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Actemra IV

Actemra IV

tocilizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tocilizumab
Indications/Uses
Monotherapy or in combination w/ MTX &/or other DMARDs for moderate to severe active RA in adult patients. Monotherapy or in combination w/ MTX for polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 yr. Monotherapy or in combination w/ MTX for active systemic juvenile idiopathic arthritis (sJIA) in patients ≥2 yr who have responded inadequately to previous therapy w/ NSAIDs & systemic corticosteroids. Coronavirus disease 2019 (Covid-19) in hospitalized adults receiving systemic corticosteroids & require supplemental oxygen or mechanical ventilation.
Dosage/Direction for Use
RA Adult 8 mg/kg IV infusion once every 4 wk. pJIA Patient ≥30 kg 8 mg/kg IV infusion once every 4 wk, <30 kg 10 mg/kg IV infusion once every 4 wk. sJIA Patient ≥30 kg 8 mg/kg IV infusion once every 2 wk, <30 kg 12 mg/kg IV infusion once every 2 wk. Covid-19 8 mg/kg as single 60-min infusion, may administer 1 additional dose at least 8 hr after initial infusion. Patient >100 kg Max: <800 mg/infusion.
Contraindications
Hypersensitivity. Active, severe infections except Covid-19.
Special Precautions
Discontinue use if anaphylactic or other serious hypersensitivity reactions occur. Not to be initiated in patients w/ active infections; if Covid-19 patients have any other concurrent serious active infection. Not recommended in patients w/ elevated ALT or AST >5 x ULN, ANC <0.5 x 109/L & platelet count <50 x 103/microliter; elevated ALT or AST >10 x ULN, ANC <1 x 109/L in Covid-19 patients. Patients w/ elevated transaminases ALT or AST >1.5 x ULN, ANC <2 x 109/L & platelet count <100 x 103/microliter. Monitor ALT & AST every 4-8 wk for 1st 6 mth then every 12 wk thereafter; neutrophil & platelet count 4-8 wk after start of therapy & thereafter for RA; during 2nd administration & thereafter for pJIA & sJIA. History of intestinal ulceration or diverticulitis; recurring infection or underlying condition eg, diabetes. Viral reactivation eg, HBV. Demyelinating disorders. May develop macrophage activation syndrome in sJIA patients. Screen for latent TB infection prior to starting therapy. Assess lipid parameters 4-8 wk following initiation of therapy. Not to be given concurrently w/ live attenuated vaccines. Active hepatic disease or impairment. Severe renal impairment. Not to be used during pregnancy. Lactation. Childn <2 yr.
Adverse Reactions
HTN. RA, pJIA & sJIA: URTI; inj site reaction. Cellulitis, oral herpes simplex, herpes zoster; abdominal pain, mouth ulceration, gastritis; rash, pruritus, urticaria; headache, dizziness; increased hepatic transaminases & wt; leucopenia, neutropenia; hypercholesterolaemia; peripheral oedema, hypersensitivity reaction; cough, dyspnoea; conjunctivitis; hypofibrinogenemia. Covid-19: Increased hepatic transaminases; constipation, diarrhoea, nausea; UTI; hypokalaemia; anxiety, insomnia.
Drug Interactions
Suppressed CYP450 enzymes hepatic expression w/ cytokines. Decreased simvastatin levels. Monitor dose of CYP450 3A4-, 1A2- or 2C9-metabolized drugs when starting or stopping treatment.
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 IV infusion conc (vial) 200 mg/10 mL
Packing/Price
1's
Form
Actemra IV infusion conc (vial) 400 mg/20 mL
Packing/Price
1's
Form
Actemra IV infusion conc (vial) 80 mg/4 mL
Packing/Price
1's
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