SELF-INJECTION GUIDE

(asfotase
40 mg/ml alfa
solution for )
injection
18 mg/0.45 ml
for28injection
mg/0.7 ml 40 mg/1 ml

100 mg/ml solution for injection

80 mg/0.8 ml

asfotase alfa
This medicinal product is subject to additional monitoring

• This document is approved by The Executive Directorate of Pharmacovigilance, at

SFDA.

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Introduction Contents

This Self-Injection Guide is for patients with paediatric- Important Information 4

onset hypophosphatasia who would benefit from
long-term enzyme replacement therapy and have been Warnings 5
prescribed Strensiq®.
What is Asfotase alfa ? 6
The guide gives detailed instructions, with clear diagrams,
on how to choose your injection site and how to carry out How do I get started on Asfotase alfa therapy? 6
and record your injection.
What dose of Asfotase alfa is used? 6
This guide is designed as a support document to the training
given by your healthcare professional. How is Asfotase alfa administered? 7

Please contact your healthcare professional if you have How to inject Strensiq® (Asfotase alfa) 8
any questions.
Storing and Travelling with Strensiq® (Asfotase alfa) 14

Local Contacts 15

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Important Information
Warnings and Precautions
Do not inject yourself with Asfotase alfa until you have had proper ‹ Some patients receiving asfotase alfa have had life threatening
training from a healthcare professional. allergic reactions similar to anaphylaxis requiring medical
treatment. Patients who experienced anaphylaxis-like symptoms
‹ Before starting, check the expiry date of Asfotase alfa. DO NOT use if had difficulty breathing, choking sensation, nausea, swelling
it has expired. around the eyes, and/or dizziness. The reactions occurred
within minutes after injecting asfotase alfa in patients, and can
‹ Always use a new vial and carefully examine Asfotase alfa liquid which
occur in patients who have been taking asfotase alfa for any
should look clear, colourless to slightly yellow and may have a few
period of time (e.g. more than one year). If you experience any
small translucent or white particles in it. Do not use it if the liquid is
of these symptoms, discontinue Asfotase alfa and seek medical
discoloured or contains any lumps or large particles in it and get a
help immediately.
new vial.
‹ If you experience an anaphylactic reaction, or an event with
‹ If you suspect that the liquid in your vial has been contaminated,
similar symptoms, your doctor will discuss with you the next
DO NOT use it, select another vial and contact your healthcare
steps and the possibility to restart Asfotase alfa under medical
professional for advice.
supervision. Always follow the instructions provided by
‹ Always use the specific dose (in number of milligrams) that has been your doctor.
prescribed by your doctor.
‹ Fatty lumps or decreased fatty tissue on the surface of the skin
‹ Vials are for single use and should only be punctured once. Used vials (localised lipodystrophy) has been reported at injection sites
must be discarded at the end of the injection. after several months in patients using Asfotase alfa. Review the
‹ Syringes and needles are for single use only and should be handled ‘How is Asfotase alfa Administered?’ section carefully to know
with care. Keep them out of reach from children and dispose of them the injection recommendations. This is important to rotate the
safely in a special sharps container. Needles and syringes must not injection from among the following sites to reduce the risk of
be mixed with normal household rubbish. lipodystrophy: buttocks, abdomen, thigh, or arms (deltoids).

‹ Store your Asfotase alfa vials in the refrigerator at a temperature ‹ If you are treated with Asfotase alfa, you may experience
between 2˚C and 8˚C. DO NOT put Asfotase alfa in or near the freezer a reaction at the injection site (e.g. pain, nodule, rash,
compartment and never inject Asfotase alfa that you know, or sus- discoloration) during the injection of the medicine or during
pect, has been frozen. the hours following the injection. If you experience any severe
reaction at the injection site, tell your doctor immediately.
‹ Store your Asfotase alfa in the original package in order to protect the
medication from light.

For detailed information on Asfotase alfa please refer to the Patient

Information Leaflet which you can find in the Strensiq® alfa pack-
age.

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What is Asfotase alfa? How is Asfotase alfa administered?

Asfotase alfa is a medication designed as a long-term enzyme Asfotase alfa is administered either three or six times per week as a
replacement therapy in patients with paediatric-onset hypophosphatasia. subcutaneous injection into the fatty layer just below the skin. This is
It is administered subcutaneously, under the skin. called the subcutaneous layer and it is just above the muscle.

Areas with a substantial amount of fat below the skin (as shown on the
How do I get started on Asfotase alfa therapy? diagram) are the most suitable areas to inject.

When injecting regularly, it is important to alternate injection sites (position

Asfotase alfa must be prescribed by your doctor.
on the body where the injections are given) to limit risk of pain, irritation
Your healthcare professional will advise you on the range of educational and lipodystrophy (clumping or loss of fat under the skin).
materials available to help with the therapy. This injection guide can help
Please discuss with your healthcare professional the best sites for you.
support you when learning how to self-inject.

What dose of Asfotase alfa is used?

Once you have been prescribed Asfotase alfa you will need to administer
the drug according to the specific dose (in number of milligrams) that
has been prescribed by your doctor. arms (detoids)

The dose you administer is based on your body weight. The correct
abdomen
dose will be calculated by your doctor and consists of a total of buttocks

6 mg per kg of body weight per week of Asfotase alfa, administered by

subcutaneous injection. You may receive either an injection of 1 mg/kg of
Asfotase alfa six times per week or an injection of 2 mg/kg of Asfotase alfa thighs
three times per week depending on the recommendation of your doctor.

For example, if your body weight is 40 kg, you will receive 40 mg six times
per week or 80 mg three times per week.

The maximum volume of medication per injection should not exceed 1ml.
If more than 1ml is required, multiple injections may be administered, one
after another.

Please remember, this guide is designed as a support document to the

training given by your healthcare professional.

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How to inject Strensiq® (Asfotase alfa) How to inject Asfotase alfa

Before you begin, take your vial(s) out of the refrigerator 15 to 30 minutes Step 1: Preparing the Asfotase alfa dose
before injecting to allow the liquid to reach room temperature (around 23°C
to 27°C). Do not warm Asfotase alfa in any other way (for example, do 1
not warm it in a microwave or in hot water). After removal of the vial from 1. Always use a new vial and carefully
refrigeration, Asfotase alfa should be administered within 3 hours. For more examine the liquid to make sure it is clear,
information about the storage of Asfotase alfa, see page 14. colourless to slightly yellow and may
have a few small translucent or white
Please remember your vials are for single use and should particles in it. Do not use it if the liquid
only be punctured once. Used vials must be discarded at the end is discoloured or contains any lumps or
of the injection. large particles in it and get a new vial.
Wash your hands thoroughly with soap and water. Remove the protective cap (shown as
red on the image) from the vial to reveal
Place all the items you will need on a clean area where they will not be
the sterile rubber seal.
disturbed. These should include: 2
2. Place a larger bore needle (e.g. 25G)
‹ Your vial(s) for injection on the empty syringe and with the
‹ Your syringe(s) protective cap on, push down and turn
clockwise the needle onto the syringe
‹ One larger bore syringe needle (e.g. 25G)
until it is tight. Remove the plastic cap
‹ One smaller bore syringe needle (e.g. 27 or 29G, with length covering the syringe needle and dispose
appropriate for subcutaneous injection) of it in your sharps container. Pay
‹ Alcohol swabs (if required) attention to not hurt yourself with the
needle.
‹ Gauze or cotton wool
‹ Your sharps container* Pull the plunger back to draw air into the
syringe equal to your dose.
‹ Plaster or adhesive bandage (if required)
Step 2: Withdrawing Asfotase alfa solution from the vial
‹ Injection diary (or other recording means e.g. paper or notebook)
1 1. Holding the syringe and vial, insert the
It is recommended to record site, dose, date, time, to avoid two
injections in the same day and to ensure you rotate injection site. It is also needle through the sterile rubber seal and
recommended to note any injection reactions. Choose the injection site into the vial.
(see diagram on page 7) and prepare it according to the advice given by Push the plunger in completely to inject
your healthcare professional. the air into the vial.
* Your healthcare professional will advise on how you can obtain a sharps container and will also
advise you on the disposal procedure.

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How to inject Asfotase alfa How to inject Asfotase alfa

2 2. Invert the vial and syringe. Step 3: Placing the needle for injection on the syringe
With the needle in the solution, pull the
1. Remove the needle from the vial. Recap with one hand by placing the
plunger to withdraw the correct dose
cap on a flat surface, slide the needle into the cap, lift it up and snap it on
into the syringe.
securely using only one hand.
2 2. Carefully remove the recapped larger
bore needle pushing down and turning
counterclockwise and dispose of it in
your sharps container.

3 3. Before removing the needle from the

vial, check that the appropriate volume
has been withdrawn and check the
syringe for air bubbles.
3 3. Place a smaller bore needle (e.g. 27
In the event that bubbles appear in the
syringe, hold the syringe with the needle or 29G) on the filled syringe and with
pointing upwards and gently tap the the protective cap on, push down and
side of the syringe until the bubbles rise turn clockwise the needle onto the
to the top. syringe until it is tight. Pull the cap
straight off the needle and dispose of it
4 4. Once all the bubbles are at the top of in your sharps container.
the syringe, gently push on the plunger
to force the bubbles out of the syringe
and back into the vial.
4 4. Hold the syringe with the needle
After removing the bubbles, recheck
pointing up and tap the barrel of the
the dose of medication in the syringe to
syringe with your finger to remove any
be sure you have drawn up the correct
air bubbles. After removing the bubbles,
amount. You may need to use several
check the dose of medication in the
vials to withdraw the complete amount
syringe to be sure you have drawn up
needed to reach the correct dose.
the correct amount. You are now ready
to inject the correct dose.

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How to inject Asfotase alfa How to inject Asfotase alfa

3
Step 4: Injecting Asfotase alfa 3. While continuing to hold the skin,
push the syringe plunger to inject the
Please refer to Section “How Asfotase alfa is administered” on page 7 for medication slowly and steadily all the
determining the most suitable areas for your injection (thighs, abdomen, way in.
arms (deltoids), buttocks). Your doctor will advise you on the possible
injection sites. Remove the needle, release the skin
1 fold and gently place a piece of cotton
1. Gently pinch the skin of the chosen wool or gauze over the injection site
injection area between your thumb for a few seconds. This will help seal
and index finger. the punctured tissue and prevent any
leakage. Do not rub the injection site
after injection.

4 4. Dispose of your syringe, needle, and

used vial into your sharps container.
Your doctor, pharmacist or nurse will
advise you on how you can obtain a
2 sharps container.
2. Holding the syringe like a pencil
or a dart, insert the needle into the
raised skin so it is at an angle of
5. If you need a second injection for
between 45º and 90º to the skin
your prescribed dose, get another
surface. For patients who have little
Asfotase alfa vial and new needles,
subcutaneous fat or thin skin, a 45º
then repeat all of the previous steps.
angle may be preferable.
Your vials are for single use and should only be punctured once.

Place a small plaster or adhesive bandage over the injection site,

if necessary.

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6 6. Record all details of the injection ‹ Check to ensure that your travel destination has refrigeration that you
in your injection diary or using other can use.
means.
‹ It is recommended that you carry your vials in a cool bag when you
It is recommended that you note: travel. The bag contains cool blocks to help keep your vials at the
correct temperature.
‹ Where you injected
‹ Keep the cool blocks in your freezer so that they are ready for use
‹ The dose injected
when you travel. Ensure that the frozen cool blocks are not in direct
‹ Date and time of injection contact with your medication.
‹ Any injection reactions
Travelling by air
If you have any concerns about injection reactions,
‹ It is recommended that you carry your medication and supplies as
preparing or administering your medication,
hand luggage.
discuss them with your healthcare professional.
‹ It may be advisable to carry a letter from your doctor explaining that
Storing and Travelling with Strensiq® (Asfotase you need to travel with your medication.

alfa) Storing and Travelling with Asfotase alfa

Storing your Asfotase alfa vials ‹ Check with your airline, or the airports you are travelling through,
for any specific rules for persons carrying injectable medication and
‹ Store your Asfotase alfa vials in the refrigerator at a temperature associated accessories.
between 2˚C and 8˚C. DO NOT put Asfotase alfa in or near the
‹ If you have any concerns about travelling, discuss them with your
freezer compartment and never inject Asfotase alfa that you know, or
healthcare professional.
suspect, has been frozen.
‹ Store your Asfotase alfa in the original package in order to protect the
medication from light.
‹ Before starting, check the expiry date of Asfotase alfa which you will
find on the vial label. DO NOT use if it has expired.

Travelling with your Asfotase alfa vials

‹ Calculate how many vials you will need for your trip. Take some extra
in case you are away for longer than expected.
‹ Remember to take your sharps container and some extra syringes.
It is recommended that you carry your supplies as hand luggage.

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‹ Local Contacts
‹ For more information about STRENSIQ® or in case of any safety
concerns, please contact your doctor, pharmacist, or nurse.
‹ Reporting of side effects
‹ If you experience any side effects, talk to your doctor, pharmacist,
or nurse. This includes any possible side effects not listed in this
guide.
‹ Adverse events (side effects to the drug) should be reported.
‹ In case of safety concerns, please contact:
‹ The National Pharmacovigilance Centre (NPC):
‹ SFDA Call Center: 19999
‹ E-mail: npc.drug@sfda.gov.sa
‹ Website: https://ade.sfda.gov.sa/
‹ Or
‹ LOCAL REPRESENTATIVE OF THE MARKETING AUTHORISATION
HOLDER IN KSA
‹ Biologix, FZ Co, Hibatullah Al Ghaffari Street-Suliemaniah
‹ Kingdom of Saudi Arabia P.O.Box 991, Riyadh 11421 Biologix
Pharmacovigilance Department
‹ Email: pharmacovigilance-ksa@biologixpharma.com
‹ Tel: +966 11 464 6955 Ext: 286
‹ Mobile: +966 55 999 4037
‹ By reporting side effects you can help provide more information on
the safety of this medicine.

Alexion Pharma Middle East FZ LL BIOLOGIX FZCo

C10th Floor, Office 1007, North Tower Hibatullah Al Ghaffari
Dubai Science Park HQ Tower Street-Suliemaniah
PO box 500594 Kingdom of Saudi Arabia
Dubai - United Arab Emirate P.O.Box 991, Riyadh 11421

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