Tocilizumab
ACTEMRA
Pronunciation: toe-si-LIZ-oo-mab (ak-TEM-ra)
What it isIL-6 receptor antibody; rheumatoid arthritis, giant cell arteritis and cytokine release syndrome.
Why this oneIt is the treatment for CAR-T cytokine release syndrome and is steroid-sparing in giant cell arteritis.
What limits it⚑ It suppresses CRP and fever, potentially masking infection. Diverticular GI perforation and transaminase elevation can stop therapy.
FDA-approved for
- rheumatoid arthritis (2010)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Rheumatoid arthritis (IV) | Adult | 4 mg/kg q4wk | 8 mg/kg q4wk | 800 mg/infusion |
| Rheumatoid arthritis (SC) | Adult <100 kg | 162 mg SC every other week | 162 mg SC weekly | |
| Rheumatoid arthritis (SC) | Adult >=100 kg | 162 mg SC weekly | 162 mg SC weekly | |
| Giant cell arteritis | Adult | IV 6 mg/kg q4wk or SC 162 mg weekly | 600 mg/infusion | |
| Polyarticular JIA (IV) | Peds | 10 mg/kg (<30 kg) or 8 mg/kg (>=30 kg) q4wk | ||
| Systemic JIA (IV) | Peds | 12 mg/kg (<30 kg) or 8 mg/kg (>=30 kg) q2wk | ||
| Cytokine release syndrome | >=2 yr | 12 mg/kg (<30 kg) or 8 mg/kg (>=30 kg) IV | 800 mg/infusion | |
| COVID-19 (hospitalized) | Adult/peds | 8 mg/kg IV (12 mg/kg if <30 kg) | 800 mg/infusion |
Renal No adjustment in mild-moderate; not studied in severe
Hepatic Not studied; do not initiate if ALT/AST >1.5x ULN
IV doses >800 mg/infusion (>600 mg in GCA) not recommended
Instructions
- Do not initiate if ANC <2,000/mm3, platelets <100,000/mm3, or ALT/AST >1.5x ULN (RA/GCA/pJIA/sJIA).
- IV: infuse over 60 minutes; do not give as bolus or push.
- Not recommended for concomitant use with biologic DMARDs.
Available strengths
- inj 162 mg/.9 mL
- inj 200 mg/10 mL
- inj 400 mg/20 mL
- inj 80 mg/4 mL
Cautions
- Serious infections incl. TB - screen and interrupt during active infection
- GI perforation
- Hepatotoxicity - monitor LFTs
- Neutropenia, thrombocytopenia, lipid elevations
- Hypersensitivity/anaphylaxis
- Demyelinating disorders
Adverse reactions
- Upper respiratory tract infections
- Nasopharyngitis
- Headache
- Hypertension
- Increased ALT
Pregnancy Insufficient human data to assess drug-associated risk
Lactation No data on presence in human milk; maternal IgG is present in milk
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 162 mg/.9 mL | inj | per unit | $821.00/mL | not offered |
| 200 mg/10 mL | inj | per unit | not offered | |
| 400 mg/20 mL | inj | per unit | not offered | |
| 80 mg/4 mL | inj | per unit | not offered |
Generic entry2024 (biosimilar)
⚠ BOXED WARNING
- Serious infections
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.
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