Names and pronunciation
(toe′si-liz′oo-mab) Actemra, Actemra ACTPen
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Drug reference
(toe′si-liz′oo-mab) Actemra, Actemra ACTPen
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Func. class.: DMARDs (disease- modifying antirheumatoid drugs)/ tumor necrosis factor (TNF) modifier
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Chem. class.: Interleukin-6 receptor antagonist
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ACTION: Interleukin-6 (IL-6) receptor inhibiting monoclonal antibody, decreases inflammation in RA
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USES: Rheumatoid arthritis, active systemic juvenile idiopathic arthritis
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CONTRAINDICATIONS: Hyper- sensitivity Precautions: Breastfeeding, pregnancy; risk for GI perforation, active hepatic disease, severe neutropenia/thrombocy- topenia, demyelinating disorders
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Black Box Warning: Invasive fungal in- fection, active TB Black Box Warning: Infection Assess before treatment and periodically; obtain TB screening before beginning treatment; invasive fungal infections: discontinue if infection occurs during administration; may use antituberculosis therapy before tocilizumab in past history of latent or ac- tive TB when adequate course of treatment cannot be confirmed and those with a negative TB with risk factors for infections • Anaphylaxis: Assess for rash, facial T swelling, dyspnea, antihistamine, cortico steroids, emergency equipment should be available • Fungal infection: Assess for flulike symptoms, dyspnea, may lead to shock, notify provider immediately • Secondary malignancy: assess for malignancy periodically • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; pregnant pa tients should enroll in the MotherToBaby Autoimmune Diseases in Pregnancy Reg istry; do not breastfeed, excretion un known Black Box Warning: To report signs, symptoms of infection, including TB and hepatitis B; to avoid others with infections • To notify prescriber if pregnancy or suspected pregnancy; not to use if breastfeeding; to consider using a non hormonal contraceptive because contra ception may be decreased
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SIDE EFFECTS CNS: Headache, dizziness CV: Hypertension GI: Perforation, abdominal pain, gastritis, mouth ulcerations HEMA: Neutropenia, thrombocytopenia INTEG: Rash, infusion reactions RESP: Upper respiratory infections, nasopharyngitis, bronchitis SYST: Serious infections, anaphylaxis, infusion-related reactions, anti-tocilizumab antibody formation, secondary malignancy
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INTERACTIONS Decrease: product level—cycloSPO- RINE, theophylline, warfarin • Do not give with live virus vaccines • Avoid use with TNF modifiers, DMARDs, immunosuppressives due to increased risk of infection
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DOSAGE AND ROUTES Moderate-severe rheumatoid arthritis • Adult: IV 4 mg/kg over 1 hr q4wk, may increase to 8 mg/kg q4wk based on clinical response, max dose 800 mg/infu- sion; do not initiate if ANC <2000/mm3, platelets <100,000/mm3 • Adult <100 kg: SUBCUT 162 mg every other week (monotherapy or in combi- nation); increase to 162 mg weekly based on response • Adult ≥100 kg: SUBCUT 162 mg weekly (monotherapy or in combina- tion) Juvenile idiopathic arthritis • Child ≥2 yr/adolescent ≥30 kg: IV 8 mg/kg over 1 hr q2wk • Child ≥2 yr/adolescent <30 kg: IV 12mg/kg every 2 weeks Polyarticular juvenile idiopathic arthritis (PJIA) • Child ≥2 yr and weighing ≥30 kg: IV INFUSION 8 mg/kg over 1 hr q4wk • Child ≥2 yr and weighing <30 kg: IV INFUSION 10 mg/kg over 1 hr q4wk Therapeutic drug monitoring • Before initiation of treatment, check ANC, platelet count, and liver function tests (ALT/AST concentrations). In adults, not recommended for use in those with <2,000/mm3, ANC platelet count <100,000/mm3, or ALT or AST >1.5 × ULN Hepatic dose • Adult patients with rheumatoid ar- thritis or giant cell arteritis with he- patic impairment Do not initiate treatment with tocilizumab if baseline AST/ALT is >1.5× ULN
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Available forms: Sol for inj 20 mg/mL; prefilled syringes 162 mg/0.9 mL
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Administer: SUBCUT route • Remove syringe, allow to warm for 30 min at room temperature. Do not warm in any other way • Use injection site such as the front of thigh, outer area of upper arm, or the abdomen except for the 2-inch area around the navel. Do not inject into moles; scars; or areas where skin is ten- der, bruised, red, hard, or not intact. Rotate injection sites with each injection. Inject at >1 inch from the last area in- jected Intermittent IV INFUSION route • Visually inspect for particulate matter, discoloration before administration; should be colorless to pale yellow liquid • From 100-mL infusion bag or bottle, withdraw vol of 0.9% sodium chloride inj equal to vol of tocilizumab sol required for patient’s dose • Slowly add tocilizumab from each vial into infusion bag or bottle; gently invert bag to avoid foaming; fully diluted sols are compatible with polypropylene, poly- ethylene, polyvinyl chloride infusion bags and polypropylene, polyethylene, glass infusion bottles • Fully diluted sol for infusion may be stored refrigerated or at room tempera- ture for ≤24 hr and should be protected from light; do not use unused product remaining in vials; no preservatives • Allow the fully diluted sol to reach room temperature before infusion • Give over 60 min with infusion set; do not administer as IV push or bolus • Do not infuse concomitantly in same IV line with other drugs
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Assess: • Rheumatoid arthritis: ROM, pain, stiff- ness at baseline q1-2wk • Blood studies: CBC with differential, LFTs, platelet count, serum lipid profile at baseline and periodically; LFTS 1-3 × ULN reduce dose, if 3-5 × ULN interrupt; platelets 50,000-100,000/mm3 interrupt until platelets are >100,000/mm3 then reduce at lower dose
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Evaluate: • Therapeutic response: ability to move more easily with less pain
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That this treatment must continue un- less safety or effectiveness is an issue • About reason for use and expected results • To avoid live vaccines; to bring immu- nizations up-to-date before treatment
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PHARMACOKINETICS Half-life approx 6 days with single dose, approx 11 days with multiple (steady- state) doses
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• Adult: IV 4 mg/kg over 1 hr q4wk, may increase to 8 mg/kg q4wk based on clinical response, max dose 800 mg/infu- sion; do not initiate if ANC <2000/mm3, platelets <100,000/mm3
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• Adult <100 kg: SUBCUT 162 mg every other week (monotherapy or in combi- nation); increase to 162 mg weekly based on response
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• Adult ≥100 kg: SUBCUT 162 mg weekly (monotherapy or in combina- tion) Juvenile idiopathic arthritis
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