Patient leaflet - Idacio 40 mg solution for injection in Pre-filled pen
1. What Idacio is and what it is used for
Idacio contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system. Idacio is intended for the treatment of the following inflammatory diseases:
- rheumatoid arthritis,
- polyarticular juvenile idiopathic 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 ingredient in Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body. The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Idacio blocks its action and reduces the inflammation in these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Idacio is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, you will be given Idacio to treat your rheumatoid arthritis.
Idacio can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. Idacio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function. Usually, Idacio is used with methotrexate. If your doctor considers that methotrexate is inappropriate, Idacio can be given alone. Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints 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 and adolescents aged 6 to 17 years. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Idacio to treat their polyarticular juvenile idiopathic 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 of the spine. Idacio is used in adults to treat these conditions. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Idacio to reduce the signs and symptoms of your disease.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Idacio is used to treat psoriatic arthritis in adults. Idacio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an 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 adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a long-term and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.
Idacio is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Idacio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease. You may first be given other medicines. If these medicines do not work well enough, you will be given Idacio.
Crohn’s disease in adults and children
Crohn’s disease is an inflammatory disease of the gut.
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 given other medicines. If you do not respond well enough to these medicines, you will be given Idacio to reduce the signs and symptoms of your 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 given other medicines. If these medicines do not work well enough, you will be given 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. The inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move 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 you use 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 severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
- if you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Warnings and precautions
Talk to your doctor or pharmacist before using Idacio
Allergic reaction
- If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Idacio and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Infection
- If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Idacio. If you are unsure, contact your doctor.
- You might get infections more easily while you are receiving Idacio treatment. This risk may increase if your lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Idacio. Tuberculosis (TB)
- As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Idacio. This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your patient reminder card. It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Travel/recurrent infection
- Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
- Tell your doctor if you have a history of recurrent infections or other conditions 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 active HBV infection or if you think you might be at risk of contracting HBV. Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening. Age over 65 years
- If you are over 65 years you may be more susceptible to infections while taking Idacio. You and your doctor should pay special attention to signs of infection while you are being treated with Idacio. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Surgery or dental procedures
- If you are about to have surgery or dental procedures tell your doctor that you are taking Idacio. Your doctor may recommend temporarily stopping Idacio.
Demyelinating disease
- If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Idacio. Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Vaccine
Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Idacio in case they cause infections. Check with your doctor before you receive any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Idacio. If you receive Idacio while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your Idacio use during your pregnancy so they can decide when your baby should receive any vaccine.
Heart failure
- It is important to tell your doctor if you have had or have a serious heart condition. If you have mild heart failure and you are being treated with Idacio, your heart failure status must be closely monitored by your doctor. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Fever, bruising, bleeding or looking pale
- In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment. Cancer
- There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If you take Idacio the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Idacio.
- In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
- There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
- On rare occasions, treatment with Idacio could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Children and adolescents
- Vaccinations: if possible children should be up to date with all vaccinations before using Idacio.
- Do not give Idacio to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
- Do not use the 40 mg pre-filled syringe or 40 mg pre-filled pen if doses other than 40 mg are recommended. Other medicines and Idacio
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Idacio can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
You should not take Idacio with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your doctor. Pregnancy and breast-feeding
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You are advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection. If you become pregnant, you should see your doctor.
Idacio should only be used during a pregnancy if needed.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Idacio can be used during breast-feeding.
If you receive Idacio during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your Idacio use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Driving and using machines
Idacio may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Idacio.
Idacio contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’. Idacio contains polysorbates
This medicine contains 0.8 mg of polysorbate 80 in each pre-filled pen which is equivalent to 1.0 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How to use Idacio
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Idacio is injected under the skin (subcutaneous use).
The recommended doses for Idacio in each of the approved uses are shown in the following table.
Idacio is not available for patients that require less than 40 mg dose. If an alternative dose is required, other adalimumab products offering such an option should be used.
| Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | 40 mg every other week | In rheumatoid arthritis, methotrexate is continued while using Idacio. If your doctor decides that methotrexate is inappropriate, Idacio can be given alone. If you have rheumatoid arthritis and you do not receive methotrexate with your Idacio therapy, your doctor may decide to give Idacio 40 mg every week or 80 mg every other week. |
| Polyarticular juvenile idiopathic arthritis | ||
| Age or body weight | How much and how often to take? | 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 | How much and how often to take? | 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 | How much and how often to take? | Notes |
| Adults | Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Idacio for as long as your doctor has told you. | If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. |
| Children and adolescents from 4 to 17 years of age 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 | How much and how often to take? | Notes |
| Adults | 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 an 80 mg dose (as two 40 mg injections on the same day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor. | It is recommended that you use an antiseptic wash daily on the affected areas. |
| Hidradenitis suppurativa | ||
| Adolescents from 12 to 17 years of age weighing 30 kg or more | Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later. | If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas. |
| Crohn’s disease | ||
| Age or body weight | How much and how often to take? | 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 in one day), 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 in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. | If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week 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 faster response is required, your doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week. | If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.* |
* Idacio is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen. Thus, it is not possible to administer Idacio to patients that require less than a full 40 mg dose.
| Ulcerative colitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | Initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. | If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week. |
| Children and adolescents from 6 to 17 years of age weighing 40 kg or more | Initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) initially, followed by 80 mg (as two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week. | Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose. |
| Children and adolescents from 6 to 17 years of age weighing less than 40 kg | Initial dose of 80 mg (as two 40 mg injections in one day) initially, followed by 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 of age while on 40 mg every other week, should continue their prescribed dose. |
| Non-infectious uveitis | ||
| Age or body weight | How much and how often to take? | Notes |
| Adults | Initial dose of 80 mg (as two 40 mg injections), followed by 40 mg every other week starting one week after the initial dose. You should continue to inject Idacio for as long as your doctor has told you. | Corticosteroids or other medicines that influence the immune system may be continued while using Idacio. Idacio can also be given alone. |
| Children and adolescents from 2 years of age weighing at least 30 kg | 40 mg every other week | Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose. Idacio is recommended for use in combination with methotrexate. |
Method and route of administration
Idacio is administered by injection under the skin (by subcutaneous injection).
Detailed instructions on how to inject Idacio are provided in section 7 ‘Instructions for use’.
If you use more Idacio than you should
If you accidentally inject Idacio more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required. Always take the outer carton of the medicine with you, even if it is empty.
If you forget to use Idacio
If you forget to give yourself an injection, you should inject the next dose of Idacio as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
If you stop using Idacio
The decision to stop using Idacio should be discussed with your doctor. Your symptoms may return upon stopping treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last Idacio injection. Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
- severe rash, hives;
- swollen face, hands, feet;
- trouble breathing, swallowing;
- shortness of breath with exertion or upon lying down or swelling of the feet.
Tell 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 on urination, feeling weak or tired or coughing;
- symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
- signs of skin cancer such as a bump or open sore that doesn’t heal;
- signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness. The following side 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);
- respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
- headache;
abdominal (belly) pain;
- nausea and vomiting;
- rash;
- pain in the muscles.
Common (may affect up to 1 in 10 people)
- serious infections (including blood poisoning and influenza);
- intestinal infections (including gastroenteritis);
- skin infections (including cellulitis and shingles);
- ear infections;
- mouth infections (including tooth infections and cold sores);
- reproductive tract infections;
- urinary tract infection;
- fungal infections;
- joint infections;
- benign tumours;
- skin cancer;
- allergic reactions (including seasonal allergy);
- dehydration;
- mood swings (including depression);
- anxiety;
- difficulty sleeping;
- sensation disorders such as tingling, prickling or numbness;
- migraine;
- symptoms of nerve root compression (including low back pain and leg pain);
- vision disturbances;
- eye inflammation;
- inflammation of the eye lid and eye swelling;
- vertigo (sensation of room spinning);
- sensation of heart beating rapidly;
- high blood pressure;
- flushing;
- haematoma (a solid swelling with clotted blood);
- cough;
- asthma;
- shortness of breath;
- gastrointestinal bleeding;
- dyspepsia (indigestion, bloating, heart burn);
- acid reflux disease;
- sicca syndrome (including dry eyes and dry mouth);
- itching;
- itchy rash;
- bruising;
- inflammation of the skin (such as eczema);
- breaking of finger nails and toe nails;
- increased sweating;
- hair loss;
- new onset or worsening of psoriasis;
- muscle spasms;
- blood in urine;
- kidney problems;
- chest pain;
- oedema (a build-up of fluid in the body which causes the affected tissue to swell);
- fever;
- reduction in blood platelets which increases risk of bleeding or bruising;
- impaired healing.
Uncommon (may affect up to 1 in 100 people)
- unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
- neurological infections (including viral meningitis);
- eye infections;
- bacterial infections;
- diverticulitis (inflammation and infection of the large intestine);
- cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
- immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
- vasculitis (inflammation of blood vessels);
- tremor;
- neuropathy (nerve damage);
- stroke;
- double vision;
- hearing loss, buzzing;
- sensation of heart beating irregularly such as skipped beats;
- heart problems that can cause shortness of breath or ankle swelling;
- heart attack;
- a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;
- lung diseases causing shortness of breath (including inflammation);
- pulmonary embolism (blockage in an artery of the lung);
- pleural effusion (abnormal collection of fluid in the pleural space);
- inflammation of the pancreas which causes severe pain in the abdomen and back;
- difficulty in swallowing;
- facial oedema (swelling);
- gallbladder inflammation, gallbladder stones;
- fatty liver (build-up of fat in liver cells);
- night sweats;
- scar;
- abnormal muscle breakdown;
- systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, joints and other organ systems);
- sleep interruptions;
- impotence;
- inflammations.
Rare (may affect up to 1 in 1,000 people)
- leukaemia (cancer affecting the blood and bone marrow);
- severe allergic reaction with shock;
- multiple sclerosis;
- nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
- heart stops pumping;
- pulmonary fibrosis (scarring of the lung);
- intestinal perforation (hole in the wall of the gut);
- hepatitis (liver inflammation);
- reactivation of hepatitis B infection;
- autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);
- cutaneous vasculitis (inflammation of blood vessels in the skin);
- Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
- facial oedema (swelling) associated with allergic reactions;
- erythema multiforme (inflammatory skin rash);
- lupus-like syndrome;
- angioedema (localized swelling of the skin);
- lichenoid skin reaction (itchy reddish-purple skin rash).
Not known (frequency cannot be estimated from available data)
- hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
- Merkel cell carcinoma (a type of skin cancer);
- Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin;
- liver failure;
- worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness);
- weight gain (for most patients, the weight gain was small).
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include: Very common (may affect more than 1 in 10 people)
- low blood measurements for white blood cells;
- low blood measurements for red blood cells;
- increased lipids in the blood;
- raised liver enzymes.
Common (may affect up to 1 in 10 people)
- high blood measurements for white blood cells;
- low blood measurements for platelets;
- increased uric acid in the blood;
- abnormal blood measurements for sodium;
- low blood measurements for calcium;
- low blood measurements for phosphate;
- high blood sugar;
- high blood measurements for lactate dehydrogenase;
- autoantibodies present in the blood;
- low blood potassium.
Uncommon (may affect up to 1 in 100 people)
- raised bilirubin measurement (liver blood test).
Rare (may affect up to 1 in 1,000 people):
- low blood measurements for white blood cells, red blood cells and platelet count.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Idacio
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/ carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
Alternative Storage:
When needed (for example when you are travelling), a single Idacio pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 28 days – be sure to protect it from light.
Once removed from the refrigerator for room temperature storage, your pre-filled pen must be used within 28 days or discarded, even if it is later returned to the refrigerator.
You should record the date when the pen is first removed from refrigerator, and the date after which it should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Idacio contains
- The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution. – The other ingredients are glacial acetic acid, trehalose dihydrate, sodium chloride, , polysorbate 80 (E433), sodium hydroxide and/or acetic acid (for pH adjustment) and water for injections.
What Idacio looks like and contents of the pack
Idacio 40 mg solution for injection (injection) in pre-filled pen is supplied as a sterile 0.8 ml clear, colourless solution of 40 mg 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 pads. Idacio is available as a pre-filled syringe and a pre-filled pen.
Marketing Authorisation Holder
Fresenius Kabi Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
This leaflet was last revised in July 2026.
- 7. Instructions for use
Be sure that you read, understand, and follow these Instructions for Use before injecting Idacio. Your healthcare provider should show you how to prepare and inject Idacio properly using the pre-filled pen before you use it for the first time. Talk to your healthcare provider if you have any questions.
M0F0034/X1 UK 
Figure A
EXP: MM/YYYY
Figure C 
Figure D
Figure F 30minutes
Figure E
Figure B
M0F0034/X1 UK Read carefully these entire instructions before using your Idacio pre-filled pen.
Important Information
- Only use Idacio pre-filled pen if your healthcare professional has trained you how to use it correctly.
- The Idacio pre-filled pen comes as a ready to use single use pre-filled pen to give a full dose of adalimumab.
- Always inject using the technique your healthcare professional taught you.
- Children under 12 years of age are not allowed to inject themselves and injection must be done by a trained adult.
- Keep the Idacio pre-filled pen out of the reach of children.
- Do not insert your fingers into the opening of the safety guard.
- Do not use an Idacio pre-filled pen that has been frozen or left in direct sunlight.
- Talk to your healthcare professional if you have any questions or concerns.
Storage Information
- Store the pre-filled pen in its original box to protect it from light.
- Store the pre-filled pen in a refrigerator between 2°C to 8°C.
- If needed, for example when traveling, a single pre-filled pen can be stored at room temperature for up to 28 days.
Get Familiar with your Idacio Pre-filled pen
Injection button
Syringe plunger Injector body Transparent syringe housing Label area
(Idacio, dose, expiration date)
Needle cap
Before Use
Needle
Syringe plunger
final position
After Use
Safety guard
extended
Needle cap
Step 1 Prepare for your Injection
Each box of Idacio pre-filled pen comes with
two or six pre-filled pens.
1.1 Prepare a clean flat surface, such as a table or
countertop, in a well-lit area.
1.2 You will also need (Figure A):
- an alcohol pad (included in the box)
- a cotton ball or gauze, and
- a sharps disposal container.
1.3 Remove the box from the refrigerator
(Figure B).
1.4 Check the expiration date on the side of the box
(Figure C).
Warning: Do not use if expiration date has passed.
1.5 Take a pre-filled pen out of the original box:
- place two fingers on the label area
pull the pre-filled pen straight up and out of
the packaging (Figure D).
Put it on a clean flat surface.
1.6 Place the remaining pre-filled pen(s) in its
original box back in the refrigerator
(Figure E).
Refer to Storage Information for how to store
your unused pre-filled pen.
1.7 Leave the pre-filled pen at room temperature
for at least 30 minutes to allow the medicine to
warm up (Figure F).
Injecting cold medicine may be painful.
Warning: Do not warm the pre-filled pen 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 with soap and water
(Figure G) and dry them well.
Warning: Gloves do not replace the need for
washing hands.
Figure G
Step 3 Check the Pre-filled Pen
3.1 Check the transparent syringe housing to
make sure that:
The liquid is clear, colorless, and free of
particles (Figure H).
The glass syringe is not cracked or broken
(Figure H).
Figure H
Transparent syringe housing
Warning: Do not use the pre-filled pen if the liquid contains particles, or is cloudy or if it is colored, or has flakes in it or shows any sign of damage.
If so, throw it away in a sharps disposal container and contact your healthcare professional or pharmacist.
3.2 Check the label to make sure that:
The name on the pre-filled pen says Idacio
(Figure I).
The expiration date on the pre-filled pen
has not passed (Figure I).
Warning: Do not use the pre-filled pen if the
name on the label is not Idacio and/or the
expiration date on the label has passed.
If so, throw away the pre-filled pen in a
sharps disposal container and contact your
healthcare professional or pharmacist.
Figure I Idacio
EXP: MM/YYYY
Step 4 Choose the Injection Site
4.1 Choose an injection site (Figure J) on:
- Top of the thighs.
Abdomen (inject at least 5 centimeters away
from the belly button).
Figure J
4.2 Choose a different site (at least 2.5 centimeters 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 sore (tender), bruised, red, hard, scarred or where you have stretch marks.
Warning: If you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches.
Step 5 Clean the Injection Site
5.1 Wipe the skin of your injection site with an
alcohol pad to clean it (Figure K).
Warning: Do not blow on or touch the injection site
after cleaning.
Figure K
Step 6 Give your Injection
6.1 Remove the needle cap
Hold the pre-filled pen upwards and pull the
needle cap straight off (Figure L).
You may see drops of liquid at the needle tip.
- Throw away the needle cap.
Warning: Do not twist the cap.
Warning: Do not recap the pre-filled pen.
Hold the pre-filled pen upwards and pull the
You may see drops of liquid at the needle tip.
Figure L
6.2 Position the pre-filled pen
Hold the pre-filled pen so that you can see
the transparent syringe housing.
Place your thumb above (not touching) the
yellow injection button (Figure M).
Figure M
Place the pre-filled pen against your skin at a 90° angle (Figure N).
90˚ Figure N
Before Injection
Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
This will unlock the injection button
(Figure O).
Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
This will unlock the injection button
Before Injection Figure O
6.3 Administer the Injection
Push the injection button
(Figure P). You will hear a loud click, which means the injection has started.
- Continue to HOLD the pre-filled pen firmly.
WATCH the syringe plunger
to make sure it moves
all the way down to the
bottom (Figure P).
After Injection
Figure P
Warning: Do not lift the pre-filled pen from the skin until the plunger has moved all the way down and all the liquid has been injected.
When the syringe plunger has moved to the bottom and has stopped moving, continue
holding it for 5 seconds.
- Lift the pre-filled pen from your skin (Figure Q).
The safety guard will slide down and lock into place to protect you from the needle (Figure Q).
Figure Q
Warning: Call your healthcare professional or pharmacist if you have any problem.
6.4 If there is blood or liquid on the skin, treat the injection site by gently pressing a cotton ball or gauze on the site (Figure R).
Figure R
Step 7 Throw away your Pre-filled Pen
7.1 Throw away your used pre-filled pen in a sharps disposal container right away after use (Figure S).
Warning: Keep your sharps disposal container out of the reach of children.
Warning: Do not throw away the pre-filled pen in your household trash.
If you do not have a sharps disposal container, you may use a household container that is:
- Made of a heavy-duty plastic;
- Can be closed with a tight-fitting, puncture-resistant lid; that will keep sharps from coming out,
- Upright and stable during use,
- Leak-resistant and
Properly labeled to warn of hazardous waste inside the container.
Figure S
7.2 When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
Do not recycle your used sharps disposal container.
Step 8 Record your Injection
8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure T).
Figure T Idacio®
Single use pre-filled pen
(adalimumab) for subcutaneous injection
40mg
- 7. Instructions For Use
Note : images for illustration purposes only.