Sylvant 100 mg polvo para concentrado para solucion para perfusion

Patient Information Leaflet

Sylvant 100 mg Powder for Concentrate for Solution for Infusion

siltuximab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

1. What you need to know before using Sylvant
2. How to use Sylvant

1. Possible adverse effects

1. Storage of Sylvant

1. Contents of the pack and additional information

What is SYLVANT

SYLVANT is a medication that contains the active ingredient siltuximab.

Siltuximab is a monoclonal antibody (a type of specialized protein) that selectively binds to a protein target in the body called interleukin-6 (IL-6).

How is SYLVANT used

SYLVANT is used to treat multicentric Castleman disease (MCD) in adult patients who are not infected with human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8).

Multicentric Castleman disease causes the formation of benign tumors (non-cancerous growths) in the lymph nodes of the body. Symptoms of this disease may include fatigue, night sweats, tingling sensation, and loss of appetite.

How SYLVANT works

Patients with MCD produce too much IL-6 and it is thought that this contributes to the abnormal growth of certain lymph node cells. By binding to IL-6, siltuximab blocks its activity and slows down abnormal cell growth. This helps to reduce the size of affected lymph nodes, which reduces disease symptoms and may help you to carry out your daily activities normally.

Do not administer SYLVANT if:

You have a severe allergy to siltuximab or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before SYLVANT is administered to you if:

• You currently have an infection; this is because SYLVANT may decrease your ability to perceive or fight off infections, which may worsen.
• You are going to be vaccinated or need to be vaccinated in the near future – this is because some vaccines should not be administered with SYLVANT.

• You have high levels of lipids in your blood (hypertriglyceridemia) – this is because SYLVANT may increase these levels. Your doctor may prescribe you medication to correct it.
• You have a condition such as stomach ulcer or diverticulitis that may increase the risk of a tear in the stomach or intestine (gastrointestinal perforation). Symptoms of a tear include worsening stomach pain, nausea, change in bowel habits, and fever – if you experience any of these symptoms, consult your doctor immediately.

• You have liver disease or changes that appear in liver function blood tests. Your doctor will keep you under observation and monitor your liver function.

If any of the above situations apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before starting to use SYLVANT.

Severe allergic reactions

Inform your doctor immediately if you have a severe allergic reaction during or after infusion. Symptoms include: difficulty breathing, chest tightness, wheezing, severe dizziness or fainting, swelling of the lips, or skin rash.

Infections

You may be more prone to infections while receiving treatment with SYLVANT.

These infections may be severe, such as pneumonia or septicemia (also known as "sepsis").

If you experience any symptoms of infection during SYLVANT treatment, inform your doctor immediately. Symptoms include: cough, flu-like symptoms, feeling unwell, warm or red skin, fever. Your doctor may suspend SYLVANT treatment immediately.

Children and adolescents

The safety and efficacy of SYLVANT in this population are unknown, therefore, SYLVANT should not be administered to children or adolescents.

Other medications and SYLVANT

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Theophylline, used to treat asthma

• Warfarin, an anticoagulant

• Ciclosporin, used during and after organ transplantation

• Oral contraceptives, used to prevent pregnancy.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before starting to use SYLVANT.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before this medication is administered to you.

• SYLVANT is not recommended during pregnancy. The effects of SYLVANT on the newborn or pregnant woman are unknown.

• You should not become pregnant while receiving SYLVANT treatment and for 3 months after completing treatment. During this time, you should use effective birth control methods.

• In some cases, if you are pregnant and need treatment for ECM, your doctor may advise that the benefits of using SYLVANT for your health outweigh the possible risks to the fetus, including the increased risk of infection and the use of certain vaccines in newborns born to mothers exposed to SYLVANT during pregnancy.

The passage of SYLVANT into breast milk is unknown. You and your doctor must decide whether to continue using SYLVANT, or to stop treatment with SYLVANT and breastfeed.

Driving and operating machinery

It is unlikely that SYLVANT will affect your ability to drive, ride a bike, or use any tools or machines.

Your doctor or nurse will only administer SYLVANT in a hospital or clinic.

• The recommended dose is 11 milligrams per kilogram of body weight, administered once every 3 weeks.

• SYLVANT will be administered as an "intravenous infusion" (through a drip in a vein, usually in the arm).

• It will be administered slowly over a period of 1 hour.

• During the SYLVANT infusion, you will be monitored for the appearance of adverse effects.

• You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment.

If you receive more SYLVANT than you should

This medication will be administered by your doctor or nurse, so it is unlikely that you will receive an excessive amount. If you believe you have been given more SYLVANT than prescribed, inform your doctor or nurse immediately. The effects of a SYLVANT overdose are unknown.

If you interrupt treatment with SYLVANT

You should not stop using SYLVANT without first speaking with your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may cause the following side effects.

Inform your doctor immediately if you experience the following side effects, as they may need to suspend your treatment:

Common(may affect up to 1 in 10 patients):

• severe allergic reaction – symptoms may include: difficulty breathing, chest tightness, rapid breathing, severe dizziness or fainting, swelling of the lips or skin rash.

Other side effects are:

Consult your doctor, pharmacist, or nurse if you experience any of the following side effects:

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

• decreased white blood cell count (neutropenia)

• decreased platelet count (thrombocytopenia)

• itching

• skin rash, skin rash with itching (eczema)

• high levels of lipids in the blood (hypertriglyceridemia)

• high levels of uric acid in the blood, which may cause gout

• abnormalities in kidney function tests

• swelling of the arms, legs, neck, or face

• high blood pressure

• respiratory infections – such as colds, nasal congestion, or sore throats

• urinary tract infections

• common cold

• sore throat

• stomach discomfort, constipation, diarrhea, heartburn, mouth ulcers (pain), nausea, vomiting

• feeling of dizziness

• headache

• joint pain, arm or leg pain

• weight gain.

Common(may affect no more than 1 in 10 people):

• high cholesterol levels in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

Do not use if you see opaque or foreign particles and/or if the solution appears discolored after reconstitution.

Composition of SYLVANT

• The active ingredient is siltuximab. Each single-use vial contains 100 mg of siltuximab. After reconstitution, the solution contains 20 mg of siltuximab per ml.

• The other components (excipients) are histidine, histidine hydrochloride, polisorbate 80, and sucrose.

Appearance of the product and contents of the pack

• SYLVANT is presented in the form of a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).

• SYLVANT is presented in packs containing 1 vial.

Marketing Authorization Holder

Recordati Netherlands B.V.

Beechavenue 54,

1119PW Schiphol-Rijk

Netherlands

Responsible for manufacturing

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

Last review date of this leaflet:07/2023.

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicines.

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The following information is intended only for healthcare professionals:

This medicine is for single use only.

1. Use aseptic technique.

1. Calculate the dose, the total volume of the SYLVANT reconstituted solution needed, and the number of vials required. The recommended needle for preparation is a 21-gauge 1½-inch (38 mm) needle. The infusion bags (250 ml) must contain Dextrose 5% and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE). Alternatively, PE bottles can be used.

1. Allow the vial or vials of SYLVANT to reach room temperature (15°C to 25°C) for approximately 30 minutes. SYLVANT must be maintained at room temperature during the entire preparation time. Each vial must be reconstituted with 5.2 ml of water for injection for single-use preparations to obtain a 20 mg/ml solution.

1. Gently rotate (DO NOT AGITATE OR MIX IN VORTEX OR ROTATE FORCEFULLY) the reconstituted vials to help dissolve the powder. Do not remove the contents until the powder has completely dissolved. The powder must dissolve in less than 60 minutes. Inspect the vials for particles and discoloration before preparing the dose. Do not use in the presence of foreign particles or visibly opaque and/or discolored solution.

1. Dilute the total volume of the dose of reconstituted solution to 250 ml with sterile Dextrose 5%, removing a volume equal to the volume of SYLVANT reconstituted from the 250 ml Dextrose 5% bag. Add the total volume of the reconstituted SYLVANT solution slowly to the 250 ml infusion bag. Mix gently.

1. The reconstituted solution must not be stored for more than 2 hours before adding it to the intravenous infusion bag. The infusion must be completed within 6 hours after adding the reconstituted solution to the infusion bag. Administer the diluted solution over a period of 1 hour using equipment coated with PVC, or polyurethane (PU), or PE, with an in-line filter of polyethersulfone (PES) 0.2 microns. SYLVANT does not contain preservatives; therefore, no unused infusion solution must be stored for reuse.

1. No compatibility studies have been performed to evaluate the co-administration of SYLVANT with other medicines. Do not administer the SYLVANT infusion together with other drugs using the same intravenous route.

1. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Traceability

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