Siltuximab

What is Siltuximab?

• Siltuximab (Sylvant) is an interleukin-6 (IL-6) antagonist used for the treatment of patients with multicentric Castleman's disease (MCD).

What are the uses of this medicine?

• This medicine is 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.

How does this medicine work?

• Siltuximab binds human IL-6 and prevents the binding of IL-6 to both soluble and membrane-bound IL-6 receptors.
• IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion.
• Overproduction of IL-6 has been linked to systemic manifestations in patients with MCD.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity reaction to siltuximab or any of the excipients in Sylvant.

What drug interactions can this medicine cause?

• Cytochrome P450s in the liver are down regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in patients treated with Sylvant may restore CYP450 activities to higher levels leading to increased metabolism of drugs that are CYP450 substrates compared to metabolism prior to treatment with Sylvant.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• Administer Sylvant 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until treatment failure.

Administration

• Sylvant is given by an intravenous (IV) infusion into a vein over 1 hour.
• Sylvant is given every 3 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As injection

• 100 mg of lyophilized powder in a single-dose vial.
• 400 mg of lyophilized powder in a single-dose vial.

This medicine is available in fallowing brand namesː

• Sylvant

What side effects can this medication cause?

The most common side effects of this medicine include:

• rash
• itching
• upper respiratory tract infection
• swelling
• weight gain
• increased blood level of uric acid

Sylvant may cause serious side effects, including:

• Infections
• Infusion and allergic reactions

What special precautions should I follow?

• Do not administer Sylvant to patients with severe infections, monitor for infections, institute prompt treatment, and interrupt Sylvant until resolution of infection.
• Do not administer live vaccines because IL-6 inhibition may interfere with the normal immune response to new antigens.
• Sylvant may cause infusion related reactions and anaphylaxis. Administer Sylvant in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.
• Gastrointestinal (GI) perforation has been reported in clinical trials. Promptly evaluate patients presenting with symptoms that may be associated or suggestive of GI perforation.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The limited available information on Sylvant use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage.

Can this medicine be used in children?

• The safety and efficacy of Sylvant have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: siltuximab
• Inactive ingredients: L-histidine and L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose

Who manufactures and distributes this medicine?

Manufactured by:

• EUSA Pharma (UK), Ltd.
• Breakspear Park, Breakspear Way
• Hemel Hempstead, Hertfordshire

What should I know about storage and disposal of this medication?

• Sylvant must be refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not use Sylvant beyond the expiration date (EXP) located on the carton and the vial.

• Dailymed label info on Siltuximab
• FDA Siltuximab