Management   |   Patient advice   |   Grading

 

Adverse event management: rash & acne

Rash and acne

Rash generally manifests as a mild or moderate erythematous and acneiform rash, which may occur or worsen in areas exposed to the sun.1

Bullous, blistering and exfoliative skin conditions have also been reported, including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis.GIOTRIF® (afatinib) treatment should be interrupted or discontinued if the patient develops any severe bullous, blistering or exfoliating conditions.1


Management recommendations1,2

Grade 1:

  • Continue GIOTRIF® (afatinib) at the current dose
  • Topical steroids could be administered
  • Topical antibiotics (clindamycin or metronidazole) can be taken twice daily

 

Grade 2:

  • Continue GIOTRIF® (afatinib) at the current dose
  • Stop topical antibiotic if being used
  • Topical steroids could be administered
  • Oral antibiotic could be used for 6 weeks (100 mg doxycycline or minocycline twice daily)

 

Grade 3–4 or prolonged* or intolerable Grade 2:

  • Refer to a dermatologist
  • Interrupt GIOTRIF® (afatinib), resuming treatment at a reduced dose (10 mg lower) if patient recovers to grade ≤1. Permanent discontinuation should be considered in patients who cannot tolerate 20 mg/day of GIOTRIF® (afatinib) treatment
  • Oral antibiotic could be used for 6 weeks (100 mg doxycycline or minocycline twice daily)
  • If infection is suspected: switch to oral antibiotic with broad-spectrum/gram-negative cover, consider skin swab for bacterial culture and the use of topical steroids
  • When used to manage EGFR TKI-induced rash, prophylactic minocycline treatment (4 weeks) has been associated with a decrease in severe rashes without affecting efficacy outcomes, making prophylactic minocycline a potential treatment option3

Advice for patients2

  • Minimise sunlight exposure, especially to direct sunlight
  • Wear light protective clothing that covers the head, face, hands, arms and legs
  • Use high factor sunscreen (SPF >30 with UVA/UVB; protection); apply generously every 2 hours or more frequently if sweating or swimming

Grading4

Adverse Event

Grade 1

Grade 2

Grade 3

Rash acneiform

Intervention not indicated

Intervention indicated

Associated with pain, disfigurement, ulceration or desquamation

Adverse Event

Rash acneiform

Grade 1

Intervention not indicated

Grade 2

Intervention indicated

Grade 3

Associated with pain, disfigurement, ulceration or desquamation

 

Adapted from CTCAE version 3.4


*>7 days

AE=adverse event, SPF=sun protection factor, UVA=ultraviolet A, UVB=ultraviolet B, CTCAE=Common Terminology Criteria for Adverse Events


References

1
GIOTRIF® (afatinib) Summary of Product Characteristics, 2018.
2
Lacouture ME, et al. Expert Rev Anticancer Ther 2013;13(6):721–728.
3
Melosky B, et al. Curr oncol 2015;22(2):123-132.
4
Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.