Sylvant 100 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

SYLVANT 100 mg powder for concentrate for solution for infusion

siltuximab

This medicinal product is subject to additional monitoring, which will allow for quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read the entire 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, ask your doctor, pharmacist, or nurse.

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

Leaflet contents

1. What SYLVANT is and what it is used for

2. What you need to know before using SYLVANT

3. How to use SYLVANT

4. Possible side effects

5. How to store SYLVANT

6. Contents of the pack and other information

1. What SYLVANT is and what it is used for

What SYLVANT is

SYLVANT is a medicine that contains the active substance siltuximab.

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

What SYLVANT is used for

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 benign tumours (non-cancerous growths) to develop in the lymph nodes throughout the body. Symptoms of this disease may include feeling tired, night sweats, tingling sensations, and loss of appetite.

How SYLVANT works

Patients with MCD produce too much IL-6, and this is thought to contribute 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 reduce the size of the affected lymph nodes, thereby reducing disease symptoms and helping you carry out your normal daily activities.

2. What you need to know before using SYLVANT

Do not use SYLVANT if:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving SYLVANT if:

• you currently have an infection; this is because SYLVANT may reduce your ability to detect or fight infections, which could worsen them.

• you are due to receive or need a vaccination soon – this is because certain vaccines should not be given while receiving SYLVANT.

• you have high levels of lipids in your blood (hypertriglyceridemia) – this is because SYLVANT may increase these levels. Your doctor may prescribe medication to correct this.

• 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, feeling sick (nausea), changes in bowel habits, and fever – if you experience any of these symptoms, contact your doctor immediately.

• you have liver disease or abnormal liver function test results. Your doctor will monitor and observe 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 treatment with SYLVANT.

Allergic reactions

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

Infections

You may be more likely to develop infections while receiving SYLVANT treatment.

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

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

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 medicines and SYLVANT

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• theophylline, used to treat asthma

• warfarin, an anticoagulant

• cyclosporine, 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 treatment with SYLVANT.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this medicine.

• Use of SYLVANT during pregnancy is not recommended. It is unknown whether SYLVANT has harmful effects on the newborn, pregnant woman, or breastfeeding woman.

• You must not become pregnant while being treated with SYLVANT and for 3 months after completing treatment. During this time, you should use effective contraceptive methods.

• In some cases, if you are pregnant and require treatment for MCD, your doctor may determine that the benefit of using SYLVANT for your health outweighs the potential risks to the fetus, including an increased risk of infection and the need for specific vaccinations in infants born to mothers exposed to SYLVANT during pregnancy.

It is unknown whether SYLVANT passes into breast milk. You and your doctor must decide whether to continue SYLVANT treatment or to breastfeed, thereby interrupting treatment with SYLVANT.

Driving and using machines

It is unlikely that SYLVANT will affect your ability to drive, ride a bicycle, or operate tools or machinery.

3. How to use SYLVANT

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

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

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

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

• During the SYLVANT infusion, you will be monitored for the occurrence of adverse reactions.

• You will continue receiving treatment until you and your doctor agree that you are no longer benefiting from it.

If you receive more SYLVANT than you should

This medicine will be administered by your doctor or nurse, so it is unlikely that you will receive too much. If you think that you have been given more SYLVANT than prescribed, inform your doctor or nurse immediately. The side effects of overdose with SYLVANT are unknown.

If you interrupt treatment with SYLVANT

Do not stop using SYLVANT without first talking to your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

Tell your doctor immediately if you experience the following adverse effects, as he or she may need to stop your treatment:

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

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

Other adverse effects are:

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

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

• decrease in the number of white blood cells (neutropenia)

• decrease in the number of platelets (thrombocytopenia)

• itching

• rash, itchy skin rash (eczema)

• elevated levels of lipids in the blood (hypertriglyceridemia)

• elevated levels of uric acid in the blood, which may lead to gout

• abnormalities in kidney function tests

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

• high blood pressure

• respiratory infections – such as of the nose, sinuses, or throat

• urinary tract infection

• common cold

• throat irritation

• stomach pain or discomfort, constipation, diarrhea, heartburn, mouth ulcers (sores) in the mouth, nausea, vomiting

• feeling dizzy

• headache

• joint pain, pain in the arm or leg

• weight gain.

Frequent (may affect up to 1 in 10 people):

• high blood cholesterol concentration

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SYLVANT

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

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

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

6. Contents of the container and other information

Composition of SYLVANT

• The active substance 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, polysorbate 80, and sucrose.

Appearance of the product and contents of the container

• SYLVANT is presented as a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).

• SYLVANT is available in packs containing 1 vial.

Marketing Authorization Holder

Recordati Netherlands B.V.

Beechavenue 54,

1119PW Schiphol-Rijk

The Netherlands

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

The Netherlands

Date of the most recent revision of this leaflet: 07/2023.

Other sources of information

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

The following information is intended for healthcare professionals only:

This medicinal product is for single use only.

1. Use an aseptic technique.

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

3. Allow the vial(s) of SYLVANT to reach room temperature (15°C to 25°C) for approximately 30 minutes. SYLVANT should be kept at room temperature throughout the preparation process. Each vial should be reconstituted with 5.2 ml of Water for Injections (single-use) to obtain a solution of 20 mg/ml.

4. Gently rotate (DO NOT SHAKE, VORTEX, OR AGITATE VIGOROUSLY) the reconstituted vials to assist in dissolving the powder. Do not remove the contents until the powder is completely dissolved. The powder should dissolve within less than 60 minutes. Inspect vials for particles and discoloration before dose preparation. Do not use if foreign particles are present, if the solution is visibly cloudy, or if discoloration is observed.

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

6. The reconstituted solution should not be stored for more than 2 hours before being added to the infusion bag. The infusion should 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 administration sets made of PVC, polyurethane (PU), or PE, with an in-line 0.2 micron polyethersulfone (PES) filter. SYLVANT contains no preservatives; therefore, any unused infusion solution should not be stored for later use.

7. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products. SYLVANT infusion should not be administered simultaneously with other drugs using the same intravenous line.

8. Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

Traceability

To improve traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded.