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.¹GIOTRIF^® (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.

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