Actemra®
GoodRxTocilizumab · intravenous infusion
Misc., Injections & Implants
OFF-LABELNot in the FDA label for this product
Non-infectious intermediate, posterior or panuveitis
4 mg/kg or 8 mg/kg by intravenous infusion every 4 weeks
RCT · n=37 · no control arm
STOP-Uveitis randomised 37 patients to 4 mg/kg or 8 mg/kg intravenous tocilizumab every 4 weeks to month 6. Its primary endpoint was safety, and repeated infusions were well tolerated; the sight measures below are all secondary. Among those with room for it, 43.5% achieved a 2-step reduction in vitreous haze; mean visual acuity improved 8.22 letters and mean central macular thickness fell 83.88 micrometres. Read the design before the numbers: the trial compared two doses of tocilizumab against each other, with no placebo or active control arm, so it shows the drug is tolerated and that treated eyes improved, not that it beats an alternative.
Contraindications
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
Available Forms80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL, 20 mg/mL single-dose vials
Mechanism of ActionTocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
Warnings & Precautions
- Serious Infections: Do not administer ACTEMRA during an active infection, including localized infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
- Hepatotoxicity: Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue ACTEMRA if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Common Side Effects
The most common serious adverse reactions were serious infections.
Pregnancy & LactationPregnancy: The available data with ACTEMRA from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: No information is available on the presence of tocilizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Maternal immunoglobulin G (IgG) is present in human milk.
Pediatric UseACTEMRA by intravenous use is indicated for the treatment of pediatric patients with: Active systemic juvenile idiopathic arthritis in patients 2 years of age and older Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Severe or life-threatening CAR T cell-induced cytokine release syndrome.