100 mg powder for concentrate for infusion solution
siltuximab
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 special type of protein ) that specifically binds to an antigen (a target protein) in the body called interleukin -6 (IL 6).
What SYLVANT is used for
SYLVANT is used to treat multicentric Castleman’s disease (MCD) in adult patients who do not have human immunodeficiency virus ( HIV ) or human herpesvirus-8 (HHV-8) infection.
Multicentric Castleman’s disease causes benign tumors (non-cancerous growths) to develop in the body’s lymph nodes. Symptoms of the disease may include feeling tired, sweating at night, having a tingling sensation, and decreased appetite.
How SYLVANT works
Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes. By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth. This helps to reduce the size of the lymph nodes which reduces the symptoms of the disease and makes it easier for you to carry out your normal daily tasks.
What you need to know before you are given SYLVANT
You should not be given SYLVANT if:
- You are severely allergic to siltuximab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given SYLVANT if:
- you currently have an infection – this is because SYLVANT can reduce your ability to recognize and fight infection, and your infection can get worse.
- you need to be vaccinated or may need to be vaccinated shortly – this is because some vaccines should not be given with SYLVANT
- you have high levels of blood fats ( hypertriglyceridemia ) – this is because SYLVANT can increase these levels. The doctor can prescribe medication to correct this.
- you have a condition such as a stomach ulcer or intestinal pouches that may increase the risk of a tear inside the stomach or intestine ( gastrointestinal perforation ). Signs that such a fissure is developing include stomach pain that gets worse, nausea, changes in bowel habits, and fever – if you get any of these see a doctor straight away.
- you have liver disease or liver changes that show up in blood tests. The doctor will monitor you and your liver function.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given SYLVANT.
Allergic reactions
Talk to your doctor right away if you have a serious allergic reaction during or after the infusion. Signs include difficulty breathing, tightness in the chest, wheezing, severe dizziness or lightheadedness, swelling of the lips, or skin rash.
Infection you
You may get an infection more easily when you are treated with SYLVANT.
These infections can be serious, e.g. pneumonia or blood poisoning (also called “sepsis”).
Talk to your doctor immediately if you develop any signs of infection during treatment with SYLVANT. Signs include cough, flu-like symptoms, feeling unwell, red or warm skin, and fever.
The doctor may immediately stop treatment with SYLVANT.
Children and young people
It is unknown whether SYLVANT is safe and effective in this group and therefore SYLVANT should not be given to children and adolescents.
Other medicines and SYLVANT
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- theophylline used to treat asthma
- warfarin, a blood thinner
- ciclosporin, used during and after organ transplantation
- birth control pills are used to prevent pregnancy.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before you are given SYLVANT.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
- SYLVANT is not recommended for use during pregnancy. It is unknown whether SYLVANT can affect the baby or a pregnant or breastfeeding woman.
- You should not become pregnant during treatment with SYLVANT and up to 3 months after the end of treatment. You should use effective contraception during this time.
- In some cases, if you are pregnant and need treatment for MCD, your doctor may advise you that the benefit of taking SYLVANT to your health outweighs any potential risks to your unborn baby, including increased risk of infection and the use of certain vaccines in children whose mothers treated with SYLVANT during pregnancy.
- It is unknown if SYLVANT passes into breast milk. You and the doctor should decide whether to continue taking SYLVANT or breast-feed and stop treatment with SYLVANT.
Driving ability and use of machinery
SYLVANT is unlikely to affect your ability to drive, cycle or use tools or machines.
How SYLVANT is given
SYLVANT will only be given to you by a doctor or nurse in a hospital or clinic.
- The recommended dose is 11 milligrams per kilogram of body weight given once every 3 weeks
- SYLVANT will be given as an ‘intravenous infusion’ (drip into a vein, usually in the arm).
- It will be given slowly over 1 hour.
- During the infusion with SYLVANT, you will be monitored for side effects.
- You will receive treatment until you and the doctor agree that you no longer benefit from the treatment.
If you have received too much SYLVANT
As this medicine will be given to you by a doctor or nurse, it is unlikely that you will get too much. If you think you have been given too much SYLVANT, talk to a doctor or nurse straight away. It is unknown what possible side effects may occur after receiving too much SYLVANT.
If you stop using SYLVANT
You should 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
Tell your doctor immediately if you notice the following side effects, as he or she may need to stop treatment:
Common (may affect up to 1 in 10 people):
- severe allergic reaction – signs may include difficulty breathing, chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, or skin rash.
Other side effects include:
Talk to your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):
- decreased number of white blood cells ( neutropenia )
- decreased number of blood platelets ( thrombocytopenia )
- itching
- rash, itchy eczema
- high levels of blood fats ( hypertriglyceridemia )
- high level of uric acid in the blood which can cause gout
- abnormal kidney function test
- swollen arms, legs, neck, or face
- high blood pressure
- respiratory infections such as in the nose, sinuses, or throat
- urinary tract infection
- cold
- sore throat
- stomach pain or discomfort, constipation, diarrhea, heartburn, mouth ulcers, nausea, vomiting
- dizziness
- headache
- pain in joints, pain in arms or legs
- weight gain
Common (may affect up to 1 in 10 people)
- high cholesterol levels in the blood
How to store SYLVANT
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and the carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 o C-8 o C). Do not freeze. Store in the original packaging. Light sensitive.
Do not use if you see cloudy or foreign particles and/or if the solution appears to be discolored after preparation.
Contents of the packaging and other information
Contents declaration
- The active substance is siltuximab. Each vial contains 100 mg of siltuximab. After reconstitution, the solution contains 20 mg of siltuximab per ml.
- Other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Appearance and package sizes of the medicine
- SYLVANT is supplied as glass vials containing a white powder to concentrate for solution for infusion (powder to concentrate).
- SYLVANT is available in packages containing 1 injection vial.
Marketing Authorisation Holder
EUSA Pharma
(Netherlands) BV
54 Beechavenue,
1119PW Schiphol-Rijk
Netherlands
Manufacturer
Janssen Biologics BV
Einsteinweg 101
NL-2333 CB Leiden
Netherlands