Actemra/Actemra SC

Tocilizumab

Moderate to severe active RA in adults as monotherapy or in combination w/ MTX &/or other DMARDs. Inhibit progression of joint damage & improve physical function. Active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 yr given alone or in combination w/ MTX. Active systemic juvenile idiopathic arthritis (sJIA) in patients ≥2 yr for IV & in patients ≥1 yr for SC, alone or in combination w/ MTX. SC: Giant cell arthritis (GCA) in adults.

RA Adult IV 8 mg/kg once every 4 wk IV infusion over 1 hr alone or in combination w/ MTX &/or other DMARDs. Patients >100 kg Max: 800 mg per infusion. SC 162 mg once every wk, used alone or in combination w/ MTX &/or other DMARDs. GCA Adult SC 162 mg once every wk SC inj, in combination w/ a tapering course of glucocorticoids. May be used alone following discontinuation of glucocorticoids. pJIA Patient ≥30 kg IV 8 mg/kg as IV infusion once every 4 wk, alone or in combination w/ MTX. SC 162 mg once every 2 wk SC inj, alone or in combination w/ MTX; <30 kg IV 10 mg/kg as IV infusion once every 4 wk, alone or in combination w/ MTX. SC 162 mg once every 3 wk SC inj, alone or in combination w/ MTX. sJIA Patient ≥30 kg IV 8 mg/kg as IV infusion once every 2 wk, alone or in combination w/ MTX. SC 162 mg once every wk SC inj, alone or in combination w/ MTX; <30 kg IV 12 mg/kg IV infusion once every 2 wk, alone or in combination w/ MTX. SC 162 mg SC inj once every 2 wk, alone or in combination w/ MTX. Patients 1-2 yr Must have min wt of 10 kg when receiving 162 mg SC.

Hypersensitivity. Known active, severe infection.

Permanently discontinue use if anaphylactic or other serious hypersensitivity reactions occurs. Active infections, history of recurring infection or w/ underlying conditions (eg, diverticulitis, diabetes). Previous history of intestinal ulceration or diverticulitis. Promptly evaluate patients w/ symptoms potentially indicative of complicated diverticulitis eg, abdominal pain. Screen & treat w/ standard antimycobacterial therapy patients for latent TB infection prior to initial therapy. Concomitant use w/ live & live attenuated vaccines. Patients w/ active hepatic disease or hepatic impairment; elevated transaminases ALT or AST >1.5x ULN, >5x ULN; low neutrophil count ie, ANC <2 x 10⁹/L, ANC <0.5 x 10⁹/L; platelet count <100 x 10³/microL & <50 x 10³/microL. Viral reactivation (eg, hepatitis B virus) may occur. Central demyelination. Higher incidence of neutropenia. Monitor ALT/AST every 4-8 wk for 1st 6 mth of treatment followed by every 12 wk thereafter in RA, GCA, pJIA & sJIA; neutrophil count for 4-8 wk after start of therapy & thereafter in RA & GCA, & at the time of 2nd administration & thereafter in pJIA & sJIA; platelets for 4-8 wk after start of therapy & thereafter in RA & GCA, & at time of 2nd administration & thereafter in pJIA & sJIA. Perform lipid parameter assessment 4-8 wk following initiation of treatment. Macrophage activation syndrome. High body wt (>100 kg). Concomitant use w/ infliximab, adalimumab, etanercept, anakinra, abatacept, rituximab, certolizumab pegol & golimumab. Pregnancy & lactation.

URTI; inj site reaction. Cellulitis, oral herpes simplex, herpes zoster; abdominal pain, mouth ulceration, gastritis; rash, pruritus, urticaria; headache, dizziness; increased hepatic transaminases, increased wt; HTN; leucopenia, neutropenia; hypercholesterolemia; peripheral oedema, hypersensitivity reaction; cough, dyspnoea; conjunctivitis.

Decrease levels of simvastatin. Drugs that are metabolised by CYP450, 3A4, 1A2, or 2C9 eg, atorvastatin, Ca channel blockers, theophylline, warfarin, phenytoin, ciclosporin or benzodiazepines.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AC07 - tocilizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

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