What are the side effects of Actemra (Tocilizumab) 8 mg/kg IV every 4 weeks?

Side Effects of Actemra (Tocilizumab) 8 mg/kg IV Every 4 Weeks

The most common side effects of Actemra (tocilizumab) 8 mg/kg IV every 4 weeks include infections (particularly upper respiratory tract infections and nasopharyngitis), headache, hypertension, and liver enzyme elevations. 1

Common Side Effects

Infections

• Upper respiratory tract infections (5-8% of patients) 1
• Nasopharyngitis (5-8% of patients) 1
• Overall infection rate: 127 events per 100 patient-years with 8 mg/kg IV dosing 1

Laboratory Abnormalities

• Neutropenia: 3.4% of patients experience decreases in neutrophil counts below 1000/mm³ 1
• Liver enzyme elevations: Increased ALT/AST, which may require dose adjustment or discontinuation 1
• Lipid abnormalities: Increased total cholesterol, LDL, HDL, and triglycerides 1

Other Common Side Effects

• Headache 1
• Hypertension 1
• Infusion reactions (7-8% of patients) 1
  • Most commonly hypertension during infusion (1%)
  • Skin reactions including rash, pruritus, and urticaria (1%)

Serious Side Effects

Serious Infections

• Rate of 5.3 events per 100 patient-years with 8 mg/kg IV dosing 1
• Most common serious infections include:
  • Pneumonia
  • Urinary tract infection
  • Cellulitis
  • Herpes zoster
  • Gastroenteritis
  • Diverticulitis
  • Sepsis
  • Bacterial arthritis
  • Opportunistic infections 1

Gastrointestinal Perforations

• Overall rate of 0.26 events per 100 patient-years 1
• Most commonly reported as complications of diverticulitis 1
• Higher risk in patients taking concomitant NSAIDs, corticosteroids, or methotrexate 1

Hypersensitivity Reactions

• Anaphylaxis reported in 0.2% of patients 1
• Most commonly observed during the second to fourth infusion 1
• Can include:
  • Swelling of face, lips, mouth, or tongue
  • Breathing difficulties
  • Skin rash or hives
  • Dizziness or fainting
  • Tachycardia 1

Hepatitis B Reactivation

• Can occur in carriers of hepatitis B virus 1
• Screening recommended before initiating treatment 1

Management of Infusion Reactions

For mild to moderate reactions (Grade 1-2):

• Reduce infusion rate or temporarily interrupt infusion 2
• Consider premedication for subsequent infusions
• NSAIDs, antihistamines, and corticosteroids may be used to manage symptoms 2

For severe reactions (Grade 3):

• Permanently discontinue Actemra 2
• Manage with antihistamines, oxygen, fluids, corticosteroids as clinically appropriate 2

Monitoring Recommendations

• Complete blood count with differential: At baseline, 4-8 weeks after starting therapy, and every 3 months thereafter 2
• Liver function tests: At baseline, every 4-8 weeks for first 6 months, then every 3 months 2
• Lipid profile: At baseline, 4-8 weeks after starting therapy, 6 months after starting therapy, then annually 2
• Tuberculosis screening: Before initiation 2
• Hepatitis B and C screening: Before initiation 2

Special Considerations

Patients with Rheumatoid Arthritis

• Efficacy is maintained when used as monotherapy or in combination with DMARDs 3
• Median time to low disease activity may be shorter when combined with conventional DMARDs compared to monotherapy 3

Patients with Interstitial Lung Disease

• Monitor for respiratory symptoms as tocilizumab has been used to treat interstitial lung disease in systemic autoimmune rheumatic diseases 2

Patients with Risk of GI Perforation

• Use with caution in patients with diverticulitis history
• Avoid concomitant NSAIDs if possible 1

Practical Administration Tips

• The standard infusion time is 60 minutes, but studies have shown that a faster infusion rate (31 minutes) is equally safe and effective 4
• For patients with good response to 4-week intervals, extending the interval to 6 weeks may be possible with maintained efficacy and potentially fewer side effects 5

Remember that proper monitoring and early recognition of adverse events are essential for safe and effective treatment with tocilizumab.