Product Information for the Patient

Imraldi 40 mg Pre-filled Syringe

adalimumab

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• Your doctor will also give you a patient information leaflet, which contains important safety information that you need to know before and during treatment with Imraldi. Keep this patient information leaflet during your treatment and the 4 months after your last injection (or your child's) of Imraldi.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 product information. See section 4.

Imraldi contains adalimumab as its active substance, a medication that acts on the body's immune system.

Imraldi is indicated for the treatment of:

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

The active principle of Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.

The target of adalimumab is a protein (called tumor necrosis factor (TNFα), whose levels increase in the previously mentioned inflammatory diseases. By binding to TNFα, Imraldi reduces the process of inflammation in these diseases.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Imraldi is used to treat rheumatoid arthritis in adults. If you have active moderate to severe rheumatoid arthritis, you may be given other disease-modifying medications such as methotrexate before Imraldi. If the effect of these medications is not sufficient, you will be given Imraldi to treat your rheumatoid arthritis.

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

Imraldi can reduce the damage to the cartilage and bones of the joints caused by the disease and improve physical performance.

Imraldi is usually used in combination with methotrexate. If your doctor considers methotrexate not suitable, Imraldi can be administered alone.

Imraldi is used to treat juvenile idiopathic polyarticular arthritis in children and adolescents aged 2 to 17 years and arthritis associated with enthesitis in children aged 6 to 17 years. Patients may have received other disease-modifying medications, such as methotrexate, first. If the effect of these medications is not sufficient, patients will be given Imraldi to treat their juvenile idiopathic polyarticular arthritis or arthritis associated with enthesitis.

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 that affect the spine.

Imraldi 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 be treated first with other medications, and if the effect of these medications is not sufficient, you will receive Imraldi to reduce the signs and symptoms of your disease.

Psoriatic Arthritis

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

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

Psoriasis in Adults and Children

Poriasis in plaques is an inflammatory disease of the skin that causes red, scaly, crusty areas covered with silver scales. Psoriasis in plaques 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.

Imraldi is used to treat moderate to severe psoriasis in adults. Imraldi is also used to treat severe psoriasis in children and adolescents with a weight of 30 kg or more who have not responded or are not good candidates for topical therapy and phototherapy.

Hidradenitis Suppurativa in Adults and Adolescents

Hidradenitis suppurativa (also known as inverse acne) is a long-lasting 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 cause scarring in affected areas.

Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years or older. Imraldi can reduce the number of nodules and abscesses and the pain associated with the disease. You may have received other medications previously. If the effect of these medications is not sufficient, you will receive Imraldi.

Crohn's Disease in Adults and Children

Crohn's disease is an inflammatory disease of the digestive 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 be treated first with other medications. If the effect is not sufficient, you will receive 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 be given other medications first. If the effect is not sufficient, you will be given Imraldi 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. Imraldi is used to treat

• adults with non-infectious uveitis with inflammation affecting the posterior part of the eye.
• children aged 2 years or 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). Imraldi acts by reducing this inflammation.

Do not use Imraldi

• If you are allergic to adalimumab or any of the other components of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis (see "Warnings and precautions"). If you have symptoms of any infection, for example: fever, wounds, fatigue, dental problems, inform your doctor.
• If you have moderate or severe heart failure. It is important to tell 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 Imraldi.

Allergic reaction

• If you have anallergic reactionwith symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or hives, interrupt the administration of Imraldi and contact your doctor immediately, as in rare cases, these reactions can be life-threatening.

Infection

• If you have anyinfection, including chronic or localized infections (for example: a leg ulcer), consult your doctor before starting treatment with Imraldi. If you are unsure, contact your doctor.
• With Imraldi treatment, you may be more likely to contract infections. This risk may be higher if you have reduced lung function. 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 can 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 temporarily interrupting Imraldi treatment.

Tuberculosis

• Since cases of tuberculosis have been described in patients treated with Imraldi, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Imraldi. This will include a thorough medical evaluation, including your medical history and diagnostic tests (for example, chest X-ray and tuberculin test). The performance and results of these tests should 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 a tuberculosis patient. You can develop tuberculosis 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.

Travel or recurrent infection

• Inform your doctor if you have lived 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 factors that increase the risk of infections.

Hepatitis B virus

• Inform your doctor if you are a carrier of thehepatitis 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 a test for HBV. Imraldi can reactivate HBV infection 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 infection can be life-threatening.

Patients over 65 years

• 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 while being treated with Imraldi. It is essential to inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue, or dental problems.

Surgical or dental intervention

• If you are to undergosurgical or dental intervention, inform your doctor that you are taking Imraldi. Your doctor may recommend temporarily interrupting Imraldi treatment.

Demyelinating disease

• If you have or develop ademyelinating disease(a disease that affects the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether you should be treated 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 in any part of the body.

Vaccines

• Certainvaccinescontain live, although weakened, forms of bacteria or viruses that cause diseases and should not be administered during Imraldi treatment. Consult your doctor before administering any type of vaccine. If possible, administer all scheduled vaccines to children before starting Imraldi treatment. If you receive Imraldi while pregnant, your child may have a higher risk of contracting infections for about 5 months after the last dose you received during pregnancy. It is essential 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 vaccine.

Heart failure

• If you havemild heart failureand are being treated with Imraldi, 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 new symptoms of heart failure or worsening of existing symptoms (for example: difficulty breathing, swelling of the feet) appear, contact your doctor immediately. Your doctor will decide whether you should continue taking Imraldi.

Fever, bruises, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough of the type of white blood cells to fight infections (white blood cells) or those that contribute to stopping bleeding (platelets). If you havefeverpersistently, or you easily bleed or bruise, or you appear verypale, contact your doctor immediately. Your doctor may decide to interrupt treatment.

Cancer

• In very rare cases, certain types ofcancerhave been reported in children and adults treated with Imraldi or other TNF-alpha blockers. People with severe rheumatoid arthritis and who have had the disease for a long time may have a higher risk than average of developing alymphoma(a cancer that affects the lymphatic system), and leukemia (a cancer that affects the blood and bone marrow). If you are being treated with Imraldi, the risk of developing lymphoma, leukemia, and other types of cancer may increase. A rare and severe type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• Additionally, cases ofskin cancer (non-melanoma)have been observed in patients using Imraldi. Inform your doctor if new skin damage areas appear during or after treatment, or if existing marks or damaged areas change appearance.
• Cancers, other than lymphoma, have been reported in patients with a specific lung disease, called chronic obstructive pulmonary disease (COPD), treated with another TNF-alpha blocker. If you have COPD, or smoke heavily, consult your doctor if treatment with a TNF-alpha blocker is suitable for you.

Lupus-like syndrome

• In rare cases, Imraldi treatment may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as persistent rash without explanation, fever, joint pain, or fatigue.

Children and adolescents

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

Other medicines and Imraldi

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

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

Do not use Imraldi with medicines 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

• You should consider using effective contraceptive methods to avoid pregnancy and continue using them for at least 5 months after the last Imraldi injection.
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• Imraldi 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 adalimumab treatment during pregnancy compared to mothers with the same disease who did not receive adalimumab treatment.
• Imraldi can be used during breastfeeding.
• If you use Imraldi 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 Imraldi during pregnancy before your child receives any vaccine. For more information on vaccines, see the "Warnings and precautions" section.

Driving and operating machinery

Imraldi's influence on the ability to drive, ride a bike, or operate machinery is small. You may experience a sensation of the room spinning (dizziness) and visual disturbances 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 informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose; that is, it is essentially "sodium-free".

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

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

Imraldi prefilled syringe and prefilled pen are only available in 40 mg doses. Therefore, it is not possible to administer Imraldi prefilled syringe or prefilled pen to pediatric patients who require less than a full dose of 40 mg. When an alternative dose is required, other presentations that offer this option must be used.

Imraldi is administered subcutaneously. The usual dose in adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and 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 is maintained during use of Imraldi. If your doctor determines that methotrexate is inappropriate, Imraldi may be administered alone.

If you have rheumatoid arthritis and do not receive methotrexate during treatment with Imraldi, your doctor may decide to give you 40 mg of adalimumab 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 Imraldi is 20 mg every other week.

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

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

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 Imraldi is 20 mg every other week.

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

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

Adults with psoriasis

The usual dosage in adults with psoriasis consists of an initial dose of 80 mg (as two injections of 40 mg 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. If that dose is not working 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 with 15 kg to 30 kg of weight

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

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

The recommended dose of Imraldi is an initial dose of 40 mg, followed by 40 mg one week later. From then on, 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 injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days) followed by a dose of 80 mg (as two injections of 40 mg per day) two weeks later. After two weeks more, continue with a dose of 40 mg weekly or 80 mg every two weeks, as instructed 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 Imraldi is an initial dose of 80 mg (as two injections of 40 mg 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 to use an antiseptic liquid daily on the affected areas.

Adults with Crohn's disease

The usual dosing regimen for Crohn's disease is 80 mg (as two injections of 40 mg on the same day) initially, followed by 40 mg every other week starting two weeks later.

If a faster effect is required, your doctor may prescribe an initial dose of 160 mg (as four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (as two injections of 40 mg per 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 with a weight 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 (as two injections of 40 mg on the same day) followed by a dose of 40 mg two weeks later.

From then on, the usual dose is 20 mg every other week. If that dose is not working well enough, 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 (as two injections of 40 mg on the same day) 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 (as four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days) followed by a dose of 80 mg (as two injections of 40 mg on the same day) two weeks later.

From then on, 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 of Imraldi in adults with ulcerative colitis is 160 mg initially (the dose can be administered as four injections on the same day or with two injections of 40 mg per day for two consecutive days) followed by 80 mg (as two injections of 40 mg per 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 with a weight less than 40 kg

The usual dose of Imraldi is an initial dose of 80 mg (as two injections of 40 mg on the same day) followed by a dose of 40 mg two weeks later. From then on, the usual dose is 40 mg every other week.

Patients who turn 18 years old while receiving treatment with 40 mg every other week must 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 Imraldi is an initial dose of 160 mg (as four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days) followed by a dose of 80 mg (as two injections of 40 mg on the same day) two weeks later. From then on, the usual dose is 80 mg every other week.

Patients who turn 18 years old while receiving treatment with 80 mg every other week must continue with their prescribed dose.

Adults with non-infectious uveitis

The usual dosing regimen in adults with non-infectious uveitis is 80 mg (as two injections on the same day) initially, 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 use of Imraldi. 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 with a weight less than 30 kg

The usual dose of Imraldi is 20 mg every other week along with methotrexate.

Your pediatrician may prescribe an initial dose of 40 mg that can 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 Imraldi is 40 mg every other week along with methotrexate.

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

Form and route of administration

Imraldi is administered subcutaneously. For use instructions, see 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 necessary. Always carry the medication box with you, even if it is empty.

If you forget to use Imraldi:

If you forget to administer an injection, inject the next dose of Imraldi 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 Imraldi:

The decision to stop using Imraldi 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 up to 4 months after or more since the last Imraldi injection.

Seek urgent medical attentionif you notice any of the following side effects:

• 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.

Contact your doctor as soon as possibleif 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;
• a lump or open wound that does not heal;
• signs and symptoms of blood abnormalities such as persistent fever, rashes, 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);
• lower respiratory tract infections (including colds, coughing, sinusitis, pneumonia);
• headache;
• abdominal pain (stomach);
• 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;
• mouth infections (including dental infection and cold sore);
• 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;
• symptoms of nerve root compression (including lower back and leg pain);
• visual changes;
• eye inflammation;
• eyelid inflammation and swelling of the eye;
• dizziness (feeling the room is spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• hematoma (a palpable swelling with coagulated blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion, bloating, and heartburn;
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• hives with itching;
• bruises;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• excessive sweating;
• hair loss;
• new-onset or worsening psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (accumulation of fluid in the body causing swelling of the affected tissue);
• fever;
• decreased platelet count in blood, increasing the risk of bleeding or bruising;
• wound healing problems.

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

• opportunistic infections (including tuberculosis and other infections that occur when resistance to disease decreases);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including lymphoma and melanoma;
• immunological changes that can affect the lungs, skin, and lymph nodes (more frequently as a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing;
• feeling of irregular heartbeat like skipping;
• heart problems that can cause difficulty breathing or swelling of the ankles;
• myocardial infarction;
• sac in the wall of a major artery, inflammation and coagulation in a vein, blockage of a blood vessel;
• lung diseases that can 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;
• inflammation of the gallbladder, gallstones;
• fat in the liver (accumulation of fat in liver cells);
• nocturnal sweating;
• scars;
• abnormal muscle cramps;
• systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organ inflammation);
• sleep interruptions;
• impotence;
• inflammations.

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

• leukemia (cancer affecting the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological changes (such as optic nerve inflammation towards the eye, and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scar in the lung);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B virus;
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include discomfort, fever, headache, and hives);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• syndrome similar to lupus;
• angioedema (localized inflammation of the skin);
• 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 (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpes virus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions;
• hepatic 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 with adalimumab observed in clinical trials do not have symptoms and can only be identified through blood analysis. 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 enzyme levels.

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.

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 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 throughthe national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 of the box after “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 the preloaded pen in the outer packaging to protect it from light.

Alternative storage:

When necessary (for example when traveling), you may store an individual Imraldi preloaded pen at room temperature (up to 25 °C) for a maximum period of 28 days (ensure it is protected from light). Once removed from the refrigerator to store the pen at room temperature, you must use it within the next 28 days or discard it, even if you return it to the refrigerator.

You must note the date when you removed the pen from the refrigerator, and the date after which you must discard the pen.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medicines that you no longer need. This will help protect the environment.

Composition of Imraldi

• The active ingredient is adalimumab.
• The other components are: sodium citrate, citric acid monohydrate, histidine, monohistidine hydrochloride, sorbitol, polisorbate 20, and water for injectable preparations.

Appearance of the product and contents of the pack

Imraldi 40 mg injectable solution in pre-filled pen is supplied as 0.4 ml of transparent to opalescent and colourless to pale brown solution.

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 guard, a rubber plunger for patient use, and 2, 2, 4 or 6 alcohol wipes included in the corresponding pack.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

Netherlands

Responsible Person

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

Netherlands

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics: 03/2025

For detailed information about this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu.

7. Instructions for use

Follow these instructions for use carefully and you will soon develop a routine for injecting safely.

• 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 can use the pen correctly.

Pre-filled pen with a single dose

Your pre-filled pen does not have a button.

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

Care of 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 sight and reach of children.

Disposal of the pen

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

Precautions

• If the pen has fallen with the cap on, you can use the pen.

If the pen has fallen without the cap, do not use it. The needle may be dirty or damaged.

• Do not use a damaged pen.

Care of the injection site

• Choose a fatty area for the injection

Fatty areas, such as the abdomen, are generally the best places to inject. Fatty areas are good for inserting the needle correctly.

• Use a different site for each new injection

When choosing a site for the injection, choose a site that has not been used recently so that it does not hurt or cause 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 and 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 pen to reach room temperature; this helps to reduce the pain during the injection.

• Do not remove the cap yet!

1. Check the medicine and expiration date

Always make sure the medicine is transparent to opalescent, colourless to pale brown, has no particles, and has not expired. If the medicine is not transparent to opalescent, colourless to pale brown, has particles, or has expired, do not use it.

You may see one or more air bubbles, which is normal and 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 abdomen (except the area around the navel) and thighs are generally the best places to inject.

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

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

1. Remove the transparent cap from the needle

Remove the transparent cap from the needle with a metal core from the pen carefully.

It is normal for some liquid to come out of the needle.

If you remove the cap from the needle before you are ready to inject, do not put it back on because it may bend or damage the needle. You may accidentally prick yourself or waste the medicine.

1. Place the green base, press and maintain pressure

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

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

1. Maintain pressure

Maintain the pen 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

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

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

Are you unsure if you have administered your full dose? Contact your doctor, nurse or pharmacist.