HUMIRA

Main information

  • Trade name:
  • HUMIRA adalimumab (rch) 10mg solution for injection pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HUMIRA adalimumab (rch) 10mg solution for injection pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216038
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216038

HUMIRA adalimumab (rch) 10mg solution for injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Abbvie Pty Ltd

Postal Address

Locked Bag 5029,BOTANY, NSW, 1455

Australia

ARTG Start Date

24/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. HUMIRA adalimumab (rch) 10mg solution for injection pre-filled syringe

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Rheumatoid Arthritis: Humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients

with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease

who have not received methotrexate.

Humira can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis: - Polyarticular Juvenile Idiopathic Arthritis: Humira in

combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis

in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Humira

can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - Enthesitis-Related

Arthritis: Humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to,

conventional therapy.,Psoriatic Arthritis: Humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural

damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing

Spondylitis: Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn's Disease in adults and Children (6

years and older): Humira is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms of the disease and to

induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or

are intolerant of infliximab.,Ulcerative colitis: Humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had

an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a

clinical response within 8 weeks of treatment to continue treatment beyond that time. (see CLINICAL TRIALS).,Psoriasis in adults and children: Humira is

indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent

patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis

Suppurativa: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an

inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis: Humira is indicated for the treatment of non-infectious

intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid

sparing, or in whom corticosteroid treatment is inappropriate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

2 prefilled syringes

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Aqueous solution practically free from visible particles

Active Ingredients

Public Summary

Page 1 of

Produced at 19.10.2017 at 03:15:52 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Adalimumab

50 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 19.10.2017 at 03:15:52 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Humira Pre-filled

Syringe

Adalimumab (rch)

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

Humira is used for the treatment of:

Rheumatoid arthritis

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.

Polyarticular Juvenile Idiopathic

Arthritis

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.

Enthesitis-related arthritis

Humira is used to treat enthesitis-

related arthritis, an inflammatory

disease of the joints in children.

Psoriatic arthritis

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.

Ankylosing spondylitis

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.

Crohn's Disease

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).

Ulcerative Colitis

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.

Psoriasis

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.

Hidradenitis suppurativa

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 PRE-FILLED SYRINGE 3 OCTOBER 2017

Uveitis

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.

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

You have a severe infection

including infection of the

bloodstream, active tuberculosis

and other infections that can

occur when the body's natural

defences are lowered.

You are already using anakinra

(Kineret) - a medicine for

rheumatoid arthritis.

You have moderate to severe

heart failure.

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 it 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 any of the following

medical conditions:

an infection, including a long-

term or localised infection (for

example, leg ulcer)

a history of recurrent infections or

other conditions that increase the

risk of infections

a history of tuberculosis, or if you

have been in close contact with

someone who has had

tuberculosis

If symptoms of tuberculosis

(persistent-cough, weight loss,

listlessness, mild fever), or any

other infection appear during or

after therapy, tell your doctor

immediately.

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 this medicine. This will

include a thorough medical

history, a chest x-ray and

tuberculin test.

the hepatitis B virus (HBV) if you

are a carrier of, or you have

active HBV or you think you

might be at risk of contracting

HBV.

Humira can cause reactivation of

HBV in people who carry this

virus. In some rare cases,

especially in you are taking other

medicines that suppress the

immune system, reactivation of

HBV can be life threatening.

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.

If you suffer from uveitis, your

doctor may check for signs and

symptoms of neurologic disease

before starting this medicine.

multiple sclerosis a disease of the

nervous system or other

demyelinating disease

allergic reactions such as chest

tightness, wheezing, dizziness,

swelling or rash

blood disorders

low resistance to disease

heart conditions including

congestive heart failure, heart

attack or worsening of existing

heart conditions

cancer or autoimmune disease

a lung disease called chronic

obstructive pulmonary disease

kidney or liver problems

Tell your doctor if you are

scheduled for any vaccines.

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.

HUMIRA PRE-FILLED SYRINGE 3 OCTOBER 2017

Tell your doctor if you are a

psoriasis sufferer who has

undergone phototherapy.

Tell your doctor if you are

pregnant or plan to become

pregnant.

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.

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

get without a prescription from

your pharmacy, supermarket

naturopath or health food shop.

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.

Tell your doctor or pharmacist if

you are taking anakinra (Kineret)

or abatacept (Orencia), other

medicines used to treat some forms

of arthritis.

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.

Tell your doctor or if you are

taking any other medicines to treat

your condition.

How to use Humira

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 unsure.

How much to use

Adults

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 as two injections 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, 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.

Children

The usual dose for children with

polyarticular juvenile idiopathic

arthritis or enthesitis-related arthritis

depends on body weight:

with a body weight of 30kg or

above, the usual dose is 40mg

given fortnightly.

with a body weight of 15kg to

less than 30kg, the recommended

dose is 20mg fortnightly.

with a body weight between 10kg

to less than 15kg, the usual dose

is 10mg fortnightly.

The usual dose for children with

Crohn's disease depends on body

weight and the severity of disease.

Treatment will begin with a larger

dose on day 1 and continue with a

smaller dose every two weeks. Your

doctor will tell you what dose to take

and when. 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:

with a body weight between 40kg

or above, the usual dose is 40mg

given once weekly for the first

two weeks, then fortnightly.

with a body weight of less than

40kg, the usual dose is 20mg

given once weekly for the first

two weeks, then fortnightly.

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.

HUMIRA PRE-FILLED SYRINGE 3 OCTOBER 2017

If Humira has no effect on the child's

condition after 16 weeks, your doctor

may tell you to stop using Humira.

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

or friend after proper training in

injection technique, or your doctor or

his/her assistant.

Instructions for preparing and

giving an injection of Humira if

you are using the Humira Pre-

filled Syringe:

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.

1.

Setting up

Wash your hands thoroughly

Set up the following items on a

clean surface

One pre-filled syringe of Humira

for injection.

One alcohol pad.

Look at the expiry date on the

syringe. Do not use the product

after the month and year shown.

Check the colour has not changed

and that there are no particles in

the solution. If it is cloudy or

discoloured or has flakes or

particles in it, you must not use it.

Do not use it if the solution is

frozen.

2.

Choosing an injection site

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

3.

Preparing an Injection Site

Do not inject in an area where the

skin is tender, reddened, bruised,

or hard. This may mean there is

an infection.

Wipe the injection site with the

enclosed alcohol pad, using a

circular motion.

Do not touch the area again

before injecting.

4.

Injecting Humira

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.

5.

Throwing away supplies

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

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, had you

not forgotten a dose. Do not try to

make up for missed doses by

taking more than one dose at a

time.

If you use too much

(overdose)

If you accidentally inject Humira

more frequently than told to by

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.

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.

HUMIRA PRE-FILLED SYRINGE 3 OCTOBER 2017

Some vaccines, such as oral polio

vaccine, should not be given while

receiving Humira.

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 the surgeon or anaesthetist that

you are using Humira. Your doctor

may recommend temporary

discontinuation of Humira.

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) together.

Do not take Humira and abatacept

(Orencia) together.

Anakinra and abatacept are other

medicines used to treat certain forms

of arthritis.

Things to be careful of

It is important to tell your doctor if

you get symptoms such as fever,

wounds, feeling tired or dental

problems.

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.

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 have any problems while

using Humira, even if you do not

think the problems are connected

with the medicine or are not listed

in this leaflet.

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.

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

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

shortness of breath with exertion

or upon lying down or swelling of

the feet

signs and symptoms suggestive of

blood disorders such as persistent

fever, bruising, bleeding, paleness

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are uncommon.

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,

malaise, wounds, dental

problems, burning on urination

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:

Injection site reactions (including

pain, swelling, redness or itching)

Upper respiratory tract infections

(including cold, runny nose, sinus

infection, sore throat)

Lower respiratory tract infections

(such as bronchitis, pneumonia)

Ear infections

Eye inflammation, inflammation

of the eye lid

Headache, dizziness, vertigo,

sensation disorders

Increased cough, sore throat

Abdominal symptoms such as

nausea, vomiting, abdominal

pain,

Rash, itching

Fatigue

Mouth inflammation and ulcers

Muscle of bone pain

Elevated lipids

Depression, anxiety

Increased heart rate

Viral infections (including the flu,

cold sore blisters, chicken pox

and shingles)

HUMIRA PRE-FILLED SYRINGE 3 OCTOBER 2017

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.

Laboratory results

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.

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.

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.

After using Humira

Storage

Keep your pre-filled syringe in the

pack until it is time to use it.

Keep Humira in a refrigerator

(2°C-8°C). Do not freeze.

Keep Humira in the refrigerator in

a way children cannot get to it.

This is important when travelling by

car, bus, train, plane or any other

form of transport.

Store a pre-filled syringe at room

temperature (below 25°C) for a

maximum period of 14 days,

protected from light.

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.

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 is a clear, colourless, sterile

solution of:

40mg adalimumab in 0.8mL

solution in a syringe (AUST R

199412) and

20mg adalimumab in 0.4mL

solution in a syringe (AUST R

199411)

10mg adalimumab in 0.2mL

solution in a syringe (AUST R

216038)

The following Pre-filled syringe

packs are available:

2 pre-filled syringes with 2

alcohol pads (Humira 10mg,

Humira 20mg and Humira 40mg

pre-filled syringe)

6 pre-filled syringes with 6

alcohol pads (Humira 40mg pre-

filled syringe)

Ingredients

Humira contains adalimumab as the

active ingredient:

It also contains other ingredients

including:

Mannitol

Citric acid monohydrate

Sodium citrate

Monobasic sodium phosphate

dihydrate

Dibasic sodium phosphate

dihydrate

Sodium chloride

Polysorbate 80

Water for injection

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:

October 2017

Australian Registration Numbers:

AUST R 199412

AUST R 199411

AUST R 216038

Version 25

HUMIRA PRE-FILLED SYRINGE 3 OCTOBER 2017

27-7-2018

Pending EC decision:  Hulio, adalimumab, Opinion date: 26-Jul-2018

Pending EC decision: Hulio, adalimumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

1-6-2018

Pending EC decision:  Hyrimoz, adalimumab, Opinion date: 31-May-2018

Pending EC decision: Hyrimoz, adalimumab, Opinion date: 31-May-2018

Europe - EMA - European Medicines Agency

1-6-2018

Pending EC decision:  Hefiya, adalimumab, Opinion date: 31-May-2018

Pending EC decision: Hefiya, adalimumab, Opinion date: 31-May-2018

Europe - EMA - European Medicines Agency

1-6-2018

Pending EC decision:  Halimatoz, adalimumab, Opinion date: 31-May-2018

Pending EC decision: Halimatoz, adalimumab, Opinion date: 31-May-2018

Europe - EMA - European Medicines Agency

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

29-10-2018

Cyltezo (Boehringer Ingelheim International GmbH)

Cyltezo (Boehringer Ingelheim International GmbH)

Cyltezo (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)7251 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4319/IB/05/G

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

19-9-2018

Hulio (Mylan S.A.S.)

Hulio (Mylan S.A.S.)

Hulio (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)6107 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004429/0000

Europe -DG Health and Food Safety

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

19-6-2018

SOLYMBIC (Amgen Europe B.V.)

SOLYMBIC (Amgen Europe B.V.)

SOLYMBIC (Active substance: adalimumab) - Centralised - Withdrawal - Commission Decision (2018)3913 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety