"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
(siltuximab) for Injection
Read this Patient Information before you receive SYLVANT and each time you receive treatment. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is SYLVANT?
It is not known if SYLVANT is safe and effective in children.
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 end of this leaflet for a complete list of ingredients in SYLVANT.
What should I tell my healthcare provider before receiving 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.
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.
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: 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.
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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
What are the ingredients in SYLVANT?
Active ingredient: siltuximab
Inactive ingredients: L-histidine and L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose
Last reviewed on RxList: 5/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Sylvant Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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