“Repeat dose toxicology studies of 3-months or 6-months duration with extended recovery periods were conducted using weekly IV infusion administration of 9.6 or 46 mg/kg/dose siltuximab alone or in combination with IL-2 administration.”
✓ VerifiedFDA pharmacology/toxicology review, p. 16Source ↗
Pivotal GLP studies
Cynomolgus monkey 3- and 6-month studies, weekly IV infusion 9.6 or 46 mg/kg, plus 3-month combination study with IL-2
“Repeat dose toxicology studies of 3-months or 6-months duration with extended recovery periods were conducted using weekly IV infusion administration of 9.6 or 46 mg/kg/dose siltuximab alone or in combination with IL-2 administration.”
✓ VerifiedFDA pharmacology/toxicology review, p. 16Source ↗
Route in tox
Intravenous (2-hour infusion, once weekly)
“The repeat-dose toxicity of siltuximab was evaluated following once a week (q1w) IV 2-hour infusion of 9.2 and 46 mg/kg doses of siltuximab in 3- and 6-month studies (Study T-2002-007 and T-2003-010).”