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METOJECT PEN 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE

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Metoject PEN · 91300-VPGB · AA · 07.13 · Pharma-Code: 1655
Format: 888 x 150 mm · HKS 44 · Perforation · Corrective action: KV01_jem_08.07.13 / KV02_jem_10.07.13

Package leaflet: Information for the user
Metoject® PEN 7.5 mg solution for injection in pre-filled pen
Metoject® PEN 10 mg solution for injection in pre-filled pen
Metoject® PEN 12.5 mg solution for injection in pre-filled pen
Metoject® PEN 15 mg solution for injection in pre-filled pen
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 27.5 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.

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

2. What you need to know before you use Metoject PEN

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.

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 stomach ulcer or intestinal ulcer.
• are pregnant or breast-feeding.
• receive vaccinations with live vaccines at the same time.

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.

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).
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.
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.

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 if your liver is working properly.
• Check if your kidneys are working properly.
• 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.
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.
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.
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:
• Medicines harming the liver or the blood count,
such as leflunomide.
• Antibiotics (medicines to prevent/fight certain infections)
such as: tetracyclines, chloramphenicol, and non-absorbable
broad-spectrum antibiotics, penicillines, glycopeptides,
sulphonamides (sulphur containing medicines that prevent/
fight certain infections), ciprofloxacin and cefalotin.
• Non-steroidal anti-inflammatory drugs or salicylates
(medicines against pain and/or inflammation).
• Probenecid (medicine against gout).
• Weak organic acids like loop diuretics (“water tablets”)
or some medicines used for treatment of pain and
inflammatory diseases (such as acetylsalicylic acid,
diclofenac and ibuprofen) and pyrazole (e.g. metamizol
for treating pain).
• Medicinal products, which may have adverse effects on the
bone marrow, such as trimethoprim-sulphamethoxazole
(an antibiotic) and pyrimethamine.
• Sulphasalazine (antirheumatic medicine).
• Azathioprine (an immunosuppressive agent sometimes
used in severe forms of rheumatoid arthritis).
• Mercaptopurine (a cytostatic agent).
• Retinoids (medicine against psoriasis and other
dermatological diseases).
• Theophylline (medicine against bronchial asthma
and other lung diseases).
• Proton-pump inhibitors (medicines against stomach trouble).
• Hypoglycaemics (medicines that are used to lower the
blood sugar).
Vitamins containing folic acid may impair the effect
of your treatment and should only be taken when advised
by your doctor.
Vaccination with live vaccine must be avoided.

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.

3. How to use Metoject PEN

Instructions for use

a) With cap before injection

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

b) After cap removal before
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.

Your doctor decides on the dosage, which is adjusted
individually to you. Usually it takes 4 – 8 weeks before there
is any effect of the treatment.

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

Do not take Metoject PEN during pregnancy. 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.

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.

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.
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”.

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.
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 and psoriatic arthritis with Metoject
PEN is a long-term treatment.
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.

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.

c) After injection

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:

What you need in order to administer your injection using
the Metoject PEN pre-filled pen

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.

You need:
• 1 Metoject PEN pre-filled pen
• 1 alcohol pad

In case a small air bubble is visible
through the transparent control zone,
this will not affect your dose nor will it
harm you.

Metoject PEN pre-filled pen components:
Injection button
Handling area

Transparent control zone
Cap

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
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.

Metoject PEN · 91300-VPGB · AA · 07.13 · Pharma-Code: 1655
Format: 888 x 150 mm · HKS 44 · Perforation · Corrective action: KV01_jem_08.07.13 / KV02_jem_10.07.13

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
pre-filled 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.

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.

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.
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.
If you stop using Metoject PEN
If you stop using Metoject PEN, talk to your doctor immediately.

13. Remove the Metoject PEN prefilled pen from the injection site,
perpendicular to the skin (pull up).

If you have the impression that the effect of Metoject PEN is
too strong or too weak, talk to your doctor or pharmacist.

14. The protective shield
automatically moves into place
over the needle. The protective
shield is then locked and the
needle is protected.

4. Possible side effects

15. In case of a slight bleeding
use a plaster.



91300-VPGB
AA

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 (pneumonia) [common - may affect up to
1 in 10 people]
• 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 of the liver (liver fibrosis), fatty degeneration of the
liver [all uncommon - may affect up to 1 in 100 people],
inflammation of the liver (acute hepatitis) [rare - may affect
up to 1 in 1,000 people] and liver failure [very rare - may
affect up to 1 in 10,000 people]
• 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 - may affect up to
1 in 1,000 people]
• symptoms of kidney damage such as swelling of
the hands, ankles or feet or changes in frequency
of urination or decrease or absence of urine; these
may be signs of kidney failure [rare - may affect up to
1 in 1,000 people]
• symptoms of infections, e.g. fever, chills, achiness,
sore throat; methotrexate can make you more susceptible
to infections. Rarely [may affect up to 1 in 1,000 people]
severe infections like a certain type of pneumonia
(Pneumocystis carinii pneumonia) or blood poisoning
(sepsis) may occur
• severe diarrhoea, vomiting blood and black or tarry
stools; these symptoms may indicate a rare [may affect

up to 1 in 1,000 people] severe complication of the
gastrointestinal system caused by methotrexate e.g.
gastrointestinal ulcers
• fever and serious deterioration of your general
condition, or sudden fever accompanied by a sore
throat or mouth, or urinary problems; methotrexate can
very rarely [may affect up to 1 in 10,000 people] cause a
sharp fall in white blood cells (agranulocytosis) and severe
bone marrow suppression
• 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 - may
affect up to 1 in 10,000 people]
• severe skin rash or blistering of the skin (this can also
affect your mouth, eyes and genitals); these may be
signs of the very rare [may affect up to 1 in 10,000 people]
conditions called Stevens Johnson syndrome or burned
skin syndrome (toxic epidermal necrolysis)
In the following, please find the other side effects that may
occur:
Very common: may affect more than 1 in 10 people
• Mouth inflammation, indigestion, nausea (feeling sick),
loss of appetite
• Increase in liver enzymes.
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 (leukopenia, anaemia,
thrombocytopenia)
Uncommon: may affect up to 1 in 100 people
• Throat inflammation, inflammation of the bowels, vomiting

• Increased sensitivity to light, loss of hair, increased number
of rheumatic nodules, 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 blood cells and platelets
• Inflammation and ulcer of the urinary bladder or vagina,
reduced kidney function, disturbed urination
• Joint pain, muscle pain, osteoporosis (reduction of bone
mass)
Rare: may affect up to 1 in 1,000 people
• Increased skin pigmentation, acne, blue spots due to vessel
bleeding
• Allergic inflammation of blood vessels, fever, red eyes,
infection, wound-healing impairment, decreased number
of anti-bodies in the blood
• Visual disturbances
• Inflammation of the sac around the heart, accumulation
of fluid in the sac around the heart
• Low blood pressure, occlusion of a blood vessel
by dislodged blood clot (thromboembolic events)
• Lung fibrosis, shortness of breath and bronchial asthma,
accumulation of fluid in the sac around the lung
• Electrolyte disturbances
Very rare: may affect up to 1 in 10,000 people
• Profuse bleeding, toxic megacolon (acute toxic dilatation
of the gut)
• Increased pigmentation of the nails, inflammation of the
cuticles, furunculosis (deep infection of hair follicles), visible
enlargement of small blood vessels
• Impaired vision, pain, loss of strength or sensation of
numbness or tingling in arms and legs, changes in taste
(metallic taste), convulsions, paralysis, severe headache
with fever

• Retinopathy (noninflammatory eye disorder)
• Loss of sexual drive, impotence, male breast enlargement
(gynaecomastia), defective sperm formation, menstrual
disorder, vaginal discharge
• Enlargement of lymphatic nodes (lymphoma)
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via 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 this medicine out of the sight and reach of children.
Store below 25 °C.
Keep the pre-filled pens in the outer carton in order to protect
from light.
Do not use this medicine after the expiry date stated on the
carton and pre-filled pen after EXP. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment.

6. Contents of the pack and other information

Not all pack sizes may be marketed.

What Metoject PEN contains
• The active substance is methotrexate.
1 pre-filled pen with 0.15 ml solution contains
7.5 mg methotrexate.
1 pre-filled pen with 0.2 ml solution contains
10 mg methotrexate.
1 pre-filled pen with 0.25 ml solution contains
12.5 mg methotrexate.
1 pre-filled pen with 0.3 ml solution contains
15 mg 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 0.55 ml solution contains
27.5 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.

Marketing Authorisation Holder and Manufacturer

What Metoject PEN looks like and contents of the pack
This medicinal product is presented as a solution for injection
in pre-filled pen.
The solution is clear, yellow-brown.
The following pack sizes are available:
Metoject PEN is available in packs of 1, 2, 4, 5, 6, 10, 11, 12,
14, 15, and 24 pre-filled pens. Alcohol pads are included in the
package.

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Bulgaria, Czech Republic, Denmark, Finland, Greece,
Hungary, Romania, Slovak Republic, Slovenia, Spain, United
Kingdom:
Metoject PEN
Belgium, Netherlands
Metoject
Iceland, Sweden:
Metojectpen
Germany:
metex PEN
Poland:
Metex PEN
Estonia, Latvia, Lithuania, Norway, Portugal:
Metex
This leaflet was last revised in June 2013.
91300-VPGB
AA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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