ASPAVELI Pegcetacoplan for Patients and Caregivers User Guide
- June 4, 2024
- ASPAVELI
Table of Contents
A GUIDE TO ASPAVELI®
(pegcetacoplan) for patients
and caregivers
User Guide
ASPAVELI Pegcetacoplan for Patients and Caregivers
This guide contains important information and safety considerations for
pegcetacoplan, including the risk of serious infections (including meningitis)
and guidance on self-administration.
This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any side
effects you may get. See page 8 for how to report side effects.
This guide must be used in combination with the pegcetacoplan Patient
Information Leaflet (PIL) which is provided separately. The PIL is also
available at www.medicines.org.uk/emc.
The information provided in this leaflet does not take the place of
professional medical advice. Always follow your doctor, nurse or pharmacist’s
instructions and talk with them about any questions or problems you have
regarding your health and treatment.
Introduction
This booklet has been given to you because you, or someone in your care, has
been prescribed pegcetacoplan. This guide covers what pegcetacoplan is, as
well as important
safety considerations for patients and their carers and information on where
to access the self-administration guide.
Injecting yourself or someone in your care may seem difficult when you first
begin, but there are tips that might make it easier to incorporate the
administration into your daily
routine. Read this booklet and make sure you understand the information. If
you have any questions speak to your doctor, nurse, or pharmacist.
Your doctor or nurse will provide you with a pegcetacoplan Patient Card.
Please work with your doctor or nurse to fill out the card and keep it with
you at all times to quickly
reference your treatment, doctor’s phone number, and important safety
information.
Patient Card:
You will receive a pegcetacoplan Patient Card from your doctor.
- Carry this card at all times during treatment with pegcetacoplan and for 12 weeks after your last dose.
- Show this card to any doctor, nurse, or pharmacist who treats you. This will help them to diagnose and treat you correctly.
- Seek emergency medical help for any symptoms of serious bacterial infections.
**Important information to know before starting treatment with
pegcetacoplan
**
Risk of serious infections
The use of pegcetacoplan targets the complement system, which is part of the
body’s defense against infection. As such, the use of this medicine increases
your risk of infections, including those caused by the so-called ‘encapsulated
bacteria, such as Streptococcus pneumonia, Neisseria meningitides, and
Haemophilus influenza. These are
severe bacterial infections affecting your nose, throat, and lungs or the
lining of the brain and can spread throughout the blood and body. Serious
bacterial infections may quickly
become life-threatening and cause death if not recognized and treated early.
Call your doctor or nurse or seek emergency medical help right away if you
have any of these signs and symptoms of serious infection:
- Headache and a fever
- Fever and a rash
- Fever with or without shivers or chills
- Shortness of breath
- High heart rate
- Clammy skin
- Headache with a stiff neck or stiff back
- Headache with nausea (feeling sick) or vomiting
- Eyes sensitive to light
- Muscle aches with flu-like symptoms
- Confusion
- Extreme pain or discomfort
Risk of allergic reactions
Allergic reactions may occur in some patients receiving treatment with
pegcetacoplan.
Immediately stop pegcetacoplan infusion if you develop any of these signs and
symptoms of an allergic reaction and seek immediate medical attention:
- Difficulty breathing
- Chest pain or chest tightness
- Feeling dizzy/faint
- Severe itching of the skin or raised lumps on the skin
- Swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or collapse
Prophylactic vaccinations or antibiotic treatment
Vaccines against bacteria lower the risk of getting serious infections.
However, vaccines do not prevent all serious infections.
Your doctor will ensure that you receive vaccination against the bacteria
Streptococcus pneumonia, Neisseria meningitides, and Haemophilus influenza if
you have not had these
vaccines in the past.
If you have had these vaccines in the past, you might still need additional
vaccinations before starting treatment with pegcetacoplan. Your doctor will
advise if you need additional vaccinations.
These vaccinations should be given at least 2 weeks before beginning pegcetaco
plan therapy.
If you cannot be vaccinated 2 weeks before beginning pegcetacoplan therapy,
your doctor will prescribe antibiotics (medications to treat bacterial
infections) to reduce the risk of
infection, for 2 weeks after you have been vaccinated. Pegcetacoplan will only
be supplied if your doctor or pharmacist submits proof that you are receiving
the required vaccinations or antibiotics.
Your doctor or pharmacist will receive annual vaccination reminders and will
contact you in case you need revaccination. It is important that your
vaccinations are up to date, so speak with your doctor or nurse about this.
You should also be aware that vaccines will reduce the risk of serious
infections, but do not prevent all serious infections.
-
Risk of the destruction of red blood cells (hemolysis) after drug discontinuation Do not stop treatment with pegcetacoplan without discussing this beforehand with your doctor or nurse.
-
It is very important to make sure that you do not miss or postpone any scheduled treatments. If you stop taking the medicine suddenly, you may be at risk of making your
symptoms worse. -
If pegcetacoplan treatment is stopped completely, postponed, or if treatments are missed, there is a risk that hemolysis could occur. Haemolysis is when red blood cells,
which carry oxygen through your body, and break apart. Haemolysis is connected to various symptoms of PNH, such as:- Tiredness (fatigue)
- Dark urine (hemoglobinuria)
- Tummy (abdominal) pain
- Breathlessness
- Formation of blood clots (thrombosis)
- Difficulty in swallowing
- Erectile dysfunction
-
Seek immediate medical attention if you notice any signs or symptoms of hemolysis.
Recommendations for contraception for women of childbearing potential
The effects of pegcetacoplan on an unborn child are not known. The use of
effective contraception is recommended during treatment and up to 8 weeks
after treatment by
women of childbearing age. Ask your doctor, nurse, or pharmacist for advice
before taking pegcetacoplan.
Instructions on self-administration of pegcetacoplan
Pegcetacoplan is given as a subcutaneous (under the skin) infusion with an
infusion pump. Your doctor or nurse will support you with your initial
infusions. If your doctor or nurse thinks that you can self-administer, you
will receive full training in subcutaneous infusion, after which you will be
able to administer your twice-weekly dose yourself at home.
Pegcetacoplan comes in a glass vial, which needs to be kept in the
refrigerator (2°C to 8°C [35.6°F to 46.4°F]), in the original carton, to
protect the liquid from light.
One vial contains the dose for one infusion.
You can find a detailed description of how to self-administer in the
pegcetacoplan Patient Information Leaflet, or in the video link below.
Instructions on how to view the pegcetacoplan self-administration video on
any internet-connected device
Please type the below web address into your internet browser to view the
pegcetacoplan self-administration video. You can also use the QR code below to
access the video.
https://aspaveli-instructions.com/uk
Reporting side effects
Reporting side effects of your treatment is important as it allows the
collection of more information about the safety of pegcetacoplan. If you
experience any side effects (this also includes any possible side effects not
listed in the Patient Information Leaflet), in particular serious infections
with encapsulated bacteria, severe hypersensitivity reactions, or hemolysis
after drug discontinuation, inform your doctor, nurse, or pharmacist.
Please report suspected adverse drug reactions (ADRs) to the MHRA through the
Yellow Card scheme. You can report via
- the Yellow Card website is www.mhra.gov.uk/yellowcard
- the free Yellow Card app is available from the Apple App Store or Google Play Store
Alternatively, you can report a suspected side effect to the Yellow Card
scheme by calling +44 (0) 800 731 6789 for free, Monday to Friday between 9 am
and 5 pm. You can leave a message outside of these hours.
When reporting please provide as much information as possible. By reporting
side effects, you can help provide more information on the safety of this
medicine.
Taking part in a study to further investigate the safety of pegcetacoplan
A Post-Authorisation Safety Study (PASS) is an ongoing study that is carried
out after a medicine has been authorized, to obtain further information on a
medicine’s long-term safety. The ongoing safety study for pegcetacoplan will
be initiated by the end of 2022.
Your doctor or nurse will ask if you are willing to participate in the
pegcetacoplan ongoing safety study. By agreeing to participate, you will take
part in a Sobi-sponsored ongoing safety study, which will monitor the long-
term safety of pegcetacoplan in adult patients with PNH.
If you agree to participate in the ongoing safety study, your doctor or nurse
will register you and collect some of your medical information such as
diagnosis, treatment, and medical history. You will receive detailed
information about the study and will be asked to sign a consent form to
participate.
Your participation is entirely voluntary and information that would allow
direct or indirect identification of you will be removed. In addition, you can
withdraw your permission to be involved with the study at any time.
All the information you provide will be managed in accordance with Sobi’s Data
Privacy Policy and in compliance with the purposes for which it is provided.
For complete information on how personal data is protected at Sobi, please see
our policy available here: https://sobi-uk.co.uk/privacy-policy. If you do
not agree to these uses of your information, please contact us using the
contact information provided on the web page.
More information
If you have any questions about your health or pegcetacoplan talk to your
doctor, nurse or pharmacist.
So contact information:
Email: medical.info.uk@sobi.com
Phone: +44 (0) 800 111 4754
Sobi and Aspaveli are trademarks of Swedish Orphan Biovitrum AB (publ).
© 2022 Swedish Orphan Biovitrum AB (publ). – All rights reserved.
Swedish Orphan Biovitrum Ltd,
Suite 2, Riverside 3, Granta Park,
Great Abington,
Cambridgeshire,
CB21 6AD
www.sobi-uk.co.uk
NP-19141 February 2022