METHOTREXATE

Main information

  • Trade name:
  • METHOTREXATE ACCORD methotrexate 1000mg/10mL injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METHOTREXATE ACCORD methotrexate 1000mg/10mL injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213737
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213737

METHOTREXATE ACCORD methotrexate 1000mg/10mL injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

10/10/2014

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. METHOTREXATE ACCORD methotrexate 1000mg/10mL injection vial

Product Type

Single Medicine Product

Effective date

28/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Antineoplastic chemotherapy - Methotrexate has a broad spectrum of antineoplastic activity. It is indicated for the treatment of breast cancer, gestational

choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Methotrexate may be used in combination with other

chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. It may also be used in the

treatment of Burkitt's lymphoma, advanced stages (III and IV, Peters' Staging System) of lymphosarcoma, especially in children, and in advanced cases

of mycosis fungoides. High dose therapy - In high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of

epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. Calcium folinate (leucovorin calcium) must be used in

conjunction with high dose methotrexate therapy. Psoriasis chemotherapy (see WARNING box) - Methotrexate may be of value in the symptomatic

control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. However, due to the high risk

associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic

consultation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. METHOTREXATE ACCORD methotrexate 1000mg/10mL injection vial

Dosage Form

Injection, solution

Route of Administration

Intraarterial

Intrathecal

Intravenous

Intramuscular

Visual Identification

A yellow to orange clear solution in a glass vial

Active Ingredients

Methotrexate

100 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 1 of

Produced at 26.11.2017 at 10:51:46 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

METHOTREXATE ACCORD INJECTION

Methotrexate Accord 50 mg/2 mL and 1 g/10 mL

CONSUMER MEDICINE INFORMATION

v 2.0

What is in this leaflet

This leaflet answers some common

questions about Methotrexate Accord. 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

being given methotrexate against the

benefits they expect it will 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 Methotrexate Accord

is used for

Methotrexate is used to treat some types

of cancers. It may also be used in severe

psoriasis when these conditions o not

improve with other medicines.

This medicine belongs to a group of

medicines called antineoplastic or

cytotoxic medicines. You may also hear

of these being called chemotherapy

medicines.

This medicine works by blocking an

enzyme needed by body cells to live.

This interferes with the growth of some

cells that are growing rapidly, such as

skin cells in psoriasis and cancer cells.

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 available only with a

doctor’s prescription.

Before you are given

Methotrexate Accord

When you must not be given it

You must not be given Methotrexate

Accord if you have an allergy to:

any medicine containing

methotrexate

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or other

parts of the body; rash, itching, or hives

on the skin.

Females: tell your doctor or

pharmacist if you are pregnant or

intend to become pregnant.

Like most cytotoxic medicines

methotrexate is not recommended for use

during pregnancy. If there is any need to

consider methotrexate during your

pregnancy, your doctor or pharmacist

will discuss with you the benefits and

risks of using it.

Males: tell your doctor or pharmacist

if your partner intends to become

pregnant while you are being given

methotrexate or shortly after you have

stopped treatment with methotrexate.

Methotrexate may cause birth defects if

either the male or female is using it at the

time of conception. It is recommended

that you use some kind of birth control

while you are using methotrexate and for

at least 12 weeks after you stop

treatment. A barrier method of birth

control, such as a condom, should be

used while you are being given

methotrexate and for the first week of this

12-week period. Your doctor will discuss

this with you.

Do not breast-feed if you are being

treated with this medicine.

Methotrexate passes into breast milk and

there is a possibility that your baby may

be affected.

You must not be given this medicine if

you have or have had any of the

following medical conditions:

severe kidney problems

lowered immunity due to diseases

such as HIV/AIDS, or lowered

immunity due to other treatments.

You must not be given this medicine to

treat or psoriasis if you have or have

had any of the following medical

conditions:

any blood disorders, or conditions

which cause a reduced number of red

blood cells, white blood cells, or

platelets

bone marrow disease

anaemia (low iron in the blood)

liver problems

stomach ulcers (peptic ulcer disease)

ulcerative colitis, a condition where

your colon (large bowel) is inflamed

and has ulcers

alcoholism.

You must not be given this medicine if

you are taking acitretin (a medicine to

treat psoriasis and other skin

disorders).

Tell your doctor if you have an

infection or high temperature.

Your doctor may decide to delay your

treatment until the infection has gone. A

mild illness, such as a cold, is not usually

a reason to delay treatment.

If you are not sure whether you should

be given this medicine, talk to your

doctor.

Before you are given 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:

kidney problems

lung problems

diabetes

folate deficiency.

METHOTREXATE ACCORD INJECTION

Methotrexate Accord 50 mg/2 mL and 1 g/10 mL

CONSUMER MEDICINE INFORMATION

v 2.0

If you are taking this medicine to treat

cancer, tell your doctor if you have or

have had any of the following medical

conditions:

any blood disorders, or conditions

that cause a reduced number of red

blood cells, white blood cells, or

platelets

bone marrow disease

anaemia (low iron in the blood)

stomach ulcers (peptic ulcer disease)

liver problems

ulcerative colitis, a condition where

your colon (large bowel) is inflamed

and has ulcers.

If you have not told your doctor about

any of the above, tell him/her before

you start being given Methotrexate

Accord.

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 or health food shop.

Some medicines and methotrexate may

interfere with each other. These include:

some antibiotics, including

tetracyclines, penicillins,

sulphonamides, trimethoprim and

chloramphenicol

sulphonylureas, a group of medicines

used to treat diabetes

phenytoin, a medicine used to treat

epilepsy

folic acid or folinic acid (which may

be present in multi-vitamin

preparations)

non-steroidal anti-inflammatory

medicines (NSAIDs) and salicylates,

medicines used to relieve pain,

swelling and other symptoms of

inflammation (such as aspirin,

diclofenac, indomethacin,

ketoprofen, naproxen,

phenylbutazone)

allopurinol and probenicid,

medicines used to treat gout

theophylline, a medicine used to

relieve asthma

cholestyramine, a medicine used to

lower high cholesterol

amiodarone, a medicine used to treat

heart disorders

other medicines used to treat cancer

(such as cisplatin, asparaginase,

mercaptopurine)

medicines which can affect the liver

such as azathioprine, leflunomide,

retinoids or sulfasalazine

pyrimethamine, a medicine used for

malaria

proton pump inhibitors, such as

omeprazole, pantoprazole

methoxsalen (a medicine used with

ultraviolet light in PUVA therapy for

conditions such as severe psoriasis).

Methotrexate Accord can also be affected

by the following:

• blood transfusions

• nitrous oxide anaesthetics

• vaccinations

These medicines may be affected by

methotrexate, or may affect how well it

works. You may need different amounts

of your medicines, or you may need to

take different medicines.

How Methotrexate Accord

is given

How much is given

Your doctor will decide what dose of

methotrexate you will receive. This

depends on your condition and other

factors, such as your weight, and other

medicines you are being given.

This medicine may be given alone or in

combination with other drugs. It may be

given as a short course or on an ongoing

basis.

Additional treatment may not be repeated

until your blood cell numbers return to

acceptable levels and any unwanted

effects have been controlled.

For cancer treatment, several courses of

methotrexate therapy may be needed

depending on your response to treatment.

For the treatment of psoriasis,

methotrexate therapy is usually required

long term.

Ask your doctor if you want to know

more about the dose of Methotrexate

Accord you receive.

How it is given

Methotrexate Accord may be given as an

injection into a muscle, a vein, an artery

or into the spine.

Methotrexate Accord must only be given

by a doctor or nurse.

If you have too much (overdose)

Immediately telephone your doctor or

the Poisons Information Centre

(telephone 13 11 26 in Australia) for

advice, or go to Accident and

Emergency at your nearest hospital, if

you think you or anyone else may have

taken too much Methotrexate. Do this

even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention.

Symptoms of a methotrexate overdose

may include the side effects listed below

in the ‘Side Effects’ section, but are

usually of a more severe nature. They

may include blood in your bowel motions

or black, tarry bowel motions, bleeding,

nausea, vomiting, mouth ulcers and

severe infections.

While you are being given

Methotrexate Accord

Things you must do

If you are about to be started on any

new medicine, remind your doctor and

pharmacist that you are being given

methotrexate.

Tell any other doctors, dentists, and

pharmacists who are treating you that

you are being given this medicine.

METHOTREXATE ACCORD INJECTION

Methotrexate Accord 50 mg/2 mL and 1 g/10 mL

CONSUMER MEDICINE INFORMATION

v 2.0

If you are going to have surgery, tell

the surgeon, anaesthetist or dentist

that you are taking this medicine.

It may affect other medicines used during

surgery.

Keep all of your doctor’s appointments

so your progress can be checked.

Your doctor may want to check your

blood pressure and do some blood and

other tests from time to time to check on

your progress and to check for any

unwanted side effects.

Be careful to use an effective method of

birth control while you are being

treated with methotrexate and for at

least 12 weeks after stopping

treatment.

A barrier method of birth control, such as

a condom, should be used. Your doctor

will tell you what forms of contraception

are suitable and when it is safe to stop

using contraception if you wish to do so.

If you or your partner becomes

pregnant while you are being treated

with methotrexate, or for up to 12

weeks afterwards, tell your doctor

immediately.

Protect your skin when you are in the

sun, especially between 10am and 3pm.

If outdoors, wear protective clothing

and use a 15+ (minimum) sunscreen.

Avoid exposure to sunlamps.

Methotrexate may cause your skin to be

much more sensitive to sunlight than it is

normally. Exposure to sunlight may

cause a skin rash, itching, redness, or a

severe sunburn.

Discuss with your doctor how much

water or fluids you should have whilst

you are being given this medicine.

Inadequate fluid intake can increase the

side effects of this medicine.

Ask your doctor if there are any

precautions you need to take to

prevent your urine becoming too

acidic.

Acidic urine can increase the side effects

of this medicine.

Methotrexate can lower the number of

white blood cells and platelets in your

blood. This means that you have an

increased chance of getting an infection

or bleeding. The following precautions

should be taken to reduce your risk of

infection or bleeding:

Avoid people who have infections.

Check with your doctor immediately

if you think you may be getting an

infection, or if you get a fever, chills,

cough, hoarse throat, lower back or

side pain or find it painful or difficult

to urinate.

Be careful when using a toothbrush,

toothpick or dental floss. Your

doctor, dentist, nurse or pharmacist

may recommend other ways to clean

your teeth and gums. Check with

your doctor before having any dental

work.

Be careful not to cut yourself when

you are using sharp objects such as a

razor or nail cutters.

Avoid contact sports or other

situations where you may bruise or

get injured

Methotrexate may be excreted in body

fluids and waste, including blood, urine,

faeces, vomitus and semen. In general,

precautions to protect other people should

be taken while you are receiving

methotrexate and for one week after the

treatment period by:

Flushing the toilet twice to dispose

of any body fluids and waste.

Wearing gloves to clean any spill of

body fluid or waste. Use paper

towels or old rags, a strong solution

of non-bleaching detergent and large

amounts of water to mop up the spill.

Discard the towels or rags into a

separate waste bag and dispose of

fluids in the toilet.

Washing linen or clothing that is

heavily contaminated by body fluids

or waste separately from other items.

Use a strong solution of non-

bleaching detergent and large

amounts of water.

Placing soiled disposable nappies

and other pads in a plastic bag, seal

and dispose into the garbage.

For sexual intercourse, use a barrier

method such as a condom.

Things you must not do

You must not drink alcohol whilst you

are being given this medicine.

Alcohol may increase the side effects of

methotrexate.

Things to be careful of

Be careful driving or operating

machinery until you know how

methotrexate affects you.

This medicine may cause dizziness,

drowsiness or tiredness in some people. If

you have any of these symptoms, do not

drive, operate machinery or do anything

else that could be dangerous.

Side effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

you are being given methotrexate.

This medicine may have unwanted side

effects. 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.

If you are over 65 years of age you may

have an increased chance of getting side

effects.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

Ask your doctor, nurse or pharmacist

to answer any questions you may have.

Tell your doctor, pharmacist or nurse

if you notice any of the following and

they worry you:

mild nausea

stomach pains

mild tiredness

mild chills

mild dizziness

drowsiness

increased burning of the skin from

sun exposure

METHOTREXATE ACCORD INJECTION

Methotrexate Accord 50 mg/2 mL and 1 g/10 mL

CONSUMER MEDICINE INFORMATION

v 2.0

hair loss (usually occurs only with

high doses of methotrexate)

inflamed mouth gums

inflamed mucous membranes

(mucositis) or sore mouth

loss of appetite

changes in menstrual cycle unusual

vaginal discharge

mild headaches

ringing in the ears

eye discomfort.

The above list includes side effects which

are usually mild or short-lived.

Tell your doctor or nurse as soon as

possible if you notice any of the

following:

diarrhoea

vomiting

mouth ulcers

skin rash, itchiness

difficulty speaking

back pain

stiff neck

painful joints or muscles

irritability and confusion

altered conscious state

painful urination or difficulty

urinating, lower back or side pain

(these may be symptoms of kidney

disease)

swelling of hands, ankles or feet

muscle cramps, spasms, weakness or

paralysis

blurred vision or impaired vision.

The above list includes serious side

effects, which may require medical

attention.

If any of the following happen, tell

your doctor or nurse immediately, or

go to Accident and Emergency at your

nearest hospital:

severe abdominal pain, or diarrhoea

nausea or vomiting, especially

vomiting blood

an increased tendency to bleed,

unusual bruising or get infections

rash, redness, hives, itching, pinpoint

red spots or painful blistering

resulting in peeling of layers of the

skin

lighter patches on the skin, yellowing

of the skin/eyes (jaundice)

severe blisters and bleeding in the

lips, eyes, mouth, nose and genitals

(Stevens-Johnson syndrome)

The above list includes very serious side

effects. You may need urgent medical

attention or hospitalisation.

Tell your doctor, nurse or pharmacist

if you notice anything that is making

you feel unwell.

Other side effects not listed above may

occur in some people. Some of these side

effects can only be found when your

doctor does tests from time to time to

check your progress.

The benefits and side effects of

methotrexate may take some time to

occur. Therefore, even after you have

finished your methotrexate treatment you

should tell your doctor immediately if

you notice any of the side effects listed in

this section.

After you have been given

Methotrexate Accord

Storage

Methotrexate Accord will be stored in the

pharmacy, doctor’s surgery or on the

ward. The injection is kept in a cool dry

place, protected from light, where the

temperature stays below 25°C.

Product description

What it looks like

Methotrexate Accord is a clear yellow to

orange liquid in glass vials.

Ingredients

Methotrexate Accord contains

methotrexate as the active ingredient. It

also contains:

water for injections

sodium hydroxide (added for pH

adjustment only)

sodium chloride. (Note: Sodium Chloride

is only in the 50mg/2mL strength of

Methotrexate Accord. Sodium Chloride is

not added to the 1g/10mL strength)

This medicine does not contain lactose,

sucrose, gluten, tartrazine or any other

azo dyes.

Methotrexate Accord comes in the

following strengths and pack sizes:

Strength

Pack Size

50 mg/2 mL

1 x 2 mL vial

(AUST R 213736)

1 g/10 mL

1 x 10 mL vial

(AUST R 213737)

Name and address of Sponsor

Accord Healthcare Pty Ltd

Lvl 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Date of preparation

This leaflet was prepared on 25

November 2016.

29-6-2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

Therapeutic Goods Administration - Australia

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

Danish Medicines Agency

24-5-2018

Jylamvo (Therakind Ltd)

Jylamvo (Therakind Ltd)

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Nordimet (Nordic Group B.V.)

Nordimet (Nordic Group B.V.)

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