Siltuximab

Siltuximab is used to treat multicentric Castleman disease (MCD). MCD is a rare disease in which the body produces too many of a certain type of white blood cells. MCD Your risk of certain cancers can be increased by changing the way your immune system works.

Dosage and Administration

For intravenous infusion only. Give the 11 mg/kg dose by intravenous infusion over 1 hour every 3 weeks.

Dosage Forms and Specifications

⑴ 100 mg freeze-dried powder in a single-use vial.

⑵ 400mg lyophilized powder in a single-use vial.

[Notes]

1 Current active serious infection Do not give SYLVANT to patients with serious infections until the infection has resolved. SYLVANT may mask signs and symptoms of acute inflammation including fever and suppression of acute phase reactants such as C-reactive protein (CRP). Patients receiving SYLVANT should be closely monitored for infection. Do not further administer SYLVANT until prompt anti-infectious treatment has been initiated and infection has resolved.

2 Immunization Do not give live vaccines to patients receiving SYLVANT because IL-6 inhibition may interfere with normal immune responses to neoantigens.

3 Infusion-related reactions and hypersensitivity Stop infusion of SYLVANT if the patient develops signs of allergic reaction. Discontinue further treatment with SYLVANT. If the patient experiences a mild to moderate infusion reaction, stop the infusion. If the reaction resolves, the SYLVANT infusion may be restarted at a lower infusion rate. Consider antihistamines, acetaminophen, and corticosteroids. If the patient cannot tolerate the infusion after these interventions, discontinue SYLVANT. Give SYLVANT in an environment that provides resuscitation equipment, medications, and resuscitation-trained personnel.

4 Gastrointestinal perforation Gastrointestinal (GI) perforation has been reported in clinical trials although not in MCD trials. Trial with caution in patients who may be at increased risk for GI perforation. Patients with GI perforation-related or suggestive symptoms should be evaluated promptly.

[Adverse Reactions]

The most common adverse reactions (>10% compared with placebo) during treatment with SYLVANT in MCD clinical trials were pruritus, weight gain, rash, hyperuricemia, and upper respiratory tract infection.

【Contraindications】Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

【Side Effects】SYLVANT ® (siltuximab) may cause serious side effects, including: Infection SYLVANT ® may reduce your ability to fight infection. Tell your healthcare provider right away if you have any signs or symptoms of infection during treatment with SYLVANT®. Infusions 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 treatment entirely. Tell your healthcare provider or seek 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, swollen lips, or rash.

The most common SYLVANT® side effects include: Rash Itching Upper respiratory tract infection Weight gain Increased uric acid levels