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SYLVANT
Overview
What is SYLVANT?
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 ), the resulting pH is approximately 5.2. The resulting solution contains 20 mg/mL siltuximab to be administered by intravenous infusion following dilution .
What does SYLVANT look like?
What are the available doses of SYLVANT?
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.
What should I talk to my health care provider before I take SYLVANT?
How should I use SYLVANT?
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.
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 are not met, consider delaying treatment with SYLVANT. Do not reduce dose.
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.
What interacts with SYLVANT?
Sorry No Records found
What are the warnings of SYLVANT?
Sorry No Records found
What are the precautions of SYLVANT?
Sorry No Records found
What are the side effects of SYLVANT?
Sorry No records found
What should I look out for while using SYLVANT?
Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.
What might happen if I take too much SYLVANT?
No case of overdose has been reported.
How should I store and handle SYLVANT?
SYLVANT must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use SYLVANT beyond the expiration date (EXP) located on the carton and the vial.While stored, protect from light. This product contains no preservative.SYLVANT must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use SYLVANT beyond the expiration date (EXP) located on the carton and the vial.While stored, protect from light. This product contains no preservative.Nifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Nifedipine Extended-Release Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Rx OnlyNifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Nifedipine Extended-Release Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Rx OnlyNifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Nifedipine Extended-Release Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Rx OnlyNifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Nifedipine Extended-Release Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Rx OnlyNifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Nifedipine Extended-Release Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Rx Only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
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.
The following adverse reactions are also discussed in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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