Saphnelo - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Saphnelo 300 mg concentrate for solution for infusion anifrolumab

V This medicine is subject to additional monitoring. This will allow quick identification of new afetyinformation. You can help by reporting anyside effects you may get. See the end ofsection 4 forhow 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 system. Anifrolumab attaches to a target (receptor) that these proteins act on, stopping them from working. Blocking their action in this way can reduce the inflammation in your body that causes the signs of lupus.

The benefits of using Saphnelo

Saphnelo may help to reduce your lupus disease activity and reduce the number of lupus flares you have. If you are taking medicines called ‘oral corticosteroids’, using Saphnelo may also allow your doctor to reduce the daily dose of oral corticosteroids that is needed to help control your lupus.

2. What you need to know before you are given Saphnelo

You should not be given Saphnelo

• if you are allergic to anifrolumab or any of the other ingredients of this medicine (listed in

section 6). Talk to your doctor or nurse if you are not sure.

Warnings and precautions

Talk to your doctor or nurse before you are given Saphnelo:

• if you think you have had an allergic reaction to this medicine at any time (see below under

‘Look out for signs of serious allergic reactions and infections’).

• if you get an infection or have symptoms of an infection (see below under ‘Look out for signs

of serious allergic reactions and infections’).

• if you have a long-term infection or if you have an infection that keeps coming back.
• if your lupus affects your kidneys or nervous system.
• if you have, or have had, cancer.
• if you have recently had an immunisation (vaccine) or plan to have one. You should not be

given certain types of vaccines (‘live’ or ‘live attenuated’ vaccines) while being treated with this medicine.

• if you are receiving another biologic medicinal product (such as belimumab for your lupus).

If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Saphnelo.

Look out for signs of serious allergic reactions and infections

Saphnelo may cause serious allergic reactions (anaphylaxis) see section 4. Get medical attention immediately if you think you may be having a serious allergic reaction. Signs may include:

• swelling of your face, tongue, or mouth
• breathing difficulties
• feeling faint, dizzy or lightheaded (due to a drop in blood pressure).

You may be more at risk of getting an infection when you are being treated with Saphnelo. Tell your doctor or nurse as soon as possible if you notice signs of any possible infection, including:

• fever or flu-like symptoms
• muscle aches
• cough or feeling short of breath (these may be signs of an infection in your airways, see

section 4)

• burning when you urinate or passing urine more often than usual
• diarrhoea or stomach pain
• red skin rash that can cause pain and burning (this may be a sign of shingles, see section 4).

Children and adolescents

Do not give this medicine to children and adolescents less than 18 years of age because it has not been studied in this age group.

Other medicines and Saphnelo

• Tell your doctor if you are taking, have recently taken or might take any other medicines.
• Tell your doctor if you have recently had or are going to have a vaccination. You should not be

given certain types of vaccines while using this medicine. If you are not sure, talk to your doctor or nurse before and during treatment with Saphnelo.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

It is not known if Saphnelo can harm your unborn baby.

• Before you start treatment with Saphnelo, tell your doctor if you are pregnant or think you

may be pregnant. Your doctor will decide if you can be given this medicine.

• Talk to your doctor if you plan to become pregnant while being treated with this medicine.
• If you become pregnant while being treated with Saphnelo, tell your doctor. They will discuss

with you whether you should stop treatment with this medicine.

Breast-feeding

• Before you start treatment with Saphnelo, tell your doctor if you are breast-feeding. It is

not known whether this medicine is passed into breast milk. Your doctor will discuss with you whether you should stop treatment with this medicine while you are breast-feeding, or if you should stop breast-feeding.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive and use machines.

• 3. How Saphnelo is used

A nurse or doctor will give you Saphnelo.

• The recommended dose is 300 mg.
• It is given through a drip into a vein (intravenous infusion) over 30 minutes.
• It is given every 4 weeks.

If you miss an appointment to get Saphnelo call your doctor as soon as possible to make another appointment.

Stopping treatment with Saphnelo

Your doctor will decide if you need to stop being treated with this medicine.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions:

Serious allergic reactions (anaphylaxis) are uncommon (may affect up to 1 in 100 people). Get medical attention immediately, or go to the nearest emergency department, if you get any of the following signs of a serious allergic reaction:

• swelling of your face, tongue, or mouth
• breathing difficulties
• feeling faint, dizzy or lightheaded (due to a drop in blood pressure).

Other side effects:

Tell your doctor or nurse if you get any of the following side effects.

Very common (may affect more than 1 in 10 people)

• infections of the nose or throat
• chest infection (bronchitis)

Common (may affect up to 1 in 10 people)

• infections of the sinuses or lungs
• shingles (herpes zoster) – a red skin rash that can cause pain and burning
• allergic (hypersensitivity) reactions
• infusion reactions – can happen at the time of the infusion or shortly after; symptoms may

include headache, feeling sick (nausea ), being sick (vomiting ), feeling very tired or weak (fatigue ) and feeling dizzy

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Saphnelo

The doctor, nurse or pharmacist is responsible for storing this medicine. The storage details are as follows:

• Do not use this medicine after the expiry date which is stated on the vial label and carton after

EXP. The expiry date refers to the last day of that month.

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C – 8°C).
• Do not freeze or shake.
• Store in the original package to protect from light.

6. Contents of the pack and other information

What Saphnelo contains

• The active substance is anifrolumab. Each vial contains 300 mg anifrolumab.
• The other ingredients are histidine, histidine hydrochloride monohydrate, lysine hydrochloride,

trehalose dihydrate, polysorbate 80 and water for injections.

What Saphnelo looks like and contents of the pack

Saphnelo is supplied as a clear to opalescent, colourless to slightly yellow concentrate solution.

Saphnelo is available in packs containing 1 vial.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11	Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550
Efc^rapufl Acmpa3eHeKa Etnrapua EOOfl Tea.: +359 24455000	Luxembourg/Lu­xemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11
Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111	Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 40 809034100	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EZZáSa AstraZeneca A.E. Tql: +30 210 6871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog ÄZsKTOJp «EappaKsunKii At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

In order to improve the traceability, the name and the batch number of the administered product should be clearly recorded.

Saphnelo is supplied as a single-dose vial. The solution for infusion should be prepared and administered by a healthcare professional, using aseptic technique as follows:

Preparation of solution

• 1. Visually inspect the vial for particulate matter and discolouration. Saphnelo is a clear to opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial.

• 2. Dilute 2.0 mL of the Saphnelo solution for infusion in an infusion bag to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.

• 3. Mix the solution by gentle inversion. Do not shake.

• 4. Any concentrate remaining in the vial must be discarded.

• 5. From a microbiological point of view, once diluted the medicinal product should be used

immediately. Ifnot used immediately, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C – 8°C or for 4 hours at room temperature. Discard the diluted solution if not used within that time.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Administration

• 1. It is recommended that the solution for infusion be administered immediately after preparation. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15°C to 25°C) prior to administration.

• 2. Administer the infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.

• 3. Upon completion of the infusion, flush the infusion set with 25 mL sodium chloride 9 mg/mL (0.9%) solution for injection to ensure that all of the solution for infusion has been administered.

• 4. Do not co-administer other medicinal products through the same infusion line.