A patient portrayal of a happy, younger guy with a calm, cloudy sky behind him A patient portrayal of a happy, younger guy with a calm, cloudy sky behind him

Why Sylvant

Safety Information

Patient portrayal

Established safety in SYLVANT

As with most medicines, there can be side effects. Individual experiences will vary.

Alert icon

Common side effects may include:

  • Rash
  • Itching
  • Upper respiratory tract infection (runny nose, sore throat, and cough)
  • Swelling (puffiness of the tissue underneath the skin)
  • Weight gain
  • Increased blood level of uric acid, which is normally passed through the urine
Safety icon

SYLVANT has an established and consistent safety profile in patients who responded to treatment, based on the long-term safety study that followed patients for an average of 6 years*

  • The incidence of side effects was generally similar to the original phase 2 study and included rash/itching, upper respiratory tract infections, high cholesterol, fatigue, and diarrhea
  • *Over the course of the study, some patients may not have received the recommended dose per physician-directed reasons.

Patients who responded to SYLVANT experienced control of their idiopathic multicentric Castleman disease (iMCD) signs and symptoms

A patient portrayal of a smiling black woman
Patient portrayal

In the long-term study that followed patients for an average of 6 years:

97% (n=58)

of people had control of their iMCD signs and symptoms at their last checkup of the study.† Disease control was defined as stable or improved iMCD signs and symptoms: hemoglobin levels, fatigue, anorexia, fever, weight, and size of the largest lymph node.

70% (n=42)

of people had control of their iMCD signs and symptoms for up to 6 years.

  • †58 (97%) of 60 patients reported control of their iMCD signs and symptoms at their last assessment; however, some of these patients discontinued before the 6-year data cutoff point.

Preparing for SYLVANT

Find out what to expect before and on your infusion day.

Get started

IL-6, interleukin-6; R.A.R.E., Recordati Access, Resources, and Engagement.

What is SYLVANT?

SYLVANT® (siltuximab) 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.

IMPORTANT SAFETY INFORMATION

Who should not receive SYLVANT?

Do not receive SYLVANT if you have had a severe allergic reaction to siltuximab or any of the ingredients in SYLVANT. See the Patient Information leaflet for SYLVANT for a complete list of ingredients.

Before starting SYLVANT, tell your healthcare provider (HCP) 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 any prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SYLVANT?

SYLVANT may cause serious side effects, including:

  • Infections. SYLVANT may lower your ability to fight infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection during treatment with SYLVANT.
  • 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: back pain, chest pain or tightness, nausea and vomiting, flushing, redness, irregular heart beat (palpitations), trouble breathing, wheezing, dizziness or light-headedness, swelling of the lips, skin rash, headache, or itching.
  • The most common side effects of SYLVANT include rash, itching, upper respiratory tract infection, swelling, weight gain, and increased blood level of uric acid.

These are not all the possible side effects of SYLVANT. Call your HCP for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

SYLVANT® (siltuximab) for injection, for intravenous use, is available as 100 mg or 400 mg of lyophilized powder in a single-dose vial.

Please see full Prescribing Information, including Patient Information.

What is SYLVANT?

SYLVANT® (siltuximab) 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.

IMPORTANT SAFETY INFORMATION

Who should not receive SYLVANT?

Do not receive SYLVANT if you have had a severe allergic reaction to siltuximab or any of the ingredients in SYLVANT. See the Patient Information leaflet for SYLVANT for a complete list of ingredients.