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METHOTREXATE 30 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE

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PATIENT INFORMATION LEAFLET

2859, 2860,2861,2862,2863
19.08.17[5]

Metoject® PEN 17.5 mg solution for injection
in pre-filled pen
Metoject® PEN 20 mg solution for injection in
pre-filled pen
Metoject® PEN 22.5 mg solution for injection
in pre-filled pen
Metoject® PEN 25 mg solution for injection in
pre-filled pen
Metoject® PEN 30 mg solution for injection in
pre-filled pen
(methotrexate)
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is available using any of above names but will be referred
to as Metoject PEN throughout the leaflet. Metoject PEN is also available
in strengths other than those listed in Section 6.
What is in this leaflet
1. What Metoject PEN is and what it is used for
2. What you need to know before you use Metoject PEN
3. How to use Metoject PEN
4. Possible side effects
5. How to store Metoject PEN
6. Contents of the pack and other information
1. What Metoject PEN is and what it is used for
Metoject PEN is indicated for the treatment of
 active rheumatoid arthritis in adult patients.
 polyarthritic forms of severe, active juvenile idiopathic arthritis, when the
response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been
inadequate,
 severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such as phototherapy, PUVA, and
retinoids, and severe psoriatic arthritis in adult patients,
 mild to moderate Crohn’s disease in adult patients when adequate
treatment with other medicines is not possible.
Rheumatoid arthritis (RA) is a chronic collagen disease, characterised
by inflammation of the synovial membranes (joint membranes). These
membranes produce a fluid which acts as a lubricant for many joints. The
inflammation causes thickening of the membrane and swelling of the joint.
Juvenile arthritis concerns children and adolescents less than 16 years.
Polyarthritic forms are indicated if 5 or more joints are affected within the
first 6 months of the disease.
Psoriasis is a common chronic skin disease, characterised by red
patches covered by thick, dry, silvery, adherent scales.
Psoriatic arthritis is a kind of arthritis with psoriatric lesions of the skin
and nails, especially at the joints of fingers and toes.
Metoject PEN modifies and slows down the progression of the disease.
Crohn’s disease is a type of inflammatory bowel disease that may affect
any part of the gastrointestinal tract causing symptoms such as
abdominal pain, diarrhoea, vomiting or weight loss.
2. What you need to know before you use Metoject PEN
Do not use Metoject PEN if you
 are allergic to methotrexate or any of the other ingredients of this
medicine (listed in section 6).
 suffer from liver or severe kidney diseases or blood diseases.
 regularly drink large amounts of alcohol.
 suffer from a severe infection, such as tuberculosis, HIV or other
immunodeficiency syndromes.
 suffer from mouth ulcers, stomach ulcer or intestinal ulcer.
 are pregnant or breast-feeding.
 receive vaccinations with live vaccines at the same time.
Warnings and precautions
Talk to your doctor or pharmacist before taking Metoject PEN if you:
 are elderly or if you feel generally unwell and weak.
 have problems with the way your liver works.
 suffer from dehydration (water loss).

Diarrhoea can be a possible side effect of Metoject PEN and requires an
interruption of therapy. If you suffer from diarrhoea please speak to your
doctor.
Certain brain disorders (encephalopathy/leukoencephalopathy) have
been reported in cancer patients receiving methotrexate. Such side
effects cannot be excluded when methotrexate is used to treat other
diseases.
Other medicines and Metoject PEN
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Please note that this also applies to
medicines that you will take in the future.
The effect of the treatment may be affected if Metoject PEN is
administered at the same time as certain other medicines:
 Antibiotics such as: tetracyclines, chloramphenicol, non-absorbable
broad-spectrum antibiotics, penicillines, glycopeptides, sulphonamides,
ciprofloxacin and cefalotin (medicines to prevent/fight certain infections).
 Non-steroidal anti-inflammatory drugs or salicylates (medicines
against pain and/or inflammation such as acetylsalicylic acid, diclofenac
and ibuprofen or pyrazole).
 Probenecid (medicine against gout).
 Weak organic acids like loop diuretics (“water tablets”).
 Medicines, which may have adverse effects on the bone marrow, such
as trimethoprim-sulphamethoxazole (an antibiotic) and pyrimethamine.
 Other medicines used to treat rheumatoid arthritis such as
leflunomide, sulphasalazine and azathioprine.
 Mercaptopurine (a cytostatic agent).
 Retinoids (medicine against psoriasis and other dermatological
diseases).
 Theophylline (medicine against bronchial asthma and other lung
diseases).
 Some medicines against stomach trouble such as omeprazole and
pantoprazole.
 Hypoglycaemics (medicines that are used to lower the blood sugar).

Additional information
The manner of handling and throwing away of the medicine and pre-filled
pen must be in accordance with local requirements. Pregnant healthcare
personnel should not handle and/or administer Metoject PEN.
Methotrexate should not come into contact with the surface of the skin or
mucosa. In the event of contamination, the affected area must be rinsed
immediately with plenty of water.
What you need in order to administer your injection using the
Metoject PEN pre-filled pen
You need:
 1 Metoject PEN pre-filled pen
 1 alcohol pad
Metoject PEN pre-filled pen components:

Vitamins containing folic acid may impair the effect of your treatment and
should only be taken when advised by your doctor.

a)

With cap before injection

Vaccination with live vaccine must be avoided.

b)

After cap removal before injection

Metoject PEN with food, drink and alcohol
Alcohol as well as large amounts of coffee, caffeine-containing soft drinks
and black tea should be avoided during treatment with Metoject PEN.

c)

After injection

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Do not use Metoject PEN during pregnancy. There is a risk of harm to the
foetus and miscarriage. Men and women should use an effective method
of birth control during treatment and during a further six months after
treatment with Metoject PEN has been discontinued.
In women of child-bearing age, any existing pregnancy must be excluded
with certainty by taking appropriate measures, such as pregnancy test,
prior to therapy.
As methotrexate can be genotoxic, all women who wish to become
pregnant are advised to consult a genetic counselling centre, if possible,
already prior to therapy. Men should seek advice about the possibility of
sperm preservation before starting therapy.
Stop breast-feeding prior to and during treatment with Metoject PEN.

What you need to do before administering your injection
1. Wash your hands very carefully.
2. Remove the system from its packaging.
3. Check the Metoject PEN pre-filled pen before using it:
If the Metoject PEN pre-filled pen appears
to be damaged do not use it. Use
another one and contact your doctor,
pharmacist or nurse.
In case a small air bubble is visible
through the transparent control zone, this
will not affect your dose nor will it harm
you.

Driving and using machines
Treatment with Metoject PEN may cause adverse reactions affecting the
central nervous system, such as tiredness and dizziness. Thus the ability
to drive a vehicle and/or to operate machines may, in certain cases, be
compromised. If you feel tired or drowsy do not drive or use machines.
Metoject PEN contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose;
i.e. essentially “sodium-free”.

If you are not able to see or to check the
system correctly prior to injection, ask
someone around you for assistance.
4. Set the Metoject PEN pre-filled pen on a clean flat surface (such as a
table).
Where you should administer the injection

3. How to use Metoject PEN
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Your doctor decides on the dose, which is adjusted individually to you.
Usually it takes 4 – 8 weeks before there is any effect of the treatment.
Metoject PEN is administered subcutaneously (under the skin) by or
under the supervision of a physician or healthcare staff as an injection
once a week only. Together with your doctor you decide on a suitable
weekday each week on which you receive your injection.
Use in children and adolescents
The doctor decides on the appropriate dose in children and adolescents
with polyarthritic forms of juvenile idiopathic arthritis.
Metoject PEN is not recommended in children less than 3 years of
age due to insufficient experience in this age group.

Recommended follow-up examinations and safety measures:
Even when Metoject PEN is administered in low doses, severe side
effects can occur. In order to detect them in time, check-ups and
laboratory tests have to be carried out by your doctor.

Method and duration of administration
Metoject PEN is injected once weekly!
The duration of the treatment is determined by the treating physician.
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis
vulgaris, psoriatic arthritis and Crohn’s disease with Metoject PEN is a
long-term treatment.

Before therapy:
Before starting the treatment, blood samples will be taken in order to check
that you have enough blood cells, tests to check your liver function, serum
albumin (a protein in the blood) and kidney function. Your doctor will also
check if you suffer from tuberculosis (infectious disease in combination with
little nodules in the affected tissue) and a chest X-ray will be taken.

At the start of your therapy, Metoject PEN will be injected by medical
staff. However, your doctor may decide that you are able to learn how to
inject Metoject PEN under the skin yourself. You will then receive
appropriate training.
Under no circumstances should you try to inject Metoject PEN
yourself before you have received such training.

During therapy:
You will have the following tests at least once a month during the first six
months and at least every three months thereafter:
 Examination of the mouth and throat for changes of the mucosa.
 Blood tests.
 Check of liver function.
 Check of kidney function.
 Check of respiratory system and if necessary lung function test.
Methotrexate may affect your immune system and vaccination results. It
may also affect the result of immunological tests. Inactive, chronic
infections (such as herpes zoster [shingles], tuberculosis, hepatitis B or
C) may flare up. During therapy with Metoject PEN you must not be
vaccinated with live vaccines.

You can also find guidance on how to use Metoject PEN in the section
“Instructions for use” at the end of this leaflet.
Please note that all of the contents have to be used.

Radiation-induced dermatitis and sun-burn can reappear under
methotrexate therapy (recall-reaction). Psoriatic lesions can exacerbate
during UV-irradiation and simultaneous administration of methotrexate.
Enlarged lymph nodes (lymphoma) may occur and if this is the case,
therapy must be stopped.

Instructions for use
Recommendations
 Carefully read the instructions below before starting your injection.
 Always use the injection technique advised by your doctor, pharmacist
or nurse.

The manner of handling and throwing away of the medicine and pre-filled
pen must be in accordance with local requirements. Pregnant health care
personnel should not handle and/or administer Metoject PEN.
Methotrexate should not come into contact with the surface of the skin or
mucosa. In the event of contamination, the affected area must be rinsed
immediately with plenty of water.
If you use more Metoject PEN than you should
If you use more Metoject PEN than you should, talk to your doctor
immediately.
If you forget to use Metoject PEN
Do not take a double dose to make up for a forgotten dose.

The most appropriate zones for your
injection are:
 upper thighs,
 abdomen except around the navel.
 If someone around you administers the
injection for you, the person may also
use the top of the zone at the back of
the arm, just below the shoulder.
 Change the injection area with each
injection. This will minimize any
reactions at the injection site.
 Never inject into areas where the skin is tender, bruised, red or hard or
where you have scars or stretch marks. If you have psoriasis, you
should not try to inject directly into any raised, thick, red or scaly skin
patches or lesions.
How to prepare the injection
5. Clean your skin in the chosen injection
zone using the enclosed alcohol pad.

6. Hold the Metoject PEN pre-filled pen
with one hand in the handling area.
 Do not remove the cap before you are
ready to administer the injection.

7. Use your other hand to pull the cap
straight off. The small needle shield
comes off with the cap automatically. If
not, use another pen and contact your
doctor, pharmacist or nurse.
 Do not press the button until you are
ready to inject.
 If you are unable to remove the cap, ask
someone around you for assistance.

Note: Once you have removed the cap, perform your injection
without delay.

8. With your free hand, build a skin fold
by gently squeezing the area of the
cleaned skin at the injection site.
 The fold must be held pinched until the
Metoject PEN pre-filled pen is
removed from the skin after the
injection.

9. Position the uncapped transparent end
of Metoject PEN pre-filled pen
perpendicular to the fold of skin.
10.Without pressing the button, push
the Metoject PEN pre-filled pen firmly
onto your skin in order to unlock the
button.
 If you are unable to push the Metoject
PEN pre-filled pen to the stop-point,
ask someone around you for
assistance.
How to administer the injection:
11.While holding the Metoject PEN prefilled pen firmly against the skin,
now press the button with your
thumb.
12.You will hear a click which indicates the
start of the injection.
Keep holding the pen against the raised
skin until all of the medicine is injected.
This can take up to 5 seconds.

Note:
Do not remove the Metoject PEN pre-filled pen from the skin before the
end of the injection to avoid incomplete injection.
If the injection is not triggered, release the button, make sure that the
Metoject PEN pre-filled pen is pressed firmly against the skin and push
hard on the button.
If you have troubles with your hearing, count 5 seconds from the moment
you have pressed the button and then lift the Metoject PEN pre-filled pen
from the injection site.
13.Remove the Metoject PEN pre-filled
pen from the injection site,
perpendicular to the skin (pull up).
14.The protective shield automatically
moves into place over the needle.
The protective shield is then locked
and the needle is protected.
15.In case of a slight bleeding use a
plaster.

Before throwing away the Metoject PEN pre-filled pen, check visually that
there is no liquid left in the pen, at the bottom of the transparent control
zone. If there is liquid left in the pen, not all of the medicine has been
injected correctly and you should consult your doctor.
Note
To avoid any injury, never insert your fingers in the opening of the
protective tube covering the needle. Do not destroy the pen.
Whom should you contact in case of need
 For any problem or question, contact your doctor, pharmacist or nurse.
 If you or someone around you is injured by the needle, consult your
doctor immediately and throw away the Metoject PEN pre-filled pen.

If you stop using Metoject PEN
If you stop using Metoject PEN, talk to your doctor immediately.
If you have the impression that the effect of Metoject PEN is too strong or
too weak, talk to your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The frequency as well as the degree of severity of the side effects
depends on the dosage level and the frequency of administration. As
severe side effects may occur even at low dosage, it is important that you
are monitored regularly by your doctor. Your doctor will do tests to check
for abnormalities developing in the blood (such as low white blood cells,
low platelets, lymphoma) and changes in the kidneys and the liver.
Tell your doctor immediately if you experience any of the following
symptoms, as these may indicate a serious, potentially life-threatening
side effect, which require urgent specific treatment:
 persistent dry, non-productive cough, shortness of breath and
fever; these may be signs of an inflammation of the lungs [common]
 symptoms of liver damage such as yellowing of the skin and
whites of the eyes; methotrexate can cause chronic liver damage
(liver cirrhosis), formation of scar tissue in the liver (liver fibrosis), fatty
degeneration of the liver [all uncommon], inflammation of the liver
(acute hepatitis) [rare] and liver failure [very rare]
 allergy symptoms such as skin rash including red itchy skin,
swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing) and feeling
you are going to faint; these may be signs of severe allergic reactions
or an anaphylactic shock [rare]
 symptoms of kidney damage such as swelling of the hands,
ankles or feet or changes in frequency of urination or decrease
(oliguria) or absence of urine (anuria); these may be signs of kidney
failure [rare]
 symptoms of infections, e.g. fever, chills, achiness, sore throat;
methotrexate can make you more susceptible to infections. Severe
infections like a certain type of pneumonia (Pneumocystis carinii
pneumonia) or blood poisoning (sepsis) may occur [rare]
 symptoms such as weakness of one side of the body (stroke) or
pain, swelling, redness and unusual warmth in one of your legs
(deep vein thrombosis); this may happen when a dislodged blood
clot causes blockage of a blood vessel (thromboembolic event) [rare]
 fever and serious deterioration of your general condition, or
sudden fever accompanied by a sore throat or mouth, or urinary
problems; methotrexate can cause a sharp fall in certain white blood
cells (agranulocytosis) and severe bone marrow suppression [very rare]
 unexpected bleeding, e.g. bleeding gums, blood in the urine,
vomiting blood or bruising, these can be signs of a severely reduced
number of blood platelets caused by severe courses of bone marrow
depression [very rare]
 symptoms such as severe headache often in combination with
fever, neck stiffness, feeling sick, vomiting, disorientation and
sensitivity to light may indicate an inflammation of the membranes of
the brain (acute aseptic meningitis) [very rare]
 certain brain disorders (encephalopathy/ leukoencephalopathy) have
been reported in cancer patients receiving methotrexate. Such side
effects cannot be excluded when methotrexate therapy is used to treat
other diseases. Signs of this kind of brain disorders may be altered
mental state, movement disorders (ataxia), visual disturbances or
disturbances of memory [not known]
 severe skin rash or blistering of the skin (this can also affect your
mouth, eyes and genitals); these may be signs of conditions called
Stevens Johnson syndrome or burned skin syndrome (toxic epidermal
necrolysis/Lyell’s syndrome) [very rare]
In the following, please find the other side effects that may occur:
Very common: may affect more than 1 in 10 people
 Inflammation of the mouth lining, indigestion, feeling sick, loss of
appetite, abdominal pain.
 Abnormal liver function tests (ASAT, ALAT, bilirubin, alkaline
phosphatase).
Common: may affect up to 1 in 10 people
 Mouth ulcers, diarrhoea
 Rash, reddening of the skin, itching
 Headache, tiredness, drowsiness
 Reduced blood cell formation with decrease in white and/or red blood
cells and/or platelets.
Uncommon: may affect up to 1 in 100 people
 Throat inflammation.
 Inflammation of the bowels, vomiting, inflammation of pancreas, black
or tarry stools, gastrointestinal ulcers and bleeding.
 Increased sensitivity to light, loss of hair, increased number of
rheumatic nodules, skin ulcer, shingles, inflammation of blood vessels,
herpes-like skin rash, hives.
 Onset of diabetes mellitus.
 Dizziness, confusion, depression.
 Decrease in serum albumin.
 Decrease in the number of all blood cells and platelets.
 Inflammation and ulcer of the urinary bladder or vagina, reduced kidney
function, disturbed urination.
 Joint pain, muscle pain, reduction of bone mass.
Rare: may affect up to 1 in 1,000 people
 Inflammation of gum tissue.
 Increased skin pigmentation, acne, blue spots on the skin due to vessel
bleeding (ecchymosis, petechiae), allergic inflammation of blood
vessels.
 Decreased number of anti-bodies in the blood.
 Infection (incl. reactivation of inactive chronic infection), red eyes
(conjunctivitis).
 Mood swings (mood alterations).
 Visual disturbances.
 Inflammation of the sac around the heart, accumulation of fluid in the
sac around the heart, obstruction of cardiac filling due to fluid in the sac
around the heart.
 Low blood pressure.
 Formation of scar tissue in the lung, shortness of breath and bronchial
asthma, accumulation of fluid in the sac around the lung.
 Stress fracture.
 Electrolyte disturbances.
 Fever, wound-healing impairment.
Very rare: may affect up to 1 in 10,000 people
 Acute toxic dilatation of the gut (toxic megacolon).
 Increased pigmentation of the nails, inflammation of the cuticles (acute
paronychia), deep infection of hair follicles (furunculosis), visible
enlargement of small blood vessels.

 Pain, loss of strength or sensation of numbness or tingling in arms and
legs, changes in taste (metallic taste), convulsions, paralysis,
meningism.
 Impaired vision, non-inflammatory eye disorder (retinopathy).
 Loss of sexual drive, impotence, male breast enlargement, defective
sperm formation (oligospermia), menstrual disorder, vaginal discharge.
 Enlargement of lymphatic nodes (lymphoma).
Not known: frequency cannot be estimated from the available data
 Increased number of certain white blood cells.
 Nosebleed.
 Proteins in urine.
 Feeling of weakness.
Subcutaneous application of methotrexate is locally well tolerated. Only
mild local skin reactions (such as burning sensations, erythema, swelling,
discolouration, severe itching, pain) were observed, decreasing during
therapy.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Metoject PEN
Keep out of the sight and reach of children.
Do not store above 25 °C.
Keep the pre-filled pen in the outer carton in order to protect from light.
Do not use after the expiry date stated on the packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. The
measures will help to protect the environment
If your pre-filled pen show any signs of deterioration, consult your doctor
or pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Metoject PEN contains
 The active substance is methotrexate.
1 pre-filled pen with 0.35 ml solution contains 17.5 mg methotrexate.
1 pre-filled pen with 0.4 ml solution contains 20 mg methotrexate.
1 pre-filled pen with 0.45 ml solution contains 22.5 mg methotrexate.
1 pre-filled pen with 0.5 ml solution contains 25 mg methotrexate.
1 pre-filled pen with 0.6 ml solution contains 30 mg methotrexate.
The other ingredients are sodium chloride, sodium hydroxide and
hydrochloric acid (for pH adjustment), and water for injections.
What Metoject PEN looks like and contents of the pack
Pre-filled pen containing a clear, yellow-brown solution in pre-filled
colourless glass syringe with a plunger stopper of rubber and embedded
injection needle. The syringe is externally equipped with the device for
self-administration.
Metoject PEN is available in pack of 1 pre-filled pen.
Alcohol pads included in the package.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by medac Gesellschaft für klinische Spezialpräparate mbH,
Theaterstr. 6, 22880 Wedel, Germany and procured from within the EU
by Product Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM
17.5 mg
20 mg
22.5 mg
25 mg
30 mg

-

PL 20636/2859
PL 20636/2860
PL 20636/2861
PL 20636/2862
PL 20636/2863

Leaflet issue and revision date (Ref): 19.08.17[5]

Metoject is a trademark of medac Gesellschaft für klinische
Spezialpräparate mbH.

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