SAPHNELO 300 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Saphnelo300mg concentrate for solution for infusion

anifrolumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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, even if you think they are not related to the medicine. See section 4.

Contents of the pack

1. What is Saphnelo and what is it used for
2. What you need to know before you are given Saphnelo
3. How to use Saphnelo
4. Possible side effects
5. Storage of Saphnelo
6. Contents of the pack and other information

1. What is Saphnelo and what is it used for

What is Saphnelo

Saphnelo contains the active substance anifrolumab, a ‘monoclonal antibody’ (a type of specialized protein that binds to a specific target in the body).

What is Saphnelo used for

Saphnelo is used to treat moderate to severe systemic lupus erythematosus (SLE) in adults whose disease is not well controlled with conventional treatments (‘oral corticosteroids’, ‘immunosuppressants’ and/or ‘antimalarials’).

You will be given Saphnelo in addition to your usual treatment for lupus.

Lupus is a disease where the immune system (the system that fights infections) attacks its own cells and tissues. This causes inflammation and damage to organs. It can affect almost any organ in the body, such as the skin, joints, kidneys, brain, and other organs. It can cause pain, rashes, swelling of the joints, fever, and make you feel very tired or weak.

How Saphnelo works

People with lupus have high levels of certain proteins called ‘type I interferons’ that stimulate the activity of the immune system. Anifrolumab binds to a target (receptor) on which these proteins act, preventing them from acting. Blocking their action in this way can reduce the inflammation in your body that causes the signs of lupus.

Benefits of using Saphnelo

Saphnelo may help reduce lupus activity and the number of 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 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 unsure.

Warnings and precautions

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

• if you think you have had an allergic reactionto this medicine at any time (see later in ‘Monitoring for signs of serious allergic reactions and infections’).
• if you get an infectionor have symptoms of an infection(see later in ‘Monitoring 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 been vaccinated recently or are planning to be vaccinated. You should not receive certain types of vaccines (‘live’ or ‘live attenuated’ vaccines) while using this medicine.
• if you are taking another biologic medicine (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.

Monitoring for signs of serious allergic reactions and infections

Saphnelo may cause serious allergic reactions (anaphylaxis)(see section 4). Seek medical help immediatelyif you think you may be having a serious allergic reaction. The signs may be:

• swelling of the face, tongue, or mouth
• difficulty breathing
• feeling of fainting, dizziness, or lightheadedness (due to a drop in blood pressure).

You may be at a higher risk of getting an infectionduring treatment with Saphnelo. Tell your doctor or nurse as soon as possibleif you notice signs of any possible infection, including:

• fever or flu-like symptoms
• muscle pain
• cough or shortness of breath (may be signs of a respiratory infection, see section 4)
• burning sensation when urinating or urinating more often than usual
• diarrhea or stomach pain
• red skin rash that may cause pain and itching (may be a sign of shingles, see section 4).

Children and adolescents

Do not give this medicine to children and adolescents under 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 been vaccinated recently or are planning to be vaccinated. You should not receive certain types of vaccines while using this medicine. If you are unsure, 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 taking this medicine.

Pregnancy

It is not known if Saphnelo can harm the fetus.

• Before starting treatment with Saphnelo, tell your doctor if you are pregnantor 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 pregnantwhile being treated with this medicine.
• If you become pregnantduring treatment with Saphnelo, tell your doctor. They will tell you if you should stop treatment with this medicine.

Breastfeeding

• Before starting treatment with Saphnelo, tell your doctor if you are breastfeeding. It is not known if this medicine passes into breast milk. Your doctor will tell you if you should stop treatment with this medicine during breastfeeding or if you should stop breastfeeding.

Driving and using machines

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

3. How to use Saphnelo

Saphnelo will be given to you by a nurse or doctor.

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

If you miss a doseof Saphnelo, call your doctor as soon as possible to schedule another appointment.

Stopping treatment with Saphnelo

Your doctor will decide if you should stop taking this medicine.

If you have any other questions about 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). Seek medical help immediately or go to the emergency roomif you get any of the following signs of a serious allergic reaction:

• swelling of the face, tongue, or mouth
• difficulty breathing
• feeling of fainting, dizziness, or lightheadedness (due to a drop in blood pressure).

Other side effects:

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

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

• nose or throat infections
• chest infection (bronchitis)

Common(may affect up to 1 in 10 people)

• infections of the sinuses or lungs
• shingles, a red skin rash that may cause pain and itching
• allergic reactions (hypersensitivity)
• infusion reactions: may occur at the time of infusion or shortly after; symptoms may include headache, feeling sick (nausea), vomiting, extreme tiredness or weakness (fatigue), and dizziness.

Frequency not known(cannot be estimated from the available data)

• joint pain (arthralgia)

Reporting of side effects

If you get any side effects, talk to your doctor or nurse, even if you think they are not related to the medicine. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Saphnelo

The doctor, nurse, or pharmacist is responsible for the storage of 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/CAD’. The expiry date is the last day of the month shown.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C to 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 substanceis anifrolumab. Each vial contains 300 mg of anifrolumab.
• The other ingredientsare histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate, polysorbate 80, and water for injections.

Appearance and pack size

Saphnelo is provided as a clear to opalescent, colorless or slightly yellowish solution.

Saphnelo is available in packs containing 1 vial.

Marketing authorization holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can ask for more information about this medicine from your local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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This information is intended only for healthcare professionals:

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

Saphnelo is supplied in a single-dose vial. The infusion solution should be prepared and administered by a healthcare professional using the following aseptic technique:

Preparation of the solution

1. Inspect the vial visually for particles and color changes. Saphnelo is a clear to opalescent, colorless or slightly yellowish solution. Discard the vial if the solution is cloudy, discolored, or contains visible particles. Do not shake the vial.

1. Dilute 2.0 ml of the Saphnelo infusion solution to 50 ml or 100 ml with sodium chloride 9 mg/ml (0.9%) injection solution.

1. Mix the solution by gently inverting the bag. Do not shake.

1. Discard any remaining concentrate in the vial.

1. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the chemical and physical stability of the diluted solution 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 this time.

If not used immediately, the storage times and conditions of the diluted solution before administration are the responsibility of the user.

Administration

1. It is recommended to administer the infusion solution immediately after preparation. If the infusion solution has been stored in the refrigerator, allow it to reach room temperature (15°C to 25°C) before administration.

1. Administer the infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, low-protein-binding, 0.2 to 15 micron filter.

1. After the infusion is complete, flush the line with 25 ml of sodium chloride 9 mg/ml (0.9%) injection solution to ensure that all of the infusion solution is administered.

1. Do not administer other medicines through the same infusion line.

Disposal

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.