Consumer medicine information

What is in this leaflet

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.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Read this leaflet carefully before you use Humira and keep it with the medicine. You may need to read it again.

What Humira is used for

The active ingredient in this medicine is adalimumab, which is 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 higher levels in some inflammatory diseases.

Humira is used for the treatment of a number of inflammatory diseases:

• Rheumatoid arthritis
  Rheumatoid arthritis is an inflammatory disease of the joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness. Humira is used to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis, as well as to slow down and protect the joints from further damage to help them move more freely.
  Your doctor will decide if Humira should be used with another medicine called methotrexate, or on its own.
  Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
• Polyarticular Juvenile Idiopathic Arthritis (pJIA)
  pJIA is an inflammatory disease of the joints. Humira is used to reduce the signs and symptoms of moderate to severely active pJIA, in patients 2 years of age and older, when other medicines are not appropriate. Your doctor will decide whether Humira should be used with another medicine called methotrexate or used alone.
• Enthesitis-related arthritis (ERA)
  ERA is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat ERA in children.
  You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you haven't responded well enough to these medicines.
• Psoriatic arthritis (PsA)
  PsA is an inflammatory disease of the joints that is usually associated with psoriasis. Signs and symptoms include joint pain, tenderness and swelling. Humira is used to reduce the signs and symptoms, of moderate to severely active PsA, as well as to slow down and protect the joints from further damage, to help them move more freely.
  You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you haven't responded well enough to these medicines.
• Ankylosing spondylitis
  Ankylosing spondylitis is an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and stiffness. Humira is used to reduce the signs and symptoms in patients with active disease.
• 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 children aged 6 years and over to reduce the signs and symptoms of the disease and to induce and maintain periods where the symptoms are no longer present (remission).
  You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you may either have not responded well enough, or you may have lost response or cannot tolerate these medicines.
• Ulcerative Colitis
  Ulcerative colitis is an inflammatory disease of the large intestine (bowel). Humira is used to treat moderate to severe ulcerative colitis when other medicines are not appropriate.
• Psoriasis
  Psoriasis is an inflammatory disease of the skin. Plaque psoriasis, the most common form, is a skin condition that causes red, flaky, crusty patches of the skin covered with silvery scales. 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 to treat moderate to severe forms of the disease in adults and severe forms in adolescents and children from 4 years of age for whom topical therapy (such as creams, lotions and ointments) and phototherapy (also known as light therapy) have either not worked very well, or are not suitable.
• Hidradenitis suppurativa (HS)
  HS (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus, which can have an unpleasant odour. 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.
  Humira is used for the treatment of adults and adolescents from 12 years of age with active moderate to severe HS, Humira can reduce the number of nodules and abscesses caused by the disease, and the pain that is often associated with it.
  You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you haven't responded well enough to these medicines.
  Your doctor will schedule follow-up appointments to check on your progress to determine whether you should continue treatment.
• Uveitis
  Uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira is used to treat non-infectious intermediate, posterior and pan-uveitis.
  You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you may either have not responded well enough, or you have lost response or cannot tolerate these medicines.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. 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.

Before you use Humira

When you must not use it

Do not use Humira if you have an allergy to any medicine containing adalimumab or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

• chest tightness
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• hives, itching or skin rash.

Do not use Humira if you have a severe infection including an infection of the blood (sepsis), active tuberculosis or other severe infections that can be caused by viruses, fungi, parasites or bacteria. Infections can occur when the body's natural defences are lowered.

Do not use Humira if you are already using anakinra (Kineret). Anakinra is a medicine for rheumatoid arthritis, JIA and conditions associated with a defect in a protein called cryoprin.

Do not use Humira if you have moderate to severe heart failure.

If you are not sure whether any of the above conditions apply to you, ask your doctor.

Do not use this medicine after the expiry date printed on the label / blister / carton or if the packaging is torn or shows signs of tampering.

Return out of date or damaged medicines to your pharmacist for disposal.

Before you use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if:

• you have or have had an infection, including a long-term infection or an infection in one part of the body (for example, leg ulcer).
• you have had infections which keep coming back or other conditions that increase the risk of infections.
  If you are over 65, you may be more likely to get an infection while taking Humira. It is important that you and your doctor pay special attention to signs of infection while you are being treated with Humira.
• you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
  As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation, including your medical history, and appropriate screening tests (for example a chest x-ray and tuberculin test).
  Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
  If symptoms of tuberculosis (for example a cough that doesn't go away, weight loss, lack of energy, mild fever), or any other infections appear during or after therapy, tell your doctor immediately.
• you are a carrier of the hepatitis B virus (HBV), or you have active HBV or you think you might be at risk of contracting HBV.
  In people who carry HBV, Humira can cause the virus to become active again. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life threatening.
• you have or have had a fungal infection, or have lived or travelled in countries where some fungal infections are common. These infections may develop or become more severe if you take Humira.
• you have or have had uveitis, your doctor may check for signs and symptoms of neurologic disease before starting this medicine.
• you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis)
• you have or have had allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash.
• you have or have had a blood disorder.
• you have or have had low resistance to disease.
• you have or have had a serious heart condition.
• you have or have had cancer or autoimmune disease.
• you have a lung disease called chronic obstructive pulmonary disease (COPD).
• you have or have had kidney or liver problems.

Tell your doctor if you are scheduled for any vaccines. Certain vaccines may cause infections and should not be given while patients are receiving Humira.

Wherever possible, it is recommended that children, be brought up to date with all immunisations according to current immunisation guidelines prior to starting on Humira therapy. Patients receiving Humira should not receive live vaccines.

Tell your doctor if you have psoriasis and have undergone phototherapy, also known as light therapy.

Tell your doctor if you are pregnant or plan to become pregnant. You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.

Humira should only be used during pregnancy if clearly needed.

A pregnancy study found that there was no higher risk of birth defects when the mother had used Humira during pregnancy, compared with mothers with the same disease who did not use Humira.

If you use Humira during pregnancy, your baby may have a higher 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 the baby receives any vaccine.

Tell your doctor if you are breastfeeding or plan to breastfeed. 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.

If you have not told your doctor or pharmacist about any of the above, tell them before you start using Humira.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket naturopath or health food shop. Some medicines and Humira may interfere with each other.

Tell your doctor or pharmacist if you are taking anakinra (Kineret) or abatacept (Orencia). Taking either of these two medicines together with Humira may increase the risk of infection.

Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.

Tell your doctor or if you are taking any other medicines to treat your condition.

Humira can be taken together with other medicines such as: methotrexate, and other disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use Humira

Humira is given as a subcutaneous injection (under the skin). It may be injected by the patient, family member or carer.

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label or in this leaflet, ask your doctor or pharmacist for help.

Always use Humira exactly as your doctor has instructed you.

Check with your doctor or pharmacist if you are not sure.

How much to use

Rheumatoid Arthritis in Adults

The usual dose for adults with rheumatoid arthritis is one 40 mg injection every fortnight.

If you are receiving Humira without methotrexate, your doctor may change your Humira dose to 40 mg every week or 80 mg every fortnight, depending on your response.

Other medicines may be prescribed by your doctor to be taken while you are being treated with Humira.

Psoriatic Arthritis & Ankylosing Spondylitis in Adults

The usual dose for patients with psoriatic arthritis and ankylosing spondylitis is one 40 mg injection every fortnight.

Other medicines may be prescribed by your doctor to be taken while you are being treated with Humira.

Crohn's disease & Ulcerative Colitis in Adults

The usual dose for adults with Crohn's disease or ulcerative colitis is as follows:

• initial dose of 160 mg (day 1) (given as two 80 mg injections in one day OR as one 80 mg injection per day over two consecutive days OR as four 40 mg injections in one day OR as two 40 mg injections per day over two consecutive days)
• 80 mg at day 15 (given as one 80 mg injection OR two 40 mg injections in one day).
• 40 mg starting at day 29, which then continues once every fortnight (maintenance dose).

Your doctor may change this ongoing (maintenance) dose to 40 mg every week or 80 mg every fortnight, depending on your response.

Psoriasis in Adults

The usual dose for adult patients with psoriasis is as follows:

• initial dose of 80 mg (day 1) (given as one 80 mg injection OR two 40 mg injections in one day)
• 40 mg given one week later (day 8), then
• 40 mg every fortnight from day 22 (maintenance dose).

Your doctor may change this ongoing (maintenance) dose to 40 mg every week or 80 mg every fortnight, depending on your response.

Uveitis in Adults

The usual dose for adults with uveitis is as follows:

• initial dose of 80 mg (day 1) (given as one 80 mg injection OR as two 40 mg injections in one day),
• 40 mg one week later (day 8), then
• 40 mg every fortnight, starting at day 22, which then continues (maintenance dose).

Hidradenitis suppurativa in Adults

The usual dose for adults with HS is as follows:

• initial dose of 160 mg (day 1) (given as two 80 mg injections in one day, OR as one 80 mg injection per day over two consecutive days OR as four 40 mg injections in one day OR as two 40 mg injections per day over two consecutive days)
• 80 mg (day 15) (given as one 80 mg injection OR two 40 mg injections in one day)
• 40 mg every week or 80 mg every fortnight starting at day 29, which then continues (maintenance dose).

Your doctor may prescribe other medicines for your condition to take with Humira.

Juvenile Idiopathic Arthritis & Enthesitis-related Arthritis

The usual dose for children with pJIA or ERA depends on body weight.

For a body weight of 30 kg and above:
The usual dose is 40 mg given every fortnight.

For a body weight between 10 kg and less than 30 kg:
The usual dose is 20 mg given every fortnight.

Crohn's Disease in Children

The usual dose for children with Crohn's disease depends on body weight.

For a body weight of 40 kg or above:

• initial dose 160 mg (day 1) (given as two 80 mg injections in one day OR as one 80 mg injection per day over two consecutive days OR as four 40 mg injections in one day OR as two 40 mg injections per day over two consecutive days)
• 80 mg two weeks later (day 15) (given as one 80 mg injection OR as two 40 mg injections in one day)
• 40 mg every fortnight starting at day 29, which then continues (maintenance dose).
  Your doctor may change this ongoing (maintenance) dose to 40 mg every week or 80 mg every fortnight, depending on your response.

For a body weight of less than 40 kg:

• initial dose of 80 mg (day 1) (given as one 80 mg injection OR as two 40 mg injections in one day)
• 40 mg two weeks later (day 15)
• 20 mg every fortnight, starting at day 29, which then continues (maintenance dose).

Your doctor may change this ongoing (maintenance) dose to 20 mg every week, depending on your response.

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

Psoriasis in Children

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

For a body weight of 40 kg and above:
The usual dose is 40 mg given once every week for the first two weeks, then once every fortnight.

For a body weight of less than 40 kg:
The usual dose is 20 mg given once every week for the first two weeks, then once every fortnight.

Hidradenitis suppurativa in Adolescents

The usual dose for adolescents with HS, (from 12 years of age, weighing at least 30 kg) is as follows:

• initial dose of 80 mg (day 1) (given as one 80 mg OR as two 40 mg injections in one day)
• 40 mg starting one week later (day 8)
• 40 mg every fortnight starting at day 22, which then continues (maintenance dose).

Your doctor may change this ongoing (maintenance) dose to 40 mg every week or 80 mg every fortnight, depending on your response.

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

How to use it

Humira is injected under the skin. The injection can be self-administered or given by another person, for example a family member friend or carer, but only after proper training in injection technique.

If you are using the Humira pre-filled syringe, instructions for preparing and giving an injection are provided in the Injecting Instructions supplied with the product.

Read these instructions carefully and follow them step by step. These instructions explain how to self - inject this medicine.

Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. Your doctor or his/her assistant will also show you best how to self-inject.

Do not mix the injection in the same syringe or vial with any other medicine.

Keep out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

• Do not remove the needle cover while allowing Humira to reach room temperature
• Do not warm Humira in any other way. For example, do not warm it in the microwave or in hot water.
• Do not use the syringe if liquid has been frozen (even if thawed).

STEP 2

Check the expiry date on the syringe label.

Do not use the syringe if the expiry date has passed.

Place the following on a clean, flat surface:

• One Humira single-use syringe and alcohol pad.
• One cotton ball or gauze pad (not included)
• Puncture-resistant sharps disposal container (not included)

Wash and dry your hands

STEP 3

Choose an injection site:

• On the front of your thighs or, your abdomen (belly) at least 5 cm from your navel (belly button)
• Different from and at least 3 cm from your last injection site
• Wipe the injection site in a circular motion with the alcohol pad
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

STEP 4

Hold the syringe in one hand.

Check the liquid in the pre-filled syringe.

• Make sure the liquid is clear and colourless
• Do not use the pre-filled syringe if the liquid is cloudy or has particles

Gently pull the needle cover straight off with the other hand.

• Throw the needle cover away
• Do not touch the needle with your fingers or let the needle touch anything

You may see a drop of liquid at the end of the needle. This is normal.

STEP 5

Hold the body of the syringe in one hand between the thumb and index fingers, like you would a pencil.

Gently squeeze the area of cleaned skin with your other hand and hold it firmly.

STEP 6

Insert the needle into the skin at about a 45-degree angle using a 'dart-like' motion.

• After the needle is in, let go of the skin you are holding

Slowly push the plunger all the way in until all of the liquid is injected and the syringe is empty.

STEP 7

When the injection is completed, slowly pull the needle out of the skin while keeping the syringe at the same angle.

After completing the injection, place a cotton ball or gauze pad on the skin of the injection site.

• Do not rub
• Slight bleeding at the injection site is normal

STEP 8

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.

For more information:

Australia: Call us on 1800 043 460 or visit www.abbviecare.com.au

New Zealand: Call us on 0800 900 030 or visit www.abbviecare.co.nz

How long to use it

Keep using Humira for as long as your doctor tells you.

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

Ask your doctor if you are not sure how long to take this medicine for.

If you forget to use it

If you forget to give yourself an injection, you should inject the next dose of Humira as soon as you remember. Then inject your next dose as you would have on your originally scheduled day.

Do not try to make up for missed doses by injecting more than one dose at a time.

If you use too much (overdose)

If you accidentally inject Humira more frequently than prescribed your doctor, immediately telephone your doctor or the Poisons Information Centre (Australia: Telephone 13 11 26) or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Always take the outer carton of the medicine with you.

While you are using Humira

Things you must do

Check with your doctor before you receive any vaccines.

Wherever possible, it is recommended that children be brought up to date with all immunisations according to current immunisation guidelines prior to starting Humira therapy.

Patients receiving Humira should not receive live vaccines (for example, BCG or oral polio vaccine).

If you become pregnant while using Humira, tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor you are using Humira.

Tell all doctors, dentists, and pharmacists who are treating you that you are using Humira.

If you are going to have surgery, tell all doctors that you are using Humira. Your doctor may recommend you discontinue using Humira temporarily.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not give Humira to anyone else, even if they have the same condition as you.

Do not use Humira to treat any other complaints unless your doctor tells you to.

Do not stop taking Humira, without checking with your doctor.

Do not take Humira and anakinra (Kineret) or Humira and abatacept (Orencia) together. Taking either of these two medicines with Humira may lead to an increased risk of developing a serious infection.

Things to be careful of

It is important to tell your doctor if you get symptoms of an infection, such as a fever, skin sores, feeling tired or any problems with your teeth and gums.

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, parasites or bacteria, or other infections. Sepsis, an infection of the blood, may, in rare cases, be life-threatening.

Your doctor may recommend you discontinue Humira if you develop an infection.

Be careful driving or operating machinery until you know how Humira affects you. The effects on your ability to drive and use machines whilst taking this medicine are not known.

Side effects

Tell your doctor as soon as possible if you do not feel well while using Humira or you have any problems using it.

Do this even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

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

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist any questions you may have.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience any of the following:

• Signs of an allergic reaction such as:
  - Chest tightness
  - Shortness of breath, wheezing or difficulty breathing
  - Swelling of the face, lips, tongue or other parts of the body
  - Hives, itching or skin rash.
• Signs and symptoms suggestive of heart failure such as shortness of breath with exertion or upon lying down or swelling of the feet
• Signs and symptoms suggestive of a blood disorder such as persistent fever, bruising, bleeding very easily, paleness.

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

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

• Signs of tuberculosis such as persistent cough, weight loss, listlessness, fever
• Signs of infection such as fever, lack of energy, skin sores, problems with your teeth or gums, burning when you pass urine
  You might get infections more easily while you are receiving Humira treatment.
• Signs of nervous system disorders such as numbness or tingling throughout your body, arm or leg weakness, double vision
• Signs of soft tissue infection, such as a bump or open sore that doesn't heal.

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

Tell your doctor if you notice any of the following and they worry you:

• Pain, swelling, redness or itching) at the site of injection
• Cold, runny nose, sinus infection, sore throat cough, congestion on the chest, asthma or worsening of asthma symptoms
• Lower respiratory tract infections (such as bronchitis, pneumonia)
• Pain in the ear which could suggest an ear infection
• Pain or inflammation of the eye or eye lid or changes to your vision
• Mouth ulcers, pain or excessive bleeding from the gums
• Burning or pain when passing urine, or blood in the urine
• Skin bumps or sores that don't heal
• Headache or migraine, dizziness, vertigo
• Muscle weakness or numbness, difficulty balancing
• Fever, flushing, increased sweating
• Nausea, vomiting, abdominal pain
• Reflux or heartburn
• Chest pain
• Rash, itching redness or scaly patches
• Problems with your finger or toe nails
• Hair loss
• Fatigue, tiredness, lack of energy
• Muscle, joint or bone pain
• Bleeding or bruising more easily than usual
• Feeling overwhelmed or sad, or lacking motivation (depression)
• Feeling anxious, especially fearful or worried (anxiety)
• Increased heart rate
• Viral infections (including the flu, cold sore blisters, chicken pox and shingles)
• Bacterial infections (including Urinary Tract Infection)
• Fungal Infections.

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

There have been cases of certain kinds of cancer in patients using Humira or similar medicines. 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.

Tell your doctor if new skin lesions (skin spots or sores) appear, or if existing lesions change appearance during or after Humira treatment. Very rare cases of skin cancer have been observed in patients taking Humira.

If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is right for you. 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.

Laboratory results

Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include, most commonly, increased lipids, elevated liver enzymes, and low levels of white blood cells and red blood cells in the blood.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some people.

After using Humira

Storage

Keep your pre-filled syringe in the pack until it is time to use it in order to protect it from light

Keep Humira in a refrigerator (2°C to 8°C). Do not freeze.

Keep Humira in the refrigerator in a way children cannot get to it.

Keep the medicine at the right temperature when you travel. This is important when travelling by car, bus, train, plane or any other form of transport.

When needed, you can store a pre-filled syringe at room temperature (below 25°C) for a maximum period of 14 days. Be sure to protect it from light.

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

Write down the date you first remove the syringe from the refrigerator on the label, so you can check how long it has been.

Disposal

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

If your doctor tells you to stop using Humira or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

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

• 40 mg adalimumab in 0.8 mL solution in a syringe (AUST R 199412) and
• 20 mg adalimumab in 0.4 mL solution in a syringe (AUST R 199411)

The following Pre-filled syringe packs are available:

• 2 pre-filled syringes with 2 alcohol pads (Humira 20 mg/0.4 mL and Humira 40 mg/0.8 mL pre-filled syringe)
• 6 pre-filled syringes with 6 alcohol pads (Humira 40 mg/0.8 mL pre-filled syringe)

Humira (100mg/mL) is a clear, colourless, sterile solution of:

• 20 mg adalimumab in 0.2 mL solution in a syringe (AUST R 289104)
• 40 mg adalimumab in 0.4 mL solution in a syringe (AUST R 281470)
• 80 mg adalimumab in 0.8 mL solution in a syringe (AUST R 292934)

The following Pre-filled syringe packs are available:

• 2 pre-filled syringes with 2 alcohol pads (Humira 20 mg/0.2 mL pre-filled syringe)
• 2 pre-filled syringes with 2 alcohol pads (Humira 40 mg/0.4 mL pre-filled syringe)
• 6 pre-filled syringes with 6 alcohol pads (Humira 40 mg/0.4 mL pre-filled syringe)
• 1 pre-filled syringe with 2 alcohol pads (Humira 80 mg/0.8 mL prefilled syringe)

Ingredients

Humira contains adalimumab as the active ingredient:

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

• Sodium chloride
• Monobasic sodium phosphate dihydrate
• Dibasic sodium phosphate dihydrate
• Sodium citrate dihydrate
• Citric acid monohydrate
• Mannitol
• Polysorbate 80
• Water for injections

For Humira 20 mg/0.2 mL, 40 mg/0.4 mL and 80 mg/0.8 mL pre-filled syringe, it also contains other ingredients including:

• Mannitol
• Polysorbate 80
• Water for injections

Not all presentations may be marketed.

Distributor

Humira is distributed in Australia by:

AbbVie Pty Ltd
ABN 48 156 384 262
241 O'Riordan Street
Mascot NSW 2020

This leaflet was prepared in: November 2020

Australian Registration Numbers:

AUST R 199412

AUST R 199411

AUST R 281470

AUST R 292934

AUST R 289104

Version 06

Published by MIMS January 2021

1 Name of Medicine

Adalimumab (rch).

2 Qualitative and Quantitative Composition

Humira (adalimumab) is a recombinant human immunoglobulin (IgG₁) monoclonal antibody containing only human peptide sequences. Humira was created using phage display technology resulting in fully human heavy and light chain variable regions, which confer specificity to human tumour necrosis factor (TNF), and human IgG₁ heavy chain and kappa light chain sequences. Humira binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
Adult presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL), 40 mg adalimumab per 0.8 mL (50 mg/mL) or 40 mg adalimumab per 0.4 mL (100 mg/mL). Presentations for paediatric use only contain either 20 mg adalimumab per 0.4 mL (50 mg/mL) or 20 mg adalimumab per 0.2 mL (100 mg/mL).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The solution of Humira is clear and colourless and isotonic with a pH of 5.2. The drug product is supplied as either a single-use pre-filled glass syringe or as a single use, pre-filled pen (Humira pen). Enclosed within the pen is a single-use, pre-filled glass syringe.

4 Clinical Particulars

4.1 Therapeutic Indications

Rheumatoid arthritis.

Juvenile idiopathic arthritis.

Polyarticular juvenile idiopathic arthritis.

Enthesitis related arthritis.

Psoriatic arthritis.

Ankylosing spondylitis.

Crohn's disease in adults and children (≥ 6 years).

Ulcerative colitis.

Psoriasis in adults and children.

Hidradenitis suppurativa in adults and adolescents (from 12 years of age).

Uveitis.

4.2 Dose and Method of Administration

Humira is administered by subcutaneous injection. This product is for one dose in one patient only.
Humira is intended for use under the guidance and supervision of a physician. Patients may self inject Humira if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
Sites for self injection include thigh or abdomen. Injection sites should be rotated. New injections should never be given into areas where the skin is tender, bruised, red or hard.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Humira should not be mixed in the same syringe with any other medicine. Any unused product or waste material should be disposed of in accordance with local requirements.
Humira contains no antimicrobial agent. Discard any residue.

Rheumatoid arthritis.

Juvenile idiopathic arthritis.

Psoriatic arthritis.

Ankylosing spondylitis.

Crohn's disease.

Paediatric Crohn's disease (6 to 17 years).

Ulcerative colitis.

Psoriasis.

Adults.

Paediatric plaque psoriasis (4 to 17 years).

Hidradenitis suppurativa.

Adults.

Adolescents (from 12 years of age, weighing at least 30 kg).

Uveitis.

4.3 Contraindications

Humira should not be administered to patients with known hypersensitivity to Humira or any of its excipients.
Humira is contraindicated in severe infections including sepsis, active tuberculosis and opportunistic infections (see Section 4.4 Special Warnings and Precautions for Use).
Concurrent administration of Humira and anakinra (interleukin-1 receptor antagonist) is contraindicated (see Section 4.4 Special Warnings and Precautions for Use).
Moderate to severe heart failure (NYHA class III/IV).

4.4 Special Warnings and Precautions for Use

Infections.

Hepatitis B virus.

Tuberculosis.

Other opportunistic infections.

Neurologic events.

Hypersensitivity reactions.

Haematologic events.

Immunosuppression.

Vaccinations.

Congestive heart failure.

Malignancies.

Autoimmune processes.

Concurrent administration of biologic DMARDs or TNF antagonists.

Use in psoriasis.

Surgery.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Humira has been studied in RA patients taking concomitant methotrexate (see Section 5.1 Pharmacodynamic Properties, Clinical trials, Steady state). The data do not suggest the need for dose adjustment of either Humira or methotrexate. Interactions between Humira and drugs other than methotrexate have not been evaluated in formal pharmacokinetic studies. Concurrent administration of TNF-alpha inhibitors with anakinra or abatacept has been associated with an increased risk of serious infections (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Clinical trials.

Rheumatoid arthritis.

Polyarticular juvenile idiopathic arthritis.

Hidradenitis suppurativa.

Uveitis.

Study V (DE013).

Description of selected adverse reactions.

Injection site reactions.

Infections.

Malignancies.

Autoantibodies.

Psoriasis: new onset and worsening.

Liver enzyme elevations.

Rheumatoid arthritis and psoriatic arthritis clinical trials.

Juvenile idiopathic arthritis clinical trials.

Ankylosing spondylitis clinical trials.

Hidradenitis suppurativa clinical trials.

Crohn's disease clinical trials.

Paediatric Crohn's disease clinical trials.

Ulcerative colitis clinical trials.

Psoriasis clinical trials.

Paediatric patients with plaque psoriasis clinical trial.

Uveitis clinical trials.

Concurrent treatment with azathioprine/ 6-mercaptopurine.

Polyarticular juvenile idiopathic arthritis clinical trials.

Additional adverse reactions from postmarketing surveillance or phase IV clinical trials.

4.9 Overdose

The maximum tolerated dose of Humira has not been established in humans. No dose limiting toxicities have been observed during clinical trials with Humira. Multiple doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose limiting toxicities. In case of over dosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Tumour necrosis factor alpha (TNF-alpha) inhibitors.
ATC code: L04AB04.

Mechanism of action.

Pharmacodynamics.

Steady state.

Clinical trials.

Clinical trials for rheumatoid arthritis.

Clinical response.

RA studies I, II and III.

RA study IV.

RA study V.

Radiographic response.

Physical function.

Results.

Quality of life.

Injection site pain.

Clinical trials for juvenile idiopathic arthritis.

Polyarticular juvenile idiopathic arthritis (pJIA).

pJIA study I.

pJIA study I clinical response.

pJIA study II.

pJIA study II clinical response.

Enthesitis related arthritis (ERA).

Clinical trials for psoriatic arthritis.

ACR and PASI response.

Radiographic response.

Quality of life and physical function.

Clinical trials for ankylosing spondylitis.

Clinical trials for Crohn's disease.

Adults.

Clinical results.

CD study I/CD study II.

CD study III (M02-404).

Patient reported outcomes.

Children and adolescents.

Efficacy results.

Clinical trials for ulcerative colitis.

Quality of life.

Clinical trials for psoriasis.

Adults.

Clinical results.

Quality of life.

Children and adolescents.

Clinical trials for hidradenitis suppurativa.

Adults.

Clinical response.

Adolescents.

Clinical trials for uveitis.

Clinical results.

Quality of life.

Immunogenicity.

5.2 Pharmacokinetic Properties

Absorption.

Distribution and elimination.

Specific populations.

Race/ethnicity.

Gender/weight.

Paediatric patients.

Geriatric patients.

Hepatic and renal insufficiency.

Disease states.

Drug interactions, methotrexate.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Humira 80 mg/0.8 mL (100 mg/mL).

Humira 40 mg/0.8 mL (50 mg/mL).

Humira 40 mg/0.4 mL (100 mg/mL).

Humira 20 mg/0.4 mL (50 mg/mL).

Humira 20 mg/0.2 mL (100 mg/mL).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (in a refrigerator) and store the syringe in the outer carton to protect from light. Do not freeze.
Do not use beyond the expiration date.
When required (for example, when travelling), a single Humira prefilled syringe or pen may be stored below 25°C (room temperature) for a maximum period of 14 days, but must be protected from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
The date of removal from the refrigerator should be recorded on the syringe label, to allow the syringe to be discarded after the maximum 14 days if not used.

6.5 Nature and Contents of Container

Humira (adalimumab) solution for injection for paediatric use is supplied as a sterile solution of either 20 mg adalimumab dissolved in 0.4 mL sterile solution or 20 mg adalimumab dissolved in 0.2 mL sterile solution in the following packaging configurations:
Humira 20 mg per 0.4 mL solution for injection in single-use pre-filled syringe:
Carton containing 2 blisters, each containing 1 pre-filled syringe and 1 alcohol pad.
Humira 20 mg per 0.2 mL solution for injection in single-use pre-filled syringe:
Carton containing 2 blisters, each containing 1 pre-filled syringe and 1 alcohol pad.
Humira (adalimumab) solution for injection is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 mL sterile solution for subcutaneous administration in the following packaging configurations:
Humira 40 mg per 0.8 mL solution for injection in single-use pre-filled syringe (for patient use):
carton containing 1 alcohol pad and 1 blister with 1 pre-filled syringe;
carton containing 2 alcohol pads and 2 blisters, each containing 1 pre-filled syringe;
carton containing 3 alcohol pads and 3 blisters, each containing 1 pre-filled syringe;
carton containing 4 alcohol pads and 4 blisters, each containing 1 pre-filled syringe;
carton containing 6 alcohol pads and 6 blisters, each containing 1 pre-filled syringe.
Humira 40 mg per 0.8 mL solution for injection in single-use pre-filled pen (for patient use):
carton containing 2 alcohol pads and 1 blister with 1 pre-filled pen;
carton containing 2 alcohol pads and 2 blisters, each containing 1 pre-filled pen;
carton containing 4 alcohol pads and 3 blisters, each containing 1 pre-filled pen;
carton containing 4 alcohol pads and 4 blisters, each containing 1 pre-filled pen;
carton containing 6 alcohol pads and 6 blisters, each containing 1 pre-filled pen.
Humira (adalimumab) solution for injection is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 mL sterile solution for subcutaneous administration in the following packaging configurations:
Humira 40 mg per 0.4 mL solution for injection in a single-use pre-filled syringe:
carton containing 1 alcohol pad and 1 blister with 1 pre-filled syringe;
carton containing 2 alcohol pads and 2 blisters, each containing 1 pre-filled syringe;
carton containing 4 alcohol pads and 4 blisters, each containing 1 pre-filled syringe;
carton containing 6 alcohol pads and 6 blisters, each containing 1 pre-filled syringe.
Humira 40 mg per 0.4 mL solution for injection in a single-use pre-filled pen:
carton containing 2 alcohol pads and 1 blister with 1 pre-filled pen;
carton containing 2 alcohol pads and 2 blisters, each containing 1 pre-filled pen;
carton containing 4 alcohol pads and 4 blisters, each containing 1 pre-filled pen;
carton containing 6 alcohol pads and 6 blisters, each containing 1 pre-filled pen.
Humira (adalimumab) solution for injection is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 mL sterile solution for subcutaneous administration in the following packaging configurations:
Humira 80 mg solution for injection in single-use pre-filled syringe (for patient use):
Carton containing 2 alcohol pads and 1 blister with 1 pre-filled syringe.
Humira 80 mg solution for injection in single-use pre-filled pen (for patient use):
carton containing 2 alcohol pads and 1 blister with 1 pre-filled pen;
carton containing 4 alcohol pads and 3 blisters, each containing 1 pre-filled pen.
Not all presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes