IMRALDI 40 mg Injectable Solution in Pre-filled Syringe

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, you may need to read it again.
• Your doctor will also give you a patient information card, which contains important safety information that you need to know before and during treatment with Imraldi. Keep this patient information card during your treatment and for 4 months after your last injection (or your child's) of Imraldi.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Imraldi and what is it used for

Imraldi contains the active substance adalimumab, a medicine that works on the immune system (the body's defense system).

Imraldi is used to treat:

• rheumatoid arthritis,
• juvenile idiopathic polyarticular arthritis,
• enthesitis-related arthritis,
• 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 substance in 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 inflammatory diseases mentioned above. By binding to TNFα, Imraldi reduces the inflammation process 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 moderate to severe active rheumatoid arthritis, you may have been given other medicines that modify the disease, such as methotrexate, before. If the effect of these medicines is not good enough, you will be given Imraldi to treat your rheumatoid arthritis.

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

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

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

Juvenile Idiopathic Polyarticular Arthritis and Enthesitis-Related Arthritis

Juvenile idiopathic polyarticular arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually appear in childhood.

Imraldi is used to treat juvenile idiopathic polyarticular arthritis in children and adolescents from 2 to 17 years of age and enthesitis-related arthritis in children from 6 to 17 years of age. Patients may have received other disease-modifying medicines, such as methotrexate, before. If the effect of these medicines is not good enough, patients will be given Imraldi to treat their juvenile idiopathic polyarticular arthritis or enthesitis-related arthritis.

Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases 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 medicines and if the effect of these medicines is not good enough, you will be given 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 function.

Plaque Psoriasis in Adults and Children

Plaque psoriasis is an inflammatory disease of the skin that causes red, scaly, crusty, and silvery patches. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift off 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 the 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 with a weight of 30 kg or more who have not responded to or are not candidates for topical therapy and phototherapy.

Hidradenitis Suppurativa in Adults and Adolescents

Hidradenitis suppurativa (also known as inverse acne) is a long-term and often painful inflammatory disease of the skin. Symptoms can include painful nodules (lumps) and abscesses (boils) that can secrete pus. It usually affects specific areas of the skin, such as under the breast, armpits, inner thighs, groin, and buttocks. There can also be scarring in the affected areas.

Imraldi is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Imraldi can reduce the number of nodules and abscesses and the pain that is usually associated with the disease. You may have received other medicines before. If the effect of these medicines is not good enough, you will be given 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 from 6 to 17 years of age. If you have Crohn's disease, you will be treated first with other medicines. If the effect of these medicines is not good enough, 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 from 6 to 17 years of age. If you have ulcerative colitis, you may be given other medicines first. If the effect of these medicines is not good enough, 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 that affects the back of the eye.
• children from 2 years of age with chronic non-infectious uveitis with inflammation that affects the front of the eye.

This inflammation can lead to a decrease in vision and/or the presence of floaters in the eye (black dots or thin lines that move along the field of vision). Imraldi works by reducing this inflammation.

2. What you need to know before you start 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 severe 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 that you inform your doctor.
• If you have moderate or severe heart failure. It is important that you 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 an allergic reactionwith symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, discontinue the administration of Imraldi and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

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.
• With Imraldi treatment, you may be more likely to get infections. This risk may be higher if you have reduced lung function. These infections can be serious and include tuberculosis, viral, fungal, parasitic, or bacterial infections, 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 that if you have symptoms such as fever, wounds, fatigue, or dental problems, you inform your doctor. Your doctor may recommend that you temporarily discontinue Imraldi treatment.

Tuberculosis

• Since 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 (e.g., chest X-ray and tuberculin test).

The performance and results of these tests should be recorded on your patient information card. It is crucial that you inform your doctor if you have had tuberculosis or have been in contact with a tuberculosis patient. Tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis. If 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/recurring infection

• Tell your doctor if you have lived or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• • Tell your doctor if you have a history of recurring infections or other conditions or factors that increase the risk of infections.

Hepatitis B virus

• Tell 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 people carrying this virus. In rare cases, especially if you are taking other medications that suppress the immune system, HBV reactivation can be life-threatening.

Patient over 65 years old

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

Surgical or dental intervention

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

Demyelinating disease

• If you have or develop a demyelinating disease(a disease that affects the insulating layer surrounding the 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

• Certain vaccinescontain live, albeit weakened, forms of bacteria or viruses that cause diseases, and these vaccines should not be administered during treatment with Imraldi.

Consult your doctor before administering any type of vaccine. If possible, administer all scheduled vaccines to children before starting treatment with Imraldi. If you receive Imraldi while pregnant, your child may have a higher risk of infection for about 5 months after the last dose of Imraldi you received during pregnancy. It is essential that you 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 have mild heart failureand are being treated with Imraldi, your doctor should continuously monitor your heart failure. It is essential that you inform your doctor if you have had or have serious heart problems. If new symptoms of heart failure appear or existing ones worsen (e.g., difficulty breathing or swelling of the feet), you should contact your doctor immediately. Your doctor will decide whether you should continue taking Imraldi.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce a sufficient number of the type of blood cells that fight infections (white blood cells) or those that help stop bleeding (platelets). If you have persistent feveror suffer from bruisingor bleedingvery easily or are very pale, consult your doctor immediately. Your doctor may decide to interrupt treatment.

Cancer

• In very rare cases, certain types of cancerhave been reported in children and adults treated with Imraldi or other TNFα-blocking agents. People with severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing lymphoma(a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you are being treated with Imraldi, the risk of lymphoma, leukemia, and other types of cancer may increase. A specific and severe type of lymphoma has been observed in rare cases in patients treated with Imraldi. Some of these patients were also receiving treatment with azathioprine or mercaptopurine.

Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.

• Additionally, cases of non-melanoma skin cancerhave been observed in patients using Imraldi. Inform your doctor if new areas of damaged skin appear or if existing marks or damaged areas change in appearance during or after treatment.
• Cancers other than lymphomahave been reported in patients with a specific lung disease, called chronic obstructive pulmonary disease (COPD), treated with another TNFα-blocking agent. If you have COPD or are a heavy smoker, you should consult your doctor to determine whether treatment with a TNFα blocker is suitable for you.

Lupus-like syndrome

• In rare cases, 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 old 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

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

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

Do not use Imraldi with medicines whose active substances are anakinra or abatacept due to an increased risk of serious infections. If you are unsure, consult your doctor.

Pregnancy and breastfeeding

• • You should consider using adequate contraceptive methods to avoid becoming pregnant 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 have a baby, ask your doctor for advice 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 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 infection.
• • It is essential that you inform your child's pediatrician 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 using machines

Imraldi has a minor influence on the ability to drive, ride a bicycle, or use machines. You may experience dizziness and vision disturbances 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 them before taking this medicine.

Sodium

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

3. How to use Imraldi

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 in pre-filled syringe and 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 who require less than a full 40 mg dose. When an alternative dose is required, other presentations that offer this option should be used.

Imraldi is injected under the skin (subcutaneously). The normal dose in adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, 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 is maintained during the use of Imraldi.

If your doctor determines that methotrexate is inappropriate, Imraldi can be administered alone.

If you have rheumatoid arthritis and do not receive methotrexate during your 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 polyarticular juvenile idiopathic arthritis

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

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 enthesitis-related arthritis

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

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 40 mg injections on one 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 indicated.

If that 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 with 15 kg of weight up to 30 kg

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 30kg 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 40 mg injections on one 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 one day) two weeks later.

After two more 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 one 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 80 mg (as two injections on one 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 40 mg injections on one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two injections on one 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 frequency of the dose to 40 mg weekly.

Children and adolescents with Crohn's disease

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

The usual dosing regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections on one day) followed by 40 mg two weeks later.

From then on, the usual dose is 20 mg every other week. If that dose does not work well enough, your doctor may increase the frequency of the dose to 20 mg weekly.

Childrenandadolescents from 6 to 17years of age with a weightof40kg or more:

The usual dosing regimen is 80 mg (as two 40 mg injections on one day) initially followed by 40 mg two weeks later. If a faster 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.

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 frequency of the dose to 40 mg weekly.

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 one day or with two 40 mg injections per day for two consecutive days) followed by 80 mg (as two injections on one 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 6years of age with a weight less than 40kg

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

Patient who reach 18 years of age while receiving treatment with 40 mg every other week should continue with their prescribed dose.

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

The usual dose of Imraldi is 160 mg (as four 40 mg injections on one 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 one day) two weeks later. From then on, the usual dose is 80 mg every other week.

Patient who reach 18 years of age 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 80 mg (as two injections on one 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 indicated.

In non-infectious uveitis, it is possible to continue the administration of corticosteroids or medications that act on the immune system during the use of Imraldi. Imraldi can 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 2years of age with a weight of 30kg 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 injected under the skin (subcutaneously). 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, you must 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, you should inject the next dose of Imraldi as soon as you remember. Then, the next dose will be administered 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 interrupting treatment.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild to moderate. However, some can be serious and require treatment. Adverse effects may appear up to 4 months or more after the last injection of Imraldi.

Seek medical attention urgentlyif you notice any of the following effects:

• severe rash, hives, 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 feet.

Contact your doctor as soon as possibleif you notice any of the following effects:

• signs of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating;
• feeling of weakness or fatigue;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• a lump or an 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):

• injection site reactions (including pain, swelling, redness, or itching);
• lower respiratory tract infections (including colds, runny nose, sinusitis, pneumonia);
• headache;
• abdominal pain (stomach);
• nausea and vomiting;
• rash;
• muscle pain.

Common(may affect up to 1 in 10 people):

• severe infections (including sepsis and flu);
• intestinal infections (including gastroenteritis);

• skin infections (including cellulitis and herpes);
• ear infection;
• mouth infections (including dental infection and cold sore);
• infections of the reproductive system;
• urinary tract infections;
• 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, itching, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• vertigo (feeling of the room spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• hematoma (a palpable swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, and heartburn);
• acid reflux;
• dry eye syndrome (including dryness in eyes and mouth);
• itching;
• pruritic rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• new onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body that causes swelling of the affected tissue);
• fever;
• low platelet count in blood, which increases 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 disease resistance decreases);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including lymphoma and melanoma (a type of skin cancer);
• immune system disorders that can affect 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, tinnitus;
• feeling of irregular heartbeat like skips;
• heart problems that can cause difficulty breathing or swelling of ankles;
• myocardial infarction;
• aneurysm in the wall of a major artery, inflammation, and clotting in a vein, blockage of a blood vessel;
• pulmonary diseases that can cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis that causes 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 crisis;
• systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organs);
• sleep disturbances;
• impotence;
• inflammations.

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

• leukemia (cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis, and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lung);
• 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 discomfort, fever, headache, and rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• lupus-like syndrome;
• angioedema (localized skin inflammation);
• lichenoid reaction on the skin (red-purple rash with itching).

Frequency Not Known(cannot be estimated from the available data):

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

Some adverse effects with adalimumab observed in clinical trials do not have symptoms and can only be identified through a blood test. These include:

Very Common(may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased lipids in blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people):

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the carton label after "EXP". The expiration date is the last day of the month indicated.

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

Store the pre-filled syringe in the outer packaging to protect it from light.

Alternative storage:

When necessary (e.g., when traveling), you can store a single pre-filled syringe of Imraldi at room temperature (up to 25 °C) for a maximum period of 28 days (make sure to protect it from light). Once you have removed the syringe from the refrigerator to store it at room temperature, you must use it within the next 28 days or discard it, even if you put it back in the refrigerator.

You must record the date you removed the syringe from the refrigerator and the date after which you must discard the syringe.

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

6. Container Contents and Additional Information

Imraldi Composition

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

Product Appearance and Container Contents

Imraldi 40 mg injectable solution in a pre-filled syringe is supplied as 0.8 ml of a clear to opalescent and colorless to pale brown solution.

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 shield, a rubber plunger, a safety protector, and wings for patient use, and 2, 2, 4, or 6 alcohol swabs included in the corresponding pack.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

Netherlands

Manufacturer

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 contact the local representative of the marketing authorization holder:

Date of last revision of this prospectus: 01/2024

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

1. Instructions for use

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

• Before administering the injection, ask your doctor or nurse to show you how to use the pre-filled syringe. Your doctor or nurse must ensure that you can use the syringe correctly.

Pre-filled syringe with a single dose

After pushing the plunger completely, the needle will retract to avoid needlestick injuries.

Care of your pre-filled syringe

Storage of the syringe

• Store the syringe in the refrigerator, but do not freeze it.
• Keep the syringe in its box and 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.

• Discard the used syringe in a special container as instructed by your doctor, nurse, or pharmacist.

Precautions

• If the syringe has fallen WITH the cap, you can use the syringe.

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

• Do not use a damaged syringe.

Care of 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 are easier to pinch and allow for correct insertion of the needle.

• Use a different place for each new injection

When choosing an injection site, select a site that has not been used recently to avoid pain or bruising.

• Push the plunger slowly

Sometimes rapid injections can be painful. If you push the plunger slowly, the injection will be more comfortable.

How to inject with your pre-filled syringe

1. Gather the necessary materials for the injection

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

• Don't forget to wash your hands!
• Don't remove the cap yet!

1. Wait for 15-30 minutes

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

• Don't remove the cap yet!

1. Check the medication and expiration date

Always make sure that the medication is clear to opalescent, colorless to pale brown, does not contain particles, and has not expired. If the medication is not clear to opalescent, colorless to pale brown, contains particles, or has expired, do not use it.

You may see an air bubble, which is normal and not a reason to discard the medication.

• Don't 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 swab. 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 needle cap

Remove the needle cap carefully.

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 for the injection do not put it backbecause you may bend or damage the needle. You may accidentally prick yourself or waste the medication.

1. Pinch the skin and insert the needle

Gently pinch the skin and insert the needle completely at an angle of about 45 degrees.

1. Push the plunger completely

Hold the syringe and press the plunger completely.

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

1. Remove the syringe and discard it

Remove the syringe from the skin.

After injecting the Imraldi medication, confirm that the needle has retracted and discard the used syringe immediately in a special container as instructed by your doctor, nurse, or pharmacist.

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