Frequently Asked Questions

FREQUENTLY ASKED QUESTIONS

Frequently Asked Questions icon

FREQUENTLY ASKED QUESTIONS

SYLVANT® is a prescription medicine that is used to treat patients with Multicentric Castleman’s Disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection. It was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT® did not bind to virally produced interleukin-6 (IL-6) in a nonclinical study. It is not known if SYLVANT® is safe and effective in children.

A doctor or nurse in a hospital or clinic will give you SYLVANT® as an intravenous (IV) infusion. It is given slowly over a period of 1 hour.

The recommended dosing of SYLVANT® is once every 3 weeks.

Even if you are not experiencing symptoms and are feeling better, it is important to continue to receive treatment with SYLVANT® for as long as your doctor recommends.

You may have symptom relief, and your doctor will order tests to assess how you are doing on treatment. But it is also important for you to tell your doctor how you are feeling during each visit. To learn more about Multicentric Castleman’s Disease (MCD) and SYLVANT®, click here

Though the cause of MCD is not fully understood, it is believed that a protein in the body called interleukin-6 (IL-6) has a role in the disease.

When produced in the normal amounts, IL-6 helps regulate the activity of the immune system. Often, high levels of IL-6 are seen in patients with MCD. As a result, white blood cells called lymphocytes multiply too rapidly. This causes the lymph nodes to become enlarged, and other symptoms may occur.

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®: trouble breathing, chest tightness, wheezing, dizziness or light-headedness, swelling of the lips, or skin rash.

The most common SYLVANT® side effects include:

  • Rash
  • Itching
  • Upper respiratory tract infection
  • Weight gain
  • Increased blood level of uric acid

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SYLVANT®.

Report any signs of new or worsening medical conditions to your healthcare provider.

Call your doctor for medical advice about side effects.

Learn more in Important Safety Information

SYLVANT® works by blocking the action of an important protein called interleukin-6 (IL-6), a substance produced in the lymph nodes. SYLVANT® is a monoclonal antibody that prevents IL-6 from binding to IL-6 receptors.

Patients should not receive SYLVANT® if they have had a severe allergic reaction to siltuximab or any of the ingredients in SYLVANT®. The active ingredient in SYLVANT® is siltuximab. The inactive ingredients are L-histidine and L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose.

Even if you are not experiencing symptoms and are feeling better, it is important to continue to receive treatment with SYLVANT® for as long as your doctor recommends.

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 over-the-counter medicines, vitamins, and herbal supplements

General information about the safe and effective use of 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.

Report any signs of new or worsening medical conditions to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).