Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or nurse.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I taking SAPHNELO?
SAPHNELO contains the active ingredient anifrolumab. SAPHNELO is used to treat moderate
to severe lupus (systemic lupus erythematosus or SLE) in adults whose disease is not
well controlled by standard treatment.
2. What should I know before I am given SAPHNELO?
Talk to your doctor if you have ever had an allergic reaction to anifrolumab or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
are pregnant or plan to become pregnant, or are breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or nurse if you are taking, have recently taken, or might take any
other medicines.
4. How is SAPHNELO given to you?
SAPHNELO will be given to you in a hospital or clinic by a doctor or nurse.
5. What should I know while taking SAPHNELO?
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Things you should do
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Remind any doctor, dentist or nurse you visit that you are taking SAPHNELO.
Keep your appointments with your doctor so that you do not miss a dose and your progress
is monitored.
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Things you should not do
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Do not stop taking this medicine suddenly, unless you have discussed this with your
doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how SAPHNELO
affects you.
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Call your doctor straight away if you
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Become pregnant while taking SAPHNELO
Have an infection while you are being treated with SAPHNELO, have had a serious allergic
reaction to SAPHNELO (anaphylaxis), plan to have an immunisation (vaccine), or are
diagnosed with cancer
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Looking after your medicine
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SAPHNELO will be stored by your healthcare providers at the hospital or clinic where
you receive treatment.
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6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. The most common side effects are headache, feeling sick,
being sick, feeling tired or weak and dizziness (infusion-related reaction), rash,
redness, itching or swelling of the skin where you have received SAPHNELO (hypersensitivity).
The more serious side effects are fever or flu-like symptoms, body aches, cough, chest
pain, shortness of breath, wheezing or sore throat (infection of the nose, throat,
airways or chest, sinuses or lungs), red skin rash that can cause pain and burning
(shingles).
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.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Active ingredient: anifrolumab
Consumer Medicine Information (CMI)
This leaflet provides important information about taking SAPHNELO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking SAPHNELO.
Where to find information in this leaflet:
1. Why am I taking SAPHNELO?
SAPHNELO contains the active ingredient anifrolumab. SAPHNELO is a monoclonal antibody (a type of specialised protein) that blocks the
action of a group of proteins called Type I Interferons (IFN). Type I interferons
are found at high levels in people with lupus and blocking them can reduce the inflammation
in your body that causes the signs and symptoms of lupus.
SAPHNELO is used to treat moderate to severe lupus (systemic lupus erythematosus or
SLE) in adults whose disease is not well controlled by standard treatment. You will be given SAPHNELO as well as your usual treatment for lupus.
Lupus is a disease in which the immune system (the system in the body that fights
infections) attacks your own cells and tissues, causing inflammation and organ damage.
It can affect almost any organ in the body, including skin, joints, kidneys, brain
and other organs, and can cause pain, rashes, fatigue, swelling in joints, and fevers.
2. What should I know before I am given SAPHNELO?
Warnings
Do not take SAPHNELO if:
you are allergic to anifrolumab or any of the ingredients listed at the end of this
leaflet
Check with your doctor if you:
have any other medical conditions
take any medicines for any other conditions
have a long term infection or if you have an infection that keeps coming back
get an infection or have symptoms of an infection. Symptoms may include fever or flu-like
symptoms, muscle or joint aches, cough, shortness of breath, stinging or burning while
urinating, diarrhoea or stomach pain, shingles (a red skin rash that can cause pain
and burning)
think you have had an allergic reaction. Symptoms may include swelling of your face,
tongue or mouth, breathing difficulties, feeling faint, dizzy or lightheaded
have recently had or plan to have an immunisation (vaccine)
have, or have had, cancer
if your lupus affects your kidneys or nervous system
if you are receiving another biologic medicinal product (such as belimumab for your
lupus)
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. It is not known if SAPHNELO can harm your unborn baby. Your doctor will decide if
you can be given SAPHNELO.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether SAPHNELO is passed into breast milk. Your doctor will discuss
with you whether you should stop treatment with SAPHNELO while you are breastfeeding
or if you should stop breastfeeding.
Children and adolescents
SAPHNELO should not be used in children and adolescents below 18 years of age.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SAPHNELO.
4. How is SAPHNELO given to you?
SAPHNELO will be given to you in a hospital or clinic.
A doctor or nurse will give you SAPHNELO through a drip in your vein (intravenous
infusion) over 30 minutes, every 4 weeks
The recommended dose is 300 mg
If you miss an appointment to get SAPHNELO
Call your doctor as soon as possible to reschedule your appointment
It is important that you do not miss a dose of SAPHNELO
If you stop taking SAPHNELO
Do not stop treatment with SAPHNELO unless you have discussed this with your doctor
If you have any further questions about your treatment, ask your doctor
5. What should I know while taking SAPHNELO?
Things you should do
Remind your doctor, dentist or nurse you visit that you are taking SAPHNELO
Keep your appointments with your doctor so that you do not miss a dose and your progress
is monitored
Call your doctor straight away if you:
become pregnant while taking SAPHNELO
have an infection while you are being treated with SAPHNELO. Your doctor will want
to check that your infection is being properly treated. Symptoms may include fever
or flu-like symptoms, muscle or joint aches, cough, shortness of breath, stinging
or burning while urinating, shingles (a red skin rash that can cause pain and burning)
have had a serious allergic reaction to SAPHNELO. Symptoms may include swelling of
your face, tongue or mouth, breathing difficulties, feeling faint, dizzy or lightheaded
plan to have an immunisation (vaccine)
are diagnosed with cancer
Things you should not do
Do not stop taking this medicine suddenly, unless you have discussed this with your
doctor
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SAPHNELO
affects you.
It is not expected that SAPHNELO will affect your ability to drive or use any machines
or tools. Be careful if you feel tired, dizzy, or have a headache.
Looking after your medicine
SAPHNELO will be stored by your healthcare providers at the hospital or clinic where
you receive treatment.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Serious side effects
The above list includes serious side effects that require medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems.
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SAPHNELO contains
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Active ingredient
(main ingredient)
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anifrolumab
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Other ingredients
(inactive ingredients)
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histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate,
polysorbate 80, and water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What SAPHNELO looks like
SAPHNELO (AUST R 350930) is a clear to opalescent, colourless to slightly yellow concentrated
solution supplied in a clear vial closed by a rubber stopper with an aluminium seal.
There is 1 vial in each pack.
Who distributes SAPHNELO
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
Macquarie Park NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in June 2024.
SAPHNELO is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2024
VV-RIM-04931514 V2.0