Patient Information Leaflet

AMGEVITA 20mg pre-filled syringe solution

AMGEVITA 40mg pre-filled syringe solution

AMGEVITA 80mg pre-filled syringe solution

adalimumab

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Your doctor will give you apatient information leaflet,which contains important safety information that you need to know before and during treatment with AMGEVITA. Keep thispatient information leaflet.
• If you have any questions, ask 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 you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

Table of Contents

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. Storage of AMGEVITA
6. Contents of the pack and additional information

AMGEVITA contains adalimumab as its active substance, a drug that acts on the body's immune system (defense).

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

The active substance of AMGEVITA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific target.

The target of adalimumab is a protein called Tumor Necrosis Factor-alpha (TNFα), which is involved in the immune system (defense) and is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, AMGEVITA reduces the inflammatory process in those diseases.

Rheumatoid Arthritis

Rheumatoid Arthritis is an inflammatory disease of the joints.

AMGEVITA is used to treat rheumatoid arthritis in adults. If you have active moderate to severe rheumatoid arthritis, you may be given AMGEVITA before other disease-modifying drugs such as methotrexate. If you do not respond sufficiently to these drugs, you will be given AMGEVITA to treat your rheumatoid arthritis.

AMGEVITA can also be used in the treatment of severe, active, and progressive rheumatoid arthritis without prior treatment with methotrexate.

AMGEVITA reduces the damage to the cartilage and bones of the joints caused by the disease and improves physical performance.

AMGEVITA is usually used in combination with methotrexate. If your doctor determines that methotrexate is not suitable, AMGEVITA can be administered alone.

Polyarticular Juvenile Idiopathic Arthritis and Arthritis associated with Enthesitis

Polyarticular Juvenile Idiopathic Arthritis and Arthritis associated with Enthesitis are inflammatory diseases of the joints that usually appear for the first time in childhood.

AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients aged 2 years and older and arthritis associated with enthesitis in patients aged 6 years and older. You may have received other disease-modifying drugs, such as methotrexate, first. If you do not respond sufficiently well to these drugs, you will receive AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.

Ankylosing Spondylitis and Undifferentiated Axial Spondyloarthritis without radiographic evidence of Ankylosing Spondylitis

Ankylosing Spondylitis and Undifferentiated Axial Spondyloarthritis without radiographic evidence of Ankylosing Spondylitis are inflammatory diseases that affect the spine.

AMGEVITA is used to treat ankylosing spondylitis and undifferentiated axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or undifferentiated axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will be treated first with other drugs, and if you do not respond sufficiently to these drugs, you will receive AMGEVITA to reduce the signs and symptoms of your disease.

Psoriatic Arthritis

Psoriatic Arthritis is an inflammatory disease of the joints associated with psoriasis.

AMGEVITA is used to treat psoriatic arthritis in adults. AMGEVITA reduces the joint damage caused by the disease in the cartilage and bone and improves physical performance.

Plaque Psoriasis in adults and children

Plaque Psoriasis is a skin disease that causes red, scaly, crusty, and scaly areas. Plaque Psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful. It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in skin cell production.

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 between 4 and 17 years of age who have not responded or are not good candidates for topical and phototherapy treatments.

Hidradenitis Suppurativa in adults and adolescents

Hidradenitis Suppurativa (also known as inverse acne) is a chronic and often painful inflammatory skin disease. Symptoms can include sensitive nodules (bumps) and abscesses (boils) that can secrete pus. It usually affects specific areas of the skin, such as under the chest, armpits, inner thighs, groin, and buttocks. It can also leave scars in the affected areas.

AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. AMGEVITA can reduce the number of nodules and abscesses and the pain that usually accompanies this disease. You may have received other medications previously. If you do not respond sufficiently well to these medications, you will receive AMGEVITA.

Crohn's Disease in adults and children

Crohn's Disease is an inflammatory disease of the digestive tract.

AMGEVITA is used to treat Crohn's Disease in adults and children aged 6 to 17 years. If you have Crohn's Disease, you will be treated first with other medications. If you do not respond sufficiently to these medications, you will receive AMGEVITA to reduce the signs and symptoms of Crohn's Disease.

Ulcerative Colitis in adults and children

Ulcerative Colitis is an inflammatory disease of the large intestine.

AMGEVITA is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you suffer from ulcerative colitis, you may be given other medications first. If you do not respond well to these medications, you will be given AMGEVITA to reduce the signs and symptoms of your disease.

Non-infectious Uveitis in adults and children

Non-infectious Uveitis is an inflammatory disease that affects certain parts of the eye.

AMGEVITA is used to treat

• Adults with non-infectious uveitis with inflammation affecting the posterior part of the eye.
• Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the anterior part of the eye.

This inflammation can lead to a decrease in vision and/or the presence of spots in the eye (black dots or thin lines that move across the field of vision). AMGEVITA acts by reducing this inflammation.

Do not use AMGEVITA

• If you are allergic to adalimumab or any of the other components of this medication (listed in section6).
• If you have a severe infection, including active tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a weakened immune system) (see “Warnings and precautions”). If you have symptoms of any infection, for example: fever, wounds, fatigue, dental problems, it is essential to inform your doctor.
• If you have moderate or severe heart failure. It is essential to inform your doctor if you have had or have any serious heart problems (see “Warnings and precautions”).

Warnings and precautions

Consult your doctor or pharmacist before starting to use AMGEVITA:

Allergic reactions

• If you notice an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or hives, discontinue the administration of AMGEVITA and contact your doctor immediately, as in rare cases, these reactions can be life-threatening.
  

Infections

• If you have any infection, including chronic or localized infections (for example: a leg ulcer), consult your doctor before starting treatment with AMGEVITA. If you are unsure, contact your doctor.
• With AMGEVITA treatment, you may be more susceptible to infections. This risk may be higher if you have damaged lungs. These infections can be severe and include tuberculosis, virus, fungus, parasite, or bacterial infections, or other opportunistic infections and sepsis that could, in rare cases, be life-threatening. Therefore, it is essential to inform your doctor if you have symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend that you temporarily discontinue treatment with AMGEVITA.

Tuberculosis

• Since cases of tuberculosis have been described in patients treated with adalimumab, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with AMGEVITA. This will include a thorough medical evaluation, including your medical history and appropriate diagnostic tests (for example, chest X-ray and tuberculin test). The results of these tests should be recorded in yourpatient information card.It is very important to inform your doctor if you have had tuberculosis or have been in contact with a tuberculosis patient.
• Tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis.
• If you develop symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection during or after treatment, contact your doctor immediately.

Infections recurrent/while traveling

• Inform your doctor if you reside or travel to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform your doctor if you have a history of recurrent infections or other conditions or factors that increase the risk of infections.

Hepatitis B virusB

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have had active HBV infections or if you think you may be at risk of contracting HBV. Your doctor should perform a test for HBV. AMGEVITA can cause reactivation of HBV in people who are carriers of this virus. In rare cases, especially if you are taking other medications that suppress the immune system, reactivation of HBV can be life-threatening.

Over 65 years old

• If you are over 65 years old, you may be more susceptible to infections while being treated with AMGEVITA. Both you and your doctor should pay special attention to the appearance of signs of infection while being treated with AMGEVITA. It is essential to inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue, or dental problems.

Surgical or dental interventions

• If you are to undergo a surgical or dental procedure, inform your doctor that you are taking AMGEVITA. Your doctor may recommend that you temporarily discontinue treatment with AMGEVITA.

Demyelinating diseases

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

Vaccines

• Certain vaccines contain live, but weakened, bacteria or viruses that cause diseases that can lead to infections and should not be administered if you are being treated with AMGEVITA. Consult with your doctor before administering any type of vaccine. If possible, it is recommended that children update their vaccination schedule according to current vaccination guidelines before starting treatment with AMGEVITA.
• If you receive AMGEVITA while pregnant, your child may have a higher risk of contracting an infection for approximately 5 months after the last dose they received of AMGEVITA during pregnancy. It is essential to inform your child's doctor and other healthcare professionals about your use of AMGEVITA during pregnancy, so they can decide whether your child should receive any vaccine. For more information on vaccines, see the “Warnings and precautions” section.

Heart failure

• If you have mild heart failure and are being treated with AMGEVITA, your doctor should closely monitor your heart failure. It is essential to inform your doctor if you have had or have any serious heart problems. If you develop new symptoms of heart failure or worsening existing symptoms (for example: difficulty breathing, swelling of the feet), contact your doctor immediately. Your doctor will decide whether you should continue taking AMGEVITA.

Fever, petechiae, bleeding, or pallor

• In some patients, the body may be unable to produce a sufficient number of white blood cells that help the body fight infections or platelets that contribute to stopping bleeding. If you have persistent fever, petechiae, or bleed easily or are very pale, contact your doctor immediately. Your doctor may decide to discontinue treatment.

Cancer

• In rare cases, certain types of cancer have been reported in children and adults treated with adalimumab or other TNF blockers. People with severe rheumatoid arthritis and who have had the disease for a long time may have a higher risk than the general population of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
• If you are being treated with AMGEVITA, the risk of developing lymphoma, leukemia, and other types of cancer may increase. Rare cases of a specific and severe type of lymphoma have been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA.
• Cases of skin cancer (non-melanoma) have been reported in patients using adalimumab. Inform your doctor if you develop new skin lesions or if existing lesions change appearance during or after treatment.
• Cancers, other than lymphoma, have been reported in patients with a specific lung disease, known as Chronic Obstructive Pulmonary Disease (COPD), treated with another TNF blocker. If you have COPD or smoke heavily, consult your doctor if treatment with a TNF blocker is suitable for your case.

Autoimmune diseases

• In rare cases, treatment with AMGEVITA may lead to a condition similar to lupus. Contact your doctor if you have symptoms such as persistent rash without explanation, fever, joint pain, or fatigue.

To improve the traceability of this medication, your doctor or pharmacist should record the name and batch number of the medication administered in your medical history. In the event that you are asked for this information in the future, you can also take note of these details.

Children and adolescents

• Vaccines: If possible, your child should update their vaccination schedule according to current vaccination guidelines before starting treatment with AMGEVITA.

• Do not administer AMGEVITA to children with juvenile idiopathic polyarticular arthritis under 2 years old.

• Do not administer AMGEVITA to children with plaque psoriasis under 4years old.

• Do not administer AMGEVITA to children with Crohn's disease or ulcerative colitis under 6years old.

Use of AMGEVITA with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

AMGEVITA can be taken with methotrexate or certain disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and gold preparations), steroids, or pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs).

Do not use AMGEVITA with medications whose active ingredients are anakinra or abatacept due to an increased risk of severe infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• Consider using suitable contraceptive methods to avoid pregnancy and continue using them for at least 5 months after the last treatment with AMGEVITA.
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about the use of this medication.
• AMGEVITA should only be used during pregnancy if necessary.
• According to a study in pregnancy, there was no increased risk of congenital defects when the mother had received treatment with AMGEVITA during pregnancy compared to mothers with the same disease who did not receive treatment with AMGEVITA.
• AMGEVITA can be used during breastfeeding.
• If you use AMGEVITA while pregnant, your child may have a higher risk of contracting an infection.
• It is essential to inform your child's doctor and other healthcare professionals about your use of AMGEVITA during pregnancy before your child receives any vaccine. For more information on vaccines, see the “Warnings and precautions” section.

Driving and operating machinery

The influence of AMGEVITA on the ability to drive, ride a bike, or operate machinery is small. You may experience a sensation of the room spinning and visual disturbances after taking AMGEVITA.

AMGEVITA contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose of 0.8ml; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor again.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

AMGEVITA is administered subcutaneously. The normal dose in adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and patients with psoriatic arthritis is 40 mg administered in alternate weeks as a single dose.

In the case of rheumatoid arthritis, treatment with methotrexate is maintained during the use of AMGEVITA. If your doctor determines that methotrexate is inappropriate, AMGEVITA may be administered alone.

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

Children, adolescents, and adults with juvenile idiopathic polyarticular arthritis

Children and adolescents from 2 years of age with 10 kg to 30 kg of weight

The recommended dose of AMGEVITA is 20 mg in alternate weeks.

Children, adolescents, and adults from 2 years of age with a weight of 30 kg or more

The recommended dose of AMGEVITA is 40 mg administered in alternate weeks.

Children, adolescents, and adults with arthritis associated with enthesitis

Children and adolescents from 6 years of age with 15 kg to 30 kg of weight

The recommended dose of AMGEVITA is 20 mg in alternate weeks.

Children, adolescents, and adults from 6 years of age with a weight of 30 kg or more

The recommended dose of AMGEVITA is 40 mg in alternate weeks.

Adults with plaque psoriasis

The normal dosage in adults with plaque psoriasis consists of an initial dose of 80 mg, followed by 40 mg in alternate weeks starting one week after the initial dose. Continue to inject AMGEVITA for as long as your doctor has instructed. Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Children and adolescents with plaque psoriasis

Children and adolescents from 4 to 17 years of age with 15 kg to 30 kg of weight

The recommended dose of AMGEVITA is an initial dose of 20 mg followed by 20 mg one week later. From then on, the usual dose is 20 mg in alternate weeks.

Children and adolescents from 4 to 17 years of age with a weight of 30 kg or more

The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by 40 mg one week later. From then on, the usual dose is 40 mg in alternate weeks.

Adults with hidradenitis suppurativa

The usual dosing regimen for hidradenitis suppurativa is an initial dose of 160 mg (two injections of 80 mg on the same day or one injection of 80 mg per day for two consecutive days), followed by a dose of 80 mg two weeks later. After two weeks, continue with a dose of 40 mg weekly or 80 mg every two weeks, as prescribed by your doctor. It is recommended to use an antiseptic liquid daily on the affected areas.

Adolescents with hidradenitis suppurativa from 12 to 17 years of age, with a weight of 30 kg or more

The recommended dose of AMGEVITA is an initial dose of 80 mg, followed by 40 mg in alternate weeks starting one week later. If you have an inadequate response to AMGEVITA 40 mg in alternate weeks, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

It is recommended to use an antiseptic liquid daily on the affected areas.

Adults with Crohn's disease

The usual dosing regimen for Crohn's disease is an initial dose of 80 mg, followed by 40 mg in alternate weeks starting two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (two injections of 80 mg on the same day or one injection of 80 mg per day for two consecutive days), followed by 80 mg two weeks later, and then 40 mg in alternate weeks. Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Children and adolescents with Crohn's disease

Children and adolescents from 6 to 17 years of age with a weight of less than 40 kg

The usual dosing regimen is an initial dose of 40 mg, followed by a dose of 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg, followed by 40 mg two weeks later.

From then on, the usual dose is 20 mg in alternate weeks. Depending on your response, your doctor may increase the frequency of the dose to 20 mg weekly.

Children and adolescents from 6 to 17 years of age with a weight of 40 kg or more

The usual dosing regimen is an initial dose of 80 mg, followed by a dose of 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (two injections of 80 mg on the same day or one injection of 80 mg per day for two consecutive days), followed by 80 mg two weeks later.

From then on, the usual dose is 40 mg in alternate weeks. Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Adults with ulcerative colitis

The usual dosing regimen of AMGEVITA in adults with ulcerative colitis is an initial dose of 160 mg (two injections of 80 mg on the same day or one injection of 80 mg per day for two consecutive days), followed by 80 mg two weeks later, and then 40 mg in alternate weeks. Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age with a weight of less than 40 kg

The usual dose of AMGEVITA is an initial dose of 80 mg, followed by a dose of 40 mg (as a single injection of 40 mg) two weeks later. From then on, the usual dose is 40 mg in alternate weeks.

Patients who are 18 years of age or older while receiving treatment with 40 mg in alternate weeks should continue with their prescribed dose.

Children and adolescents from 6 years of age with a weight of 40 kg or more

The usual dose of AMGEVITA is an initial dose of 160 mg (two injections of 80 mg on the same day or one injection of 80 mg per day for two consecutive days), followed by a dose of 80 mg two weeks later. From then on, the usual dose is 80 mg in alternate weeks.

Patients who are 18 years of age or older while receiving treatment with 80 mg in alternate weeks should continue with their prescribed dose.

Adults with non-infectious uveitis

The usual dose in adults with non-infectious uveitis is an initial dose of 80 mg, followed by 40 mg in alternate weeks starting one week after the initial dose. Continue to inject AMGEVITA for as long as your doctor has instructed.

In non-infectious uveitis, treatment with corticosteroids or other immunomodulating medications may be continued during the use of AMGEVITA. AMGEVITA may also be administered alone.

Children and adolescents from 2 years of age with chronic non-infectious uveitis

Children and adolescents from 2 years of age with a weight of less than 30 kg

The usual dose of AMGEVITA is 20 mg in alternate weeks along with methotrexate.

Your pediatrician may prescribe an initial dose of 40 mg, which may be administered one week before starting the usual regimen.

Children and adolescents from 2 years of age with a weight of 30 kg or more

The usual dose of AMGEVITA is 40 mg in alternate weeks along with methotrexate.

Your pediatrician may prescribe an initial dose of 80 mg, which may be administered one week before starting the usual regimen.

Form and route of administration

AMGEVITA is administered subcutaneously.

Instructions for use are provided in the "Instructions for Use" section.

If you use more AMGEVITA than you should

If you accidentally inject AMGEVITA more frequently than prescribed by your doctor, inform your doctor. Always carry the medication box with you, even if it is empty.

If you forget to use AMGEVITA

If you forget to administer an injection, inject the next dose of AMGEVITA as soon as you remember. Then, administer the next dose as usual, as if you had not forgotten a dose.

If you interrupt treatment with AMGEVITA

The decision to stop using AMGEVITA should be discussed with your doctor. Your symptoms may return after treatment interruption.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects can appear at least up to 4 months after the last injection of AMGEVITA.

Seek medical attention immediately if you notice any of the following signs of allergic reaction or heart failure:

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

Seek medical attention as soon as possible if you notice any of the following side effects:

• signs of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating;
• feeling weak or tired;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• signs of skin cancer such as a lump or open wound that does not heal;
• signs and symptoms of blood disorders such as persistent fever, petechiae, bleeding, and pallor.

The symptoms described above may be signs of the side effects listed below, which have been observed with adalimumab.

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

• reactions at the injection site (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, cough, sinusitis, pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• hives;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including sepsis and flu);
• gastrointestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• oral infections (including dental infection and mouth ulcers);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• difficulty sleeping;
• sensory changes such as tingling, itching, or numbness;
• migraine;
• nerve root compression (including lower back and leg pain);
• visual changes;
• eye inflammation;
• eyelid inflammation and swelling of the eye;
• dizziness (feeling of spinning or room spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• bruising;
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion, bloating, and heartburn;
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• hives with itching;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• excessive sweating;
• hair loss;
• new onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• swelling;
• fever;
• decreased platelet count in blood, increasing the risk of bleeding or bruising;
• wound healing problems.

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

• leukemia (blood and bone marrow cancer);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological changes (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (lung scarring);
• intestinal perforation (hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B virus;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (potentially life-threatening reaction with symptoms similar to flu and hives with blisters);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• systemic lupus erythematosus (including skin, heart, lung, joint, and other organ inflammation);
• angioedema (localized skin inflammation);
• lichenoid reaction in the skin (red, purple hives with itching).

Frequency not known (cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (rare blood cancer often fatal);
• Merkel cell carcinoma (type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions;
• liver failure;
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness);
• weight gain (for most patients, weight gain was reduced).

Some side effects observed with adalimumab do not have symptoms and can only be identified 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;
• high lipid levels in blood;
• high liver enzymes.

Common (may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• high uric acid levels in blood;
• abnormal sodium levels in blood;
• low calcium levels in blood;
• low phosphate levels in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium levels in blood.

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

• high bilirubin levels (liver function test).

Very rare (may affect up to 1 in 1,000 people)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly (see details below). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Spanish Medicines Agency's Pharmacovigilance System for Human Use:

www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label/container and on the packaging after EXP or CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze.

Store in the original packaging to protect it from light.

You can store an individual pre-filled syringe of AMGEVITA 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 a period of 14 days.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This way, you will help protect the environment.

Composition of AMGEVITA

• The active ingredient is adalimumab. Each pre-filled syringe contains 20mg of adalimumab in 0.2ml of solution, 40mg of adalimumab in 0.4ml of solution, or 80mg of adalimumab in 0.8ml of solution.
• The other components are L-lactic acid, sucrose, polisorbate 80, sodium hydroxide, and water for injection.

Appearance of the product and contents of the pack

AMGEVITA is a transparent, colorless to slightly yellowish solution.

Each pack contains 1 pre-filled syringe of 20mg for single use (with a yellow plunger).

Each pack contains 1, 2, or 6 pre-filled syringes of 40mg for single use (with a blue plunger).

Each pack contains 1, 2, or 3 pre-filled syringes of 80mg for single use (with an orange plunger).

Marketing Authorization Holder and Responsible Manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing Authorization Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen Technology Ireland UC

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet: May 2024

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.