Adult/Adolescent administration guidelines

Metoject PEN
®
PATIENT GUIDE
YOUR MEDICATION
Metoject® PEN is a licensed, pre-filled methotrexate autoinjector.
Metoject® PEN characteristics
■Easy to handle
■One button activation
■Room temperature storage
■24 months shelf life from date of manufacture
■Automatic needle shield protection
■Preservative and latex free
■Colour coded for easy dosage identification
■Single use
PAGE 2
QUICK SUMMARY
Important facts about Metoject® PEN
■Inject ONCE a week
■Do not try and remove the air bubble in the Metoject® PEN
■Inject at a 90° angle
■Rotate injection sites
■Store at room temperature (below 25°C)
■Monthly monitoring is essential
■Do not drink large amounts of alcohol
■Check with your nurse first if you need to take other
medication
■Do not use if you are trying for a baby
■Transport Metoject® PEN in your hand luggage when flying
■Check with your nurse if you need any vaccinations
PAGE 3
Metoject® PEN pre-filled methotrexate autoinjector
You have been prescribed Metoject® solution for injection. Metoject®
is indicated for the treatment of active rheumatoid arthritis in adults,
polyarthritic forms of severe, active juvenile idiopathic arthritis, severe
recalcitrant disabling psoriasis and severe psoriatic arthritis in adult patients.
The active substance is methotrexate.
Metoject® PEN is available in the following doses:
7.5mg, 10mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg, 25mg, 27.5mg and
30mg.
Do NOT use Metoject® if:
■ You are allergic to methotrexate
■ You suffer from severe liver, kidney or blood diseases
■ You drink large amounts of alcohol
■ You suffer from any severe infection e.g. tuberculosis or HIV
■ You are pregnant or breastfeeding
■ You have a stomach, oral or intestinal ulcer
If you need any vaccinations, please check with your nurse FIRST.
Please consult your nurse if:
■ You suffer from dehydration (water loss)
■ You have shingles or chicken pox
PAGE 4
Monitoring
Even when administered in low doses there is a possibility that you
could experience some side effects; therefore you will need to have
regular check ups and blood tests. You will be familiar with these
tests if you have already taken oral methotrexate.
Before starting treatment with Metoject®, blood samples will be
taken from you. These will be used to check your liver and kidney
functions, for example.
Do not start treatment with Metoject® if you have shingles or
chicken pox.
Travel advice
Metoject® should be stored at room temperature. However, if the
room temperature rises above 25°C, then store in a cooler, dry place
or in a fridge (minimum temperature 2°C).
When flying, Metoject® must always be carried in your hand
luggage. If required by the airline, ask your doctor for a letter
confirming you are on this prescribed medication.
■ If you need any vaccinations before travelling, please check
with your nurse FIRST
■ If you develop diarrhoea and or/vomiting whilst on holiday,
stop taking Metoject® and seek medical advice
■ For further travel advice, speak to your GP, nurse or
pharmacist
PAGE 5
Metoject® PEN reminders
■Only inject Metoject® ONCE a week
■Inject on the same day each week
■If you forget to inject Metoject® on the correct day, ring your nurse
specialist for advice
■ Do not drink large amounts of alcohol as methotrexate can cause
liver damage. You can reduce this risk by avoiding alcohol.
■Do not get pregnant whilst taking Metoject®
■Do not breastfeed during treatment with Metoject®
■Patients who are sexually active must use effective contraception
during treatment and for six months after stopping treatment
■If you experience tiredness or dizziness during treatment, do not
drive or use machinery
■Contact your GP or consultant URGENTLY if you develop a dry
cough or become breathless whilst on Metoject®
■Methotrexate can interact with other drugs so please check with
your GP or pharmacist before you take any other medication
PAGE 6
INJECTION SITES
■Choose a different
injection site each week
to minimise possible
irritation.
■Injection sites are
situated in the abdomen
or thigh.
■Never inject into areas
where the skin is
tender, bruised, red
or hard.
■If you choose the
abdomen, avoid the 5cm
diameter around the
tummy button.
PAGE 7
Guidelines to administering Metoject® PEN
Before administering Metoject® PEN, please remember to:
■Choose a quiet, clean area which has a flat surface
■Wash your hands
■Choose a different injection site each week to minimise possible skin
irritation
■Never inject into areas where the skin is tender, bruised, red or hard
Please read the following guidelines carefully.
PEN details
Release
button
Handling
area
Dosage
colour
code
Viewing
window
Protection
cap
covering
needle
shield
PAGE 8
Before
injection with
protection cap
in place
Before
injection
after removal
of protection
cap, revealing
needle shield
After
injection
with locked
needle
shield in
place
1
Metoject® PEN 7.5mg solution for injection
in pre-filled pen
7.5 mg
methotrexate
PL 11587/0076
Store below 25 oC. Keep the pre-filled pen
in the outer carton in order to protect from light.
Any remaining product should be discarded
in accordance with local requirements.
Keep out of the sight and reach of children.
medac GmbH • Theatrestr. 6 - 22880 Wedel • Germany
Metoject® PEN 7.5mg solution for injection
in pre-filled pen
methotrexate
7.5 mg
■ Check that your drug is Metoject® PEN,
has not passed the expiry date, is the
correct dosage and has your name on it.
■ Remove the PEN from the packaging.
2
■ Check the PEN for damage by looking
through the viewing window before
injection.
■ An air bubble MAY be visible in the PEN.
This is to ensure all the medication is
administered during injection and is
completely harmless.
■ Do not remove the yellow protection
cap until you are ready to administer
the injection.
3
■ Before injection, pull off the yellow
protection cap in a downwards motion,
revealing the needle shield.
■ Do not twist or bend the protection cap
whilst you are removing it.
■ Do not press the yellow release button
until you are ready to inject.
■ Once you remove the protection cap,
administer your injection without delay.
Choose your injection site. To inject your thigh, go to step 4.
To inject your abdomen, go to step 9.
PAGE 9
INJECTING THE THIGH – see step 14 for alternative technique
4
■ Gently grip the skin at the injection site
using your thumb and index finger and
maintain throughout the injection
process.
■ Place the transparent end of the PEN at a
90° angle on your skin.
■ Without pressing the yellow release
button, push the PEN firmly against your
skin until the needle shield slides fully into
the viewing window. This will unlock the
yellow release button.
5
■ Start the injection by pressing the yellow
release button with your thumb.
5 sec.
■ A clicking noise indicates the start of the
injection.
■ Maintain the pressure of the PEN against
the skin and count slowly to 5 seconds,
until all the medicine is injected.
■ Do not move the PEN during injection.
6
■ After 5 seconds, release the skin and
remove the PEN. There should be no
remaining fluid in the PEN.
■ The needle protection shield will
automatically slide over the needle and lock
into place.
PAGE 10
7
■ Dab the injection site with clean cotton wool
or a swab.
■ Do not rub the injection site as this may
irritate the skin.
8
■ For your safety, dispose of the PEN into a
special sharps bin.
■ All other packaging can be disposed of in
your normal household waste.
PAGE 11
INJECTING THE ABDOMEN – see step 16 for alternative technique
9
■ Avoid the 5cm diameter around the tummy
button.
■ Gently grip the skin at the injection site
using your thumb and index finger and
maintain throughout the injection
process.
■ Place the transparent end of the PEN at a
90° angle on your skin.
■ Without pressing the yellow release
button, push the PEN firmly against your
skin until the needle shield slides fully into
the viewing window. This will unlock the
yellow release button.
10
■ Start the injection by pressing the yellow
release button with your thumb.
5 sec.
■ A clicking noise indicates the start of the
injection.
■ Maintain the pressure of the PEN against
the skin and count slowly to 5 seconds,
until all the medicine is injected.
■ Do not move the PEN during the
injection.
11
■ After 5 seconds, release the skin and
remove the PEN. There should be no
remaining fluid in the PEN.
■ The needle protection shield will
automatically slide over the needle and lock
into place.
PAGE 12
12
■ Dab the injection site with clean cotton
wool or a swab.
■ Do not rub the injection site as this may
irritate the skin.
13
■ For your safety, dispose of the PEN into a
special sharps bin.
■ All other packaging can be disposed of in
your normal household waste.
PAGE 13
ALTERNATIVE INJECTION TECHNIQUE FOR THE THIGH
14
■ Place the transparent end of the PEN at a
90° angle on your skin.
■ Without pressing the yellow release
button, push the PEN firmly against your
skin until the needle shield slides fully into
the viewing window. This will unlock the
yellow release button.
15
■ Whilst still holding the PEN firmly against
your skin, start the injection by pressing
the yellow release button with the palm of
your other hand.
■ A clicking noise indicates the start of the
injection.
■ Maintain the pressure of the PEN against
the skin and count slowly to 5 seconds,
until all the medicine is injected.
■ Do not move the PEN during injection.
For the remainder of the injection process in the thigh, return to step 6
and continue.
PAGE 14
ALTERNATIVE INJECTION TECHNIQUE FOR THE ABDOMEN
16
■ Avoid the 5cm diameter around the tummy
button.
■ Place the transparent end of the PEN at a
90° angle on your skin.
■ Without pressing the yellow release
button, push the PEN firmly against your
skin until the needle shield slides fully into
the viewing window. This will unlock the
yellow release button.
17
■ Whilst still holding the PEN firmly against
your skin, start the injection by pressing
the yellow release button with the palm of
your other hand.
■ A clicking noise indicates the start of the
injection.
■ Maintain the pressure of the PEN against
the skin and count slowly to 5 seconds,
until all the medicine is injected.
■ Do not move the PEN during injection.
For the remainder of the injection process in the abdomen, return to step 11
and continue.
PAGE 15
Injectable methotrexate
FREQUENTLY ASKED QUESTIONS
Why won’t my injection start with the Metoject® PEN?
Metoject® PEN contains a safety device which requires sufficient pressure to be
applied to the skin to unlock the yellow release button. The injection site surface
must be firm throughout the process. Once activated, maintain pressure during
the injection without moving the PEN for at least 5 seconds.
What should I do if there is a drop of liquid on the tip of the needle?
Occasionally a small drop of liquid may be visible on the tip of the needle once
you have removed the protection cap. This is completely normal and nothing to
worry about.
How many doses are in the Metoject® PEN?
The PEN is a single use device and will deliver only one dose. The PEN device
should be disposed of after administration.
How do I store Metoject® PEN?
Metoject® PEN is stored at room temperature (less than 25°C). It can be kept in
the fridge (minimum temperature 2°C) but should be allowed to warm to room
temperature before administration. It can be stored for up to two years from date
of manufacture.
medac code: medacuk 055/11/2014
Date of preparation: November 2014