Humira (adalimumab) for psoriasis and hidradenitis suppurativa (patient leaflet)

HUMIRA (ADALIMUMAB)

Humira (adalimumab) 40 mg solution for injection in pre-filled pen

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

•	Keep this leaflet. You may need it again later.
•	Your doctor will also give you a Humira Patient Safety Card (Patient Reminder Card). This card contains important safety information that you should be aware of before starting Humira and during treatment with Humira. Keep this card with you.
•	If you have any further questions, please contact your doctor or pharmacist.
•	Do not share this medicine with others. It has been prescribed for you only. It may harm them, even if they have the same symptoms as you.
•	If you experience any of the side effects listed in section 4, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist.

What is in this leaflet
1. What is Humira and what is it used for?
2. When should you not use Humira?
3. How to use Humira?
4. Possible side effects
5. How to store Humira?
6. Contents of the pack and other information
7. Injecting Humira

1. What is Humira and what is it used for?

Humira contains the active substance adalimumab. Adalimumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Humira belongs to a group of medicines that block the activity of tumor necrosis factor (TNF) in the body (TNF inhibitors). TNF is a specific protein involved in inflammatory processes in the body and non-infectious uveitis affecting the back of the eye.

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 affecting the back of the eye

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory joint disease. Humira is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other anti-rheumatic medications, such as methotrexate. If you do not respond well enough to this medication, you will be given Humira. Humira can also be prescribed to treat severe, active, and progressive rheumatoid arthritis without prior methotrexate treatment. Humira can slow the damage to the joints caused by the inflammatory disease and allow them to move more freely. Your doctor will determine whether you should use Humira alone or in combination with methotrexate.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory joint disease. Humira is used to treat polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. You may first be given other anti-rheumatic medications, such as methotrexate. If you do not respond well enough to this medication, you will be given Humira. Your doctor will determine whether you should use Humira alone or in combination with methotrexate.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat enthesitis-related arthritis in patients 6 years and older. You may first be given other disease-modifying anti-rheumatic medications, such as methotrexate. If you do not respond well enough to this medication, 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 of the spine. Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may be given other medications first. If you do not respond well enough to this medication, you will be given Humira.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease that is usually associated with psoriasis. Humira is used to treat psoriatic arthritis in adults. Humira can slow the damage caused to the joints and help them move more freely. You may be given other medications first. If you do not respond well enough to this medication, you will be given Humira.

Plaque psoriasis
Plaque psoriasis is a 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, thicken, and separate 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 in whom topical therapy and light therapies did not work well or who were not eligible for them.

Hidradenitis suppurativa
Hidradenitis suppurativa (also called acne inversa) is a chronic, often painful, inflammatory skin condition. Symptoms may include painful swellings (abscesses) that may drain pus. Certain areas of the skin are most commonly affected, such as under the breasts, the armpits, the inner thighs, the groin, and the buttocks. Scarring may develop in these affected areas. Humira is used to treat:

•	moderate to severe hidradenitis suppurativa in adults and
•	moderate to severe hidradenitis suppurativa in adolescents aged 12 years and older.

Humira can reduce the number of abscesses caused by the disease and also the pain that often accompanies the condition. You may be given other medications first. If you do not respond well enough to this medication, 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 aged 6 years and older.

You may be given other medications first. If you do not respond well enough to this medication, you will be given Humira to treat your Crohn's disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the colon. Humira is used to treat moderate to severe ulcerative colitis in adults. You may be given other medications first. If you do not respond well enough to this medication, you will be given Humira.

Non-infectious uveitis affecting the back of the eye
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. Humira is used to treat adults with non-infectious uveitis who have inflammation that affects the back of the eye. This inflammation leads to a decrease in vision and/or the presence of floaters (black dots or streaks that move across the vision). Humira works by reducing this inflammation.

2. When should you not use this medicine or be extra careful with it?

When should you not use this medicine?

•	You are allergic to any of the ingredients in this medicine. These ingredients are listed in section 6.
•	You have active tuberculosis or other serious infections (see also "When should you be especially careful with this medicine?"). It is important to tell your doctor if you develop any symptoms of an infection, such as fever, wounds, fatigue, or dental problems.
•	You have moderate to severe heart failure. It is important to tell your doctor if you have or have had a serious heart condition (see also "When should you be especially careful with this medicine?").

When should you be extra careful with this medicine?

Talk to your doctor or pharmacist before taking this medicine.

Allergic reactions

•	If you experience allergic reactions with symptoms such as shortness of breath, wheezing, dizziness, swelling or rash, do not inject more Humira and contact your doctor immediately.

Infections

•	If you have an infection, such as a long-term infection or an infection in one part of the body (e.g., a leg ulcer), always contact your doctor before starting Humira. If you have any doubts, contact your doctor.
•	When taking Humira, you may get infections more easily. This risk may be higher if you have lung problems. These infections can be serious. Examples of such infections include: - tuberculosis - infections caused by viruses, fungi, parasites or bacteria - other infections (e.g. fungal infections) - serious blood infection (sepsis) These infections can be life-threatening in rare cases. It is therefore important to tell your doctor about symptoms such as fever, wounds, tiredness or dental problems. Your doctor may decide to temporarily stop treatment with Humira.
•	Tell your doctor if you are staying or travelling in areas where fungal infections (e.g. histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
•	Tell your doctor if you have had recurring infections or other conditions that increase the risk of infection.
•	If you are over 65 years old, you may be more susceptible to infections while taking Humira. You and your doctor should pay extra attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you develop any signs of infection, such as fever, wounds, fatigue, or dental problems.

Tuberculosis

•	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. If you have active tuberculosis, do not use Humira.
•	Because cases of tuberculosis have been reported with Humira treatment, your doctor will test you for symptoms of tuberculosis before starting treatment with Humira. This will include a thorough medical evaluation, including your medical history and appropriate screening tests (e.g., a chest X-ray and a tuberculin test). The manner in which these tests were performed and the results should be recorded on your Humira patient record.
•	Tuberculosis may develop during treatment with Humira, even if you have been treated to prevent tuberculosis.
•	If you develop symptoms of tuberculosis (e.g. cough that does not go away, weight loss, lack of energy, mild fever) or any other infection during or after this therapy, tell your doctor immediately.

Hepatitis B

•	Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you are at risk of infection with HBV.
•	Your doctor should test you for HBV. In people who carry HBV, Humira can cause the virus to reactivate.
•	In some rare cases, especially if you are taking other medicines that suppress the immune system, HBV reactivation can be life-threatening.

Surgical interventions

•	If you need surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may recommend temporarily stopping Humira treatment.

Demyelinating disorders

•

If you have or develop multiple sclerosis or another demyelinating disease, your doctor will decide whether you can take or continue taking Humira. Contact your doctor immediately if you experience symptoms such as changes in vision, weakness in your arms or legs, or numbness or tingling in any part of the body.

Vaccinations

•	Certain vaccinations can cause infections and should not be given during Humira therapy.
•	Ask your doctor for advice before receiving any vaccine.
•	It is recommended that children, if possible, be brought up to date with all immunizations they should receive according to current immunization guidelines before starting Humira treatment.
•	If you were treated with Humira during your pregnancy, your baby may be at increased risk of developing this infection for up to approximately five months after the last dose of Humira you received during pregnancy. It is important that you tell your baby's doctors and other healthcare professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart problems

•	It is important that you inform your doctor if you have or have had a serious heart condition.
•	If you have mild heart failure, your doctor will monitor your condition.
•	If new symptoms of heart failure develop or if existing symptoms worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will then decide whether you should use Humira.
•	If you develop a fever that doesn't go away, bruise easily or bleed very easily, or look very pale, contact your doctor immediately. In some patients, the body may not produce enough blood cells to help fight infection or quickly stop bleeding. Your doctor may decide to stop the treatment.

Cancer

•	There have been rare cases of certain types of cancer in children and adult patients taking Humira or other TNF blockers.
•	People with severe rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of developing lymphoma (a type of cancer that affects the lymphatic system) and leukemia (a type of cancer that affects the blood and bone marrow).
•	Taking Humira may increase your risk of developing lymphoma, leukemia, or another cancer. In rare cases, an unusual and serious type of lymphoma has been observed in patients taking Humira. Some of these patients were also treated with azathioprine or 6-mercaptopurine.
•	Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. Non-melanoma skin cancers may also occur in patients taking Humira.
•	If new skin lesions appear during or after treatment or if existing skin lesions change in appearance, tell your doctor.
•	There have been cases of cancer, other than lymphoma, in patients with a specific type of lung disease, Chronic Obstructive Pulmonary Disease (COPD), treated with a different TNF blocker. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Children and young people up to 18 years of age

•	Vaccinations: If possible, your child should have received all vaccinations before starting Humira treatment.

Are you taking any other medicines?

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

Do not use Humira together with medicines containing the following active substances:

•	anakinra
•	abatacept

Humira can be used in combination with:

•	methotrexate
•	certain antirheumatic agents (e.g. sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
•	steroids or pain relievers, including nonsteroidal anti-inflammatory drugs (NSAIDs).

If you have any questions, please contact your doctor.

Pregnancy and breastfeeding:

Humira is not recommended for pregnant women. If you take Humira, you will be advised to avoid pregnancy. You must use adequate contraception for at least 5 months after the last Humira treatment. Talk to your doctor if you become pregnant. If you take Humira during your pregnancy, your baby may have an increased risk of getting an infection. It is important that you tell your baby's doctors and other healthcare professionals about your Humira use during your pregnancy before your baby receives any vaccine. For more information, see the section on vaccinations.
It is unknown whether adalimumab passes into breast milk. You must stop breastfeeding during treatment with Humira and for at least 5 months after the last Humira treatment. If you think you are pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines:

Humira may have a minor effect on your ability to drive, cycle, or operate machinery. A spinning sensation and visual disturbances may occur after using Humira.

3. How to use Humira

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure about the correct use, talk to your doctor or pharmacist.

The recommended doses of Humira for all approved indications are described below.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis: 40 mg every other week. For rheumatoid arthritis, methotrexate is continued while you are taking Humira. If your doctor decides that methotrexate is not suitable, Humira can be given on its own. If you have rheumatoid arthritis and are not receiving methotrexate during your Humira treatment, your doctor may decide to prescribe 40 mg of Humira every week.

Polyarticular juvenile idiopathic arthritis: Adolescents and adults 13 years and older: 40 mg every other week. Children 2 to 12 years: The dose depends on the patient's height and weight. Your doctor will tell you the correct dose.

Enthesitis-related arthritis. Children, adolescents, and adults 6 years and older: The dose depends on the patient's height and weight. Your doctor will tell you the correct dose.

Plaque psoriasis: Adults: Initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week, starting one week after the initial dose. If you have not responded adequately, your doctor may increase the dose frequency to 40 mg weekly. Children and adolescents aged 4 years and older: The dose depends on the patient's weight. Your doctor will tell you the appropriate dose.

Hidradenitis suppurativa: Adults: 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 an 80 mg dose (two 40 mg injections in one day) two weeks later. After a further two weeks, continue with a dose of 40 mg weekly. It is recommended that you use an antiseptic on the affected areas daily. Adolescents aged 12 years and over weighing at least 30 kg: Initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later. If you have not responded adequately, your doctor may increase the dose frequency to 40 mg weekly. It is recommended that you use an antiseptic on the affected areas daily.

Crohn's disease: Adults: Initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting 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 (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week. Your doctor may increase the dose frequency to 40 mg weekly.
Children and adolescents aged 6 years and older weighing 40 kg or more: Initial dose of 80 mg (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 (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 in one day) two weeks later. The usual dose is then 40 mg every other week. Your doctor may increase the dose frequency to 40 mg weekly. Children and adolescents aged 6 years and older weighing less than 40 kg: Initial dose of 40 mg, followed by 20 mg two weeks later. If a faster response is needed, your doctor may prescribe a starting dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. The usual dose is then 20 mg every other week. Your doctor may increase the dose frequency to 20 mg weekly.

Ulcerative colitis: Adults: 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 in one day) two weeks later. The usual
dose is then 40 mg every other week. Your doctor may increase the dose frequency to 40 mg weekly.

Adults with non-infectious uveitis: Initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the initial dose. Corticosteroids or other medicines that affect the immune system may be continued alongside Humira. Humira can also be used on its own.

How and where to give Humira?

Humira is given as an injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Humira can be found in section 7, "Injecting Humira".

If you take more Humira than you should

If you accidentally inject Humira more often than your doctor or pharmacist told you to, contact your doctor or pharmacist immediately and tell them that you have taken too much. Always keep the container with you, even if it is empty.

If you forget to use Humira:

If you forget to inject yourself, you should take your next Humira injection as soon as you remember. You should take your next injection on the day that your next injection was scheduled.

If you stop

taking Humira: The decision to stop taking Humira should be discussed with your doctor. Your symptoms may return if you stop taking Humira. 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 everyone gets them. Most side effects are mild to moderate. However, some side effects may be serious and require treatment. Side effects may occur up to at least 4 months after the last Humira injection.

Tell your doctor immediately if you experience any of the following symptoms:

•	Severe rash, hives, or other signs of an allergic reaction;
•	Swollen face, hands or feet;
•	Breathing problems and swallowing problems;
•	Shortness of breath during physical exertion or after lying down, or swelling of the feet;

Tell your doctor as soon as possible if you experience any of the following symptoms:

•	Signs of infection such as fever, feeling sick, wounds, dental problems or burning sensation when urinating;
•	Feeling weak or tired;
•	Coughing;
•	Tingling;
•	Numbness;
•	Double vision;
•	Weakened arms or legs;
•	A bump or open sore that doesn't heal;
•	Signs and symptoms that could indicate an abnormal blood count, such as persistent fever, bruising, bleeding and pallor.

The symptoms described above may be indications of the side effects listed below that have been observed after treatment with Humira:

Very common (may affect more than 1 in 10 people)

Injection site reactions (including pain, swelling, redness or itching); respiratory infections (including colds, runny nose, sinus infection, pneumonia); headache; stomach ache; nausea and vomiting; skin rash; pain in the muscles, ligaments, tendons and bones.

Common (may affect up to 1 in 10 people)

Serious infections (including blood poisoning and influenza); skin infections (including cellulitis and shingles); ear infections; mouth infections (including tooth infections and cold sores); genital infections; urinary tract infection; fungal infections; joint infections; benign tumors; skin cancer; allergic reactions (including hay fever); dehydration; mood swings (including depression); anxiety; difficulty sleeping; sensory disturbances such as tingling, prickling or numbness; migraine; nerve root compression (including lower back pain and leg pain); vision disturbances; eye inflammation; inflammation of the eyelid and swelling of the eye; vertigo (a feeling of dizziness or spinning); sensation of fast heart beat; high blood pressure; flushing; hematoma (bruising); cough; asthma; shortness of breath; gastrointestinal bleeding; dyspepsia (indigestion, bloating, heartburn); belching; sicca syndrome (including dry eyes and dry mouth); itching; itchy rash; bruising; inflammation of the skin (such as eczema); broken fingernails and toenails; excessive sweating; hair loss; new or worsening of psoriasis; muscle spasms; blood in urine; kidney problems; chest pain; oedema (swelling); fever; reduction in the number of platelets in the blood which increases risk of bleeding or bruising; delayed recovery.

Sometimes (may affect up to 1 in 100 people)

Opportunistic infections (including tuberculosis and other infections that occur when resistance to disease is lowered); nervous system infections (including viral meningitis); eye infections; bacterial infections; diverticulitis (inflammation and infection of the large bowel); cancer; cancer of the lymphatic system; melanoma; immune system disorders that can affect the lungs, skin and lymph nodes (usually presenting as an inflammatory disease called sarcoidosis); vasculitis (inflammation of a blood vessel); tremor; neuropathy (nerve disorder); stroke; double vision; hearing loss, ringing in the ears; sensation of irregular heartbeat such as skipped beats; heart problems which can cause shortness of breath or ankle swelling; heart attack; a bulge in the wall of a major artery, inflammation and blockage of a vein, blockage of a blood vessel; lung diseases causing shortness of breath (including inflammation); pulmonary embolism (blockage of a lung artery); pleural effusion (abnormal collection of fluid between the pleural membranes); inflammation of the pancreas causing severe pain in the abdomen and back; difficulty swallowing; swelling of the face; gallbladder inflammation, gallstones; fatty liver; night sweats; scar; abnormal muscle breakdown; systemic lupus erythematosus (inflammation of the skin, heart, lungs, joints and other organ systems); sleep disruptions; impotence; inflammation.

Rare (may affect up to 1 in 1,000 people)

Leukaemia (cancer that affects the blood and bone marrow); severe allergic reaction with shock; multiple sclerosis; nerve disorders (such as optic neuritis and Guillain-Barré syndrome which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body); cardiac arrest; pulmonary fibrosis (scar tissue formation in the lung); bowel perforation (hole in the bowel); hepatitis; reactivation of hepatitis B; 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 (early symptoms include general discomfort, fever, headache and skin rash); swelling of the face combined with allergic reactions; erythema multiforme (inflamed skin rash); lupus-like syndrome.

Unknown (frequency cannot be determined from the available data)

Hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal); Merkel cell carcinoma (a type of skin cancer); liver failure; worsening of a condition called dermatomyositis (manifested as a skin rash along with muscle weakness).

Some side effects seen with Humira have no symptoms and can only be detected with blood tests. These include:

Very common (may affect more than 1 in 10 people)

Decreased white blood cell count; decreased red blood cell count; increased fats in the blood; increased liver enzyme levels.

Common (may affect up to 1 in 10 people)

Increased white blood cell count; decreased platelet count; increased uric acid in the blood; abnormal sodium levels in the blood; low calcium levels in the blood; low phosphate levels in the blood; high blood glucose; high lactate dehydrogenase levels in the blood; presence of autoantibodies in the blood.

Rare (may affect up to 1 in 1,000 people)

•	decreased number of white blood cells, red blood cells and platelets.

Unknown (the available data cannot determine how often)

•	liver failure.

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 in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP. 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 travelling), a single Humira pre-filled pen may be stored at room temperature (up to a maximum of 25°C) for up to 14 days - make sure the syringe is protected from light. Once removed from the refrigerator for storage at room temperature, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator. Write down the date the pen is first removed from the refrigerator and the date it should be discarded after. Do not throw away any medicines via wastewater or household waste. Ask your doctor or 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
The active substance is adalimumab. The other ingredients are mannitol, polysorbate 80, and water for injections.

What does Humira look like and how much is in the pack?

Humira 40 mg solution for injection in a pre-filled pen is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 mL of solvent. The Humira single-use pre-filled pen is a gray and dark pink pen that comes with a glass syringe containing Humira. The pen has two caps—one is gray with a "1" printed on it and the other is dark pink with a "2" printed on it. There is a window on each side of the pen to show the Humira solution in the syringe. The Humira pre-filled pen is available in packs of 1, 2, 4, and 6 pre-filled pens. The pack containing 1 pre-filled pen includes 2 alcohol swabs (1 spare). Packs containing 2, 4, and 6 pre-filled pens each contain 1 alcohol swab. Not all pack sizes may be marketed. Humira is available as a vial, a pre-filled syringe, and a pre-filled pen.

Marketing Authorisation Holder
AbbVie Ltd Maidenhead SL6 4UB
United Kingdom

Manufacturer
AbbVie Biotechnology GmbH Knollstrasse
67061 Ludwigshafen Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Netherlands
AbbVie BV
Tel: +31 (0)88 322 2843

7. Injecting Humira

The following instructions show you how to give yourself an injection of Humira using the pre-filled pen. Read the instructions carefully and follow them step by step. You will be trained in the self-injection technique by your doctor, nurse or pharmacist. Do not attempt to inject yourself until you are sure you understand how to prepare and give the injection. After proper training in injection technique, you can give this injection yourself or have it given by another person, for example a family member or friend. Only give one injection using each pre-filled pen.

Do not use the pre-filled pen and contact your doctor or pharmacist immediately if:

•	the solution is cloudy or discolored or if flakes or particles are visible
•	the expiry date (EXP) has passed
•	the liquid has been frozen or in direct sunlight
•	the pre-filled pen has been dropped or pinched

Do not remove the caps until just before the injection. Keep out of the sight and reach of children.

STEP 1

Remove Humira from the refrigerator. Let Humira warm up to room temperature for 15 to 30 minutes before injecting. Do not remove the gray and dark pink caps while allowing Humira to warm up to room temperature. Do not warm Humira in any other way, such as in a microwave or in hot water.

STEP 2

Check the expiration date (EXP). Do not use the pre-filled pen if the expiration date (EXP) has passed. On a clean, flat surface, have the following items ready: 1 disposable pre-filled pen and 1 alcohol wipe. Wash and dry your hands.

STEP 3

Choose an injection site: On the front of your thighs or on your abdomen, at least 5 cm away from your navel; at least 3 cm away from the previous injection site. Wipe the injection site with an alcohol swab using a circular motion. Do not inject through clothing. Do not inject into an area where the skin is sore, red, bruised, hard, has scars or stretch marks, or areas with psoriatic plaques.

STEP 4

Hold the pre-filled pen with the gray cap 1 facing up. Check the inspection window. One or more bubbles in the window are normal. Make sure the solution is clear and colorless. Do not use the pre-filled pen if the solution is cloudy or if particles are visible. Do not use the pre-filled pen if it has been dropped or crushed.

STEP 5

Pull off the gray cap 1 in one motion. Discard the cap. Do not recap the pen. Check that the small black needle cap of the syringe has been removed along with the cap. It is normal for a few small droplets of liquid to come out of the needle. Pull off the dark pink cap 2 in one motion. Discard the cap. Do not recap the pen. The pre-filled pen is now ready for use. Turn the pre-filled pen so that the white arrow points toward the injection site.

STEP 6

Pinch the skin at the injection site to raise it and hold it firmly. Make sure the white arrow points toward the injection site (thigh or abdomen). Place the white needle shield at a right angle (90 degrees) on the injection site. Hold the pre-filled pen so you can see the control window.

STEP 7

Press the pre-filled pen against the injection site and keep pressing. Press the dark pink activation button and count slowly to 10. A loud "click" indicates the injection has begun. Continue pressing the pre-filled pen against the injection site. The injection is complete when the yellow indicator stops moving.

STEP 8

Once the injection is complete, slowly pull the pre-filled pen away from your skin. The white needle shield will cover the needle tip. If more than a few drops of fluid are visible at the injection site, contact your doctor, nurse, or pharmacist. After the injection, press a cotton ball or piece of gauze over the injection site. Do not rub. A little bleeding at the injection site is normal.

STEP 9

Dispose of the used pre-filled pen in the designated container, as instructed by your doctor, nurse, or pharmacist. Do not reuse the pre-filled pen and do not throw it in the trash. Always keep the pre-filled pen and its container out of the sight and reach of children. The caps, alcohol swab, cotton ball or gauze, blister pack, and packaging can be thrown in the trash.

Source: www.skin-diseases.eu

2023

07-10-2025 ( JRM ) www.skin-diseases.eu

pocketbook

QR-code for print-version of this brochure (PDF).

QR-code for webpage-version of this brochure.