Idacio 40 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

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

adalimumab

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

• Keep this leaflet, as you may need to read it again.
• Your doctor will provide you with a patient information card containing important safety information you need to know before and during treatment with Idacio.

Keep this patient information card throughout your treatment and for 4 months after your (or your child's) last injection of Idacio.

• 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 this leaflet

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

1. What Idacio is and what it is used for

Idacio contains the active substance adalimumab, a medicine that acts on the immune system (defence) of your body.

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

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic 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 Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that target a specific substance in the body.

The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, Idacio blocks its action and reduces the inflammatory process in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease affecting the joints.

Idacio 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 medicines are not sufficiently effective, you will be given Idacio to treat your rheumatoid arthritis.

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

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

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

Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children aged 6 to 17 years. Patients may have first received other disease-modifying drugs such as methotrexate. If these medicines are not sufficiently effective, patients will receive Idacio to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

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

Idacio is used in adults to treat these diseases. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be treated with other medicines. If these medicines are not sufficiently effective, you will receive Idacio to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.

Idacio is used to treat psoriatic arthritis in adults. Idacio 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.

Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years who have not responded or are not suitable candidates for topical medications or ultraviolet light treatments.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called inverse acne) is a long-lasting, often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may discharge pus. It usually affects specific skin areas such as under the breasts, under the arms, inner thighs, groin, and buttocks. Scarring may also occur in affected areas.

Idacio is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Idacio can reduce the number of nodules and abscesses and the pain usually associated with this disease. You may have received other medicines previously. If these medicines are not sufficiently effective, you will receive Idacio.

Crohn's disease in adults and children

Crohn's disease is an inflammatory bowel disease.

Idacio is used to treat Crohn's disease in adults and children aged 6 to 17 years. If you have Crohn's disease, you will first be treated with other medicines. If you do not respond sufficiently to these medicines, you will receive Idacio 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.

Idacio is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first be prescribed other medicines. If these medicines are not sufficiently effective, you will be prescribed Idacio 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.

• Adults with non-infectious uveitis with inflammation affecting the back of the eye.
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.

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

Idacio is used to treat:

• adults with non-infectious uveitis with inflammation affecting the back of the eye.
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.

2. What you need to know before using Idacio

Do not use Idacio

• if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

• if you have a serious infection, including tuberculosis, sepsis (blood infection), or other opportunistic infections (unusual infections associated with a weakened immune system). If you have symptoms of any infection, such as fever, wounds, fatigue, or dental problems, it is important to inform your doctor (see "Warnings and precautions").

• 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 Idacio.

Allergic reaction

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

Infection

• If you have any infection, including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with Idacio. If you are unsure, contact your doctor.

• You may be more likely to get infections while being treated with Idacio. This risk may be higher if you have reduced lung function. These infections may be more severe and include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (blood infection). In rare cases, these infections can be life-threatening. Therefore, it is important to inform your doctor if you experience symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping treatment with Idacio.

Tuberculosis (TB)

• Since cases of tuberculosis have been reported in patients treated with Idacio, your doctor will examine you for signs or symptoms of tuberculosis before starting treatment with Idacio. This will include a thorough medical evaluation, including your medical history and diagnostic tests (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests 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 with tuberculosis. Tuberculosis may develop during treatment even if you have received preventive treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Infection due to travel/recurrent infections

• Inform your doctor if you have lived in or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

• Inform your doctor if you have a history of recurrent infections or other conditions or risk factors that increase your susceptibility to infections.

Hepatitis B virus

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), have active HBV infection, or think you may be at risk of contracting HBV. Your doctor should perform a test for HBV. Adalimumab 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 can be life-threatening.

Patients aged 65 years or older

• If you are over 65 years of age, you may be more susceptible to infections while being treated with Idacio. Both you and your doctor should pay special attention to signs of infection during treatment. It is important to inform your doctor if you experience symptoms of infection such as fever, wounds, fatigue, or dental problems.

Surgical or dental procedures

• If you are scheduled for surgery or a dental procedure, inform your doctor that you are using Idacio. Your doctor may recommend temporarily stopping treatment with Idacio.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Idacio. 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 but weakened forms of bacteria or viruses that cause disease and should not be given during treatment with Idacio, as these vaccines may cause infections. Consult your doctor before receiving any vaccine. If possible, children should receive all age-appropriate vaccines according to the vaccination schedule before starting treatment with Idacio. If you receive Idacio during pregnancy, your baby may have an increased risk of infections for up to 5 months after your last dose of Idacio. It is important to inform your child's doctor and other healthcare professionals about your use of Idacio during pregnancy so they can decide whether your child should receive any vaccines.

Heart failure

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

Fever, bruising, bleeding, or paleness

• In some patients, the body may be unable to produce enough of certain types of blood cells that fight infections (white blood cells) or those that help stop bleeding (platelets). If you have persistent fever, bruise easily, 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 adalimumab 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 and leukemia (cancers affecting blood cells and bone marrow). If you are being treated with Idacio, your risk of developing lymphoma, leukemia, and other types of cancer may increase. A specific and serious type of lymphoma has been observed rarely in patients treated with adalimumab. Some of these patients were also receiving azathioprine or mercaptopurine.

Inform your doctor if you are taking azathioprine or 6-mercaptopurine with adalimumab.

• In addition, cases of skin cancer (non-melanoma type) have been observed in patients using adalimumab. Inform your doctor if new skin lesions appear during or after treatment, or if existing marks or skin lesions change in appearance.

• Cancers other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) who were treated with another TNF blocker. If you have COPD or are a heavy smoker, consult your doctor about whether treatment with a TNF blocker is appropriate for you.

Lupus-like syndrome

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

Children and adolescents

• Vaccination: if possible, your child should be up to date with all vaccines before starting Idacio.
• Do not administer Idacio to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled syringe or the 40 mg pre-filled pen if doses other than 40 mg are recommended.

Other medicines and Idacio

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

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

You must not use Idacio together with medicines containing anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab and other TNF antagonists with anakinra or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You are advised to avoid becoming pregnant and should use effective contraception during treatment with Idacio and continue using it for at least 5 months after the last dose of Idacio. If you become pregnant, you should contact your doctor.

Idacio should be used during pregnancy only if clearly needed.

According to a pregnancy study, there was no increased risk of congenital malformations in mothers who received adalimumab during pregnancy compared to mothers with the same disease who did not receive adalimumab.

Idacio may be used during breastfeeding.

If you use Idacio during pregnancy, your baby may have a higher risk of infection.

It is important to inform your baby's pediatrician and other healthcare professionals about your use of Idacio during pregnancy before the baby receives any vaccines (for more information on vaccines, see section "Vaccination").

Driving and using machines

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

Idacio contains sodium

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

Idacio contains polysorbates

This medicine contains 0.8 mg of polysorbate 80 in each pre-filled pen, equivalent to 1.0 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Idacio

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

Idacio is injected under the skin (subcutaneous route).

The recommended dose of Idacio for each of the approved uses is shown in the following table. Idacio is not available for patients who require a dose lower than 40 mg. If an alternative dose is required, other adalimumab products that offer this option should be used.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Age or body weight	Dose and frequency of administration	Notes
Adults	40 mg every other week	In rheumatoid arthritis, treatment with methotrexate is continued alongside Idacio. If your physician decides that methotrexate is not suitable, Idacio may be given alone. If you have rheumatoid arthritis and are not receiving methotrexate with Idacio, your physician may decide to administer 40 mg weekly or 80 mg every other week.

Polyarticular juvenile idiopathic arthritis
Age or body weight	Dosage and frequency of administration	Notes
Children, adolescents, and adults from 2 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Enthesitis-related arthritis
Age or body weight	Dosage and frequency of administration	Notes
Children, adolescents, and adults from 6 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Plaque psoriasis
Age or body weight	Dose and frequency of administration	Notes
Adults	Initial dose of 80 mg (two injections of 40 mg on the same day), followed by 40 mg every other week, starting one week after the initial dose. You must continue injecting Idacio for as long as your doctor has instructed you to.	Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
Children and adolescents from 4 to 17 years weighing 30 kg or more	Initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.	Not applicable

Hidradenitis suppurativa
Age or body weight	Dose and frequency of administration	Notes
Adults	Initial dose of 160 mg (given as four 40 mg injections in one day or two 40 mg injections per day on two consecutive days), followed by a dose of 80 mg (given 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 other week, as directed by your doctor.	It is recommended that you use an antiseptic solution daily on affected areas.
Adolescents aged 12 to 17 years weighing 30 kg or more	Initial dose of 80 mg (given as two 40 mg injections on one day), followed by 40 mg every other week starting one week later.	Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week. It is recommended that you use an antiseptic solution daily on affected areas.

Crohn's Disease
Age or body weight	Dosage and frequency of administration	Notes
Children, adolescents, and adults from 6 years of age weighing 40 kg or more	Initial dose of 80 mg (as two 40 mg injections on one day), 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 in 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. After that, the usual dose is 40 mg every other week.	Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	Initial dose of 40 mg, followed by 20 mg two weeks later. If a more rapid response is required, your doctor may prescribe an initial dose of 80 mg (two 40 mg injections on one day), followed by 40 mg two weeks later. After that, the usual dose is 20 mg every other week.	Depending on your response, your doctor may increase the frequency of dosing to 20 mg weekly. *

• Idacio is only available in a 40 mg pre-filled syringe and a 40 mg pre-filled pen. Therefore, it is not possible to administer Idacio to patients who require less than a full 40 mg dose.

Ulcerative colitis
Age or body weight	Dose and frequency of administration	Notes
Adults	The initial dose is 160 mg (four 40 mg injections in one day or two 40 mg injections per day on two consecutive days), followed by 80 mg (two 40 mg injections in one day). Thereafter, the usual dose is 40 mg every other week.	Depending on your response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks.
Children and adolescents aged 6 to 17 years weighing 40 kg or more	Initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day on two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week.	You should continue using the usual dose of 80 mg every other week, even after turning 18 years old.
Children and adolescents aged 6 to 17 years weighing less than 40 kg	Initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	You should continue using the usual dose of 40 mg every other week, even after turning 18 years old.

Non-infectious uveitis
Age or body weight	Dosage and frequency of administration	Notes
Adults	Initial dose of 80 mg (two injections in one day), followed by 40 mg every other week starting one week after the initial dose. You must continue receiving Idacio for as long as your doctor has instructed.	Treatment with corticosteroids or other immunosuppressive medications may be continued while using Idacio. Idacio may also be administered alone.
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every other week	Your doctor may prescribe an initial dose of 80 mg, which may be administered one week before starting the regular regimen. Concomitant use of Idacio with methotrexate is recommended.

Form and route of administration

Idacio is administered by injection under the skin (subcutaneous route). For instructions for use, see section 7, “Instructions for use”.

If you use more Idacio than you should

If Idacio is accidentally injected more frequently than needed, you must inform your doctor or pharmacist. Always carry the medicine pack with you, even if it is empty.

If you forget to use Idacio

If you forget to administer an injection, you should inject the next dose of Idacio as soon as you remember. Then, administer the following dose as usual, as if no dose had been missed.

If you stop using Idacio

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most adverse effects are mild to moderate. However, some may be serious and require treatment. Adverse effects may occur up to 4 months or more after the last injection of Idacio.

Seek urgent medical attention if you notice any of the following signs of an allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing or swallowing;
• shortness of breath during exercise or when lying down, or swelling of the feet.

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

• signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning sensation when urinating;
• feeling weak or tired, cough;
• symptoms of nervous system problems such as tingling, numbness, double vision, or weakness in arms or legs;
• signs of skin cancer such as a bump or an open sore that does not heal;
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The following adverse effects 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 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);
• infections in the reproductive system;
• urinary tract infection;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• drowsiness and 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;
• bruises (a palpable swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, and heartburn);
• acid reflux;
• Sicca syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• 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 tissue);
• 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)

• unusual 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 cancer affecting the lymphatic system (lymphoma); and melanoma (a type of skin cancer);
• immune-mediated disorders that may affect the lungs, skin, and lymph nodes (most frequently as a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• double vision;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause difficulty breathing or swollen ankles;
• heart attack;
• aneurysm (a sac in the wall of a major artery), inflammation and clotting in a vein, blockage of a blood vessel;
• lung diseases that may cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of an artery in the lung);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation; gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle twitching;
• systemic lupus erythematosus (an immune disorder involving inflammation of the skin, heart, lungs, joints, and other organs);
• sleep disturbances;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1000 people)

• leukemia (cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nervous system disorders (such as inflammation of the optic nerve of the eye and Guillain-Barré syndrome, a disease that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lung);
• intestinal perforation (a hole in the intestinal wall);
• hepatitis (inflammation of the liver);
• 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 (a potentially life-threatening reaction with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• 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);
• liver failure;
• worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness).

Some adverse effects observed in clinical trials with adalimumab do not cause symptoms and can only be detected by a blood test. 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)

• elevated bilirubin levels (liver function test).

Rare (may affect up to 1 in 1000 people)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Idacio

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

Do not use the Idacio pre-filled pen after the expiry date stated on the label/carton after “EXP”. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep the pre-filled pen in its outer packaging to protect it from light.

Alternative storage:

When necessary (for example, when travelling), a single pre-filled pen of Idacio may be stored at room temperature (up to 25°C) for a maximum of 28 days (ensure protection from light). Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within the following 28 days or discarded, even if it is later returned to the refrigerator.

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

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

6. Package contents and other information

Composition of Idacio

The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution.

The other components are: glacial acetic acid, trehalose dihydrate, sodium chloride, polysorbate 80 (E433), sodium hydroxide and water for injections.

Appearance of the product and contents of the container

Idacio 40 mg solution for injection in a pre-filled pen is supplied as 0.8 ml of a sterile, colourless, clear solution containing 40 mg of adalimumab.

The Idacio pre-filled pen contains a pre-filled syringe with Idacio. Each pack contains 2 or 6 pre-filled pens with 2 or 6 alcohol-impregnated wipes.

Idacio may be available in a pre-filled syringe and in a pre-filled pen.

Marketing Authorisation Holder

Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstraße 36,
8055 Graz
Austria

Date of the most recent revision of this leaflet

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

1. Instructions for use

Make sure you read, understand and follow these instructions before injecting Idacio. Your doctor should show you how to prepare and inject Idacio using the pre-filled syringe before you use the medicine for the first time. Consult your doctor if you have any doubts.

Note: Images for illustrative purposes only

Read these instructions carefully before using your Idacio pre-filled pen.

Important information

• Only use the Idacio pre-filled pen if a healthcare professional has shown you how to use it correctly.

• The Idacio pre-filled pen comes as a ready-to-use, single-dose pen designed to deliver one complete dose of adalimumab.

• Always inject yourself using the technique taught by your healthcare professional.

• Children under 12 years of age cannot self-inject and the injection must be administered by a trained adult.

• Keep the Idacio pre-filled pen out of the reach of children.

• Do not insert your fingers into the safety guard opening.

• Do not use an Idacio pre-filled pen that has been frozen or exposed to direct sunlight.

• Speak with your healthcare provider if you have any questions or concerns.

Storage information

• Keep the pre-filled pen in its original carton to protect it from light.

• Store the pre-filled pen in the refrigerator, between 2°C and 8°C.

• If necessary, for example when travelling, a single pre-filled pen may be stored at room temperature for up to 14 days.

Familiarise yourself with your Idacio pre-filled pen

After use

Step 1: Prepare your injection

Each pre-filled pen pack of Idacio contains two or six pre-filled pens.

1.1 Prepare a clean, flat surface, such as a table or counter, in a well-lit area.

1. You will also need (Figure A):

? an alcohol-impregnated wipe (included in the pack)
? a cotton ball or gauze, and
? a sharps disposal container.

Figure A

1.3 Remove the carton from the refrigerator (Figure B).

Figure B

1.4 Check the expiry date on the side of the carton (Figure C).

Figure C

Warning: Do not use if the expiry date has passed.

1.5 Remove one pre-filled pen from the original packaging:

• place two fingers on the label area
• pull the pre-filled pen upward and out of the packaging (Figure D).

Figure D

Place it on a clean, flat surface.

1.6 Return the remaining pens to their original carton and store in the refrigerator (Figure E).

Figure E

Refer to the storage information for instructions on how to store unused pre-filled pen(s).

1.7 Allow the pre-filled pen to warm to room temperature for at least 30 minutes before use. (Figure F).

Figure F

Injecting cold medication may be painful.

Warning: Do not warm the pen in any other way, such as in a microwave, hot water, or direct sunlight.

Warning: Do not remove the needle cap until you are ready to inject.

Step 2: Wash your hands

2.1 Wash your hands thoroughly with soap and water and dry them well. (Figure G).

Warning: Gloves do not replace the need to wash your hands.

Figure G

Step 3: Check the pre-filled pen

3.1 Check the transparent syringe barrel to make sure that:

• The liquid is clear, colourless, and free from particles (Figure H).
• The glass syringe is not cracked or broken (Figure H).

Figure H

Warning: Do not use the pre-filled pen if the liquid contains particles, is cloudy or discoloured, has flakes, or shows any sign of damage.

If so, discard it in a sharps disposal container and contact your healthcare professional or pharmacist.

1. Check the label to make sure that:

• The name on the pre-filled pen is Idacio (Figure I).
• The expiry date on the pre-filled pen has not passed (Figure I).

Figure I

Warning: Do not use the pre-filled pen if the name on the label is not Idacio and/or if the expiry date on the label has passed.

If so, discard the pre-filled pen in a sharps disposal container and contact your healthcare professional or pharmacist.

Step 4: Choose the injection site

1. Choose an injection site (Figure J) on:

• The front of the thighs.
• The abdomen (inject at least 5 centimetres away from the navel).

Figure J

4.2 Choose a different site (at least 2.5 centimetres away from the previous injection site) each time to reduce redness, irritation, or other skin problems.

Warning: Do not inject into an area that is painful (tender), bruised, red, hard, scarred, or where you have stretch marks.

Warning: If you have psoriasis, do not inject into any lesions or into red, thickened, raised, or scaly areas.

Step 5: Clean the injection site

5.1 Clean the skin at the injection site with an alcohol wipe. (Figure K).

Warning: Do not blow on or touch the injection site after cleaning.

Figure K

Step 6: Administer your injection

1. Remove the needle cap

• Hold the pre-filled pen upright and pull the needle cap straight off. (Figure L)

Figure L

You may see drops of liquid at the tip of the needle.

• Discard the needle cap.

Warning: Do not twist the cap.

Warning: Do not recap the pre-filled pen.

1. Position the pre-filled pen

• Hold the pre-filled pen so that you can see the transparent syringe barrel.
• Place your thumb on top (without touching) the yellow injection button (Figure M).

Figure M

• Place the pre-filled pen against your skin at a 90° angle (Figure N).

Figure N Before injection

• Push and hold the pre-filled pen firmly against your skin until the safety shield is fully depressed. This will unlock the injection button (Figure O).

Figure O Before injection

1. Administer the injection

• Press the injection button (Figure P).
• You will hear a click, which means the injection has started.
• Continue to hold the pre-filled pen firmly in place.
• WATCH the syringe plunger to make sure it moves all the way down. (Figure P).

Figure P After injection

Warning: Do not lift the pre-filled pen from the skin until the plunger has moved completely down and all the liquid has been injected.

• When the syringe plunger has moved all the way down and stopped moving, continue to hold it in place for 5 seconds.
• Lift the pre-filled pen away from the skin (Figure Q).

The safety shield will slide down and lock into place to protect you from the needle. (Figure Q).

Figure Q

Warning: Contact your doctor or pharmacist if you have any problems.

6.4 If there is blood or liquid at the injection site, treat the site by gently pressing a cotton ball or gauze pad against it (Figure R).

Figure R

Step 7: Dispose of your used pre-filled pen

7.1 Dispose of your used pre-filled pen in a sharps disposal container immediately after use (Figure S).

Figure S

Warning: Keep the sharps disposal container out of the reach of children.

Warning: Do not throw the pre-filled pen into household waste.

If you do not have a sharps disposal container, you may use a household container that is:

• Made of heavy-duty plastic;
• Has a tight, puncture-resistant lid; this will prevent sharps from coming out;
• Upright and stable during use;
• Leak-resistant; and
• Properly labelled to warn of hazardous waste inside the container.

7.2 When your sharps disposal container is nearly full, you must follow local guidelines for proper disposal of the container.

Do not recycle your used sharps disposal container.

Step 8: Record your injection

8.1 To help you remember when and where to give your next injection, keep a record of the dates and sites used for your injections (Figure T).

Figure T