances such as tingling, and crawling or numbness;
  • migraine;
  • nerve root compression (including low back pain and leg pain);
  • visual disturbances;
  • eye inflammation;
  • inflammation of the eyelid and swelling of the eyes;
  • dizziness;
  • the feeling of the heart beating fast;
  • Hypertension;
  • redness;
  • bleeding (blood accumulation outside the blood vessels);
  • cough;
  • asthma;
  • shortness of breath;
  • bleeding in the gastrointestinal tract;
  • dyspepsia (indigestion, bloating, heartburn);
  • gastric acid reflux (acid reflux);
  • dry eyes and dry mouth;
  • itching;
  • itchy rash;
  • bruises;
  • dermatitis (such as eczema );
  • fragile fingernails and toenails;
  • increased sweating;
  • hair loss;
  • new onset or worsening of psoriasis;
  • muscle spasms;
  • blood in the urine;
  • kidney problems;
  • chest pain;
  • edema (fluid accumulation);
  • fever;
  • decreased platelet count ( platelets ) which increases the 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 may occur when resistance to the disease is reduced);
  • neurological infections (including meningitis caused by viruses );
  • eye infections;
  • bacterial infections;
  • diverticulitis ( inflammation and infection of the colon);
  • cancer;
  • cancer affecting the lymphatic system;
  • melanoma;
  • immune disorders that can affect the lungs, skin, and lymph nodes (usually as sarcoidosis );
  • vasculitis ( inflammation of the blood vessels);
  • shaking;
  • neuropathy (nerve disease);
  • stroke ;
  • hearing loss, ringing ears;
  • the feeling of the heart beating irregularly like a missed heartbeat;
  • heart problems that can cause shortness of breath or swollen feet;
  • myocardial infarction;
  • a hernia in the great artery wall, inflammation, and clot in a vein, blockage of a blood vessel;
  • lung disease causing shortness of breath (including pneumonia );
  • pulmonary embolism (blockage in a pulmonary artery);
  • pleural effusion (abnormal fluid accumulation between the lungs and chest);
  • inflammation of the pancreas that causes severe pain in the abdomen and back;
  • difficulty swallowing;
  • facial edema (accumulation of fluid in the face);
  • gallbladder inflammation, gallstones;
  • fatty liver;
  • night sweats;
  • scar;
  • abnormal muscle breakdown;
  • the systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organ systems);
  • sleep interruption;
  • impotence;
  • inflammation is.

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

  • leukemia (cancer that affects the blood and bone marrow );
  • severe allergic reaction with shock;
  • multiple sclerosis;
  • nerve disorders (such as ocular nerve inflammation and Guillain-Barré syndrome which can cause muscle weakness, sensory disturbances, tingling in the arms and upper body);
  • the heart stops pumping;
  • pulmonary fibrosis (scarring of the lung);
  • holes in the intestine;
  • hepatitis;
  • reactivation of hepatitis B;
  • autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
  • cutaneous vasculitis ( inflammation of the blood vessels in the skin);
  • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache, and rash);
  • facial edema associated with allergic reactions;
  • erythema multiforme (inflammatory skin rash);
  • lupus-like syndrome (persistent, unexplained rash, fever, joint pain, or fatigue);
  • angioedema (local swelling of the skin);
  • lichenoid skin reactions (itchy red-purple skin rash).

No known frequency (cannot be calculated from the available data)

  • hepatosplenic T-cell lymphoma (rare blood cancer that is often fatal);
  • Merkel cell carcinoma (a type of skin cancer);
  • liver failure;
  • aggravation of a condition called dermatomyositis (looks like a rash and is accompanied by muscle weakness).

Some side effects observed with adalimumab may not show symptoms and can only be detected by blood tests. These include:

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

  • low blood cell counts;
  • low blood cell counts;
  • elevated lipids in the blood;
  • elevated liver enzymes.

Common (may affect up to 1 in 10 people)

  • high blood cell counts;
  • low blood platelet counts;
  • elevated uric acid in the blood;
  • aberrant blood sodium levels;
  • low blood levels of calcium;
  • low blood levels of phosphate;
  • high blood sugar;
  • high blood levels of lactate dehydrogenase;
  • autoantibodies present in the blood;
  • low blood levels of potassium.

Uncommon (may affect up to 1 in 100 people)

  • elevated levels of bilirubin (blood test of the liver).

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

  • low blood counts for white blood cells, red blood cells, and platelets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Store in the original package. Sensitive to light.

A AMGEVITA prefilled injection pen can be stored at temperatures up to a maximum of 25 ° C for more than 14 days. The pre-filled pen must then be protected from light and discarded if not used within 14 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is adalimumab. A pre-filled pen contains 40 mg adalimumab in 0.8 ml solution.
  • The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide, and water for injection.

What the medicine looks like and the contents of the pack

AMGEVITA is clear and colorless to the slightly yellowish solution.

One pack contains one, two, four, or six pre-filled disposable pens (SureClick).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

Amgen Europe BV 
Minervum 7061 
NL ‑ 4817 ZK Breda 
Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Other sources of information

Further information on this medicine is available on the European Medicines Agency

Instructions for use:AMGEVITA SureClick pre-filled pen for single useFor subcutaneous use

Illustration of the different parts
Before use After use
Important! The needle is inside

Important
Read the following important information before using an AMGEVITA pre-filled pen:
Use of AMGEVITA pre-filled pensIt is important that you do not try to give yourself an injection unless you or your caregiver have been given instructions.
Use not AMGEVITA pre-filled pen if it has been dropped on a hard surface. The pen may have been damaged even if you do not see any cracks. Use a new AMGEVITA pre-filled pen.
The needle housing of the AMGEVITA prefilled injection pen is made of dry natural rubber, a type of latex. Tell your healthcare provider if you are allergic to latex.
Step 1: Prepare
A. Develop an AMGEVITA pre-filled pen from the package.
Carefully lift the pre-filled pen straight up from the box.
Return the original packaging with unused pens to the refrigerator.
Leave the pre-filled pen at room temperature for  15 to 30  minutes before injecting to make injection more comfortable.Do not put the pre-filled pen back in the refrigerator when it has reached room temperature.Do not attempt to heat the pre-filled pen using any heat source such as hot water or a microwave oven.Shake not the pre-filled pen.Do not remove the yellow sleeve from the pre-filled pen yet.
B. Check AMGEVITA pre-filled pen.

Check that the medicine in the window is clear and colorless to slightly yellowish.
Do not use the pre-filled pen if:The medicine is cloudy or discolored or contains flakes or particles.Some part of the pen appears to be cracked or damaged.The pre-filled pen has been dropped on a hard surface.The yellow sleeve is missing or not fitted properly.The expiration date on the label has passed.In all cases, a new pen should be used.
C. Gather all the material you need for injection one.
Wash your hands thoroughly with soap and water.Place a new, pre-filled pen on a clean and well-lit work surface.
You also need the following items, which are not included in the package:Alcohol wipesCotton swab or compressBand-AidWaste containers for sharp objects
D. Select and wash the injection site.
You can use:The thighThe abdomen, except in a circle of 5 centimeters closest to the navelWipe the injection site with an alcohol swab. Let the skin dry.Do not touch this area again before injecting.If you want to use the same injection site, make sure that it is not the exact same site as the previous injection .- Do not inject in areas that are sore, bruised, red or hard. Avoid injecting into areas with scars or stretch marks.If you have psoriasis , avoid injecting directly into swollen, thick, red or scaly skin areas or lesions.
Step 2: Get ready
E. Pull the yellow sleeve straight off when you are ready to inject.
It is normal to see a drop of the medicine on the tip of the needle or the yellow safety guard. Do not twist or bend the yellow sleeve. Do not put the yellow sleeve back on 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 the area of ​​the injection site to get a tense surface.
The stretching methodFirmly stretch the skin by moving your thumb and fingers in the opposite direction to create a tense area of ​​about 5 cm.
OR
The nip method inch with a firm grip between the thumb and fingers together the skin so that an area of ​​about 5 cm is formed. Important! Keep the skin stretched or pinched until the injection is complete.
Step 3: Inject
G. Continue to keep the skin stretched or pinched. Place the pre-filled pen against the skin at a 90-degree angle. The yellow sleeve must be removed.
Important! Do not touch the blue start button yet.
HRS. Firmly push the pre-filled pen against the skin until it stops.
Important! You should push all the way down, but do not touch the blue start button until you are ready to inject.
IN. Press the blue start button when you are ready to inject. You will hear a click.
J. Continue to press down on the skin. The injection can take about 10 seconds.
Important! If the window is not yellow when you lift the pen or if it looks like the medicine is still being injected, it means that you have not received a full dose . In this case, contact a doctor immediately.
Step 4: Finish
K. Discard the used pen and the yellow sleeve.
Immediately place the used pen and needle sleeve in a sharp waste container when finished. Throw not the pen household waste. Talk to a doctor or pharmacist about how to dispose of waste. There may be local guidelines for this. Do not reuse the pre-filled pen. Recycle not the pen or the waste container and dispose of them in household waste. Important: Always keep the waste container away from sharp objects out of the reach and sight of children.
IN. Examine the injection site.
If it bleeds, you can press a cotton ball or compress against the injection site. Do not rub against the injection site. Apply a patch if needed.

Muhammad Nadeem

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