INFLECTRA

Main information

  • Trade name:
  • INFLECTRA infliximab (rmc) 100mg Powder for Injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INFLECTRA infliximab (rmc) 100mg Powder for Injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217066
  • Last update:
  • 09-10-2017

Patient Information leaflet

INFLECTRA™

infliximab [rmc] (in-FLIX-i-MAB)

_________________________________________________________________________________

Consumer Medicine Information

Date of dispensing

Consumer name

pharmacy name

Consumer address

pharmacy address

What is in this

leaflet

This leaflet answers some

common questions about

INFLECTRA™. 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 INFLECTRA™

against the benefits it is

expected to have for you.

If you have any concerns

about being given this

medicine, ask your doctor

or pharmacist.

Keep this leaflet.

You may need to read it

again.

What

INFLECTRA™ is

used for

INFLECTRA™ contains the

active ingredient, infliximab.

INFLECTRA™ is an

approved biosimilar

medicine. Comparability in

safety, efficacy and quality

between INFLECTRA™ and

the reference product has

been established.

Infliximab is a monoclonal

antibody that is produced

from human and mouse

proteins by recombinant

technology. Monoclonal

antibodies are proteins that

recognise and bind to

certain special proteins in

the body.

Infliximab acts by binding to

a special protein in the body

called tumour necrosis

factor alpha (TNFα). In

people with diseases such

as Crohn's disease,

ulcerative colitis, rheumatoid

arthritis, ankylosing

spondylitis, psoriatic arthritis

and psoriasis, the body

produces too much TNFα,

which can cause the body's

immune system to attack

normal healthy parts of the

body.

INFLECTRA™ can block

the damage caused by too

much TNFα.

Rheumatoid arthritis

Rheumatoid arthritis is an

inflammatory disease of the

joints. INFLECTRA™ is

used to reduce the signs

and symptoms of

rheumatoid arthritis and to

prevent damage to the

joints. You will also be given

a disease-modifying

medicine called

methotrexate.

Ankylosing Spondylitis

Ankylosing spondylitis is an

inflammatory disease of the

spine. INFLECTRA™ can

reduce the signs and

symptoms of ankylosing

spondylitis, thereby

improving physical function.

Psoriatic arthritis

Psoriatic arthritis is an

inflammatory disease of the

joints in which psoriasis

usually occurs in association

with arthritis. Often the

fingers and toes are

affected, although it may

occur in other parts of the

body. INFLECTRA™ is

used to reduce the signs

and symptoms of psoriatic

arthritis and improve the

physical function in adults

who have not responded

well enough to previous

treatments with other

disease-modifying anti-

rheumatic drugs

(DMARDS). INFLECTRA™

may be given alone or in

combination with

methotrexate.

Psoriasis

Psoriasis is an inflammatory

disease of the skin.

INFLECTRA™ is used to

treat patients with moderate

to severe psoriasis who

have not responded well

enough to treatments such

as phototherapy or

conventional systemic

treatments, or when these

treatments are not

appropriate.

Crohn's disease

Crohn's disease is a chronic

inflammatory disease of the

bowel. It may also affect any

part of the gut.

Page 1 of 6

INFLECTRA™ is used to

treat moderate to severe

Crohn's disease in adult

patients and in children and

adolescent patients (6 to 17

years old) who have not

responded well enough to

other treatments.

INFLECTRA™ can also

reduce the number of

abnormal openings from the

bowel through the skin

(called draining

enterocutaneous fistula), a

common complication of

Crohn's disease.

Ulcerative Colitis

Ulcerative colitis is an

inflammatory disease of the

bowel. INFLECTRA™ is

used to treat the signs and

symptoms of ulcerative

colitis in adult patients and

in children and adolescent

patients (6 to 17 years old)

who have not responded

well enough to other

treatments.

Do not give INFLECTRA™

to children with Crohn's

disease or ulcerative

colitis who are younger

than 6 years.

Do not give INFLECTRA™

to children and

adolescents with any

other disease.

Your doctor, however, may

prescribe INFLECTRA™ for

another purpose.

Ask your doctor if you

have any questions about

why INFLECTRA™ has

been prescribed for you.

Before you are

given

INFLECTRA™

When you must not be

given it

Do not use INFLECTRA™

if you have an allergy to

mouse proteins or any of

the ingredients listed at

the end of this leaflet.

Some of the symptoms of

an allergic reaction to

INFLECTRA™ may include

skin rash, hives, fatigue,

wheezing, difficulty in

breathing, and/or low blood

pressure.

Do not use INFLECTRA™

if you have severe

infections such as

tuberculosis and infected

abscesses, a repeating

infection or have had

repeating infections.

Do not use INFLECTRA™

if you are already taking

another medicine for

arthritis, which contains

the substance called

anakinra.

If you have never been

given INFLECTRA™ and

have congestive heart

failure, you should not use

Before you are given it

Tell your doctor if you:

currently have an

infection, or if you are

prone to infections, or

if you have a history

of infections

INFLECTRA™ may affect

the normal immune

response. You might get

infections more easily.

Some cases of serious

infections, including

tuberculosis (TB) and sepsis

have been reported in

patients treated with

INFLECTRA™.

have ever had or

been in close contact

with TB, even if you

were treated for it.

have ever had or had

been in close contact

with hepatitis B

Reactivation of hepatitis B

have been reported in

people treated with TNFα

blockers. However, these

reports are very rare.

have lived in or

travelled to an area

where fungal

infections called

histoplasmosis,

coccidioidomycosis,

or blastomycosis are

common. Ask your

doctor if you don't

know if these

infections are

common in the area

in which you have

lived in or travelled

to.

These infections are caused

by fungus that can affect the

lungs or other parts of your

body.

have had cancer

A type of blood cancer

called lymphoma has been

reported in patients

receiving TNF blockers. The

reports are rare but are

more frequent than

expected for people in

general. Cancers, other than

lymphoma, have also been

reported.

have a long history of

Crohn's disease

rheumatoid arthritis,

ankylosing spondilitis

or psoriatic arthritis,

especially if you have

a highly active

disease and/or have

been taking medicine

that reduces the

activity of the body's

natural defences.

You may be more likely to

develop infections and

lymphomas than people in

general, even without

receiving TNF blockers

such as INFLECTRA™.

are pregnant or plan

to become pregnant

Page 2 of 6

Like most medicines,

INFLECTRA™ is not

recommended in pregnancy.

You must use adequate

contraception to avoid

falling pregnant.

are breast-feeding

Like most medicines,

INFLECTRA™ is not

recommended while breast-

feeding. It is not known

whether INFLECTRA™

passes into breastmilk.

have or have had a

disease that affects

the nervous system

such as multiple

sclerosis and

seizures, or if you

experience any

numbness, weakness,

tingling, or sight

disturbances.

suffer from congestive

heart failure.

Steps must be taken to

monitor any changes to your

condition during treatment

with INFLECTRA™.

have ongoing blood

disorders or a history

of blood disorders.

are scheduled to

receive any vaccines

Patients receiving

INFLECTRA™ should not

receive some types of

vaccines.

Your doctor will discuss with

you the benefits of using

INFLECTRA™ against the

potential risks.

Taking or being given

other medicines

Tell your doctor if you are

taking any other

medicines, including any

that you buy without a

prescription from your

pharmacy, supermarket or

health food shop.

Some medicines may affect

the way other medicines

work.

Do not use INFLECTRA™

if you are already taking

another medicine for

arthritis, which contains

the substance anakinra.

Tell your doctor if you are

already taking another

medicine for arthritis which

contains the substance call

abatacept.

Tell your doctor if you are

receiving other treatments

for rheumatoid

arthritis

for ankylosing

spondilitis

for psoriatic arthritis

for psoriasis, such as

phototherapy or other

treatments for Crohn’s

disease or ulcerative

collitis

to prevent rejection in

organ transplantation.

Tell your doctor you are

taking INFLECTRA™

before receiving any

vaccinations. Some

vaccinations should not

be given while you are

being treated with

INFLECTRA™.

Your doctor or pharmacist

will be able to tell you what

to do when being given

INFLECTRA™ with other

medicines.

How INFLECTRA™

is given

INFLECTRA™ is only

available on prescription.

INFLECTRA™ is given in a

drip into a vein (called an

infusion) over at least 2

hours.

If you were able to tolerate

the first 3 two-hour

infusions, your doctor may

decide to give your next

INFLECTRA™ infusions

over a period of not less

than 1 hour.

For children and

adolescents (6-17 years) the

infusion is given over at

least 2 hours.

A period of observation

follows treatment.

Rheumatoid arthritis

The recommended starting

dose is an infusion of 3

mg/kg. You will get

additional doses of 3 mg/kg

at 2 and 6 weeks after your

first infusion and then every

8 weeks after that.

If, after 12 weeks of

treatment, your arthritis

does not respond well

enough to the 3 mg/kg dose,

your doctor may decide to

gradually increase your

dose to a maximum of 7.5

mg/kg every 8 weeks.

You will also be taking

methotrexate as part of your

treatment.

Ankylosing Spondylitis

The recommended starting

dose is an infusion of 5

mg/kg. You will get

additional doses of 5 mg/kg

at 2 and 6 weeks after your

first infusion and then every

6 weeks after that.

Psoriatic arthritis

The recommended starting

dose is an infusion of 5

mg/kg. You will receive

additional doses of 5 mg/kg

at 2 and 6 weeks after your

first infusion, then every 8

weeks after that.

INFLECTRA™ may be

given alone or in

Page 3 of 6

combination with

methotrexate.

Psoriasis

The recommended starting

dose is an infusion of 5

mg/kg. You will get

additional doses of 5 mg/kg

at 2 and 6 weeks after your

first infusion, and then every

8 weeks after that.

Crohn's disease

The recommended starting

dose for Crohn's disease in

adults and in children and

adolescents (6 to 17 years);

and for closure of fistula in

adult patients is an initial

infusion of 5 mg/kg followed

by additional doses of 5

mg/kg at 2 and 6 weeks

after your first infusion, and

then every 8 weeks after

that. In some cases, your

doctor may decide to

increase your dose up to 10

mg/kg.

Ulcerative colitis

The recommended starting

dose for ulcerative colitis in

adults and in children and

adolescents (6 to 17 years)

is an infusion of 5 mg/kg.

You will get additional doses

of 5 mg/kg at 2 and 6 weeks

after your first infusion, and

then every 8 weeks after

that.

While you are

being given

INFLECTRA™

Things you must do

Tell your doctor, nurse or

pharmacist if the medicine

starts to upset you or your

symptoms become worse.

Tell your doctor or dentist

that you are being treated

with INFLECTRA™ before

you undergo any surgical

procedures.

Tell your doctor:

if symptoms of TB

(persistent cough,

weight loss,

listlessness, fever), or

any other infection

appear. Do this

immediately.

if symptoms of

hepatitis B (upset

stomach, loss of

appetite, vomiting,

tiredness, dark yellow

or brown urine, and

yellow eyes or skin)

appear. You must do

this immediately.

that you are taking

INFLECTRA™ before

receiving any

vaccinations.

Some vaccinations should

not be given while you are

being treated with

INFLECTRA™.

You should continue to

take adequate

contraceptive measures to

avoid pregnancy.

Your doctor will also advise

you not to breastfeed.

Things to be careful of

Tell your doctor if you

think you have an

infection.

INFLECTRA™ may affect

the normal immune

response. There is a

possibility that you may be

more prone to infections.

You will be watched closely

for signs of infection.

Tell your doctor

immediately if you

develop a skin rash or

hives.

Your doctor may discontinue

INFLECTRA™ until the

symptoms go away and

then begin giving the

medicine again. Symptoms

will resolve with appropriate

treatment.

If you suffer from

congestive heart failure,

tell your doctor

immediately if your

condition worsens.

INFLECTRA™ is unlikely to

make you drowsy. If you are

tired, do not drive a car or

work with machinery.

Side effects

Tell your doctor, nurse, or

pharmacist as soon as

possible if you do not feel

well while you are being

given INFLECTRA™.

All medicines can have side

effects. Sometimes they are

serious, most of the time

they are not. You may need

medical treatment if you get

some of the side effects.

Generally, patients with

rheumatoid arthritis, Crohn's

disease, ankylosing

spondylitis, psoriatic

arthritis, or psoriasis already

take several medicines to

treat their disease.

These medicines may

themselves cause side

effects.

If you get additional side

effects or any new

symptoms, please tell

your doctor.

Ask your doctor or

pharmacist to answer any

questions you may have.

Do not be alarmed by the

following list of possible side

effects. You may not

experience any of them.

During the infusion of

INFLECTRA™ the following

reactions may occur:

Page 4 of 6

fever or chills

itchiness or hives

chest pain

low blood pressure

high blood pressure

shortness of breath

These reactions are more

likely to occur during the first

and second infusion but

may also appear up to six

months after the last

infusion.

Tell your doctor

immediately if you notice

any of the following:

pain or tenderness in

chest,muscles, joints or

swelling of the hands,

feet,ankles, face, lips,

mouth or throat,which

may cause difficulty

inswallowing or

breathing

fever

muscle pains

joint pains

tiredness

abnormal chest sounds

rash

itching

symptoms that may

indicate heart failure,

e.g. shortness of breath,

especially with exercise

or lying down, or

swelling of your feet.

Tell your doctor or nurse

as soon as possible if you

notice any of the

following:

headache

nausea or vomiting

dizziness and light-

headedness

fatigue

fever

rash

hives

itching

sore throat

coughing

hoarseness

shortness of breath

chest pain

back pain

muscle pain

abdominal pain

indigestion

diarrhoea

weight loss, muscle

wasting

problems with urination

changes in the way

your heart beats, for

example, if you notice it

beating faster

flushing

dry skin or increased

sweating

fluid retention

new onset of psoriasis,

mainly on the soles of

the feet and on palms

worsening of

rheumatoid arthritis.

There have been very rare

cases where people taking

INFLECTRA™ have

developed liver problems.

Signs that you could be

having a problem include:

jaundice (skin and eyes

turning

yellow)

dark-brown coloured

urine

right-sided abdominal

pain

fever

severe fatigue

(tiredness).

You should contact your

doctor immediately if you

develop any of these

symptoms.

Tell your doctor if you

notice any other effects.

Most of the side effects are

mild to moderate in severity.

Other side effects not listed

above may also occur in

some patients. Some side

effects may appear up to six

months after the last

infusion.

Cancers

In clinical studies, more

cancers were seen in

patients who received TNF-

blockers, including

INFLECTRA™, than

patients who did not receive

these treatments.

In children and adults being

treated with TNF-blockers,

the chances of getting

lymphoma or other cancers

may increase. It should be

noted, however, that

patients with

longstanding and active

rheumatoid arthritis or

Crohn's disease may

already have a higher risk

for developing cancers even

without TNF-blockers,

making it difficult to estimate

the risk of developing

cancers in these patients.

Nevertheless, the role of

TNFblockers in the

development of cancers

cannot be excluded.

A rare type of cancer called

Hepatosplenic T-cell

Lymphoma (HSTCL) has

been reported rarely in

adolescents and young

adults with Crohn's disease

or ulcerative colitis who

have received

INFLECTRA™. All of these

patients were also receiving

drugs known as

azathioprine or 6-

mercaptopurine. No cases

of HSTCL have been

reported in patients

receiving INFLECTRA™

only. HSTCL often results in

death. The role of TNF

blockers in the development

of cancers in children and

adolescents remain unclear.

Talk to your doctor if you

are concerned about this.

Skin cancers (melanoma,

Merkel cell carcinoma, basal

cell carcinoma and

squamous cell carcinoma)

Page 5 of 6

have been reported rarely in

patients treated with

TNFblockers, including

INFLECTRA™.

Tell your doctor if you

notice any new skin

lesions during or after

therapy or if existing

lesions change

appearance.

Patients with a lung disease

called Chronic Obstructive

Pulmonary Disease and

who have a history of heavy

smoking may have an

increased risk for getting

cancer while being treated

with INFLECTRA™.

After

INFLECTRA™ has

been stopped

Tell your doctor

immediately if:

you notice any of the

following side effects,

even if they occur

several weeks after

stopping treatment

with INFLECTRA™.

skin rash or hives

frequent infections

symptoms of TB

(persistent cough,

weight loss,

listlessness, fever), or

any other infection

appear.

symptoms of

hepatitis B (upset

stomach, loss of

appetite, vomiting,

tiredness, dark yellow

or brown urine, and

yellow eyes or skin)

appear.

These symptoms may

appear several months after

your last INFLECTRA™

treatment.

You should continue to

take adequate

contraceptive measures to

avoid pregnancy for at

least 6 months after the

last infusion of

INFLECTRA™.

Your doctor will advise you

not to breastfeed for at least

6 months after your last

infusion of INFLECTRA™.

Tell your doctor if you

notice any other effects.

Storage

INFLECTRA™ should be

stored at 2°C to 8°C

(Refrigerate.) Do not use

beyond the expiry date.

INFLECTRA™ vials are for

single use only. Any unused

portion should be discarded.

Product

description

What it looks like

INFLECTRA™ comes as a

white powder in a glass vial.

Ingredients

Active ingredient:

Infliximab [rmc] 100 mg per

vial

Inactive ingredients:

sodium phosphate

monobasic

monohydrate

sodium phosphate

dibasic dihydrate

sucrose

polysorbate 80

Sponsor

Hospira Pty Ltd

ABN 13 107 058 328

Level 3 500 Collins St

Melbourne

VIC 3000

Australian Registration

Number

AUST R 217066

Date of Preparation:

September 2015

Page 6 of 6

1-8-2018

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Pfizer Europe MA EEIG)

Inflectra (Active substance: Infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5206 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2778/T/64

Europe -DG Health and Food Safety

23-5-2018

Zessly (Sandoz GmbH)

Zessly (Sandoz GmbH)

Zessly (Active substance: infliximab) - Centralised - Authorisation - Commission Decision (2018)3215 of Wed, 23 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4647

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

15-5-2018

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Active substance: infliximab) - Centralised - Yearly update - Commission Decision (2018)3056 of Tue, 15 May 2018

Europe -DG Health and Food Safety

3-5-2018

Remsima (Celltrion Healthcare Hungary Kft.)

Remsima (Celltrion Healthcare Hungary Kft.)

Remsima (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)2769 of Thu, 03 May 2018

Europe -DG Health and Food Safety

23-3-2018

Pending EC decision:  Zessly, infliximab, Opinion date: 22-Mar-2018

Pending EC decision: Zessly, infliximab, Opinion date: 22-Mar-2018

Europe - EMA - European Medicines Agency