Side Effects of Actemra (Tocilizumab) Intravenous Solution
Actemra (tocilizumab) can cause serious side effects including infections, gastrointestinal perforations, liver toxicity, and hypersensitivity reactions that may significantly impact morbidity and mortality; careful monitoring is essential during treatment. 1
Common Side Effects
Infections: The most common serious adverse event
- Upper respiratory tract infections
- Nasopharyngitis
- Serious infections including pneumonia, cellulitis, urinary tract infections, sepsis, and bacterial arthritis
- Opportunistic infections including tuberculosis 1
Laboratory Abnormalities:
- Elevated liver enzymes (ALT/AST)
- Decreased neutrophil counts
- Decreased platelet counts
- Increased lipid parameters 1
Other Common Side Effects:
- Headache
- Hypertension
- Injection site reactions (for subcutaneous formulation)
- Dizziness 1
Serious Side Effects
1. Serious Infections
- Risk of bacterial, viral, fungal, and mycobacterial infections
- Some infections may be fatal
- Patients should be evaluated for tuberculosis before starting treatment (except in COVID-19 patients)
- Patients should be monitored for signs of infection during and after treatment 1
2. Gastrointestinal Perforations
- Rate of approximately 0.26 events per 100 patient-years
- Higher risk in patients taking NSAIDs, corticosteroids, or methotrexate
- Presents with fever, abdominal pain, and change in bowel habits 1
3. Hepatotoxicity
- Can cause serious life-threatening liver problems
- May require liver transplant in severe cases
- Monitor for symptoms including fatigue, anorexia, jaundice, abdominal swelling, dark urine 1
4. Hypersensitivity Reactions
- Including anaphylaxis and serious skin reactions
- Can occur with any infusion, even if previous infusions were well-tolerated
- Signs include swelling of face/lips/mouth/tongue, breathing difficulty, wheezing, skin rash, dizziness, fast heartbeat 1
5. Demyelinating Disorders
- Rare cases of multiple sclerosis and chronic inflammatory demyelinating polyneuropathy
- Use with caution in patients with pre-existing or recent demyelinating disorders 1
Special Populations and Considerations
Cytokine Release Syndrome (CRS) Management
- Tocilizumab is used to treat CRS in CAR T-cell therapy patients
- Dosing: 8 mg/kg IV (not exceeding 800 mg/dose)
- Can be repeated every 8 hours if no improvement (maximum 3 doses in 24 hours, 4 doses total) 2
Pediatric Use
- Used in children with COVID-19 and hyperinflammation
- Weight-based dosing: <30 kg: 12 mg/kg IV; ≥30 kg: 8 mg/kg IV (maximum 800 mg)
- Monitor for liver function abnormalities and elevated triglycerides 2
Pregnancy
- May cause fetal harm
- Women of reproductive potential should be informed of potential risk 1
Monitoring Recommendations
Before Treatment:
- Complete blood count
- Liver function tests
- Lipid profile
- Tuberculosis screening (except in COVID-19 patients)
During Treatment:
- Regular monitoring of CBC, liver enzymes, and lipid parameters
- Monitor for signs of infection
- Watch for symptoms of liver injury
- Monitor for allergic reactions during infusion 1
Contraindications and Precautions
Active Hepatic Disease: Treatment not recommended in patients with active hepatic disease or impairment 1
Vaccinations:
- Avoid live vaccines during treatment
- Patients should be brought up to date with immunizations before starting therapy 1
Concomitant Medications:
- Use caution with other immunosuppressive agents
- Increased risk of GI perforation with NSAIDs and corticosteroids 1
Conclusion
Actemra (tocilizumab) has a complex side effect profile that requires careful patient selection and monitoring. The most significant risks include serious infections, gastrointestinal perforations, hepatotoxicity, and hypersensitivity reactions. Regular laboratory monitoring and vigilance for clinical symptoms of these adverse events are essential for safe use of this medication.