Humira 40 mg soluciÓn inyectable en pluma precargada
Introduction
Patient Information Leaflet
Humira 40 mg pre-filled syringe
adalimumab
Read this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- Your doctor will give you apatient information leaflet, which contains important safety information that you need to know before you start using and during treatment with Humira. Keep thispatient information leaflet.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What Humira is and what it is used for
2. What you need to know before you start using Humira
3. How to use Humira
4. Possible side effects
5. Storage of Humira
6. Contents of the pack and additional information
7. How to inject Humira
1. What is Humira and what is it used for
Humira contains adalimumab as active substance
Humira is used to treat
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Arthritis associated with enthesitis
- Ankylosing spondylitis
- Non-radiographic axial spondyloarthritis
- Psoriatic arthritis
- Plaque psoriasis
- Hidradenitis supurativa
- Crohn's disease
- Ulcerative colitis
- Non-infectious uveitis
The active substance of Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is involved in the immune system (defense) and is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, Humira reduces the inflammatory process in those diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may be given other disease-modifying medications such as methotrexate before Humira. If your response to these medications is not sufficient, Humira will be administered.
Humira can also be used in the treatment of severe, active, and progressive rheumatoid arthritis without previous treatment with methotrexate.
Humira can reduce the damage to the joints caused by the inflammatory disease and can help you move more freely.
Your doctor will decide whether Humira should be used with methotrexate or as monotherapy.
Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may have received other disease-modifying medications, such as methotrexate, first. If you do not respond sufficiently well to those medications, Humira will be administered.
Your doctor will decide whether Humira should be used with methotrexate or as monotherapy.
Arthritis associated with enthesitis
Arthritis associated with enthesitis is an inflammatory disease of the joints and the places of tendon fixation in the bone.
Humira is used to treat arthritis associated with enthesitis in patients from 6 years of age. You may have received other disease-modifying medications, such as methotrexate, first. If you do not respond sufficiently well to those medications, Humira will be administered.
Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases that affect the spine.
Humira is used to treat severe ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults. You may be given other medications first. If you do not respond sufficiently well to those medications, Humira will be administered.
Psoriatic arthritis
Psiatic arthritis is an inflammatory disease of the joints that often occurs with psoriasis.
Humira is used to treat psoriatic arthritis in adults. Humira can reduce the damage caused by the disease in the joints and can help you move more freely. You may be given other medications first. If you do not respond sufficiently well to those medications, Humira will be administered.
Plaque psoriasis
Plaque psoriasis is a skin disease that causes red, scaly, crusty areas covered with silver scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful.
Humira is used to treat
- moderate to severe chronic plaque psoriasis in adults and
- severe chronic plaque psoriasis in children and adolescents between 4 and 17 years of age who have not responded or are not good candidates for topical therapy and phototherapy.
Hidradenitis supurativa
Hidradenitis supurativa (also known as inverse acne) is a chronic and often painful inflammatory skin disease. Symptoms can include sensitive nodules (bumps) and abscesses (boils) that can secrete pus. It usually affects specific areas of the skin, such as under the chest, armpits, inner thighs, groin, and buttocks. It can also cause scarring in affected areas.
Humira is used to treat
- moderate to severe hidradenitis supurativa in adults and
- moderate to severe hidradenitis supurativa in adolescents from 12 to 17 years of age.
Humira can reduce the number of nodules and abscesses caused by the disease and the pain that usually accompanies this disease. You may be given other medications first. If you do not respond sufficiently well to those medications, Humira will be administered.
Crohn's disease
Crohn's disease is an inflammatory disease of the digestive tract.
Humira is used to treat
- moderate to severe Crohn's disease in adults and
- moderate to severe Crohn's disease in children and adolescents from 6 to 17 years of age
You may have received other medications previously. If you do not respond sufficiently well to those medications, you will receive Humira.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine.
Humira is used to treat
- moderate to severe ulcerative colitis in adults and
- moderate to severe ulcerative colitis in children and adolescents from 6 to 17 years of age
You may have received other medications previously. If you do not respond sufficiently well to those medications, you will receive Humira.
Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used to treat
- adults with non-infectious uveitis with inflammation affecting the posterior part of the eye.
- children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the anterior part of the eye.
This inflammation can lead to a decrease in vision and/or the presence of spots in the eye (black dots or thin lines that move across the field of vision). Humira acts by reducing this inflammation.
You may have received other medications previously. If you do not respond sufficiently well to those medications, you will receive Humira.
2. What you need to know before starting to use Humira
No use Humira:
- If you are allergic to adalimumab or any of the other components of this medication (listed in section 6).
- If you have active tuberculosis or other serious infections (see "Warnings and precautions"). If you have symptoms of any infection, such as fever, wounds, fatigue, dental problems, inform your doctor.
- If you have moderate or severe heart failure. It is essential to inform 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 Humira.
Allergic reactions
- If you experience an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or hives, discontinue Humira administration and contact your doctor immediately, as these reactions can be life-threatening in rare cases.
Infections
- If you have any infection, including chronic or localized infections in any part of the body (e.g., a leg ulcer), consult your doctor before starting Humira treatment. If unsure, contact your doctor.
- With Humira treatment, you may be more susceptible to infections. This risk may be higher if you have lung damage. These infections can be severe and include:
- Tuberculosis
- Infections caused by viruses, fungi, parasites, or bacteria
- Severe blood infection (sepsis)
In rare cases, these infections can be life-threatening. It is essential to inform your doctor if you have symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend discontinuing Humira for a period.
- Inform your doctor if you reside or travel to regions where fungal infections (e.g., histoplasmosis, coccidioidomycosis, or blastomycosis) are common.
- Inform your doctor if you have had recurrent infections or other conditions that increase the risk of infections.
- If you are over 65 years old, you may be more susceptible to infections while on Humira treatment. Both you and your doctor should pay close attention to the appearance of infection symptoms while on Humira treatment. It is essential to inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue, or dental problems.
Tuberculosis
- It is crucial to inform your doctor if you have had tuberculosis at any time or have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Humira.
- Since cases of tuberculosis have been reported in patients on Humira treatment, your doctor will examine you for signs or symptoms of tuberculosis before starting your Humira treatment. This will include a thorough medical evaluation, including your medical history and appropriate diagnostic tests (e.g., chest X-ray and tuberculin test). The results of these tests should be recorded on yourpatient information card.
- Tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis.
- If you experience symptoms of tuberculosis (e.g., persistent cough, weight loss, fatigue, or fever), or any other infection during or after treatment, contact your doctor immediately.
Hepatitis B
- Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have had active HBV infections, or if you think you may be at risk of contracting HBV.
- Your doctor should perform a test for HBV. In HBV carriers, Humira can cause the virus to become active again.
- In rare cases, especially if you are taking other medications that suppress the immune system, reactivation of HBV can be life-threatening.
Surgery or dental intervention
- Inform your doctor if you are scheduled for surgery or dental intervention. Your doctor may recommend temporarily discontinuing Humira treatment.
Autoimmune disease
- In rare cases, Humira treatment may lead to a condition similar to lupus. Contact your doctor if you experience symptoms such as persistent rash without explanation, fever, joint pain, or fatigue.
Children and adolescents
- Vaccines: If possible, your child should catch up on all vaccinations before using Humira.
Using Humira with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
You should not take Humira with medications containing the following active ingredients due to an increased risk of severe infections:
- Anakinra
- Abatacept
Humira can be taken with:
- Metotrexate
- Certain disease-modifying antirheumatic drugs (e.g., sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold preparations)
- Steroids or pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs).
If you have any doubts, consult your doctor.
Pregnancy and breastfeeding
- Consider using effective birth control methods to avoid pregnancy and continue using them for at least 5 months after thelast Humira treatment.
- If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about using this medication.
- Humira should only be used during pregnancy if necessary.
- A study on pregnancy found no increased risk of congenital defects when mothers received Humira treatment during pregnancy compared to mothers with the same disease who did not receive Humira treatment.
- Humira can be used during breastfeeding.
- If you use Humira while pregnant, your child may be at a higher risk of contracting an infection.
- It is essential to inform the pediatrician and other healthcare professionals about the use of Humira during pregnancy before the child receives any vaccinations. For more information on vaccinations, see the "Warnings and precautions" section.
Driving and operating machinery
The influence of Humira on the ability to drive, ride a bike, or operate machinery is small. You may experience a sensation of the room spinning and visual disturbances after using Humira.
3. How to Use Humira
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The following table indicates the recommended doses of Humira for each of its approved uses. Your doctor may prescribe a different dose of Humira if you need one.
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, continue treatment with methotrexate during Humira use. If your doctor decides that methotrexate is inappropriate, Humira may be administered as monotherapy. If you have rheumatoid arthritis and are not receiving methotrexate with your Humira treatment, your doctor may decide to administer 40 mg of Humira weekly or 80 mg every two weeks. |
Juvenile Idiopathic Polyarticular Arthritis | ||
Age or body weight | How much and how often to take | Notes |
Children, adolescents, and adults from 2 years of age with a body weight of 30 kg or more | 40 mg every other week | No applicable |
Children and adolescents from 2 years of age with a body weight of 10 kg to 30 kg | 20 mg every other week | No applicable |
Arthritis associated with enthesitis | ||
Age or body weight | How much and how often to take | Notes |
Children, adolescents, and adults from 6 years of age with a body weight of 30 kg or more | 40 mg every other week | No applicable |
Children and adolescents from 6 years of age with a body weight of 15 kg to 30 kg | 20 mg every other week | No applicable |
Psoriasis | ||
Age or body weight | How much and how often to take | Notes |
Adults | The initial dose is 80 mg (two injections of 40 mg on the same day), followed by 40 mg every other week starting one week after the first dose. | If you do not respond adequately, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks. |
Children and adolescents from 4 to 17 years of age with a body weight of 30 kg or more | The initial dose is 40 mg, followed by 40 mg one week later. From then on, the usual dose is 40 mg every other week. | No applicable |
Children and adolescents from 4 to 17 years of age with a body weight of 15 kg to 30 kg | The initial dose is 20 mg, followed by 20 mg one week later. From then on, the usual dose is 20 mg every other week. | No applicable |
Hidradenitis supurativa | ||
Age or body weight | How much and how often to take | Notes |
Adults | The initial dose is 160 mg (four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by a dose of 80 mg (two injections of 40 mg on the same day) two weeks later. After two weeks, continue with a dose of 40 mg weekly or 80 mg every two weeks, as prescribed by your doctor. | It is recommended to use a daily antibacterial liquid on the affected areas. |
Adolescents from 12 to 17 years of age with a body weight of 30 kg or more | The initial dose is 80 mg (two injections of 40 mg on the same day), followed by 40 mg every other week starting one week later. | If you do not respond adequately to Humira 40 mg every other week, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks. It is recommended to use a daily antibacterial liquid 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 with a body weight of 40 kg or more | The initial dose is 80 mg (two injections of 40 mg on the same day), followed by 40 mg two weeks later. If a faster response is needed, your doctor may prescribe an initial dose of 160 mg (four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg on the same day) two weeks later. From then on, the usual dose is 40 mg every other week. | Your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks. |
Children and adolescents from 6 to 17 years of age with a body weight of less than 40 kg | The initial dose is 40 mg, followed by 20 mg two weeks later. If a faster response is needed, your doctor may prescribe an initial dose of 80 mg (two injections of 40 mg on the same day), followed by 40 mg two weeks later. From then on, the usual dose is 20 mg every other week. | Your doctor may increase the frequency of the dose to 20 mg weekly. |
Ulcerative Colitis | ||
Age or body weight | How much and how often to take | Notes |
Adults | The initial dose is 160 mg (four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by a dose of 80 mg (two injections of 40 mg on the same day) two weeks later. From then on, the usual dose is 40 mg every other week. | Your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks. |
Children and adolescents from 6 years of age with a body weight of less than 40 kg | Initial dose of 80 mg (two injections of 40 mg on the same day), followed by 40 mg (one injection of 40 mg) two weeks later. From then on, the usual dose is 40 mg every other week. | You must continue to use Humira at the usual dose, even after turning 18 years old. |
Children and adolescents from 6 years of age with a body weight of 40 kg or more | Initial dose of 160 mg (four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg on the same day) two weeks later. From then on, the usual dose is 80 mg every other week. | You must continue to use Humira at the usual dose, even after turning 18 years old. |
Non-infectious Uveitis | ||
Age or body weight | How much and how often to take | Notes |
Adults | The initial dose is 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 may continue treatment with corticosteroids or other immunomodulating drugs. Humira may also be administered alone. |
Children and adolescents from 2 years of age with a body weight of less than 30 kg | 20 mg every other week | Your doctor may prescribe an initial dose of 40 mg, which may be administered one week before starting the usual regimen. It is recommended to use Humira in combination with methotrexate. |
Children and adolescents from 2 years of age with a body weight of 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 usual regimen. It is recommended to use Humira in combination with methotrexate. |
Form and route of administration
Humira is administered subcutaneously (under the skin).
Instructions for injecting Humira can be found in section 7 "How to inject Humira".
Using more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist, inform your doctor or pharmacist. Always carry the medication box with you, even if it is empty.
Missing a dose
If you forget to administer an injection, administer the next dose of Humira as soon as you remember. Then, administer the next dose as usual, as if you had not forgotten a dose.
Stopping treatment with Humira
The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.
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 side effects, although not everyone will experience them. Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects can appear at least up to 4 months after the last Humira injection.
Seek medical attention immediately if you notice any of the following side effects
- severe rash, urticaria, or other signs of allergic reaction
- swelling of the face, hands, feet
- difficulty breathing, swallowing
- shortness of breath with physical activity or lying down, or swelling of the feet
Seek medical attention as soon as possible if you notice any of the following side effects
- signs of infection such as fever, nausea, wounds, dental problems, burning sensation while urinating
- feeling weak or tired
- cough
- tingling
- numbness
- double vision
- weakness in arms or legs
- open sore or lump that does not heal
- signs and symptoms of blood abnormalities such as persistent fever, rashes, bleeding, and pallor
The symptoms described above may be signs of the side effects listed below, which have been observed with Humira.
Very common(may affect more than 1 in 10 people)
- reactions at the injection site (including pain, swelling, redness, or itching); lower respiratory tract infections (including cold, cough, sinusitis, pneumonia)
- headache
- abdominal pain
- nausea and vomiting
- pruritus
- muscle pain
Common(may affect up to 1 in 10 people)
- serious infections (including sepsis and flu)
- gastrointestinal infections (including gastroenteritis)
- skin infections (including cellulitis and herpes)
- ear infection
- oral infections (including dental infection and cold sore)
- reproductive system infections
- urinary tract infections
- fungus infections
- joint infections
- benign tumors
- skin cancer
- allergic reactions (including seasonal allergy)
- dehydration
- mood changes (including depression)
- anxiety
- difficulty sleeping
- sensorial alterations such as tingling, itching, or numbness
- migraine
- nerve root compression (including lower back and leg pain)
- visual disturbances
- eye inflammation
- eyelid inflammation and swelling of the eye
- dizziness (feeling of spinning or dizziness)
- rapid pulse
- high blood pressure
- flushing
- hematoma (accumulation of blood outside blood vessels)
- cough
- asthma
- difficulty breathing
- gastrointestinal bleeding
- indigestion, bloating, and heartburn
- acid reflux
- dry eye syndrome (including dry eyes and mouth)
- itching
- pruritus with itching
- bruises
- skin inflammation (such as eczema)
- hand and foot nail breakage
- excessive sweating
- hair loss
- new onset or worsening of existing psoriasis
- muscle spasms
- blood in urine
- kidney problems
- chest pain
- swelling (edema)
- fever
- decreased platelet count in blood, increasing the risk of bleeding or bruising
- wound healing problems
Uncommon(may affect up to 1 in 100 people)
- opportunistic infections (including tuberculosis and other infections that occur when resistance to disease decreases)
- neurological infections (including viral meningitis)
- eye infections
- bacterial infections
- diverticulitis (inflammation and infection of the large intestine)
- cancer
- cancer affecting the lymphatic system
- melanoma
- immunological alterations that may affect the lungs, skin, and lymph nodes (the most common presentation is sarcoidosis)
- vasculitis (inflammation of blood vessels)
- tremor (feeling shaky)
- neuropathy (disorder of the nervous system)
- stroke
- hearing loss, tinnitus
- sensation of irregular pulse like skipping
- heart problems that may cause difficulty breathing or swelling of the ankles
- heart attack
- sac in the wall of a major artery, inflammation and coagulation in a vein, blockage of a blood vessel
- pulmonary diseases that may cause difficulty breathing (including inflammation)
- pulmonary embolism (blockage of a pulmonary artery)
- pleural effusion (abnormal fluid accumulation in the pleural space)
- pancreatitis causing severe abdominal and back pain
- difficulty swallowing
- facial edema (swelling of the face)
- gallbladder inflammation; gallstones
- fat in the liver
- nocturnal sweating
- scars
- abnormal muscle crisis
- systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organ inflammation)
- sleep interruptions
- impotence
- inflammations
Rare(may affect up to 1 in 1000 people)
- leukemia (cancer affecting the blood and bone marrow)
- severe allergic reaction with shock
- multiple sclerosis
- neurological alterations (such as optic nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
- cardiac arrest
- pulmonary fibrosis (scar in the lung)
- intestinal perforation (hole in the intestine)
- 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 pruritus)
- facial edema associated with allergic reactions
- erythema multiforme (inflammatory rash on the skin)
- lupus-like syndrome
- angioedema (localized skin inflammation)
- lichenoid reaction in the skin (red-purple rash with itching)
Frequency not known(cannot be estimated from available data)
- hepatosplenic T-cell lymphoma (rare blood cancer often fatal)
- Merkel cell carcinoma (a type of skin cancer)
- Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions
- hepatic failure
- worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness)
- weight gain (for most patients, weight gain was reduced)
Some side effects observed with Humira may not have symptoms and can only be identified through blood tests. These include:
Very common(may affect more than 1 in 10 people)
- low white blood cell count
- low red blood cell count
- high lipid levels in blood
- high liver enzyme levels
Common(may affect up to 1 in 10 people)
- high white blood cell count
- low platelet count
- high uric acid levels in blood
- abnormal sodium levels in blood
- low calcium levels in blood
- low phosphate levels in blood
- high blood sugar
- high lactate dehydrogenase levels in blood
- presence of autoantibodies in blood
- low potassium levels in blood
Uncommon(may affect up to 1 in 100 people)
- high bilirubin levels (liver function test)
Rare(may affect up to 1 in 1000 people)
- low counts in blood for white cells, red cells, and platelets
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.
You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Humira
Keep this medication out of the sight and reach of children.
Do not use the pre-filled pen of Humira after the expiration date that appears on the packaging after “CAD”.
Store in refrigerator (between 2?°C and 8?°C). Do not freeze.
Store the pre-filled pen in the outer packaging to protect it from light.
Alternative storage:
When necessary (for example when traveling), you may store an individual pre-filled pen of Humira at room temperature (up to 25°C) for a maximum period of 14 days (ensure it is protected from light). Once you have removed it from the refrigerator to store the pen at room temperature,you must use it within the next 14 days or discard it, even if you return it to the refrigerator.
You must note the date when you removed the pen from the refrigerator, and the date after which you must discard the pen.
Medicines should not be disposed of through the drains or in the trash. Ask your doctor or pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Humira
The active ingredient is adalimumab.
The other components are mannitol, polisorbate 80, and water for injectable preparations.
Appearance of the product and contents of the pack
Humira 40mg injectable solution in pre-filled pen is supplied as a sterile solution of 40mg of adalimumab dissolved in 0.4ml of solution.
The pre-filled pen of Humira is a single-use, bicolor grey/plum pen that contains a glass syringe with a solution of adalimumab. It has two caps - one is grey and has a 1 printed on it, and the other is plum and has a 2 printed on it. It has a window on each of the faces of the pen through which you can see the Humira solution that the syringe contains.
Humira pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens. The pack of 1 pre-filled pen comes with 2 alcohol-impregnated wipes (one spare). For the packs of 2, 4, and 6 pre-filled pens, each pre-filled pen comes with 1 alcohol-impregnated wipe. Some pack sizes may not be marketed.
Humira may be available in vial, pre-filled syringe, and/or pre-filled pen.
Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Manufacturer
AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen Germany
You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:
België/Belgique/Belgien AbbVie SA Tél/Tel: +32 10477811 | Lietuva AbbVie UAB Tel: +370 5 205 3023 | |
Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tél/Tel: +32 10 477811 | ||
Ceská republika AbbVie s.r.o. Tel: +420 233 098 111 | Magyarország AbbVie Kft. Tel.:+36 1 455 8600 | |
Danmark AbbVie A/S Tlf: +45 72 30-20-28 | Malta V.J.Salomone Pharma Limited Tel: +356 22983201 | |
Deutschland AbbVie DeutschlandGmbH & Co.KG Tel: 00800 222843 33 (free of charge) Tel: +49 (0) 611/1720-0 | Nederland AbbVie B.V. Tel: +31 (0)88 322 2843 | |
Eesti AbbVieOÜ Tel: +372 623 1011 | Norge AbbVie AS Tlf: +47 67 81 80 00 | |
Ελλ?δα AbbVieΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. Τηλ: +30 214 4165 555 | Österreich AbbVie GmbH Tel: +43 1 20589-0 | |
España AbbVieSpain, S.L.U. Tel: +34 91 384 09 10 | Polska AbbVie Polska Sp. z o.o.
| |
France AbbVie Tél: +33 (0) 1 45 60 13 00 | Portugal
| |
Hrvatska AbbVie d.o.o. Tel + 385 (0)1 5625 501 | România AbbVie S.R.L. Tel: +40 21 529 30 35 | |
Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenija AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060 | |
Ísland Vistor hf. Tel: +354 535 7000 | Slovenská republika AbbVie s.r.o. Tel: +421 2 5050 0777 | |
Italia AbbVie S.r.l. Tel: +39 06 928921 | Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 | |
Κ?προς Lifepharma (Z.A.M.)Ltd Τηλ.: +357 22 34 74 40 | Sverige AbbVie AB Tel: +46 (0)8 684 44 600 | |
Latvija AbbVie SIA Tel: +371 67605000 | United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090 |
Last update of this leaflet
The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
To request a copy of this leaflet in
7. How to inject Humira
- The following instructions explain how to inject Humira subcutaneously yourself using the pre-filled pen. Read these instructions carefully first and then follow them step by step.
- Your doctor, nurse, or pharmacist will instruct you on the technique for self-injection.
- Do not attempt to administer the injection yourself until you are sure you understand how to prepare and administer the injection.
- After you have been correctly instructed, you or another person, such as a family member or friend, can administer the injection.
- Use only each pre-filled pen for one injection.
Humira Pre-filled Pen
Grey cap1 White needle cap White arrow Plum cap2
Needle Inspection window Plum activator button
Do not use the pre-filled pen and call your doctor or pharmacist if
- the liquid is cloudy, coloured, or has scales or particles in it
- the expiry date (EXP) has passed
- the liquid has been frozen or exposed to direct sunlight
- the pre-filled pen has fallen or been crushed
Do not remove both caps until just before the injection. Keep Humira out of sight and reach of children.
STEP1 Take Humira out of the refrigerator. Leave Humira at room temperature between15 and 30minutes before the injection.
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STEP2 Pen Wipe | Check the expiry date (EXP).Do notuse the pre-filled pen if the expiry date (EXP) has passed. On a clean and flat surface place
Wash your hands and dry them. |
STEP3 Injection sites Injection sites | Choose a place on your body to administer the injection:
Clean the injection site with the alcohol-impregnated wipe in circular motions.
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STEP4 | Hold the pre-filled pen with the grey cap1 facing upwards. Check the inspection window.
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STEP5 Grey cap Plum cap | Remove the grey cap1 directly and pull it off. Do not put it back on.
Remove the plum cap2 and pull it off. Do not put it back on. The pre-filled pen is now ready for use. Turn the pre-filled pen so that the white arrow points towards the injection site. |
STEP6 | Pinch the skin at the injection site with your other hand to make it stand up and hold it firmly until you have finished administering the injection. Point the white arrow towards the injection site (thigh or abdomen). Place the white needle cap straight(at a 90° angle)against the injection site. Hold the pre-filled pen so that you can see the inspection window. Do notpress the plum activator button until you are ready to administer the injection. |
STEP7 10 seconds | Push firmlythe pre-filled penagainst the injection site before starting the administration. Continue to pinchto prevent the pre-filled pen from coming out of the skin during the injection. Pressthe plum activator button and count slowly to10seconds.
The injection is complete when the yellow indicator has stopped moving. |
STEP8 | When the injection is complete, slowly separate the pre-filled pen from the skin. The white needle cap will cover the needle tip.
If there is more than a few drops of liquid at the injection site, contact your doctor, nurse, or pharmacist. After completing the injection, place a cotton ball or gauze over the skin at the injection site.
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STEP9 Dispose of the pre-filled pen in a special disposal container (sharps container) as instructed by your doctor, nurse, or pharmacist.
The caps, alcohol-impregnated wipe, cotton ball or gauze, blister pack, and packaging can be thrown away in household waste. |
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