300 mg concentrate for solution for infusion
anifrolumab
What Saphnelo is and what it is used for
What Saphnelo is
Saphnelo contains the active substance anifrolumab and is a monoclonal antibody (a targeted protein that binds to a specific target in the body).
What Saphnelo is used for
Daphne is used to treating moderate to severe SLE (systemic lupus erythematosus) in adults whose disease is not well controlled by standard treatments [“oral corticosteroids” ( cortisone ), “immunosuppressants” and/or “antimalarial drugs”].
You will receive Saphnelo in addition to your usual treatment for SLE.
SLE is a disease in which the system that is supposed to fight diseases (the immune system) attacks your cells and tissues. This causes inflammation and can also cause damage to the organs. SLE can affect almost any organ in the body, including skin, joints, kidneys, brain, and other organs. This in turn can cause pain, rash, swelling of joints, and fever and can make you feel very tired or weak.
How Saphnelo works
People with SLE have high levels of proteins called “type I interferons” which stimulate the activity of the immune system. Anifrolumab binds to a specific target in the body ( receptor ) on which these proteins act and prevents them from functioning. By inhibiting their effect, one can in this way reduce inflammation in the body.
The benefits of using Saphnelo
Daphne can help reduce disease activity and reduce the number of SLE relapses you have. If you are taking medicines called ‘oral corticosteroids’, using Saphnelo may allow your doctor to reduce the daily dose of one of these, which is needed to help control your SLE.
What you need to know before you are given Saphnelo
Daphne should not be given to you
- if you are allergic to anifrolumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor if you are unsure.
Warnings and cautions
Talk to your doctor or nurse before giving you Saphnelo:
- if you think you have ever had an allergic reaction to this medicine (see below under “Be observant for signs of severe allergic reactions and infections”).
- if you get an infection or have symptoms of an infection (see below under “Be observant for signs of severe allergic reactions and infections”).
- if you have a long-term infection or if you have a recurring infection.
- if you have SLE that affects your kidneys or nervous system.
- if you have or have had cancer.
- if you have recently received an immunization (vaccine) or are planning to receive one. Certain types of vaccine (“live” or “live attenuated” vaccine) should not be given to you while you are being treated with this medicine.
- if you are taking another biological medicine (eg belimumab for your SLE ).
If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Saphnelo.
Be observant of signs of severe allergic reactions and infection
Daphne can cause severe allergic reactions ( anaphylaxis ) see section 4. Seek medical advice immediately if you think you may have had a severe allergic reaction. Signs of this may include:
- swelling of the face, tongue, or mouth
- breathing difficulties
- feeling dizzy or dizzy (due to a drop in blood pressure).
You may have a higher risk of getting an infection when you are treated with Saphnelo. Tell your doctor or nurse as soon as possible if you notice signs of a possible infection, which include:
- fever or flu-like symptoms
- muscle aches
- cough or shortness of breath (these may be signs of a respiratory infection, see section 4)
- burning sensation when urinating or need to urinate more often than usual
- diarrhea or abdominal pain
- red rash that may cause pain or a burning sensation (this may be a sign of shingles, see section 4).
Children and young people
Do not give this medicine to children and adolescents under 18 years of age. Daphne has not been studied in this age group.
Other drugs and Saphnelo
- Tell your doctor if you have recently taken, or might take any other medicines.
- Tell your doctor if you have recently had or will receive a vaccination. You should not receive 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 breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
It is not known if Saphnelo can harm your unborn baby.
- Before starting treatment with Saphnelo, tell your doctor if you are pregnant or think you may be pregnant. Your doctor will decide if you can get this medicine.
- Talk to your doctor if you are planning to become pregnant during treatment with this medicine.
- If you become pregnant while being treated with Saphnelo, tell your doctor. They will discuss with you if you should stop being treated with this medicine.
Breast-feeding
- Before starting treatment with Saphnelo, tell your doctor if you are breastfeeding. It is not known if Saphnelo passes into breast milk. Your doctor will discuss with you whether you should stop being treated with this medicine while you are breastfeeding, or you should stop breastfeeding.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
How Saphnelo is used
A doctor or nurse will give you this medicine.
- The recommended dose is 300 mg.
- It is given as a drip into a vein ( intravenous infusion ) for 30 minutes.
- It is given every four weeks.
If you miss a visit when you should have received Saphnelo, contact your doctor as soon as possible to book a new visit.
If you stop taking Saphnelo
Your doctor will decide if you need to stop treatment with this medicine.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions:
Severe allergic reactions ( anaphylaxis ) are uncommon (may affect up to 1 in 100 people). Seek immediate medical attention or the nearest emergency department if you experience any of the following signs of a severe allergic reaction:
- swelling of the face, tongue, or mouth
- breathing difficulties
- feeling dizzy or dizzy (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 user in 10)
- the infection you in the nose or throat
- respiratory tract infection ( bronchitis )
Common (may affect up to 1 in 10 people)
- infection is in the sinuses or lungs
- Shingles ( herpes zoster) – a red rash that can cause pain and burning sensation
- allergic reactions ( hypersensitivity reactions )
- infusion reactions – may occur at the time of infusion or shortly thereafter; Symptoms may include headache, nausea, vomiting, feeling very tired, weakness and dizziness.
How to store Saphnelo
The doctor, nurse, or pharmacist is responsible for storing this medicine. The storage instructions are as follows:
- Do not use this medicine after the expiry date which is stated on the vial and carton label after EXP. The expiration date is the last day of the specified 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. Sensitive to light.
Contents of the packaging and other information
Content declaration
- The active substance is anifrolumab. Each vial contains 300 mg of anifrolumab.
- The other ingredients are histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate, polysorbate 80, and water for injections.
What the medicine looks like and the contents of the pack
Daphne is supplied as a clear to opalescent, colorless to pale yellow concentrated solution.
Daphne is available in packs containing 1 vial.
Marketing Authorization Holder and Manufacturer
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaAstrology Bulgaria BODYTel: +359 24455000 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 | HungaryAstraZeneca Kft.Tel .: +36 1 883 6500 |
| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
| GermanyAstraZeneca GmbHTel: +49 40 809034100 | The NetherlandsAstraZeneca BVTel: +31 79 363 2222 |
| EestiAstraZenecaTel: +372 6549 600 | NorwayAstraZeneca ASTel: +47 21 00 64 00 |
| GreeceAstraZeneca AE:Ηλ: +30 210 6871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00 |
| FranceAstraZenecaTel: +33 1 41 29 40 00 | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 | SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777 |
| ItalyAstraZeneca SpATel: +39 02 9801 1 | Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010 |
| ΚύπροςAlexander the Great:Ηλ: +357 22490305 | SwedenAstraZeneca ABTel: +46 8 553 26 000 |
| LatviaSIA AstraZeneca LatvijaTel: +371 67377100 | United Kingdom (Northern Ireland)AstraZeneca UK LtdTel: +44 1582 836 836 |