What is SYLVANT (Siltuximab)?
SYLVANT is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection.
It is not known if SYLVANT is safe and effective in children.
What is the most important information I should know about SYLVANT?
SYLVANT can cause serious side effects. These serious side effects include:
- Infections. SYLVANT may lower your ability to fight infections.
- Infusion and allergic reactions. If you have an infusion or allergic reaction while receiving SYLVANT, your healthcare provider will stop your infusion and treat your reaction. If you have a severe infusion or allergic reaction, your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms during or after your infusion of SYLVANT: trouble breathing, chest tightness, wheezing, dizziness or lightheadedness, swelling of the lips, or skin rash.
- The most common side effects of SYLVANT include: rash, itching, upper respiratory tract infection, weight gain, and increased blood level of uric acid.
How will I receive SYLVANT ?
- SYLVANT is given by an intravenous (IV) infusion into a vein over 1 hour.
- SYLVANT is given every 3 weeks
Important Safety Information
- Do not receive SYLVANT if you have had a severe allergic reaction to siltuximab or any of the ingredients in SYLVANT.
- You should not receive a live vaccine during your treatment with SYLVANT.
- It is not known if SYLVANT will harm your unborn baby. You should not become pregnant while receiving treatment with SYLVANT
- Get medical help right away if you have any of these symptoms during or after your infusion of SYLVANT: trouble breathing, chest tightness, wheezing, dizziness or lightheadedness, swelling of the lips, or skin rash
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking SYLVANT?
- Before you receive SYLVANT, tell your healthcare provider about all of your medical conditions, including if you:
- Have an infection. You should not receive SYLVANT if you have a severe infection.
- have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive a live vaccine during your treatment with SYLVANT.
- Have or have had any stomach or bowel (intestine) problems, such as diverticulitis or ulcers. Tell your healthcare provider if you have pain in your stomach area.
- Are pregnant or plan to become pregnant. It is not known if SYLVANT will harm your unborn baby. You should not become pregnant while receiving treatment with SYLVANT. Females who are able to become pregnant should use effective birth control during treatment with SYLVANT and for 3 months after stopping treatment.
- Are breastfeeding or plan to breastfeed. It is not known if SYLVANT passes into your breast milk. You and your healthcare provider should decide if you will take SYLVANT or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements.
General information about SYLVANT
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about SYLVANT that is written for health professionals.
What are the ingredients in SYLVANT?
Active ingredient: Siltuximab
Inactive ingredient: L-histidine and L-histidine monohydrochloride monohydrate, polysorbate 80, and
sucrose