Humira 80 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Humira 80 mg solution for injection in a pre-filled pen

adalimumab

Read all of 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 a patient information card containing important safety information you need to know before and during treatment with Humira. Keep this patient information card.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

The target of adalimumab is a protein called tumour 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 medications such as methotrexate before. If your response to these medications is not sufficient, you will be given Humira.

Humira may also be used in the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.

Humira can reduce joint damage caused by inflammatory disease and may help improve mobility.

Your doctor will decide whether Humira should be used with methotrexate or as monotherapy.

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 from the nail bed, which can be painful.

Humira is used to treat chronic moderate to severe plaque psoriasis in adults.

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 drain 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 aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the pain usually associated with it. You may have received other medications previously. If you do not respond adequately to those 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 aged 6 to 17 years.

You may have received other medications previously. If you do not respond adequately to those 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 aged 6 to 17 years.

You may have received other medications previously. If you do not respond adequately to those 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, and
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.

This inflammation may lead to reduced vision and/or the presence of floaters (black spots or thin lines moving across the field of vision). Humira works by reducing this inflammation. You may have received other medications previously. If you do not respond adequately to those medications, you will be given Humira.

2. What you need to know before using Humira

Do not use Humira:

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (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, or dental problems, it is important to 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

Talk to 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 chronic infections, or a localized infection in any part of your 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. For this reason, it is important to inform your doctor if you develop 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 (for example: histoplasmosis, coccidioidomycosis, or blastomycosis) are common.

• Inform your doctor if you have had recurrent infections or other conditions that increase your risk of infections.

• If you are over 65 years old, you may be more likely to develop infections during treatment with Humira. You and your doctor should pay special attention to signs of infection while you are receiving Humira. It is important to inform your doctor if you develop symptoms of infection, 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 has had it. 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 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 skin 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 persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear 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 blood test for HBV. In 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, please inform your doctor that you are taking Humira. Your doctor may recommend that you temporarily stop treatment with Humira.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease affecting the protective covering around nerves, such as multiple sclerosis), your doctor will decide whether you should start or continue treatment with Humira. Immediately inform your doctor 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 given while you are being treated with Humira.

• Consult your doctor before receiving any type of vaccine.

• If possible, it is recommended that you receive age-appropriate vaccines before starting treatment with Humira.

• If you receive 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 your doctor and other healthcare professionals about your use of Humira during pregnancy so they can determine when 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 (such as difficulty breathing or swelling in your feet), 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 certain types of blood cells that help fight infections or stop bleeding. Your doctor may decide to stop treatment. If you develop persistent fever, easy bruising or bleeding, or look 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-blocking agents.

• People with more severe rheumatoid arthritis or 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) or 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 but 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.

• Cases of cancers other than lymphoma have been reported in patients with a specific lung disease called Chronic Obstructive Pulmonary Disease (COPD), treated with another TNF-blocking agent. If you have COPD or are a heavy smoker, you should consult your doctor about whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

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

Children and adolescents

• Vaccines: If possible, your child should be up to date with all recommended vaccines before starting Humira.

Using 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 use Humira together with medicines containing the following active substances due to an increased risk of serious infections:

• anakinra
• abatacept

Humira may be used together with:

• methotrexate
• certain disease-modifying antirheumatic drugs (DMARDs) (such as sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts)
• corticosteroids or pain medicines, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any questions, 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 are planning 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 disease who did not receive Humira.
• Humira may be used during breastfeeding.
• If you use Humira while pregnant, your baby may have a higher risk of infection.
• It is important to inform the pediatrician and other healthcare professionals about your use of Humira during pregnancy before your baby receives any vaccines. For more information on vaccines, see the section “Warnings and precautions”.

Driving and using machines

The effect of Humira on the ability to drive, ride a bicycle, or operate machinery is minimal. Dizziness (feeling the room is spinning) and vision disturbances may occur after using Humira.

Humira contains polysorbate

This medicine contains 0.4 mg of polysorbate 80 in each 80 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. If in doubt, consult your doctor again.

The recommended doses of Humira for each of the approved uses are shown in the following table. Your doctor may prescribe a different presentation of Humira if you require a different dose.

Rheumatoid arthritis
Age or body weight	How much and how often to take	Notes
Adults	40 mg every other week	In rheumatoid arthritis, continue methotrexate therapy during treatment with Humira. If your doctor decides that methotrexate is inappropriate, Humira may be given as monotherapy. If you have rheumatoid arthritis and are not receiving methotrexate with your Humira treatment, your doctor may decide to give you 40 mg of Humira every week or 80 mg every two weeks.

Plaque Psoriasis
Age or body weight	How much and how often should it be taken?	Notes
Adults	The initial dose is 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	If you achieve an inadequate response, your doctor may increase your dose to 40 mg weekly or 80 mg every two weeks.

Hidradenitis suppurativa
Age or body weight	How much and how often should it be taken?	Notes
Adults	The initial dose is 160 mg (two injections of 80 mg on one day or one injection of 80 mg per day for two consecutive days), followed by a dose of 80 mg (one injection of 80 mg) two weeks later. After an additional 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 a daily antiseptic wash on the affected areas.
Adolescents aged 12 to 17 years weighing 30 kg or more	The initial dose is 80 mg (one injection of 80 mg), followed by 40 mg every other week starting one week later.	If you have an inadequate response to Humira 40 mg every other week, your doctor may increase your dose to 40 mg weekly or 80 mg every two weeks. It is recommended that you use a daily antiseptic wash on the affected areas.

Crohn's Disease
Age or body weight	How much and how often should it be taken?	Notes
Children, adolescents, and adults aged 6 to 17 years weighing 40 kg or more	The initial dose is 80 mg (one 80 mg injection), followed by 40 mg two weeks later. If a more rapid response is needed, the doctor may prescribe an initial dose of 160 mg (two 80 mg injections on the same day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. After that, the usual dose is 40 mg every other week.	Your doctor may increase your 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, the doctor may prescribe an initial dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later. After that, the usual dose is 20 mg every other week.	Your doctor may increase the administration frequency to 20 mg weekly.

Ulcerative colitis
Age or body weight	How much and how often should it be taken?	Notes
Adults	The initial dose is 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. After that, the usual dose is 40 mg every other week.	Your doctor may increase your 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 (one 80 mg injection), 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 (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) 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 should it be taken?	Notes
Adults	The initial dose is 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	Corticosteroids or other immunosuppressive medications may continue to be used during treatment with Humira. Humira may also be administered as monotherapy.
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 administered one week before starting the regular schedule of 20 mg every other week. Humira is recommended to be used in combination with methotrexate.
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every other week	Your doctor may prescribe an initial dose of 80 mg, which may be administered one week before starting the regular schedule of 40 mg every other week. Humira is recommended to be used in combination with methotrexate.

Form and route of administration

Humira is injected under the skin (subcutaneous route).

Section 7, "How to inject Humira," provides detailed instructions on administering Humira injections.

If you use more Humira than you should

If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist, you must report this. Always carry the medicine carton with you, even if it is empty.

If you forget to use Humira

If you miss a dose, inject the next dose of Humira as soon as you remember. Then continue with your next dose at the usual time, as if you had not missed a dose.

If you stop using Humira

The decision to discontinue 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 up to at least 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, feet
• difficulty breathing, swallowing
• shortness of breath with physical activity or when lying down, or swelling of feet

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

• signs of infection such as fever, feeling sick, wounds, dental problems, 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, 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)
• 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 sores)
• infections in the reproductive system
• urinary tract infection
• fungal infections
• joint infections
• benign tumors
• skin cancer
• allergic reactions (including seasonal allergies)
• dehydration
• mood changes (including depression)
• anxiety
• 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 (sensation 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 burning)
• acid reflux
• dry eye syndrome (including dry eyes and mouth)
• itching
• itchy rash
• bruising
• skin inflammation (such as eczema)
• cracking or splitting 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
• problems with 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
• immune system disorders that may affect the lungs, skin, and lymph nodes (most commonly presenting as 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 shortness of breath 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 cramps
• 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
• nervous system 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 (reddish-purple itchy rash)

Frequency not known (cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi's sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more frequently as purplish skin lesions
• liver failure
• worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness)
• weight gain (for 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 count of platelets
• increased blood uric acid
• abnormal blood sodium levels
• low blood calcium levels
• low blood phosphate levels
• high blood sugar
• high blood lactate dehydrogenase levels
• presence of autoantibodies in blood
• low blood potassium levels

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels (liver function test)

Rare (may affect up to 1 in 1000 people)

• low blood counts of white blood cells, red blood cells, and platelets

Reporting of adverse effects

If you experience any adverse effect, consult 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 detailed 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 this medicine after the expiry date stated on the container after “EXP”.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Keep the prefilled pen in the outer carton to protect it from light.

Alternative storage:

When necessary (for example, when travelling), a single prefilled pen of Humira 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 any containers and medicines 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.

Nature and contents of the container

Humira 80 mg solution for injection in a pre-filled pen is supplied as a sterile solution containing 80 mg of adalimumab dissolved in 0.8 ml of solution.

The Humira pre-filled pen is a single-use, two-tone grey/plum-colored pen containing a glass syringe filled with Humira. It has two caps: one is grey and marked with a "1", the other is plum-colored and marked with a "2". There is a viewing window on each side of the pen through which you can see the Humira solution contained in the syringe.

The Humira pre-filled pen is available in pack sizes containing:

• 1 pre-filled pen for patient use with 2 alcohol wipes (1 spare).
• 3 pre-filled pens for patient use with 4 alcohol wipes (1 spare).

Only certain pack sizes may be marketed.

Humira may also be available in vials, pre-filled syringes, and/or pre-filled pens.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer responsible for manufacturing

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder.

Belgium/Belgique/Belgien AbbVie SA Tel/Tel: +32 10 477811	Lithuania AbbVie UAB Tel: +370 5 205 3023
	Luxembourg/Luxemburg AbbVie SA Belgium/Belgien 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 (toll-free) 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 CO. LTD 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. Tel.: +48 22 372 78 00
France AbbVie Tél: +33 (0) 1 45 60 13 00	Portugal AbbVie, Lda. Tel: +351 (0)21 1908400
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 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.

To request a copy of this leaflet in, or to listen to it in

1. How to inject Humira

• The following instructions explain how to self-inject Humira using the pre-filled pen. Please read all instructions carefully first, and then follow them step by step.

• Your doctor, nurse, or pharmacist will show you the technique for self-injection.

• Do not attempt to give yourself the injection until you are certain you understand how to prepare and administer it.

• After proper training, either you or another person, such as a family member or friend, may administer the injection.

• Use each pre-filled pen only once for a single injection.

Humira Pre-filled Pen

Grey cap1 White needle cover White arrow Plum-colored cap2

Needle Inspection window Plum-colored activation button

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

• the liquid is cloudy, discolored, or contains flakes or particles
• the expiry date (EXP) has passed
• the liquid has been frozen or exposed to direct sunlight
• the pre-filled pen has been dropped or crushed

Do not remove all caps until immediately before injection. Keep 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. Do not remove the grey or plum-colored caps while allowing Humira to warm to room temperature Do not heat Humira in any other way. For example, do not heat it in a microwave or in hot water
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 1 single-use prefilled pen and 1 alcohol wipe Wash your hands and dry them.
STEP 3 Injection sites Injection sites	Choose an injection site on your body: On the front of your thighs or On the abdomen (belly), at least 5 cm away from the navel At least 3 cm away from your last injection site Clean the injection site with the alcohol wipe using circular motions. Do not inject through clothing Do not inject into areas of irritated skin, bruised, red, hard, scarred skin, stretch marks, or areas with psoriatic plaques
STEP 4	Hold the prefilled pen with the grey cap 1 pointing upward. Inspect the viewing window. It is normal to see one or more bubbles in the viewing window Ensure the liquid is clear and colorless Do not use the prefilled pen if the liquid is cloudy or contains particles Do not use the prefilled pen if it has been dropped or crushed
STEP 5 Cap 1 Cap 2	Pull the grey cap 1 straight off and discard it. Do not reattach it. Ensure the black needle shield comes off with the cap It is normal to see a few drops of liquid from the needle Remove the plum-colored cap 2 by pulling it straight off. 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	With your other hand, pinch the skin at the injection site 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 viewing window. Do not press the plum-colored activator button until you are ready to administer the injection.
STEP 7 15 seconds	Firmly press the prefilled pen against the injection site before starting administration. Continue pressing firmly to prevent the prefilled pen from coming off the skin during injection. Press the plum-colored activator button and count slowly to 15 seconds. An audible "click" indicates the start of the injection Continue firmly pressing the prefilled pen against the injection site until the injection is complete 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. It is normal to see a small amount of liquid at the injection site If more than a few drops of liquid appear at the injection site, contact your doctor, nurse, or pharmacist. After completing the injection, place a cotton ball or gauze over the injection site. Do not rub the area It is normal to have slight bleeding at the injection site
STEP 9 Dispose of the prefilled pen in a special waste container (sharps container) as instructed by your doctor, nurse, or pharmacist. Do not recycle or throw the prefilled pen into household trash Always keep the prefilled pen and sharps container out of sight and reach of children The caps, alcohol wipe, cotton ball or gauze, blister pack, and packaging may be discarded in household trash.