siltuximab (Rx)

Brand and Other Names:Sylvant
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 100mg/vial
  • 400mg/vial
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Castleman Disease

Indicated for multicentric Castleman disease in patients who are negative for HIV and human herpesvirus-8

11 mg/kg IV q3weeks; infuse over 1 hr

Continue until treatment failure

Dosage Modifications

Renal impairment

  • CrCl ≥15 mL/min: No initial dosage adjustment required
  • End-stage renal disease: No information

Hepatic impairment

  • Mild-to-moderate (Child-Pugh A and B): No initial dosage adjustment required
  • Severe (Child-Pugh C): No information

Dosing Considerations

Do not administer with severe infection until resolved

Discontinue with severe infusion-related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes; do not reinstitute treatment

Hematology lab tests

  • Perform hematology tests before each dose for first 12 months and every 3 dosing cycles thereafter
  • If following criteria not met, consider delaying treatment (do NOT reduce dose):
  • If following criteria not met, consider delaying treatment (do NOT reduce dose)
    • ANC: ≥1 x 10^9/L
    • Platelets: ≥75 x 10^9/L (before 1st dose); ≥50 x 10^9/L (retreatment criteria)
    • Hgb: <17 g/dL

Safety and efficacy not established

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Interactions

Interaction Checker

and siltuximab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Pruritus (28%)

            Rash (28%)

            Edema (16-26%)

            Upper respiratory tract infection (26%)

            Increased weight (19%)

            Abdominal pain/distension (12%)

            Hyperuricemia (11%)

            1-10%

            Thrombocytopenia (9%)

            Lower respiratory tract infection (8%)

            Constipation (8%)

            Oropharyngeal pain (8%)

            Renal impairment (8%)

            Headache (8%)

            Hypertriglyceridemia (8%)

            Hypotension (4-6%)

            Hypercholesterolemia (4%)

            Skin hyperpigmentation (4%)

            Eczema (4%)

            Psoriasis (4%)

            Dry skin (4%)

            Decreased appetite (4%)

            Dehydration (4%)

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            Warnings

            Contraindications

            Severe hypersensitivity

            Cautions

            Do not administer to patients with severe infections until the infection resolves; may mask signs and symptoms of acute inflammation, including suppression of fever and of acute phase reactants such as C-reactive protein

            Monitor closely for infections; institute prompt, anti-infective therapy and do not administer further therapy with siltuximab until the infection resolves

            Do not administer with live vaccines; may interfere with normal immune response

            Stop infusion if signs of anaphylaxis occur; if mild-to-moderate reaction, may restart at lower infusion rate; consider premedicating with antihistamines, acetaminophen, and corticosteroids; discontinue if infusion not tolerated after these interventions

            Advise women to avoid pregnancy; women of childbearing potential should use contraception during and for 3 months after treatment

            Gastrointestinal perforation reported

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk; because many drugs and immunoglobulins are excreted in human milk, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Anti-interleukin-6 (IL-6) monoclonal antibody

            Binds human IL-6 and prevents the binding of IL-6 to both soluble and membrane-bound IL-6 receptors; overproduction of IL-6 has been linked to systemic manifestations of multicentric Castleman disease

            Absorption

            Peak plasma time: Occurs at end of IV infusion

            Peak plasma concentration: 332 mcg/mL

            Predose trough level: 84 mcg/mL

            Distribution

            Vd: 4.5 L (70 kg male)

            Elimination

            Half-life: 20.6 days

            Clearance: 0.23 L/day

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            Administration

            IV Preparation

            Use aseptic technique

            Calculate the dose and total volume of reconstituted solution required and the number of vials needed

            Allow the vial(s) to come to room temperature over ~30 minutes

            Siltuximab should remain at room temperature for the duration of the preparation

            Reconstitute vials with sterile water for injection; 100-mg vial with 5.2 mL and 400-mg vial with 20 mL

            Reconstituted concentration is 20 mg/mL

            Gently swirl vials to aid dissolution of lyophilized powder; do NOT shake or swirl vigorously

            Do not withdraw contents until all solids are completely dissolved (should dissolve in <60 minutes)

            Within 2 hr of reconstitution, further dilute in D5W (PVC with DEHP, or polyolefin)

            Withdraw volume from 250-mL bag of D5W that is equal to total calculated volume of reconstituted siltuximab, then slowly add calculated volume of reconstituted siltuximab; gently invert to mix solution

            IV Administration

            Administer in a setting that has resuscitation equipment, medication, and personnel trained to provide resuscitation

            Administer IV over 1 hr using administration sets lined with PVC with DEHP or polyurethane containing a 0.2 micron inline polyethersulfone filter

            Complete infusion within 4 hr of dilution of the reconstituted solution to the infusion bag

            Do not infuse concomitantly in the same IV line with other agents

            Do not store any unused portion of the reconstituted product or of the infusion solution

            Storage

            Unopened vials

            • Refrigerate at 2-8ºC (36-46ºF)
            • Protect from light
            • Contains no preservatives
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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