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Afatinib

Class
Targeted therapy
Subclass
EGFR tyrosine kinase inhibitors
Generic name
Afatinib
Brand names
Gilotrif®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Metastatic squamous non-small cell lung cancer • Post-platinum-based chemotherapy
•
40 mg PO daily a duration until disease progression, or until the formulation is no longer tolerated by the patient
Non-small cell lung cancer • Metastatic
•
40 mg PO daily a duration until disease progression, or until the formulation is no longer tolerated by the patient
Indications for use
Labeled indications
Adults
•
Treatment of metastatic squamous non-small cell lung cancer (post-platinum-based chemotherapy)
•
Treatment of non-small cell lung cancer (metastatic)
Safety risks
Boxed warnings
Gastrointestinal perforation
•
Use extreme caution history of peptic ulcer, using NSAIDs, or antiangiogenic agents.
Warnings and precautions
Dehydration
•
Use caution renal impairment.
Liver disease
•
Use caution with pre-existing hepatic disease.
Ocular inflammatory disease
•
Use caution with a history of keratitis, ulcerative keratitis, or severe dry eye.
Reactivation of skin rash
•
Use caution with prolonged grade 2 cutaneous adverse reactions.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 15-20 mL/min/1.73 m²
•
Use with caution. Monitor serum concentrations.
eGFR < 15 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
•
Use with caution. Dose as in eGFR < 15 mL/min/1.73 m². Monitor serum concentrations.
Peritoneal dialysis
•
Use with caution. Dose as in eGFR < 15 mL/min/1.73 m². Monitor serum concentrations.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor serum aminotransferases. Monitor for toxicity. - Hold afatinib therapy if worsening liver function develops.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor serum aminotransferases. Monitor for toxicity. - Hold afatinib therapy if worsening liver function develops.
Child-Pugh C (severe)
•
Use with caution. Monitor serum aminotransferases. Monitor for toxicity. - Closely monitor the patients and adjust the dose if not tolerated - Hold afatinib therapy if worsening liver function develops.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Avoid use. Evidence of fetal harm in humans. Pregnancy should be avoided during treatment and for at least 2 weeks after the last dose of afatinib.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Loss of appetite, nausea, vomiting
Common 1-10%
•
Interstitial lung disease, ↑ serum ALT, ↑ serum AST, ↑ serum TBIL, paronychia, acute cystitis, diarrhea, dyspnea, vomiting, skin dryness, Stevens-Johnson syndrome
Uncommon < 1%
•
Respiratory failure, renal failure, sepsis, stomatitis
Interactions
Drug(s)
Check Interactions
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