Saphnelo 300 mg concentrado para solucion para perfusion

Prospect: information for the patient

Saphnelo300mg concentrate for infusion solution

Anifrolumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect thoroughly before you are administered this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospect. See section4.

1.What Saphnelo is and for what it is used

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

3.How to use Saphnelo

4.Possible adverse effects

5.Storage of Saphnelo

6.Contents of the package and additional information

What is Saphnelo

Saphnelo contains the active ingredient 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 treatmild to severe lupus(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 in which the system that fights infections (the immune system) 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, joint swelling, fever, and make you feel very tired or weak.

How Saphnelo works

People with lupus have high levels of 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 lupus symptoms.

Benefits of using Saphnelo

Saphnelo may help reduce lupus activity and the number of flares you have. If you are taking medications called "oral corticosteroids", using Saphnelo may also allow your doctor to reduce the daily dose of oral corticosteroids needed to help control your lupus.

Do not receive Saphnelo

• if you are allergic to anifrolumab or any of the other components of this medication (listed in section6). Consult your doctor or nurse if you have any doubts.

Warnings and precautions

Consult your doctor or nurse before receiving Saphnelo:

• if you think you have had anallergic reactionto this medication at some point (see more on «Monitoring for possible signs of severe allergic reactions and infections»).
• if you contract an infection or have symptoms of aninfection(see more on «Monitoring for possible signs of severe allergic reactions and infections»).
• if you have a long-term infection or if you have an infection that keeps recurring.
• if lupus affects your kidneys or nervous system.
• if you have or have had cancer.
• if you have recently been vaccinated or plan to be. Do not receive certain types of vaccines (live or attenuated microbe vaccines) during treatment with this medication.
• if you are receiving another biologic medication (such as belimumab for lupus).

If you are unsure whether any of the above applies to you, consult your doctor or nurse before receiving Saphnelo.

Monitoring for signs of severe allergic reactions and infections

Saphnelo may causesevere allergic reactions (anaphylaxis)see section4.Seek medical attention immediatelyif you think you may be having a severe allergic reaction. The signs may be:

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

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

• fever or flu-like symptoms
• muscle pain
• cough or feeling of lack of air (may be signs of respiratory tract infection, see section4)
• burning sensation while urinating or urinating more frequently than usual
• diarrhea or stomach pain
• red rash that may cause pain and itching (may be a sign of shingles, see section4).

Children and adolescents

Do not administer this medication to children and adolescents under 18years old because it has not been studied in this age group.

Other medications and Saphnelo

• Inform your doctor if you are taking, have taken recently, or may need to take any other medication.
• Inform your doctor if you have recently been vaccinated or plan to be. Do not receive certain types of vaccines while using this medication. If you are unsure, consult your doctor or nurse before and during treatment with Saphnelo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

The effects of Saphnelo on the fetus are unknown.

• Inform your doctor before starting treatment with Saphnelo if you are pregnantor think you may be pregnant. Your doctor will decide if you can receive this medication.
• Consult your doctor if you plan to become pregnantwhile receiving treatment with this medication.
• If you become pregnantwhile receiving treatment with Saphnelo, inform your doctor. They will tell you if you should stop treatment with this medication.

Breastfeeding

• Inform your doctor before starting treatment with Saphnelo if you are breastfeeding. It is unknown if this medication passes into breast milk. Your doctor will tell you if you should stop treatment with this medication during breastfeeding or if you should stop breastfeeding.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive and operate machinery.

A nurse or doctor will administer Saphnelo to you.

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

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

Discontinuation of Saphnelo treatment

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

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Severe Allergic Reactions:

Severe allergic reactions (anaphylaxis) are rare (may affect up to 1 in 100 people).Seek immediate medical attention or visit the nearest emergency serviceif you experience any of the following signs of a severe allergic reaction:

• Swelling of the face, tongue, or mouth
• Difficulty breathing
• Sensation of dizziness, drowsiness, or fainting (due to a drop in blood pressure).

Other Adverse Effects:

Inform your doctor or nurse if you notice any of the following adverse effects.

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

• Upper respiratory tract infections or sore throats
• Chest infections (bronchitis)

Common(may affect up to1 in 10 people)

• Paranasal sinus or lung infections
• Herpes zoster, a red skin rash that may cause pain and itching
• Allergic reactions (hypersensitivity)
• Reactions to infusion: may occur during infusion or shortly after; symptoms may include headache, nausea, vomiting, intense fatigue or weakness, and dizziness.

Unknown Frequency(cannot be estimated from available data)

• Joint pain (arthritis)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

The doctor, nurse, or pharmacist is responsible for the storage of this medication. The storage details are as follows:

• Do not use this medication after the expiration date that appears on the vial label and the box after "EXP/CAD". The expiration date is the last day of the month indicated.
• Keep this medication out of the sight and reach of children.
• Store in a refrigerator (between 2°C and 8°C).
• Do not freeze or shake.
• Store in the original packaging to protect it from light.

Composition of Saphnelo

• Theactive principleis anifrolumab. Each vial contains 300mg of anifrolumab.
• Theother componentsare histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate, polisorbate 80 and water for injection.

Appearance of the product and contents of the pack

Saphnelo is supplied as a clear to opalescent, colourless or slightly yellowish concentrated solution.

Saphnelo is available in packs containing 1vial.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible Person

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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This information is intended for healthcare professionals:

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

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

Preparation of the infusion solution

1. Visually inspect the vial for particles and colour changes. Saphnelo is a clear to opalescent, colourless or slightly yellowish concentrated solution. Discard the vial if the solution is turbid, has colour changes or visible particles. Do not shake the vial.

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

1. Mix the solution gently by 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 has been demonstrated for 24hours at 2°C-8°C or for 4hours at room temperature. Discard the diluted solution if not used within that time.

If not used immediately, the times and conditions of storage after dilution and before use 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 (between 15°C and 25°C) before administration.

1. Administer the infusion solution intravenously over 30minutes through a sterile in-line filter with a pore size of 0.2 to 15microns with low protein binding or an additional filter.

1. After completion of the infusion, wash the equipment with 25ml of sodium chloride 9mg/ml (0.9%) solution for injection to ensure that all the infusion solution has been administered.

1. Do not administer other medicinal products through the same infusion line.

Elimination

The unused medicinal product and all materials that have been in contact with it will be disposed of in accordance with local regulations.