Bengali DIL edition of afatinib instructions

Note: before purchasing and taking medicines, a hospital genetic test report and a doctor's diagnosis report or certificate must be produced

indication
Patients with metastatic non-small cell lung cancer (NSCLC) tested for the presence of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
Usage
40 mg once daily orally until disease progression or intolerable toxic side effects occurred.
Taken on an empty stomach, i.e. at least 1 h before or at least 2 h after a meal. Do not supplement missing doses within 12 hours of the next dose if missed once. For patients with dysphagia, approximately 50 ml of water (without the use of a carbonate solution) is available to dissolve the drug completely after oral administration or by nasopharyngeal tube administration.
warning
Before initiating therapy, a well validated, well-established assay to assess the EGFR mutation status of patients is required to avoid false negative or false-positive results.
Adverse effects
Diarrhoea: almost all (96%) afatinib treated patients developed diarrhoea, with grade 3 diarrhoea in 15%. Severe diarrhea without effective treatment may lead to dehydration and renal impairment (6.1%), with grade 3 renal impairment in 1.3%.
Rash or acneiform dermatitis: prevention of infection can be achieved by external application of the affected area in bedough (mupirocin ointment).
Dry skin: the affected area may be applied externally with vitamin E ointment.
Paronychia: to prevent paronychia, nails can be trimmed and avoid embedding of the nail edge in the skin. If suppuration has occurred, apply the affected area with iodophore, or with cefalose or levofloxacin drug powder.
Stomatitis: supplemented with multivitamin B and vitamin C, for ruptured oral mucosa, a rehabilitation Neo solution containing gargling is available.
Decreased appetite: eat fewer and more meals, and eat digestible, low-fat foods.
Hand foot syndrome (7%): common indications include, but are not limited to, numbness, dysesthesia, paresthesia, tingling, painless or aching sensation of a stressed area of the hand and foot, swelling or erythema of the skin, desquamation, fissures, induration like blisters or severe pain, etc.
Bullous and exfoliative skin disorders (0.15%): common indications include, but are not limited to, bullae, blistering, and excoriated lesions.
Interstitial lung disease (ILD): common indications include, but are not limited to, dyspnea, cough, fever, pulmonary infiltrates, alveolar allergies, etc.
Hepatotoxicity (10.1%): 0.18% of them were fatal. Indications for drug-induced liver damage include, but are not limited to, yellowing of the skin or eyes, dark or brown (tea colored) urine, right upper quadrant pain, bleeding or more easy bruising than normal, lethargy, nausea.
Keratitis (0.8%): common indications include, but are not limited to, acute ocular inflammation or deterioration, lacrimation, light sensitivity, ocular pain, red eye, swelling, redness, blurred vision, or other changes in vision.
Left ventricular dysfunction: common indications include new onset or worsening shortness of breath or intolerance to activity, cough, fatigue, swollen joint legs, palpitations, and or sudden weight gain.
Reproductive toxicity: highly effective forms of contraception should be used during treatment and for at least 2 weeks after the last administration of afatinib in women of reproductive age.
Drug drug interactions
P-glycoprotein (P-gp) inhibitors: concomitant administration of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with afatinib may increase exposure to afatinib (oral administration of ritonavir 200 mg 1 hour before afatinib administration increased systemic exposure to afatinib by 48%. There was no change in afatinib exposure when ritonavir was administered concomitantly or 6 hours after afatinib administration.) At the time of intolerance, the daily afatinib dose of 10mg was reduced. The previous dose was resumed after termination of the P-gp inhibitor and was able to tolerate it.
P-gp inducers: concomitant administration of P-gp inducers (including but not limited to rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's wort) with afatinib may reduce exposure to afatinib (compared with afatinib rifampin 600 mg once daily for 7 days, which reduces exposure to afatinib by 34%). Increasing the daily afatinib dose by 10mg while tolerated. The previous dose was resumed 2 to 3 days after termination of the P-gp inducer.