Humira 40 mg solution for injection in pre-filled pen
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Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Humira 40 mg solution for injection in pre-filled pen
adalimumab
Read the 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 give you a patient information card containing important safety information you need to know before starting and during treatment with Humira. Keep this patient information card.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Humira is and what it is used for
- What you need to know before using Humira
- How to use Humira
- Possible side effects
- How to store Humira
- Contents of the pack and other information
- How to inject Humira
1. What Humira is and what it is used for
Humira contains the active substance adalimumab.
Humira is used to treat:
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Enthesitis-related arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Hidradenitis suppurativa
- Crohn's disease
- Ulcerative colitis
- Non-infectious uveitis
The active substance in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific site.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which plays a role in the immune (defence) system and is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, Humira reduces the inflammatory process in these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may have been given other disease-modifying drugs such as methotrexate first. If your response to these medications is not sufficient, you will be given Humira.
Humira may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Humira can reduce joint damage caused by inflammatory disease and may 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 joint disease.
Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may have first received other disease-modifying drugs such as methotrexate. If you do not respond adequately to these medications, you will be given Humira.
Your doctor will decide whether Humira should be used with methotrexate or as monotherapy.
Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease affecting the joints and the sites where tendons attach to bone.
Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. You may have first received other disease-modifying drugs such as methotrexate. If you do not respond adequately to these medications, you will be given Humira.
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 affecting the spine.
Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may have first been treated with other medications. If you do not respond adequately to these medications, you will be given Humira.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease that is often associated with psoriasis.
Humira is used to treat psoriatic arthritis in adults. Humira can reduce joint damage caused by the disease and may help you move more freely. You may have first been treated with other medications. If you do not respond adequately to these medications, you will be given Humira.
Plaque psoriasis
Plaque psoriasis is a skin disease that causes red, scaly, crusty areas covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift away 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 aged 4 to 17 years
who have not responded to, or are not suitable candidates for, topical therapy and phototherapy.
Hidradenitis suppurativa
Hidradenitis suppurativa (sometimes called inverse acne) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may discharge pus. It usually affects specific areas of the skin such as under the breasts, under the arms, inner thighs, groin, and buttocks. Scarring may also occur in affected areas.
Humira is used to treat:
- Moderate to severe hidradenitis suppurativa in adults, and
- Moderate to severe hidradenitis suppurativa 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 typically associated with it. You may have first been treated with other medications. If you do not respond adequately to these medications, you will be given Humira.
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 previously received other medications. If you do not respond adequately to these medications, you will be given 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 previously received other medications. If you do not respond adequately to these medications, you will be given Humira.
Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Humira 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.
This inflammation may lead to decreased vision and/or the presence of floaters (black spots or thin lines moving across the visual field). Humira works by reducing this inflammation.
You may have previously received other medications. If you do not respond adequately to these medications, you will be given Humira.
2. What you need to know before starting Humira
Do not use Humira:
-
if you are allergic to adalimumab or to any of the other components of this
medicinal product (listed in section 6). -
if you have active tuberculosis or other serious infections (see “Warnings and
precautions”). If you have symptoms of any infection, for example:
fever, wounds, fatigue, dental problems, it is important that you inform your
doctor. -
if you have moderate or severe heart failure. It is important to tell your
doctor if you have had or currently have any serious heart problems (see “Warnings and
precautions”).
Warnings and precautions
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 rash, stop administering Humira and contact your doctor immediately, as in rare cases these reactions may be life-threatening.
Infections
-
If you have any infection, including a chronic infection or a localized infection in any part of the body (for example: a leg ulcer), consult your doctor before starting treatment with Humira. If you are unsure, contact your doctor.
-
While being treated with Humira, you may be more likely to get infections. This risk may be higher if you have lung damage. These infections can be serious and include:
-
tuberculosis
-
infections caused by viruses, fungi, parasites or bacteria
-
serious blood infection (sepsis)
In rare cases, these infections could be life-threatening. It is important that you inform your doctor if you have symptoms such as fever, wounds, fatigue or dental problems. Your doctor may instruct you to temporarily stop using Humira.
-
Inform your doctor if you live in or travel to regions where fungal infections (such as, for example, histoplasmosis, coccidioidomycosis or blastomycosis) are common.
-
Inform your doctor if you have had recurrent infections or other disorders that increase the risk of infections.
-
If you are over 65 years of age, you may be more susceptible to infections while being treated with Humira. Both you and your doctor should pay special attention to the appearance of signs of infection during treatment with Humira. It is important to inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue or dental problems.
Tuberculosis
-
It is very important to inform your doctor if you have ever had tuberculosis or if you have been in close contact with someone who had tuberculosis. If you have active tuberculosis, you must not use Humira.
-
Since cases of tuberculosis have been reported in patients treated with Humira, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Humira. This will include a thorough medical evaluation, including your medical history and appropriate diagnostic tests (for example, chest X-ray and tuberculin test). The performance and results of these tests must be recorded on your patient information card.
-
Tuberculosis may develop during treatment even if you have received treatment to prevent tuberculosis.
-
If symptoms of tuberculosis (such as, for example, persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after completion of treatment, contact your doctor immediately.
Hepatitis B
- Inform your doctor if you are a carrier of 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 people who are carriers of HBV, Humira may cause the virus to become active again.
- In rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV may be life-threatening.
Surgery or dental procedures
- If you are scheduled for surgery or a dental procedure, inform your doctor that you are using Humira. Your doctor may recommend that you temporarily interrupt treatment with Humira.
Demyelinating disease
- If you have or develop a demyelinating disease (a disease affecting the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Humira. 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 may cause infections and should not be administered while being treated with Humira.
- Consult your doctor before receiving any type of vaccine.
- If possible, it is recommended that children receive all age-appropriate vaccines before starting treatment with Humira.
- If you received Humira while pregnant, your baby may have an increased risk of infections for approximately five months following your last dose of Humira during pregnancy. It is important to inform the baby’s doctor and other healthcare professionals about your use of Humira during pregnancy so they can decide whether your baby should receive any vaccines.
Heart failure
- If you have mild heart failure and are being treated with Humira, your doctor may monitor you closely. It is important to tell your doctor if you have had or currently have serious heart problems. If you develop new symptoms or your symptoms worsen (difficulty breathing, or swelling in your feet), you must contact your doctor immediately. Your doctor will decide whether you should continue taking Humira.
Fever, bruising, bleeding or pale appearance
- In some patients, the body may be unable to produce enough of the type of blood cells that help the body fight infections or those that help stop bleeding. Your doctor may decide whether to interrupt treatment. If you develop persistent fever, easy bruising or bleeding, or appear pale, contact your doctor immediately.
Cancer
-
Very rarely, certain types of cancer have been reported in children and adults treated with Humira or other TNF blockers.
-
People with more severe rheumatoid arthritis and those who have had the disease for a long time may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow).
-
If you are being treated with Humira, your risk of developing lymphoma, leukemia or other types of cancer may increase. A rare and serious type of lymphoma has been observed in rare cases in patients treated with Humira. Some of these patients were also receiving azathioprine or 6-mercaptopurine.
-
Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
-
Cases of non-melanoma skin cancer have been observed in patients using Humira.
-
Inform your doctor if new skin lesions appear during or after treatment, or if existing lesions change in appearance.
-
Cancers other than lymphoma have been reported in patients with a specific lung disease called Chronic Obstructive Pulmonary Disease (COPD), treated with another TNF blocker. If you have COPD or are a heavy smoker, consult your doctor whether treatment with a TNF blocker is appropriate for you.
Autoimmune disease
- Rarely, treatment with Humira may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as persistent unexplained rash, fever, joint pain or fatigue.
Children and adolescents
- Vaccines: if possible, your child should be up to date with all recommended vaccines before using Humira.
Use of Humira with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.
You must not take Humira with medicines containing the following active substances due to an increased risk of serious infections:
- anakinra
- abatacept
Humira may be taken together with:
- methotrexate
- certain disease-modifying antirheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide and injectable gold salt preparations)
- steroids or pain medicines, including non-steroidal anti-inflammatory drugs (NSAIDs).
If you have any doubts, consult your doctor.
Pregnancy and breastfeeding
- You should consider using appropriate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after your last dose of Humira.
- If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor about using this medicine.
- Humira should be used during pregnancy only if necessary.
- According to a pregnancy study, there was no increased risk of congenital malformations when mothers received Humira during pregnancy compared to mothers with the same condition who did not receive Humira.
- Humira may be used during breastfeeding.
- If you use Humira while pregnant, your child may have a higher risk of developing an infection.
- It is important to inform the pediatrician and other healthcare professionals about your use of Humira during pregnancy before the baby receives any vaccines. For more information on vaccines, see the section “Warnings and precautions”.
Driving and use of machines
The effect of Humira on the ability to drive, ride a bicycle or operate machinery is minor. Dizziness and visual disturbances may occur after using Humira.
Humira contains polysorbate
This medicine contains 0.4 mg of polysorbate 80 in each 40 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How to use Humira
Follow exactly the administration instructions for this medicine 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 needed.
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 | For rheumatoid arthritis, continue methotrexate treatment during Humira use. If your doctor determines 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. |
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 |
Children and adolescents from 2 years of age weighing between 10 kg and 30 kg | 20 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 |
Children and adolescents from 6 years of age weighing between 15 kg and 30 kg | 20 mg every other week | Not applicable |
Plaque 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 achieve an inadequate response, your doctor may increase the dose to 40 mg weekly or 80 mg every two weeks. |
Children and adolescents aged 4 to 17 years weighing 30 kg or more | The initial dose is 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week. | Not applicable |
Children and adolescents aged 4 to 17 years weighing between 15 kg and 30 kg | The initial dose is 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week. | Not applicable |
Hidradenitis suppurativa | ||
Age or body weight | How much and how often to take | Notes |
Adults | The initial dose is 160 mg (four 40-mg injections in one day or two 40-mg injections per day for two consecutive days), followed by a dose of 80 mg (two 40-mg injections in one day) two weeks later. After another two weeks, continue with a dose of 40 mg weekly or 80 mg every two weeks, as prescribed by your doctor. | It is recommended that you use an antiseptic solution daily on affected areas. |
Adolescents aged 12 to 17 years, weighing 30 kg or more | The initial dose is 80 mg (two 40-mg injections in one day), followed by 40 mg every other week starting one week later. | If an inadequate response is obtained with 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 that you use an antiseptic solution daily on affected areas. |
Crohn's Disease | ||
Age or body weight | How much and how often to take | Notes |
Children, adolescents, and adults aged 6 years and older weighing 40 kg or more | The initial dose is 80 mg (two 40-mg injections on the same day), followed by 40 mg two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (four 40-mg injections in one day or two 40-mg injections per day for two consecutive days), followed by 80 mg (two 40-mg injections on one day) two weeks later. Thereafter, 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 aged 6 to 17 years weighing less than 40 kg | The initial dose is 40 mg, followed by 20 mg two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 80 mg (two 40-mg injections on one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week. | Your doctor may increase the dosing frequency to 20 mg weekly. |
Ulcerative colitis | ||
Age or body weight | How much and how often it should be taken | Notes |
Adults | The initial dose is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by a dose of 80 mg (two 40 mg injections in one day) two weeks later. After that, 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 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. After that, the usual dose is 40 mg every other week. | You should continue using Humira at the usual dose even after turning 18 years old. |
Children and adolescents from 6 years of age 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. After that, the usual dose is 80 mg every other week. | You should continue using 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 40 mg injections on the same day), followed by 40 mg every other week starting one week after the initial dose. | Treatment with corticosteroids or other immunosuppressive medications may be continued. Humira may also be administered alone. |
Children and adolescents from 2 years of age weighing less than 30 kg | 20 mg every other week | Your doctor may prescribe an initial dose of 40 mg, which may be given one week before starting the regular dosing schedule. |
Children and adolescents from 2 years of age weighing at least 30 kg | 40 mg every other week | Your doctor may prescribe an initial dose of 80 mg, which may be given one week before starting the regular dosing schedule. |
Form and route of administration
Humira is injected under the skin (subcutaneous route).
Section 7, "How to inject Humira," provides detailed instructions on how to inject Humira.
If you use 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 medicine carton with you, even if it is empty.
If you forget to use Humira
If you forget to administer an injection, you should inject the next dose of Humira as soon as you remember. Then, take the following dose as usual, as if no dose had been missed.
If you stop using Humira
The decision to discontinue treatment with Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.
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 as late as 4 months after the last injection of Humira.
Contact your doctor immediately if you notice any of the following effects
- severe rash, hives, or other signs of allergic reaction
- swelling of the face, hands, or feet
- difficulty breathing or swallowing
- shortness of breath during physical activity or when lying down, or swelling of the feet
Contact your doctor as soon as possible if you notice any of the following effects
- signs of infection such as fever, nausea, wounds, dental problems, or burning sensation when urinating
- feeling weak or tired
- cough
- tingling
- numbness
- double vision
- weakness in arms or legs
- a lump or open wound that does not heal
- signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness
The symptoms described above may be signs of the adverse effects listed below, which have been observed with 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, 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
- oral infections (including dental infection and cold sore)
- infections in the reproductive system
- urinary tract infection
- fungal infections
- joint infection
- benign tumors
- skin cancer
- allergic reactions (including seasonal allergy)
- dehydration
- mood changes (including depression)
- anxiety
- difficulty sleeping
- sensory disturbances such as tingling, burning, or numbness
- migraine
- nerve root compression (including lower back and leg pain)
- visual disturbances
- eye inflammation
- eyelid inflammation and eye swelling
- dizziness (feeling of spinning or lightheadedness)
- sensation of rapid heartbeat
- high blood pressure
- flushing
- bruising (accumulation of blood outside blood vessels)
- cough
- asthma
- difficulty breathing
- gastrointestinal bleeding
- dyspepsia (indigestion, bloating, and heartburn)
- acid reflux
- dry eye syndrome (including dry eyes and mouth)
- itching
- itchy rash
- bruising
- skin inflammation (such as eczema)
- cracking or breaking of fingernails and toenails
- increased sweating
- hair loss
- new onset psoriasis or worsening of existing psoriasis
- muscle spasms
- blood in urine
- kidney problems
- chest pain
- edema (swelling)
- fever
- decreased platelet count in blood, increasing the risk of bleeding or bruising
- poor wound healing
Uncommon (may affect up to 1 in 100 people)
- opportunistic infections (including tuberculosis and other infections that occur when disease resistance is reduced)
- neurological infections (including viral meningitis)
- eye infections
- bacterial infections
- diverticulitis (inflammation and infection of the large intestine)
- cancer
- cancer affecting the lymphatic system
- melanoma
- immunological disorders that may affect the lungs, skin, and lymph nodes (the most frequent presentation is sarcoidosis)
- vasculitis (inflammation of blood vessels)
- tremor (feeling shaky)
- neuropathy (nervous system disorder)
- stroke
- hearing loss, ringing in the ears
- sensation of irregular heartbeat such as palpitations
- heart problems that may cause difficulty breathing or ankle swelling
- heart attack
- aneurysm (bulge 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 of the face)
- gallbladder inflammation; gallstones
- fatty liver
- night sweats
- scarring
- abnormal muscle spasms
- systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs)
- sleep disturbances
- impotence
- inflammations
Rare (may affect up to 1 in 1000 people)
- leukemia (cancer affecting blood and bone marrow)
- severe allergic reaction with shock
- multiple sclerosis
- nerve disorders (such as optic neuritis and Guillain-Barré syndrome, which may cause muscle weakness, abnormal sensations, tingling in arms and upper body)
- cardiac arrest
- pulmonary fibrosis (scarring of 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 malaise, fever, headache, and rash)
- facial edema (swelling of the face) associated with allergic reactions
- erythema multiforme (inflammatory skin rash)
- lupus-like syndrome
- angioedema (localized skin swelling)
- lichenoid skin reaction (itchy, reddish-purple rash)
Frequency not known (cannot be estimated from available data)
- hepatosplenic T-cell lymphoma (a rare, often fatal blood cancer)
- Merkel cell carcinoma (a type of skin cancer)
- Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents as purplish skin lesions
- liver failure
- worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness)
- weight gain (in most patients, weight gain was minimal)
Some adverse effects observed with Humira may not cause symptoms and can only be detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)
- low blood count of white blood cells
- low blood count of red blood cells
- increased blood lipids
- increased liver enzymes
Common (may affect up to 1 in 10 people)
- high blood count of white blood cells
- low blood platelet count
- 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 of 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 Humira
Keep this medicine out of the sight and reach of children.
Do not use the Humira pre-filled pen after the expiry date stated on the packaging after "EXP".
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect it from light.
Alternative storage:
When necessary (for example, when travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum of 14 days (ensure it is protected from light). Once the pen has been removed from the refrigerator for storage at room temperature, it must be used within the following 14 days or discarded, even if it is returned to the refrigerator.
You should record the date on which the pen was removed from the refrigerator, and the date after which the pen must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Humira
The active substance is adalimumab.
The other components are mannitol, polysorbate 80, and water for injections.
Appearance of the product and contents of the container
Humira 40 mg solution for injection in a pre-filled pen is supplied as a sterile solution containing 40 mg of adalimumab dissolved in 0.4 ml of solution.
The Humira pre-filled pen is a single-use, two-tone grey/plum-coloured pen containing a glass syringe with a solution of adalimumab. It has two caps—one is grey and marked with the number 1, the other is plum-coloured and marked with the number 2. There is a viewing window on each side of the pen through which you can see the Humira solution contained in the syringe.
Humira pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens. The pack containing 1 pre-filled pen includes 2 alcohol wipes (one spare). For packs containing 2, 4, and 6 pre-filled pens, each pen comes with 1 alcohol wipe. Some pack sizes may not be marketed.
Humira may be available in vial, pre-filled syringe, and/or pre-filled pen.
Marketing Authorization Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Manufacturer responsible for manufacturing
AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen, Germany
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium AbbVie SA Tel/Tel: +32 10 477811 | Lithuania AbbVie UAB Tel: +370 5 205 3023 |
| Luxembourg/Luxembourg AbbVie SA Belgium/Belgium Tel/Tel: +32 10 477811 |
Czech Republic AbbVie s.r.o. Tel: +420 233 098 111 | Hungary AbbVie Kft. Tel.: +36 1 455 8600 |
Denmark AbbVie A/S Tlf.: +45 72 30-20-28 | Malta V.J.Salomone Pharma Limited Tel: +356 21220174 |
Germany AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (free of charge) Tel: +49 (0) 611 / 1720-0 | Netherlands AbbVie B.V. Tel: +31 (0)88 322 2843 |
Estonia AbbVie OÜ Tel: +372 623 1011 | Norway AbbVie AS Tlf: +47 67 81 80 00 |
Greece AbbVie PHARMACEUTICAL S.A. Tel: +30 214 4165 555 | Austria AbbVie GmbH Tel: +43 1 20589-0 |
Spain AbbVie Spain, S.L.U. Tel: +34 91 384 09 10 | Poland AbbVie Polska Sp. z o.o.
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France AbbVie Tél: +33 (0) 1 45 60 13 00 | Portugal
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Croatia AbbVie d.o.o. Tel + 385 (0)1 5625 501 | Romania AbbVie S.R.L. Tel: +40 21 529 30 35 |
Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenia AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060 |
Iceland Vistor Tel: +354 535 7000 | Slovakia AbbVie s.r.o. Tel: +421 2 5050 0777 |
Italy AbbVie S.r.l. Tel: +39 06 928921 | Finland/Suomi AbbVie Oy Puh/Tel: +358 (0) 10 2411 200 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel.: +357 22 34 74 40 | Sweden AbbVie AB Tel: +46 (0)8 684 44 600 |
Latvia AbbVie SIA Tel: +371 67605000 |
Date of the most recent review of this leaflet
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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- How to inject Humira
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The following instructions explain how to self-administer Humira subcutaneously using the prefilled pen. First, read all instructions carefully and then follow them step by step.
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Your doctor, nurse, or pharmacist will show you the technique for self-injection.
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Do not attempt to give yourself the injection until you are certain you understand how to prepare and administer it.
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After proper training, either you or another person, such as a family member or friend, may administer the injection.
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Use each prefilled pen only once for a single injection.
Humira Prefilled Pen
Grey cap1 White needle cover White arrow Plum-colored cap2
Needle Inspection window Plum-colored activation button
Do not use the prefilled pen and contact your doctor or pharmacist if
- the liquid is cloudy, discolored, or contains flakes or particles
- the expiration date (EXP) has passed
- the liquid has been frozen or exposed to direct sunlight
- the prefilled pen has been dropped or crushed
Do not remove all caps until immediately before injection. Keep Humira out of the sight and reach of children.
STEP 1 Remove Humira from the refrigerator. Allow Humira to reach room temperature for 15 to 30 minutes before injection.
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STEP 2 Pen
Alcohol wipe | Check the expiration date (EXP). Do not use the prefilled pen if the expiration date (EXP) has passed. On a clean, flat surface, place
Wash your hands and dry them. |
STEP 3 Injection sites
Injection sites | Choose an injection site on your body:
Clean the injection site with the alcohol-impregnated wipe using circular motions.
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STEP 4
| Hold the prefilled pen with the grey cap 1 pointing upward. Check the inspection window.
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STEP 5 Cap 1
Cap 2 | Pull the grey cap 1 straight off. Discard it and do not reattach it.
Pull off the plum-colored cap 2. Discard it and do not reattach it. The prefilled pen is now ready for use. Rotate the prefilled pen so that the white arrow points toward the injection site. |
STEP 6
| Pinch the skin at the injection site with your other hand to lift it, and hold it firmly until the injection is complete. Point the white arrow toward the injection site (thigh or abdomen). Place the white needle cap straight (at a 90° angle) against the injection site. Hold the prefilled pen so that you can see the inspection window. Do not press the plum-colored activator button until you are ready to administer the injection. |
STEP 7 10 seconds
| Firmly press the prefilled pen against the injection site before starting the injection. Continue pressing firmly to prevent the prefilled pen from moving away from the skin during injection. Press the plum-colored activator button and slowly count to 10 seconds.
The injection is complete when the yellow indicator stops moving. |
STEP 8
| Once the injection is complete, slowly remove the prefilled 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 pad over the injection site.
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STEP 9 Dispose of the prefilled pen in a special waste container (sharps container) as instructed by your doctor, nurse, or pharmacist.
The caps, alcohol wipe, cotton ball or gauze, blister pack, and packaging may be disposed of in household trash. |
