Amgevita 40 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

AMGEVITA 40mg solution for injection in a pre-filled pen

adalimumab

Read the entire 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 a patient information card containing important safety information you need to know before and during treatment with AMGEVITA.

Keep this patient information card.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 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 system (defence).

AMGEVITA is indicated for the treatment of the following inflammatory diseases:

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

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

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which plays a role in the immune system (defence) and is found at elevated levels in the inflammatory diseases described above. By targeting 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 active rheumatoid arthritis, you may have been given other disease-modifying drugs such as methotrexate first. If your response to these medicines is not sufficient, you will be given AMGEVITA to treat your rheumatoid arthritis.

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

AMGEVITA reduces joint damage to cartilage and bone caused by the disease and improves physical function.

AMGEVITA is usually used in combination with methotrexate. If your doctor determines that methotrexate is not suitable, 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 typically first appear in 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. You may have first received other disease-modifying drugs such as methotrexate. If you do not respond adequately to these medicines, you will receive AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

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

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

Psoriatic arthritis

Psoriatic arthritis is joint inflammation associated with psoriasis.

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

Plaque psoriasis in adults and children

Plaque psoriasis is a skin disease that causes red, scaly, crusted areas covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a defect 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 to 17 years who have not responded to, or are not suitable candidates for, topical treatments and phototherapies.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called inverse acne) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may discharge pus. It typically affects specific areas of the skin such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also occur in 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 typically associated with this disease. You may have previously received other medicines. If you do not respond adequately to these, you will receive AMGEVITA.

Crohn's disease in adults and children

Crohn's disease is an inflammatory disease 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 treated with other medicines. If you do not respond adequately to these, 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 have ulcerative colitis, you may first be prescribed other medicines. If you do not respond well to these, AMGEVITA will be prescribed to reduce the signs and symptoms of your disease.

Non-infectious uveitis in adults and children

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

AMGEVITA is used to treat:

• Adults with non-infectious uveitis with inflammation affecting the posterior part 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 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 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, such as fever, wounds, fatigue, or dental problems, it is important to inform your doctor.
• if you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have any serious heart problems (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with AMGEVITA:

Allergic reactions

• If you experience an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop using AMGEVITA and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

• If you have any infection, including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with AMGEVITA. If you are unsure, contact your doctor.
• You may be more likely to develop infections while being treated with AMGEVITA. This risk may be higher if you have lung damage. These infections can be serious and include tuberculosis, viral, fungal, parasitic, or bacterial infections, other opportunistic infections, and sepsis, which in rare cases could be life-threatening. Therefore, it is important to inform your doctor if you experience symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping treatment with AMGEVITA.

Tuberculosis

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

Recurrent infections/travel

• 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 a history of recurrent infections or other conditions or risk factors that increase the likelihood of infections.

Hepatitis B virus

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

Age over 65 years

• If you are over 65 years of age, 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 during treatment. It is important to inform your doctor if you experience symptoms of infection, such as fever, wounds, fatigue, or dental problems.

Surgical or dental procedures

• If you are scheduled for surgery or a dental procedure, inform your doctor that you are taking AMGEVITA. Your doctor may recommend temporarily stopping treatment with 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 anywhere in the body.

Vaccinations

• Certain vaccines contain live but weakened bacteria or viruses that can cause disease and lead to infections and must not be administered while you are being treated with AMGEVITA. Consult your doctor before receiving any type of vaccine. If possible, children should be up to date with their vaccination schedule according to current vaccination guidelines before starting treatment with AMGEVITA.
• If you receive AMGEVITA during pregnancy, your baby may have an increased risk of infections for approximately 5 months after your last dose of AMGEVITA. It is important to inform your baby’s doctor and other healthcare professionals about your use of AMGEVITA during pregnancy so they can decide whether your baby should receive any vaccines.

Heart failure

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

Fever, bruising, bleeding, or paleness

• In some patients, the body may be unable to produce enough of certain types of blood cells that help fight infections (white blood cells) or stop bleeding (platelets). If you have persistent fever, bruising, easy bleeding, or appear very pale, contact your doctor immediately. Your doctor may decide to stop treatment.

Cancer

• Very rarely, certain types of cancer have been reported in children and adults treated with adalimumab or other TNF blockers. People with more severe rheumatoid arthritis and long-standing disease may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) or leukemia (a cancer affecting blood and bone marrow).
• If you are being treated with AMGEVITA, your risk of developing lymphoma, leukemia, or other types of cancer may increase. A specific and serious type of lymphoma has been observed rarely 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 skin cancer (non-melanoma type) have been observed in patients using adalimumab. Inform your doctor if new skin lesions appear during or after treatment or if existing lesions change in appearance.
• Cancers other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) who were treated with another TNF blocker. If you have COPD or are a heavy smoker, consult your doctor to determine whether treatment with a TNF blocker is appropriate for you.

Autoimmune diseases

• Rarely, treatment with AMGEVITA may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as unexplained persistent 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 medicine administered in your medical record. If requested in the future, you may also note down these details.

Children and adolescents

• Vaccinations: If possible, your child should be up to date with all vaccinations before using AMGEVITA.

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

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

• Do not administer AMGEVITA to children under 6 years of age with Crohn’s disease or ulcerative colitis.

Using AMGEVITA with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

AMGEVITA may be taken together with methotrexate or certain disease-modifying antirheumatic drugs (DMARDs) (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts), corticosteroids, or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

You must not use AMGEVITA together with medicines containing anakinra or abatacept as this increases the risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using effective contraception to avoid becoming pregnant 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 have a baby, consult your doctor before using this medicine.
• AMGEVITA should be used during pregnancy only if clearly needed.
• According to a pregnancy study, there was no increased risk of congenital malformations in mothers who received AMGEVITA during pregnancy compared to mothers with the same disease who did not receive AMGEVITA.
• AMGEVITA may be used during breastfeeding.
• If you use AMGEVITA while pregnant, your baby may have an increased risk of infection.
• It is important to inform your baby’s pediatrician and other healthcare professionals about your use of AMGEVITA during pregnancy before your baby receives any vaccines. For more information on vaccines, see the section “Warnings and precautions”.

Driving and using machines

The effect of AMGEVITA on the ability to drive, ride a bicycle, or operate machinery is minimal. Dizziness and visual disturbances may occur after taking AMGEVITA.

AMGEVITA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose; hence, essentially “sodium-free”.

3. How to use AMGEVITA

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis

AMGEVITA is injected under the skin (subcutaneously). The usual dose in adults with rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and for patients with psoriatic arthritis is 40 mg administered every other week as a single dose.

In the case of rheumatoid arthritis, treatment with methotrexate should be continued during AMGEVITA therapy. If your doctor determines that methotrexate is inappropriate, AMGEVITA may be given alone.

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

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis

Children, adolescents, and adults aged 2 years and older weighing 30 kg or more

The recommended dose of AMGEVITA is 40 mg administered every other week.

Children, adolescents, and adults with enthesitis-related arthritis

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 dosage regimen in adults with plaque psoriasis is an initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose. You should continue injecting 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 aged 4 to 17 years weighing 30 kg or more

The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa

The usual dosing schedule for hidradenitis suppurativa is 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 a dose of 80 mg (as two 40 mg injections on the same day) two weeks later. After an additional two weeks, continue with a dose of 40 mg weekly or 80 mg every two weeks, as prescribed by your doctor. It is recommended that you use an antiseptic wash 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 (as two 40 mg injections on the same day), followed by 40 mg every other week starting one week later. If you have an inadequate response to AMGEVITA 40 mg every other week, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

It is recommended that you use an antiseptic wash daily on affected areas.

Adults with Crohn’s disease

The usual dosing regimen for Crohn’s disease is an initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg every other week starting 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 (as two 40 mg injections on the same day) two weeks later, and thereafter 40 mg every other week. 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 aged 6 to 17 years weighing less than 40 kg

The usual dosing regimen is 40 mg initially, 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 your response, your doctor may increase the dosing frequency to 20 mg weekly.

The 40 mg pre-filled pen cannot be used for the 20 mg dose. A pre-filled syringe of 20 mg is available for the 20 mg dose.

Children and adolescents aged 6 to 17 years weighing 40 kg or more

The usual dosing regimen is 80 mg (as two 40 mg injections on the same day) initially, 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 (as two 40 mg injections on the same day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Adults with ulcerative colitis

The usual dosage of AMGEVITA in adults with ulcerative colitis is 160 mg initially (as four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections on the same day) two weeks later, and thereafter 40 mg every other week. 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 aged 6 years and older weighing less than 40 kg

The usual dose of AMGEVITA is 80 mg (as two 40 mg injections on the same day) initially, followed by a dose of 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

Patients who turn 18 years old while receiving treatment with 40 mg every other week should continue with their prescribed dose.

Children and adolescents aged 6 years and older weighing 40 kg or more

The usual dose of AMGEVITA is 160 mg (as four 40 mg injections on the same day or two 40 mg injections per day on two consecutive days) initially, followed by a dose of 80 mg (as two 40 mg injections on the same day) two weeks later. Thereafter, the usual dose is 80 mg every other week.

Patients who turn 18 years old while receiving treatment with 80 mg every other week 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 (as two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose. You should continue injecting AMGEVITA for as long as your doctor has instructed.

In non-infectious uveitis, treatment with corticosteroids or other immunosuppressive medications may be continued during AMGEVITA therapy. AMGEVITA may also be administered alone.

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

Children and adolescents aged 2 years and older weighing less than 30 kg

The usual dose of AMGEVITA is 20 mg every other week in combination with methotrexate.

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

The 40 mg pre-filled pen cannot be used for the 20 mg dose. A pre-filled syringe of 20 mg is available for the 20 mg dose.

Children and adolescents aged 2 years and older weighing 30 kg or more

The usual dose of AMGEVITA is 40 mg every other week in combination with methotrexate.

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

Method and route of administration

AMGEVITA is injected under the skin (subcutaneously).

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, inform your doctor. Always keep the medicine carton 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 following dose as usual, as if you had not missed a dose.

If you stop using AMGEVITA

The decision to discontinue AMGEVITA should be discussed with your doctor. Your symptoms may return after stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most adverse effects are mild to moderate. However, some may be serious and require treatment. Adverse effects may occur up to at least 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, feet;
• difficulty breathing or swallowing;
• shortness of breath during exercise or when lying down, swelling of the feet.

Contact your doctor as soon as possible if you notice any of the following 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 an open sore that does not heal;
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The symptoms described above may be signs of the adverse 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, runny nose, sinusitis, pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people)

• serious infections (including blood poisoning and flu);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• oral infections (including dental infection and mouth ulcers);
• reproductive system infections;
• urinary tract infection;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• difficulty sleeping;
• sensory disturbances such as tingling, burning, or numbness;
• migraine;
• nerve root compression (including low back and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• vertigo (sensation of dizziness or spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• flushing;
• bruising;
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, and heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage in hands and feet;
• increased sweating;
• hair loss;
• new-onset psoriasis or worsening of existing psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema;
• fever;
• decreased platelet count in blood, increasing the risk of bleeding or bruising;
• problems with wound healing.

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (including tuberculosis and other infections that occur when disease resistance is reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including cancer affecting the lymphatic system (lymphoma) and melanoma (skin cancer);
• immunological 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, tinnitus;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause difficulty breathing or ankle swelling;
• heart attack;
• aneurysm (bulging in the wall of a major artery), vein inflammation and clotting, blockage of a blood vessel;
• lung diseases that may cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of an artery in the lung);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis (inflammation of the pancreas) causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema;
• gallbladder inflammation; gallstones;
• fatty liver;
• night sweats;
• scarring;
• abnormal muscle spasms;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
• sleep disturbances;
• impotence;
• inflammations.

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

• leukemia (cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nerve 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 (lung scarring);
• intestinal perforation (a 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 flu-like symptoms and blistering rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized skin swelling);
• lichenoid skin reaction (reddish-purple itchy rash).

Frequency not known (cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more frequently as purplish skin lesions;
• liver failure;
• worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain was minimal).

Some adverse effects observed with adalimumab do not have symptoms and can only be detected through blood tests. These include:

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

• low blood count of white blood cells;
• low blood count of red blood cells;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people)

• high blood count of white blood cells;
• low blood count of platelets;
• increased blood uric acid;
• abnormal blood sodium values;
• low blood calcium level;
• low blood phosphate level;
• high blood sugar;
• high blood lactate dehydrogenase levels;
• presence of autoantibodies in blood;
• low blood potassium level.

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels (liver function test).

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

A single pre-filled pen of AMGEVITA may be stored at temperatures up to a maximum of 25 °C for a maximum period of 14 days. The pre-filled pen must be protected from light and must be 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of AMGEVITA

• The active substance is adalimumab. Each pen contains 40 mg of adalimumab in 0.4 ml of solution.
• The other components are L-lactic acid, sucrose, polysorbate 80, sodium hydroxide and water for injections.

Appearance of the product and contents of the pack

AMGEVITA is a clear, colourless to slightly yellowish solution.

Each pack contains 1, 2 or 6 single-use SureClick prefilled pens containing 40 mg.

Marketing Authorisation Holder and Manufacturer

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 medicine, please contact the local representative of the Marketing Authorisation Holder.

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu.