Siltuximab

Siltuximab
Identifier
External IDs	CAS number : 541502-14-1;
Drug information
ATC code	L04 AC11
DrugBank	DB09036
Drug class	Monoclonal antibody

Siltuximab (CNTO 328, tradename Sylvant ) is a monoclonal antibody that is used in the treatment of multicenter Castleman's disease .

history

Sylvant, a monoclonal IgG1 antibody produced by Janssen-Cilag , was approved by the American FDA in April 2014 . The approval was given in the priority review process , which enables accelerated approval . In the European Union siltuximab was in March 2007, the status of an orphan drug granted (a drug for the treatment of rare diseases), where in March 2014 approval by the European Medicines Agency EMA from the Committee for Human Medicinal Products (ger .: Committee for Medicinal Products for Human Use, CHMP).

Properties of the molecule and its manufacture

Siltuximab is an IgG1κ-type monoclonal antibody . The protein consists of a total of 1324 amino acids with a molar mass of approx. 148 kDa. Siltuximab is produced in a cell line of Chinese hamster ovaries ( CHO cells ) after development in the murine cell line SP2 / 0 was started.

Effective range

Siltuximab is used in the treatment of multicenter Castleman's disease , which is a disease of the lymphatic system . This leads to abnormal growth of the lymph nodes and the formation of benign tumors . The term multicentric refers to the effects of the disease on several lymph nodes and other organs. Siltuximab binds to human interleukin 6 and thus prevents its binding to soluble and membrane-bound interleukin 6 receptors.

administration

Siltuximab is administered at a dose of 11 mg / kg body weight as an infusion over a period of one hour, the infusion being given every three weeks.

Side effects

Side effects include an increase in weight, a rash and itchy skin.

Web links

Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Siltuximab

Individual evidence

↑ The European Commission grants approval for SYLVANT® (siltuximab) for the treatment of patients with multicenter Castleman's disease (MCD). PR Newswire, June 5, 2014, accessed April 30, 2016 .
↑ ^a ^b ^c FDA approves Sylvant for rare Castleman's disease. FDA, accessed July 14, 2014 .
↑ ^a ^b PHARMACOLOGY REVIEW (S). (pdf) FDA, accessed on July 15, 2014 (English).
↑ Sylvant. EMA, accessed July 14, 2014 .
↑ CHMP assessment report. (pdf) EMA, accessed on July 16, 2014 (English).
↑ ^a ^b Summary of the EPAR for the public: Sylvant. (pdf) EMA, accessed on July 14, 2014 .
↑ ^a ^b Highlights of prescribing information. (pdf) FDA, accessed July 14, 2014 .

[1] The European Commission grants approval for SYLVANT® (siltuximab) for the treatment of patients with multicenter Castleman's disease (MCD). PR Newswire, June 5, 2014, accessed April 30, 2016 .

[FDA-2] FDA approves Sylvant for rare Castleman's disease. FDA, accessed July 14, 2014 .

[FDA_review-3] PHARMACOLOGY REVIEW (S). (pdf) FDA, accessed on July 15, 2014 (English).

[EMA-4] Sylvant. EMA, accessed July 14, 2014 .

[EPAR-5] CHMP assessment report. (pdf) EMA, accessed on July 16, 2014 (English).

[EMA_2-6] Summary of the EPAR for the public: Sylvant. (pdf) EMA, accessed on July 14, 2014 .

[Label-7] Highlights of prescribing information. (pdf) FDA, accessed July 14, 2014 .