Sylvant (siltuximab)

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Siltuximab is administered by IV infusion over 60 minutes.

Unopened vials of siltuximab lyophilized powder for injection should be protected from light and stored at 2-8degreesC.

Prior to administration, commercially available siltuximab lyophilized powder for injection must be reconstituted and diluted using proper aseptic technique. Based on the indicated dosage of siltuximab, the appropriate number of vials of the drug should be reconstituted. The vials containing siltuximab lyophilized powder should be removed from the refrigerator and allowed to come to room temperature (15-25degreesC) over approximately 30 minutes prior to reconstitution; the drug should remain at room temperature for the duration of the preparation. A 21-gauge, 1.5-inch needle is recommended by the manufacturer for preparation. The lyophilized powder is reconstituted by adding 5.2 mL of sterile water for injection to a vial labeled as containing 100 mg of siltuximab or by adding 20 mL of sterile water for injection to a vial labeled as containing 400 mg of siltuximab to provide a solution containing 20 mg/mL. The vials should then be gently swirled to facilitate dissolution of the lyophilized powder, which should dissolve in less than 1 hour. The vials should not be shaken or swirled vigorously. The contents of the reconstituted vials should not be removed until all of the solids have completely dissolved. The reconstituted solution should be inspected visually for particulate matter and discoloration prior to dilution and should not be used if particles are present or if the solution appears discolored or visibly opaque. The reconstituted siltuximab solution should be kept at room temperature for no more than 2 hours prior to addition into the infusion bag.

Reconstituted siltuximab solution should then be diluted in 5% dextrose injection to provide a total volume of 250 mL (i.e., if a 250-mL bag of 5% dextrose injection is used, a volume of the diluent equal to the total required volume of reconstituted siltuximab solution should be removed from the bag prior to addition of the reconstituted siltuximab solution). The total required volume of reconstituted siltuximab solution should then be added slowly to the diluent in a diethylhexyl phthalate (DEHP)-plasticized polyvinylchloride (PVC) or non-PVC (polyolefin) infusion bag. The diluted solution should then be mixed by gentle inversion. Diluted infusion solutions of the drug are stable for up to 4 hours after dilution of the reconstituted solution (including infusion time) when stored at room temperature. Siltuximab infusion solution should be administered by IV infusion through a 0.2-mcm inline polyethersulfone filter. The diluted infusion solution should be administered through PVC- or polyurethane-lined administration sets.

Siltuximab should not be administered simultaneously through the same IV line with any other drug. Commercially available vials of siltuximab for injection contain no preservatives and are intended for single use only; any unused portions of the reconstituted or diluted solutions should be discarded. Procedures for proper disposal should be followed.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been conducted to date with siltuximab.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Severe hypersensitivity reaction to siltuximab or any ingredient in the formulation. (See Infusion-related Reactions and Hypersensitivity under Cautions: Warnings/Precautions.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in more than 10% of patients receiving siltuximab for the treatment of MCD and at an incidence that is at least 10% higher than that reported with placebo include rash (e.g., maculopapular, papular, generalized, pruritic), pruritus, upper respiratory tract infection, weight gain, localized edema, abdominal pain, thrombocytopenia, nasopharyngitis, and hyperuricemia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

MCD usually affects adults. Safety and efficacy of siltuximab have not been established in pediatric patients younger than 18 years of age.

There are no adequate and well-controlled studies in pregnant women. Maternal and fetal toxicity was not observed when siltuximab was administered to pregnant animals; however, siltuximab crossed the placenta and fetal serum concentrations were similar to maternal concentrations. Administration of a human antibody to IL-6 to pregnant animals caused decreased globulin concentrations in pregnant animals and offspring.

Infants born to pregnant women treated with siltuximab may be at an increased risk of infection; therefore, caution is advised in the administration of live vaccines in these infants. Pregnancy should be avoided during siltuximab therapy. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use contraception during siltuximab treatment and for 3 months following discontinuance of the drug.

It is not known whether siltuximab is distributed into human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are distributed into human milk and because of the potential for adverse reactions to siltuximab in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

In clinical trials evaluating siltuximab as single-agent therapy, 35% of patients were 65 years of age or older. Although no overall differences in safety were observed between geriatric patients and younger adults in these clinical trials and in other clinical experience, the possibility of increased sensitivity to the drug in some geriatric patients cannot be ruled out. Clinical studies evaluating siltuximab for the treatment of MCD did not include sufficient numbers of patients 65 years of age and older to determine the effect of age on the drug's efficacy for this condition.

In a population pharmacokinetic analysis, age (range: 18-85 years) did not affect exposure of siltuximab.