Imraldi 40 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Imraldi 40 mg solution for injection in pre-filled syringe

adalimumab

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

• Keep this leaflet, as you may need to read it again.
• Your doctor will 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 during your treatment and for 4 months after your (or your child's) last injection of Imraldi.
• If you have any questions, consult 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, 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 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 the immune (defence) system of your body.

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 target.

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

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 have been given other disease-modifying drugs such as methotrexate first. If these medications do not provide an adequate response, you will be given Imraldi to treat your rheumatoid arthritis.

Imraldi may also be used in the treatment of 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 medications 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 medications, 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, 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.

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 at least 30 kg who have not responded to, or are not suitable candidates for, topical therapy and phototherapies.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called inverse acne) is a long-term, often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may discharge pus. It typically affects specific skin areas such as under the breasts, under the arms, 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 your condition. You may have received other medications previously. If these do not provide an adequate response, you will receive 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 medications. If these do not provide an adequate response, 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 first be prescribed other medications. 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 segment of the eye.
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the anterior segment of the eye.

This inflammation may lead to decreased vision and/or the presence of floaters (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 ingredients 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 any 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 have 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 (for example: 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 likely to get infections. This risk may be higher 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 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 skin 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 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 areas 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 risk 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 a test for HBV. 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, reactivation of HBV infection may be life-threatening.

Patients aged 65 years or older

• If you are over 65 years old, you may be more susceptible to infections while being treated with Imraldi. 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 insulating layer around 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 during pregnancy. 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 (for example: 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 types of blood cells needed to fight infections (white blood cells) or to stop bleeding (platelets). If you have persistent fever, develop bruising, 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 agents that block TNFα. 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) and leukemia (a cancer affecting blood and bone marrow). If you are being treated with Imraldi, your risk of developing lymphoma, leukemia, and other types of cancer may increase. A specific and serious type of lymphoma has been observed, albeit rarely, in patients treated with 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 TNFα blocker. If you have COPD or are a heavy smoker, consult your doctor to determine whether treatment with a TNFα 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 unexplained persistent 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 syringe 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 (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts), steroids, or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

Imraldi should not be used together with medicines containing anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after your last injection of Imraldi.
• If you are pregnant, think you might be pregnant, or plan to have a baby, consult your doctor before using this medicine.
• Imraldi should be used during pregnancy only if necessary.
• According to a pregnancy study, there was no increased risk of congenital malformations when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Imraldi can be used during breastfeeding.
• If you use Imraldi while pregnant, your child may have an increased 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 baby 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 minor. Dizziness (a sensation that the room is spinning) and vision disturbances may occur after taking Imraldi.

Imraldi contains sodium and sorbitol

Sorbitol

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

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose; hence, it is 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 prefilled syringe and prefilled pen is only available in 40 mg doses. Therefore, Imraldi in prefilled syringe or prefilled pen cannot be administered 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 therapy. If your doctor determines that methotrexate is inappropriate, Imraldi may be given alone.

If you have rheumatoid arthritis and are not receiving methotrexate during Imraldi treatment, 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 is not effective 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. Thereafter, 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. Thereafter, 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 a dose of 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, with a minimum weight of 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 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 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 dosing frequency to 40 mg weekly.

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.

Thereafter, 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 one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections on one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. If the effect of this dose is not sufficient, your doctor may increase the dosing frequency to 40 mg weekly.

Adults with ulcerative colitis

The usual dosing regimen for Imraldi in adults with ulcerative colitis is an initial dose of 160 mg (which may be 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 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. 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 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. 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 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 for use, 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 required. Always keep the medicine carton 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 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 when 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 a 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 mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• cracking or breaking 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 tissues);
• 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 of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immunological disorders affecting the lungs, skin, and lymph nodes (most frequently 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 shortness of breath or ankle swelling;
• myocardial infarction;
• aneurysm (bulge in the wall of a major artery), venous inflammation and clotting, blood vessel blockage;
• 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 (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 1,000 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 the 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 condition 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 levels;
• low blood phosphate levels;
• high blood sugar;
• high blood lactate dehydrogenase levels;
• presence of autoantibodies in blood;
• low blood potassium levels.

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

• high bilirubin levels (liver function test).

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

• low blood counts of 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 can also report them directly through the national reporting system included 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 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 syringe in its outer packaging to protect it from light.

Alternative storage:

When necessary (for example, when travelling), a single pre-filled syringe of Imraldi may be stored at room temperature (up to 25 °C) for a maximum of 31 days (ensure it is protected from light). Once removed from the refrigerator for storage at room temperature, the syringe 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 the syringe was removed from the refrigerator, as well as the date after which the syringe must be discarded.

Medicines should 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.

Description of the product and contents of the pack

Imraldi 40 mg solution for injection in a pre-filled syringe is supplied as 0.4 ml of a solution that ranges from transparent to opalescent and from colourless to pale brown.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Biogen Belgium NV/SA Tel/Tel: + 32 2 2191218	Lithuania Biogen Lithuania UAB Tel: +370 5 259 6176
	Luxembourg/Luxembourg Biogen Belgium NV/SA Tél/Tel: +35 2 2 2191218
Czech Republic Biogen (Czech Republic) s.r.o. Tel: + 420 255 706 200	Hungary Biogen Hungary Kft. Tel.: + 36 1 899 9880
Denmark Biogen (Denmark) A/S Tlf: + 45 77 41 57 57	Malta Pharma.MT Ltd Tel: + 356 21337008
Germany Biogen GmbH Tel: + 49 (0) 89 99 6170	Netherlands Biogen Netherlands B.V. Tel: + 31 20 542 2000
Estonia Biogen Estonia OÜ Tel: + 372 618 9551	Norway Biogen Norway AS Tlf: + 47 618 9551
Greece Genesis Pharma S.A. Tel: + 30 2108771500	Austria Biogen Austria GmbH Tel: + 43 1 484 46 13
Spain Biogen Spain, S.L. Tel: + 34 91 310 7110	Poland Biogen Poland Sp. z o.o. Tel.: + 48 22 351 51 00
France Biogen France SAS Tél: + 33 (0)1 776 968 14	Portugal Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda Tel: + 351 21 318 8450
Croatia Ewopharma d.o.o Tel: + 385 (0)1 6646 563	Romania Ewopharma AG Representative Office Tel: + 40 212601344
Ireland Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799	Slovenia Biogen Pharma d.o.o. Tel: + 386 (0)1 511 02 90
Iceland Icepharma hf. Sími: + 354 540 8000	Slovakia Biogen Slovakia s.r.o. Tel: + 421 2 323 340 08
Italy Biogen Italia s.r.l. Tel: + 39 2 584 99 010	Finland/Suomi Biogen Finland Oy Puh/Tel: + 358 207 401 200
Cyprus Genesis Pharma (Cyprus) Ltd Τηλ: + 357 22 76 57 15	Sweden Biogen Sweden AB Tel: +46 8 594 113 60
Latvia Biogen Latvia SIA Tel: + 371 68 688 158

Date of the most recent review 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 your injection.

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

Single-dose pre-filled syringe

After fully pushing the plunger, the needle retracts automatically to prevent needlestick injuries.

Handling your pre-filled syringe

Storage of the syringe

• Store the syringe in the refrigerator, but do not freeze.
• Keep the syringe in its original carton, protected from light.
• Keep the syringe out of sight and reach of children.

Disposal of the syringe

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

Precautions

• If the syringe has been dropped WITH the needle cap still on, you may use the syringe.
• If the syringe has been dropped WITHOUT the needle cap, do not use it. The needle may be contaminated or damaged.
• Do not use a damaged syringe.

Caring for the injection site

• Choose a fatty area for the injection

Fatty areas, such as the abdomen, are generally the best sites for injection. Fatty areas are easier to pinch and allow proper needle insertion.

• Use a different site for each new injection

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

• Push the plunger slowly

Fast injections may sometimes be painful. Pushing the plunger slowly can make the injection more comfortable.

How to inject using your pre-filled syringe

1. Gather the necessary materials for injection

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

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

2. Wait 15–30 minutes

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

• Do not remove the needle cap yet!

3. Check the medicine and expiration date

Always ensure the medicine is clear to opalescent, colorless to pale brown, free of particles, and not expired. Do not use the medicine if it is not clear to opalescent, colorless to pale brown, contains particles, or is past the expiration date.

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

• Do not remove the needle cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on your body. Suitable areas include 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 injecting.

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

5. Remove the needle cap

Carefully remove the needle cap.

It is normal for a few drops of liquid to appear at the needle tip.

If you remove the needle cap before you are ready to inject, do not recap it, as this may bend or damage the needle. You risk accidental needlestick injury or wasting the medicine.

6. Pinch the skin and insert the needle

Gently pinch the skin and insert the needle fully at an angle of approximately 45 degrees.

7. Push the plunger completely

Hold the syringe steady and push the plunger fully.

Then lift your thumb to allow the needle to retract into the syringe barrel.

8. Remove the syringe and dispose of it

Remove the syringe from the skin.

After injecting Imraldi, confirm that the needle has retracted. Immediately dispose of the used syringe 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.