GIOTRIF® (afatinib) has a well-characterised side effects profile1-5

  • The most frequent adverse reactions associated with GIOTRIF® (afatinib) are diarrhoea, skin related adverse events, stomatitis and paronychia1
    • Overall tolerability-guided dose reductions have led to a lower frequency of common adverse reactions 
  • Learn more about how you can manage the AEs commonly associated with GIOTRIF® (afatinib) use here

Summary of ADRs per frequency category from all NSCLC trials and post marketing experience with daily GIOTRIF® (afatinib) doses of 40 mg or 50 mg as monotherapy1

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Paronychiaa, decreased appetite, espistaxis, diarrhoea, stomatitisb, nausea, vomiting, rashc, dermatitis acneiformd, prurituse, dry skinf

Cystitis, dehydration, hypokalaemia, dysgeusia, conjunctivitis, dry eye, rhinorrhoea, dyspepsia, cheilitis, alanine aminotransferase increased, aspartate aminotransferase increased, palmar-plantar erythrodysaesthia syndrome, nail disordersg, muscle spasms, renal impairment/failure, pyrexia, weight decrease

Keratitis, interstitial lung disease, pancreatitis

Stevens-Johnson syndromeh, toxic epidermal necrolysish

Very common (≥1/10)

Paronychiaa, decreased appetite, espistaxis, diarrhoea, stomatitisb, nausea, vomiting, rashc, dermatitis acneiformd, prurituse, dry skinf

Common (≥1/100 to <1/10)

Cystitis, dehydration, hypokalaemia, dysgeusia, conjunctivitis, dry eye, rhinorrhoea, dyspepsia, cheilitis, alanine aminotransferase increased, aspartate aminotransferase increased, palmar-plantar erythrodysaesthia syndrome, nail disordersg, muscle spasms, renal impairment/failure, pyrexia, weight decrease

Uncommon (≥1/1,000 to <1/100)

Keratitis, interstitial lung disease, pancreatitis

Rare (≥1/10,000 to <1/1,000)

Stevens-Johnson syndromeh, toxic epidermal necrolysish

 

aIncludes paronychia, nail infection, nail bed infection. bIncludes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration. cIncludes group of rash preferred terms. dIncludes acne, acne pustular, dermatitis acneiform. eIncludes pruritus, pruritus generalised. fIncludes dry skin, skin chapped. gIncludes nail disorder, onycholysis, nail toxicity, onychoclasis, ingrowing nail, nail pitting, onychomadesis, nail discoloration, nail dystrophy, nail ridging, and onychogryphosis. hBased on post-marketing experience.

Adapted from GIOTRIF® (afatinib), Summary of Product Characteristics, 2018.1

In a real-world setting, GIOTRIF® (afatinib) dose modification reduced the incidence and severity of ADRs without compromising effectiveness.6 See the data.


ADR=adverse drug reaction, AE=adverse event, NSCLC=non-small-cell lung cancer


References

1
GIOTRIF® (afatinib), Summary of Product Characteristics, 2018.
2
Sequist LV, et al. J Clin Oncol 2013;31(27):3327–3334.
3
Wu YL, et al. Lancet Oncol 2014;15(2):213–222.
4
Park K, et al. Lancet Oncol 2016;17(5):577–589.
5
Soria JC, et al. Lancet Oncol 2015;16(8):897–907.
6
Halmos B, et al. Lung Cancer 2019;127:103–111.

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