Imraldi 40 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Imraldi 40 mg solution for injection in 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 also provide you with a patient information card containing important safety information you need to know before and during treatment with Imraldi. Keep this patient information card throughout your treatment and for 4 months after your (or your child's) last injection of Imraldi.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Imraldi is and what it is used for
2. What you need to know before using Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.

Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind specifically to a particular target.

Adalimumab's target is a protein called tumour necrosis factor (TNFa), which is present at increased levels in the inflammatory diseases listed above. By binding to TNFa, Imraldi reduces the inflammatory process in these conditions.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease affecting the joints.

Imraldi is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines such as methotrexate. If these medicines do not provide an adequate response, you will be given Imraldi to treat your rheumatoid arthritis.

Imraldi may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.

Imraldi can reduce joint damage to cartilage and bone caused by the disease and improve physical function.

Imraldi is usually used in combination with methotrexate. If your doctor considers methotrexate to be inappropriate, Imraldi 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 appear in childhood.

Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children aged 6 to 17 years. Patients may have first received other disease-modifying drugs such as methotrexate. If these medicines do not provide an adequate response, patients will be given Imraldi to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases affecting the spine.

Imraldi is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines, and if these do not provide an adequate response, you will receive Imraldi to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.

Imraldi is used to treat psoriatic arthritis in adults. Imraldi can reduce joint damage caused by the disease in cartilage and bone and improve physical function.

Plaque psoriasis in adults and children

Plaque psoriasis is an inflammatory skin disease that causes red, scaly, crusty patches covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, or separate from the nail bed, which may be painful. Psoriasis is thought to be caused by a defect in the body's immune system that leads to increased production of skin cells.

Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more who have not responded to, or are not suitable candidates for, topical therapy and phototherapy.

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 drain 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.

Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses and the pain usually associated with the disease. You may have previously received other medicines. If these do not provide an adequate response, you will be given Imraldi.

Crohn's disease in adults and children

Crohn's disease is an inflammatory disease of the gastrointestinal tract.

Imraldi 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 these do not provide an adequate response, you will be given Imraldi 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.

Imraldi 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 these do not provide an adequate response, Imraldi 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. Imraldi 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 anterior part of the eye.

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

2. What you need to know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other components of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis (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 serious heart problems (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Imraldi.

Allergic reaction

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

Infection

• If you have any infection , including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with Imraldi. If you are unsure, contact your doctor.
• While being treated with Imraldi, you may be more susceptible to infections. This risk may be greater if your lung function is reduced. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, other opportunistic infections (rare infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. Therefore, it is important to inform your doctor if you develop symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping treatment with Imraldi.

Tuberculosis

• Cases of tuberculosis have been reported in patients receiving Imraldi. Your doctor will examine you for signs or symptoms of tuberculosis before starting Imraldi treatment. This will include a thorough medical evaluation, including your medical history and diagnostic tests (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded on 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 occur during or after treatment, contact your doctor immediately.

Infection due to travel/recurrent infection

• Inform your doctor if you have lived in or traveled 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 the hepatitis B virus (HBV) , if you have had an active HBV infection, or if you think you may be at risk of contracting HBV. Your doctor should perform an HBV test. Imraldi may reactivate HBV infection 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.

Patients over 65 years of age

• If you are over 65 years old, you may be more susceptible to infections while being treated with Imraldi. 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.

Surgery or dental procedures

• If you are scheduled for surgery or dental procedures , inform your doctor that you are taking Imraldi. Your doctor may recommend temporarily stopping treatment with Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether you should start or continue treatment with Imraldi. 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.

Vaccines

• Certain vaccines contain live, although weakened, forms of disease-causing bacteria or viruses, and these vaccines should not be administered during treatment with Imraldi. Consult your doctor before receiving any type of vaccine. If possible, ensure that children receive all age-appropriate scheduled vaccines before starting treatment with Imraldi. If you receive Imraldi during pregnancy, your child may have an increased risk of infections for up to 5 months after your last dose of Imraldi. It is important to inform your child’s doctor and other healthcare professionals about your use of Imraldi during pregnancy so they can decide whether your child should receive any vaccines.

Heart failure

• If you have mild heart failure and are being treated with Imraldi, your doctor should closely monitor your heart 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 Imraldi.

Fever, bruising, bleeding, or paleness

• In some patients, the body may be unable to produce enough of certain blood cells needed to fight infections (white blood cells) or to stop bleeding (platelets). If you have persistent fever , develop bruises , bleed easily, or appear very pale , consult 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 Imraldi or other TNFa blockers. People with more severe rheumatoid arthritis or those who have had the disease for a long time 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 Imraldi, your risk of developing lymphoma, leukemia, or other cancers may increase. A specific and serious type of lymphoma has been observed rarely in patients receiving Imraldi. Some of these patients were also receiving azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• Cases of non-melanoma skin cancer have also been observed in patients using Imraldi. Inform your doctor if new skin lesions appear during or after treatment, or if existing marks or 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 TNFa blocker. If you have COPD or are a heavy smoker, consult your doctor about whether treatment with a TNFa blocker is appropriate for you.

Lupus-like syndrome

• Rarely, treatment with Imraldi may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as a persistent unexplained rash, fever, joint pain, or fatigue.

Children and adolescents

• Do not administer Imraldi to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.

Other medicines and Imraldi

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

Imraldi can 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 should not use Imraldi 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 Imraldi injection.
• If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
• Imraldi 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 adalimumab during pregnancy compared to mothers with the same disease who did not receive adalimumab.
• Imraldi can be used during breastfeeding.
• If you use Imraldi while pregnant, your child may have a higher risk of infection.
• It is important to inform your child’s pediatrician and other healthcare professionals about your use of Imraldi during pregnancy before your child receives any vaccines. For more information on vaccines, see the section “Warnings and precautions.”

Driving and using machines

The effect of Imraldi on the ability to drive, ride a bicycle, or operate machinery is minimal. Dizziness (a sensation that the room is spinning) and visual disturbances may occur after taking Imraldi.

Imraldi contains sodium and sorbitol

Sorbitol

This medicine contains 20 mg of sorbitol in each pre-filled pen. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Sodium

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

3. How to use Imraldi

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

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

Imraldi in pre-filled syringe and in pre-filled pen is only available in 40 mg doses. Therefore, it is not possible to administer Imraldi in pre-filled syringe or pre-filled pen to pediatric patients requiring less than a full 40 mg dose. When an alternative dose is required, other presentations offering this option must be used.

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

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

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

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing 10 kg up to 30 kg

The recommended dose of Imraldi is 20 mg every other week.

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

The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis

Children and adolescents from 6 years of age weighing 15 kg up to 30 kg

The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents, and adults from 6 years of age weighing 30 kg or more

The recommended dose of Imraldi is 40 mg every other week.

Adults with psoriasis

The usual dosage regimen in adults with 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 Imraldi for as long as your doctor has instructed. If this dose does not work well enough, 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 weighing 15 kg up to 30 kg

The recommended dose of Imraldi is an initial dose of 20 mg followed by 20 mg one week later. After that, the usual dose is 20 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kg or more

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

Adults with hidradenitis suppurativa

The usual dosing regimen 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 80 mg (as two 40 mg injections on the same day) two weeks later. After another two weeks, continue with a dose of 40 mg weekly or 80 mg every two weeks, as prescribed by your doctor. It is recommended that you use an antiseptic liquid daily on the affected areas.

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

The recommended dose of Imraldi 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 Imraldi 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 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 (as two 40 mg injections on the same day), followed by 40 mg every other week starting two weeks later.

If a more rapid effect 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 then 40 mg every other week. If the effect of this dose is not sufficient, 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 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.

After that, the usual dose is 20 mg every other week. If this dose is not effective enough, your doctor may increase the dosing frequency to 20 mg weekly.

Children and adolescents from 6 to 17 years of age 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.

After that, the usual dose is 40 mg every other week. If the effect of this dose is not sufficient, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.

Adults with ulcerative colitis

The usual dosing regimen for Imraldi in adults with ulcerative colitis is an initial dose of 160 mg (administered as four 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 then 40 mg every other week. If the effect of this dose is not sufficient, 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 weighing less than 40 kg

The usual dose of Imraldi 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. After that, 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 from 6 years of age weighing 40 kg or more

The usual dose of Imraldi is 160 mg (as four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days) initially, followed by a dose of 80 mg (as two 40 mg injections on the same day) two weeks later. After that, 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 dosing regimen in adults with non-infectious uveitis is an initial dose of 80 mg (as two injections on the same day), followed by 40 mg every other week starting one week after the initial dose. Continue injecting Imraldi for as long as your doctor has instructed.

In non-infectious uveitis, corticosteroids or immunosuppressive medications may be continued during Imraldi treatment. Imraldi 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 weighing less than 30 kg

The usual dose of Imraldi is 20 mg every other week together 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 weighing 30 kg or more

The usual dose of Imraldi is 40 mg every other week together 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

Imraldi is injected under the skin (subcutaneous route). For instructions on use, refer to section 7.

If you use more Imraldi than you should:

If you accidentally inject Imraldi more frequently than you should, inform your doctor or pharmacist that you have used more than required. Always carry the medicine carton with you, even if it is empty.

If you forget to use Imraldi:

If you miss an injection, you should inject the next dose of Imraldi as soon as you remember. Then administer the following dose as usual, as if you had not missed a dose.

If you stop using Imraldi:

The decision to stop using Imraldi 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 experiences them. Most adverse effects are mild to moderate. However, some may be serious and require treatment. Adverse effects may occur up to 4 months or more after the last injection of Imraldi.

Seek urgent medical attention if you notice any of the following:

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

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

• signs of infection such as fever, nausea, wounds, dental problems, or burning sensation when urinating;
• feeling weak or tired;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• a lump or open wound 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);
• lower 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;
• mouth infections (including dental infection and cold sores);
• 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;
• symptoms of nerve root compression (including lower back and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation that the room is spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• flushing;
• hematoma (a palpable swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, and burning);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• cracking or splitting of fingernails and toenails;
• increased sweating;
• hair loss;
• new onset psoriasis or worsening of existing psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body causing swelling of affected tissue);
• fever;
• decreased platelet count in blood, increasing the risk of bleeding or bruising;
• impaired 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 lymphatic system cancer (lymphoma) and melanoma (a type of skin cancer);
• immune-mediated disorders affecting the lungs, skin, and lymph nodes (most commonly as a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause difficulty breathing or ankle swelling;
• myocardial infarction;
• aneurysm (ballooning of a major artery wall), vein inflammation and clotting, blockage of a blood vessel;
• lung diseases that may cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a lung artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis (inflammation of the pancreas causing severe abdominal and back pain);
• difficulty swallowing;
• facial edema;
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• 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 1000 people):

• leukemia (cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nerve disorders (such as optic neuritis affecting the eye, and Guillain-Barré syndrome, a disease that may cause muscle weakness, abnormal sensations, and tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lungs);
• intestinal perforation;
• hepatitis;
• 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 (early symptoms include malaise, fever, headache, and 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 disease called dermatomyositis (seen as skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain was minimal).

Some adverse effects with adalimumab observed in clinical trials do not cause 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 levels;
• low blood calcium;
• low blood phosphate;
• high blood sugar;
• high blood lactate dehydrogenase levels;
• presence of autoantibodies in blood;
• low blood potassium.

Uncommon (may affect up to 1 in 100 people):

• high bilirubin levels (liver function test).

Rare (may affect up to 1 in 1000 people):

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

Reporting of adverse effects

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

5. Storage of Imraldi

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

Do not use this medicine after the expiry date stated on the label of the carton after “EXP”. 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 the pre-filled pen in the outer carton to protect it from light.

Alternative storage:

When necessary (for example, when travelling), a single Imraldi pre-filled pen may be stored at room temperature (up to 25 °C) for a maximum period of 31 days (ensure it is protected from light). Once the pen has been removed from the refrigerator for storage at room temperature, it must be used within the following 31 days or must be discarded, even if it is returned to the refrigerator.

You should record the date on which you removed the pen from the refrigerator, and the date after which the pen must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imraldi

• The active substance is adalimumab.
• The other components are: monosodium phosphate monohydrate, disodium phosphate heptahydrate, succinic acid, disodium succinate, histidine, histidine monohydrochloride monohydrate, mannitol, polysorbate 20, and water for injections.

Nature of the product and contents of the pack

Imraldi 40 mg solution for injection in a pre-filled pen is supplied as 0.4 ml of a solution ranging from transparent to opalescent and from colorless to pale brown.

Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pens with a pre-filled syringe inside (Type I glass) with a stainless steel needle, a rigid needle cap, a rubber plunger for patient use, and 2, 2, 4 or 6 alcohol wipes included in the respective pack.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Manufacturer

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

The Netherlands

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of latest revision of this leaflet: 03/2025

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

1. Instructions for use

Follow these instructions carefully, and soon you will develop a routine for safely administering the injection.

• Before injecting yourself, ask your doctor or nurse to show you how to use the pre-filled pen. Your doctor or nurse must ensure that you are able to use the pen correctly.

Single-dose pre-filled pen

Your pre-filled pen does not have a button.

The needle is hidden beneath the green base. The injection starts automatically when you press the pre-filled pen firmly against the skin.

Caring for your pre-filled pen

Storage of the pen

• Store the pen in the refrigerator, but do not freeze it.
• Keep the pen in its box and protect it from light.
• Keep the pen out of the sight and reach of children.

Disposal of the pen

• Use each pen only once. Never reuse a pen.
• Dispose of the used pen in a special container as instructed by your doctor, nurse, or pharmacist.

Precautions

• If the pen has been dropped WITH the cap on, you may still use the pen.

If the pen has been dropped WITHOUT the cap, do not use it. The needle may be dirty or damaged.

• Do not use a damaged pen.

Caring for the injection site

• Choose a fatty area for the injection

Fatty areas, such as the abdomen, are generally the best places for the injection. Fatty areas allow proper needle insertion.

• Use a different site for each new injection

When choosing an injection site, select an area that you have not recently used to avoid pain or bruising.

How to inject with your pre-filled pen

1. Gather the necessary materials for the injection

Place the pre-filled pen and alcohol wipes on a clean, dry surface.

• Do not forget to wash your hands!
• Do not remove the cap yet!

1. Wait 15–30 minutes

Wait 15–30 minutes for the pre-filled pen to reach room temperature; this helps reduce pain during the injection.

• Do not remove the cap yet!

1. Check the medicine and expiration date

Always ensure that the medicine is clear to opalescent, colorless to pale brown, free from particles, and not expired. Do not use the medicine if it is not clear to opalescent, colorless to pale brown, if it contains particles, or if it has expired.

It is normal to see one or more air bubbles; this is not a reason to discard the medicine.

• Do not remove the cap yet!

1. Choose an injection site and clean the skin

Choose an injection site on your body. The most suitable areas are the abdomen (except the area around the navel) and the thighs.

Clean the injection site with an alcohol wipe. Do not touch the area again before the injection.

• Avoid areas of skin that are painful, bruised, scarred, scaly, or have red patches.

1. Remove the transparent needle cap

Carefully remove the transparent needle cap with metal core from the pen.

It is normal for a few drops of liquid to come out of the needle.

If you remove the needle cap before you are ready to inject, do not reattach it, as this may bend or damage the needle. You could accidentally prick yourself or waste the medicine.

1. Place the green base, press firmly, and maintain pressure

Place the green base vertically (at a 90-degree angle) on the skin, and press the pre-filled pen down firmly to start the injection.

The injection begins when you press down. You may hear a first click.

1. Maintain pressure

Keep the pen pressed against the skin until the yellow indicator fills the medicine window and stops moving.

A few seconds later, you may hear a second click.

1. Confirm completion and dispose of the pen

After injecting Imraldi, confirm that the entire window is yellow.

Dispose of the used pen in a special container as instructed by your doctor, nurse, or pharmacist.

• Are you unsure whether you administered the full dose? Contact your doctor, nurse, or pharmacist.