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Rx Item-Sylvant 100Mg Vial By ASD Healthcare

NDC 57894-0420-01 UPC/GTIN No.3-57894-42001-9 Mfg.Part No.42812BRAND: SYLVANT  NDC: 57894-0420-01,57894042001 UPC: 3-57894-42001-9,357894420019 ASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Sylvant 100Mg Vial By ASD Healthcare

$1407.91$1340.87

Item No.: RX294658 NDC No.57894042001 UPC No.:357894420019 NDC No.57894-0420-01 UPC/GTIN No.3-57894-42001-9 MPN 42812 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx294658 Sylvant 100mg Vial by ASD Healthcare Item No.3294658 NDC No.57894042001 UPC No.357894420019 Other Name Sylvant Therapeutic C

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SYLVANT- siltuximab injection, powder, lyophilized, for solution
Janssen Biotech, Inc.

1 INDICATIONS AND USAGE

SYLVANT 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.

Limitation 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage
SYLVANT 11 mg/kg is given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.

Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in Table 1 are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

Table 1: Treatment Criteria
Laboratory parameter Requirements before first SYLVANT administration Retreatment criteria
*
SYLVANT may increase hemoglobin levels in MCD patients
Absolute Neutrophil Count ≥1.0 � 109 /L ≥1.0 � 109 /L
Platelet count ≥75 � 109 /L ≥50 � 109 /L
Hemoglobin * <17 g/dL <17 g/dL
Do not administer SYLVANT to patients with severe infections until the infection resolves.

Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.
DOSAGE FORMS AND STRENGTHS

SYLVANT (siltuximab) for Injection is available as:

100 mg of lyophilized powder in a single-use vial for intravenous infusion.

400 mg of lyophilized powder in a single-use vial for intravenous infusion.

4 CONTRAINDICATIONS

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

5 WARNINGS AND PRECAUTIONS

5.1 Concurrent Active Severe Infections
Do not administer SYLVANT to patients with severe infections until the infection resolves. SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute Phase reactants such as C-reactive protein (CRP). Monitor patients receiving SYLVANT closely for infections. Institute prompt anti-infective therapy and do not administer further SYLVANT until the infection resolves.
DESCRIPTION

SYLVANT (siltuximab) is a human-mouse chimeric monoclonal antibody that binds human interleukin-6 (IL-6). SYLVANT is produced by Chinese hamster ovary cells.

SYLVANT is supplied as a sterile, white, preservative free, lyophilized powder in single-use vials.

Each SYLVANT 100 mg single-use vial contains 100 mg siltuximab, 3.7 mg L-histidine (from L-histidine and L-histidine monohydrochloride monohydrate), 0.8 mg polysorbate 80, and 169 mg sucrose.

Each SYLVANT 400 mg single-use vial contains 400 mg siltuximab, 14.9 mg L-histidine (from L-histidine and L-histidine monohydrochloride monohydrate), 3.2 mg polysorbate 80, and 677 mg sucrose.

Following reconstitution with Sterile Water for Injection, USP (per section 2.2), the resulting pH is approximately 5.2. The resulting solution contains 20 mg/mL siltuximab to be administered by intravenous infusion following dilution [see Dosage and Administration (2)].

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
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.

NDC 57894-0420-01 UPC/GTIN No.3-57894-42001-9 Mfg.Part No.42812
RX ITEM-Sylvant 100Mg Vial By ASD Health
NDC 57894-0420-01 UPC/GTIN No.3-57894-42001-9 Mfg.Part No.42812

BRAND: SYLVANT  NDC: 57894-0420-01,57894042001 UPC: 3-57894-42001-9,357894420019 ASD Specialty Healthcare-Special Order
Sylvant 100Mg Vial By ASD Healthcare
BRAND: SYLVANT NDC: 57894-0420-01,57894042001 UPC: 3-57894-42001-9,357894420019 ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
SILTUXIMAB INTRAVEN VIAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.