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 vial - It will be given to you in a hospital or clinic by a doctor or nurse.
SAPHNELO pre-filled pen - Check with your healthcare provider to decide if you can
inject SAPHNELO yourself or if your caregiver can do that for you.More instructions
can be found in Section
4. How is SAPHNELO given to you? in the full CMI.
5. What should I know while taking SAPHNELO?
|
Things you should do
|
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.
|
|
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.
|
|
Call your doctor straight away if you
|
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
|
|
Looking after your medicine
|
SAPHNELO vial will be stored by your healthcare providers at the hospital or clinic
where you receive treatment. Refer to full CMI for storage of SAPHNELO pre-filled
pen.
|
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.
SAPHNELO may help to reduce your lupus disease activity and the number of lupus flares
you are experiencing. If you are taking medicines called 'oral corticosteroids', using
SAPHNELO may also allow your healthcare provider to reduce your daily dose of the
oral corticosteroids that are needed to help control your lupus.
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 vial
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.
SAPHNELO pre-filled pen
Always use this medicine exactly as your healthcare provider has told you. Check with
your healthcare provider if you are not sure.
The recommended dose is 120 mg once a week, given as an injection under the skin (subcutaneous).
Your healthcare provider will decide if you can inject SAPHNELO yourself or if your
caregiver can do that for you. Before you use SAPHNELO, your healthcare provider should
show you or your caregiver how to use SAPHNELO pre-filled pen in the right way.
SAPHNELO vial
Call your doctor as soon as possible to reschedule your appointment if you miss an
appointment to get Saphnelo IV.
It is important that you do not miss a dose of SAPHNELO.
SAPHNELO pre-filled pen
Read the ‘Instructions for Use’ before injecting SAPHNELO and each time you get a
refill. There may be new information.
If you have used more SAPHNELO than you should, talk to your healthcare provider immediately.
If you forget to use SAPHNELO, inject a dose as soon as you remember. Then, continue
once weekly dosing based on the new day SAPHNELO was injected or on your regularly
scheduled day as long as there are at least 3-days between the doses. If you are not
sure when to inject SAPHNELO, call your healthcare provider.
If you or your caregiver have any questions, talk to your healthcare provider.
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 vial
SAPHNELO will be stored by your healthcare providers at the hospital or clinic where
you receive treatment.
SAPHNELO pre-filled pen
Store in a refrigerator at 2°C - 8°C in the original carton in order to protect from
light.
Do not freeze or shake or expose to heat.
If needed, an unopened carton can be stored at room temperature (20°C - 25°C) for
up to 7 days. Once removed from the refrigerator and brought to room temperature,
SAPHNELO must either be used within 7 days or thrown away (disposed of).
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and carton
after expiry. The expiry date refers to the last day of that month.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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 vial and pre-filled pen contains
|
Active ingredient
(main ingredient)
|
anifrolumab
|
|
Other ingredients
(inactive ingredients)
|
histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate,
polysorbate 80, and water for injections
|
Do not take this medicine if you are allergic to any of these ingredients.
What SAPHNELO looks like
SAPHNELO vial (AUST R 350930)
SAPHNELO 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.
SAPHNELO pre-filled pen (AUST R 484545)
SAPHNELO is supplied as a clear to opalescent, colourless to slightly yellow concentrate
solution.
Each pre-filled pen contains 0.8 mL/120 mg of anifrolumab (150 mg/mL).
There is 1 pre-filled pen 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 May 2026.
SAPHNELO is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2026
VV-RIM-04931514 v3