What are the side effects of intralesional bleomycin?

Side Effects of Intralesional Bleomycin

Intralesional bleomycin can cause serious pulmonary toxicity including pneumonitis and fibrosis even at low doses, with potential mortality rates of up to 20-24% in severe cases. 1 While generally considered safer than systemic administration, clinicians must be vigilant about both local and systemic adverse effects.

Common Side Effects

Local Side Effects

• Injection site reactions:
  • Pain and inflammation 2
  • Skin hyperpigmentation (24% of patients) 3
  • Superficial ulceration (reported in approximately 7% of patients) 4
  • Cellulitis 5

Systemic Side Effects

• Flu-like symptoms (fever, chills, nausea, vomiting) in approximately 24% of patients 3
• Fever (common transient side effect) 5

Serious Adverse Effects

Pulmonary Toxicity

• Bleomycin-induced pneumonitis (BIP) can occur even with intralesional administration 6
  • Presents with dry cough, progressive dyspnea, and respiratory distress
  • Can develop within 24 hours of administration 6
  • Can progress to respiratory failure requiring hospitalization 1
  • May require corticosteroid treatment and respiratory support

Risk Factors for Pulmonary Toxicity

• Age >40 years
• Cumulative dose >400 units
• Reduced renal function
• Concomitant use of cisplatin
• Pre-existing lung disease
• Smoking 1

Diagnostic Evaluation for Suspected Pulmonary Toxicity

If respiratory symptoms develop after intralesional bleomycin:

1. Immediately assess for respiratory symptoms (cough, dyspnea)
2. Check oxygen saturation
3. Obtain high-resolution CT scan (HRCT) - first-line investigation
4. Consider pulmonary function tests (PFTs), particularly DLCO 1

Management of Bleomycin Toxicity

Immediate Interventions

• Suspend further bleomycin therapy
• Consider corticosteroids (methylprednisolone IV for severe cases or oral prednisone 0.5 mg/kg for 7 days with gradual tapering)
• Provide oxygen therapy as needed
• Consider empirical antibiotics 1

Monitoring

• Regular clinical assessment of respiratory symptoms
• Follow-up HRCT to monitor disease evolution
• Monitor PFTs, particularly DLCO 1

Prevention Strategies

1. Skin protection protocol to prevent hyperpigmentation from skin trauma during injection 7
2. Dose limitations:
   • In children <1 year: 0.5-1 mg/kg per injection
   • In children >1 year and adults: 1-15 mg per session (never exceeding 15 mg)
   • Maintain 3-4 week intervals between sessions 4
3. Verify renal function before each treatment cycle 1
4. Use a toxicity checklist before and after each treatment 1

Important Considerations

• The case of severe acute lung toxicity has been reported after a very low dose (7 mg; 0.28 mg/kg) of intralesional bleomycin in a 5-year-old child with no risk factors 6
• Early detection of pulmonary toxicity is crucial as delay in diagnosis and treatment can be fatal 6
• Any physician treating patients with intralesional bleomycin must remain alert for respiratory symptoms 6

Despite these potential side effects, intralesional bleomycin has shown high satisfaction rates, with 90% of patients reporting satisfaction with treatment results 3, and has demonstrated effectiveness in 71% of cases, decreasing the need for invasive surgery 4.