Saphnelo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

anifrolumab

Available from:

AstraZeneca AB

ATC code:

L04AA

INN (International Name):

anifrolumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Lupus Erythematosus, Systemic

Therapeutic indications:

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.,

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2022-02-14

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SAPHNELO 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
anifrolumab
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 the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Saphnelo is and what it is used for
2.
What you need to know before you are given Saphnelo
3.
How Saphnelo is used
4.
Possible side effects
5.
How to store Saphnelo
6.
Contents of the pack and other information
1.
WHAT SAPHNELO IS AND WHAT IT IS USED FOR
WHAT SAPHNELO IS
Saphnelo contains the active substance anifrolumab, a ‘monoclonal
antibody’ (a type of specialised
protein that attaches to a specific target in the body).
WHAT SAPHNELO IS USED FOR
Saphnelo is used to treat MODERATE TO SEVERE LUPUS (systemic lupus
erythematosus, SLE) in adults
whose disease is not well controlled by standard therapies (‘oral
corticosteroids’,
‘immunosuppressants’ and/or ‘antimalarials’).
You will be given Saphnelo as well as your standard therapy for lupus.
Lupus is a disease in which the system that fights infections (the
immune system) attacks your own
cells and tissues. This causes inflammation and organ damage. It can
affect almost any organ in the
body, including skin, joints, kidneys, brain and other organs. It can
cause pain, rashes, swelling in
joints, fevers and make you feel very tired or weak.
HOW SAPHNELO WORKS
People with lupus have high levels of proteins called ‘type I
interferons’ which stimulate the activity
of the immune sys

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Saphnelo 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 150 mg of
anifrolumab.
One vial of 2.0 mL of concentrate contains 300 mg of anifrolumab (150
mg/mL).
Anifrolumab is a human, immunoglobulin G1 kappa (IgG1κ) monoclonal
antibody produced in mouse
myeloma cells (NS0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
Clear to opalescent, colourless to slightly yellow, pH 5.9 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Saphnelo is indicated as an add-on therapy for the treatment of adult
patients with moderate to severe,
active autoantibody-positive systemic lupus erythematosus (SLE),
despite standard therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the treatment of SLE.
Posology
The recommended dose is 300 mg, administered as an intravenous
infusion over a 30-minute period,
every 4 weeks.
In patients with a history of infusion-related reactions,
premedication (e.g., an antihistamine) may be
administered before the infusion of anifrolumab (see section 4.4).
_Missed dose_
If a planned infusion is missed, treatment should be administered as
soon as possible. A minimum
interval of 14 days should be maintained between doses.
Special populations
_Elderly (≥65 years old)_
No dose adjustment is required. There is limited information in
subjects aged ≥65 years (n=20); no
data are available in patients over 75 years of age (see section 5.2).
3
_Renal impairment_
No dose adjustment is