Actemra

Actemra

tocilizumab

Manufacturer:

Roche

Marketer:

DKSH
Concise Prescribing Info
Contents
Tocilizumab
Indications/Uses
In combination w/ methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs) for severe, active & progressive RA in adults not previously treated w/ MTX; moderate to severe active RA in adults who have inadequately responded or intolerant to previous therapy w/ ≥1 DMARDs or tumour necrosis factor (TNF) antagonist (use as monotherapy in case of MTX intolerance or where continued treatment is inappropriate). Reduce joint damage progression rate & improve physical function in combination w/ MTX. IV In combination w/ MTX for active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 yr who have inadequately responded to previous therapy w/ MTX (use as monotherapy in case of MTX intolerance or where continued treatment is inappropriate). Monotherapy or in combination w/ MTX for active systemic juvenile idiopathic arthritis (sJIA) in patients ≥2 yr who have inadequately responded to previous NSAID & systemic corticosteroid therapy.
Dosage/Direction for Use
IV RA Adult 8 mg/kg but not <480 mg infused over 1 hr once every 4 wk. Patient weighing >100 kg Max: 800 mg/infusion. pJIA Patient ≥30 kg 8 mg/kg infused over 1 hr once every 4 wk, <30 kg 10 mg/kg infused over 1 hr once every 4 wk. sJIA Patient ≥30 kg 8 mg/kg infused over 1 hr once every 2 wk, <30 kg 12 mg/kg infused over 1 hr once every 2 wk. SC RA Adult 162 mg once every wk.
Contraindications
Hypersensitivity. Active, severe infections.
Special Precautions
Discontinue use if anaphylactic reaction or other serious hypersensitivity reaction occurs. Not to be initiated in patients w/ active infections. Patients w/ history of recurring infections or underlying condition which may predispose to infection; history of intestinal ulceration/diverticulitis. Screen patients for latent TB infection prior to therapy. Not to be given concurrently w/ live & live attenuated vaccines. Viral reactivation in RA. Observe for symptoms potentially indicative of new onset central demyelinating disorders. Patients w/ low neutrophil count ie, absolute neutrophil count (ANC) <2 x 109/L; not recommended in patients w/ ANC <0.5 x 109/L; monitor neutrophil count 4-8 wk after initiation & thereafter, in RA; monitor neutrophil count at the time of 2nd infusion, in pJIA & sJIA. Perform lipid parameter assessment 4-8 wk following initiation of therapy. Increased risk of CV disorders & malignancy (in patients w/ RA). Not recommended for use in combination w/ other biological agents. Infusion reactions during & w/in 24 hr treatment. Patients on controlled Na diet. Severe renal impairment. Active hepatic disease or impairment. Patients w/ elevated ALT or AST >1.5 x ULN; not recommended in patients w/ ALT or AST >5 x ULN; monitor ALT & AST levels every 4-8 wk for the 1st 6 mth of treatment followed by every 12 wk thereafter, in RA, pJIA & sJIA. Women of childbearing potential must use effective contraception during & up to 6 mth after treatment. Pregnancy & lactation. IV Macrophage activation syndrome may develop in sJIA patients. Childn <2yr. SC Childn from birth to <18 yr.
Adverse Reactions
Upper resp tract infections; inj site reaction. Cellulitis, pneumonia, oral herpes simplex, herpes zoster; abdominal pain, mouth ulceration, gastritis; rash, pruritus, urticaria; headache, dizziness; increased hepatic transaminases & wt; HTN; leucopenia, neutropenia; hypercholesterolaemia; peripheral oedema, hypersensitivity reaction; cough, dyspnoea; conjunctivitis.
Drug Interactions
May reverse CYP450 expression (ie, for CYP450 substrates w/ narrow therapeutic index). Decreased levels of simvastatin. Drugs metabolised via CYP450 3A4, 1A2 or 2C9 (eg, atorvastatin, Ca channel blockers, theophylline, warfarin, phenytoin, ciclosporin or benzodiazepines).
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AC07 - tocilizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Actemra conc for soln for infusion 200 mg/10 mL
Packing/Price
1's
Form
Actemra conc soln for infusion 400 mg/20 mL
Packing/Price
1's
Form
Actemra conc soln for infusion 80 mg/4 mL
Packing/Price
1's
Form
Actemra soln for inj 162 mg/0.9 mL
Packing/Price
4's
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