Prescription medicine
Siltuximab Brand names: Sylvant
Siltuximab (Sylvant) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the siltuximab FDA label on DailyMed (effective August 27, 2024); the BLA 125496 record on Drugs@FDA; every siltuximab label on DailyMed.
Highlights of the record
FDA label of August 27, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Forms and strengths
- 100 mg
- 400 mg
Injection (powder) for solution.
On the market
- Earliest approval on file
- April 23, 2014 Sylvant, Recordati Rare Diseases, Inc.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 631 through July 30, 2026
What is siltuximab used for?
From the label: indications and usageSYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. ( 1 ) Limitations of Use SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. […]
FDA pharmacologic class: Interleukin-6 Antagonist.
Source: FDA drug label (Sylvant), Recordati Rare Diseases, Inc., effective August 27, 2024 (SPL set 8d663642-f52e-49c0-a023-2da083fdfc0b), via openFDA; the full label on DailyMed
Is there a generic for siltuximab (Sylvant)?
No generic siltuximab is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the siltuximab label say about other medicines?
The siltuximab label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | If the reaction resolves, the SYLVANT infusion may be restarted at a lower infusion rate. Consider medication with antihistamines, acetaminophen, and corticosteroids. |
| Atorvastatin | drug interactions | Exercise caution when SYLVANT is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin). |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. |
| Lovastatin | drug interactions | Exercise caution when SYLVANT is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin). |
| Theophylline | drug interactions | Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. |
| Warfarin | drug interactions | Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. |
Source: FDA drug label (Sylvant), Recordati Rare Diseases, Inc., effective August 27, 2024 (SPL set 8d663642-f52e-49c0-a023-2da083fdfc0b), via openFDA; the full label on DailyMed
What do FAERS reports show for siltuximab?
The FDA Adverse Event Reporting System holds 631 reports that list siltuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 128 are coded as a death and 204 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Siltuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other