This leaflet answers some common questions about Humira.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

You may need to read it again.

Humira is used for the treatment of:

Humira is used to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis, a painful disease of the joints, as well as slow down and protect against damage to joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness.

Humira is used for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis, which is an inflammatory disease involving multiple joints, in patients 2 years of age and older.

Humira is used to treat enthesitis-related arthritis, an inflammatory disease of the joints in children.

Humira is used to reduce the signs and symptoms, as well as inhibit the progression of joint damage of moderate to severely active psoriatic arthritis, a disease of the joints and skin, with some similarities to rheumatoid arthritis, as well as psoriasis and other factors.

Humira is used to reduce the signs and symptoms in patients with active ankylosing spondylitis, an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and morning stiffness.

Humira is used for the treatment of moderate to severe Crohn's disease, an inflammatory disease of the digestive tract, in adults and children aged 6 years and above to reduce the signs and symptoms of the disease and to induce and maintain periods where the symptoms are no longer present. Humira can be given to patients who have not responded well enough to conventional therapies, or who have lost response to or are intolerant to infliximab (another medicine used to treat Crohn's disease).

Humira is used for the treatment of moderate to severe ulcerative colitis an inflammatory bowel disease, in patients who have not responded well enough to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a response within 8 weeks to continue treatment.

Humira is used to treat chronic plaque psoriasis, an inflammatory disease of the skin. Plaque psoriasis can also affect nails, causing them to crumble, thicken and lift away from the nail bed which can be painful. Humira is used for moderate to severe forms of the disease in adults and severe forms in children and adolescents from 4 years of age who have not responded well enough to topical therapy and phototherapy, or who cannot be given those treatments.

Humira is used for the treatment of adult and adolescents from 12 years of age with active moderate to severe hidradenitis suppurativa (acne inversa), a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas. Your doctor will schedule follow-up appointments to check on your progress to continue treatment.

Humira is used to treat non-infectious intermediate, posterior and pan-uveitis, an inflammatory disease of the uveal tract of the eye. Humira is used in adults who have not responded well to corticosteroids or whose disease flares when they taper off corticosteroids. Signs and symptoms include inflammation, vision impairment and pain.

The active ingredient in this medicine is adalimumab, a fully human monoclonal antibody. Monoclonal antibodies are proteins made by a type of blood cell to fight a foreign protein in the body. Adalimumab recognises and binds to a specific protein (tumour necrosis factor or TNF-alpha), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and uveitis.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is only available with a doctor's prescription.

The long term effects of Humira on the growth and development of children is not known.

It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy. Patients receiving Humira should not receive live vaccines.

There is only limited experience in the effects of Humira in pregnant women. The use of this medicine in pregnant women is not recommended. Women of childbearing age are advised to use contraception to avoid falling pregnant.

It is not known whether Humira passes into breast milk. If you are breastfeeding, your doctor may advise you to stop breastfeeding while you are using this medicine.

Some medicines and Humira may interfere with each other. Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

Taking the two medicines together may increase the risk of infection.

Humira can be taken together with medicines used to treat arthritis, such as: methotrexate, steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen.

The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is one 40mg injection fortnightly.

The usual dose for adults with Crohn's disease or ulcerative colitis is an initial dose of 160mg (given as four injections on one day or two injections a day over two days), followed by 80mg two weeks later (given on one day) then 40mg starting two weeks later and continuing every two weeks.

The usual dose for adults with psoriasis or uveitis is an initial dose of 80mg, (given as 2 injections), followed by 40mg given fortnightly starting one week after the initial dose.

For adults with psoriasis, depending on your response, your doctor may increase the dose frequency to 40mg every week.

The usual dose for adults with hidradenitis suppurativa is an initial dose of 160mg (given as 4 injections in one day or 2 injections per day for two consecutive days), followed by an 80mg dose (as 2 injections on the same day) two weeks later. After a further two weeks, continue with a dose of 40mg every week.

Your doctor may prescribe other medicines for your condition arthritis to take with this medicine.

The usual dose for children with polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis depends on body weight:

The usual dose for children with Crohn's disease depends on body weight and the severity of disease.

-with a body weight of 40kg or above, the starting dose is 160mg (given as four injections on one day or two injections over two days), followed by 80mg two weeks later (given in one day). After a further two weeks, continue with 20mg or 40mg every two weeks, depending on severity of disease).

-with a body weight of less than 40kg, the starting dose is 80mg (given as two injections on one day), followed by 40mg two weeks later. After a further two weeks, continue with 10mg or 20mg every two weeks, depending on severity of disease).

Treatment of Crohn's disease in children should be supported by good nutrition to allow appropriate growth.

The usual dose for children with psoriasis depends on the body weight:

The usual dose for adolescents (from 12 years, weighing at least 30kg) with hidradenitis suppurativa is an initial dose of 80mg (two 40mg injections in one day), followed by 40mg fortnightly starting one week later. If you have an inadequate response, your doctor may increase the dose to 40mg every week.

It is recommended you use an antiseptic wash daily on the affected areas.

If Humira has no effect on the child's condition after 16 weeks, your doctor may tell you to stop using Humira.

Humira is injected under the skin. The injection can be self-administered or given by another person, for example a family member or friend after proper training in injection technique, or your doctor or his/her assistant.

Your doctor or his/her assistant will also show you best how to self-inject.

Choose a site on your thigh or stomach (except the area around the navel).

Change the place that you inject each time so that you do not become sore in one area. Each new injection should be given at least 3 cm from the last injection site

Rotate between thigh and stomach

Do not shake the syringe

The presence of one or more bubbles in the syringe is normal.

Remove the cap from needle syringe, being careful not to touch the needle or let it touch any surface.

With one hand, gently grasp the cleaned area of skin and hold firmly.

With the other hand, hold syringe at 90-degree angle to skin, with the grooved side up.

With one quick, short motion, push needle all the way into skin

Release the skin with the first hand

Push plunger to inject solution - it can take from 2 to 5 seconds to empty the syringe.

When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted

Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may occur. Do not rub the injection site. Use a plaster if you want to.

The Humira syringe should never be reused. Never recap a needle.

After injecting Humira, immediately throw away the used syringe in a special 'sharps' container as instructed by your doctor, nurse or pharmacist.

Keep this container out of the reach and sight of children.

Humira will not cure your condition but should help control your symptoms.

You may need urgent medical attention. Always take the outer carton of the medicine with you.

It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.

Some vaccines, such as oral polio vaccine, should not be given while receiving Humira.

Anakinra and abatacept are other medicines used to treat certain forms of arthritis.

You might get infections more easily while you are receiving Humira treatment. These infections may be serious and include tuberculosis, infections caused by viruses, fungi or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening. Your doctor may recommend temporary discontinuation of Humira.

The effects on your ability to drive and use machines whilst taking this medicine are not known.

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side-effects.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are uncommon.

The above list includes serious side effects. You may need urgent medical attention. Serious side effects are rare.

The above list includes the more common side effects of Humira. They are usually mild and short-lived.

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include increased lipids in the blood, elevated liver enzymes, and increased uric acid in the blood.

Other side effects not listed above may occur in some people.

There have been cases of certain kinds of cancer in patients taking Humira or other TNF blockers. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher chance of getting a kind of cancer that affects the lymph system, called lymphoma, or that affects the blood, called leukaemia. If you take Humira your risk may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Humira. Some of those patients were also treated with azathioprine or 6-mercaptopurine. In addition very rare cases of skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

There have been cases of cancers other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another 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.

This is important when travelling by car, bus, train, plane or any other form of transport.

Once removed from the refrigerator and stored at room temperature, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.

Humira (50mg/mL) is a clear, colourless, sterile solution.

The following Pre-filled syringe packs are available:

Humira contains adalimumab as the active ingredient:

For Humira 10mg/0.2mL, 20mg/0.4mL and 40mg/0.8mL pre-filled syringe, it also contains other ingredients including: