Indications
AFB Tablet is used for:
Non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult Dose
Oral
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: In patient w/ activating EGFR mutation(s) (exon 19 deletion, exon 21 substitution); In patient w/ metastatic squamous non-small cell lung carcinoma (NSCLC) (progressed following platinum-based therapy): 40 mg once daily, increased if tolerated to up to 50 mg once daily after 3 wk at initial dose.
Hepatic impairment
Mild-to-moderate (Child Pugh A or B): No dosage adjustment necessary
Severe (Child Pugh C): Closely monitor and adjust dose if not tolerated
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30-89 mL/min/1.73 m²): No dosage adjustment necessary
Severe (CrCl 15-29 mL/min/1.73 m²): 30 mg PO qDay
Severe (CrCl<15 mL/min/1.73 m²): Not studied
Administration
Should be taken on an empty stomach. Take at least 1 hr before or 3 hr after meals. Swallow whole. For patients w/ difficulty swallowing, tab may be dispersed in approx 100 mL of plain, non-carbonated water. No other liqd should be used. Drop the tab in water & stir w/o crushing until it disperses (approx 15 min). Drink immediately. Rinse glass w/ another 100 mL of water & drink. Dispersed liqd may also be administered via nasogastric tube.
Contra Indications
Hypersensitivity to afatinib. Dialysis patients. Severe hepatic (Child-Pugh class C) and renal (eGFR <15 mL/min/1.73m2) impairment. Lactation.
Precautions
May cause diarrhea that results in dehydration with or without renal impairment; some reported cases were fatal; withhold therapy for severe and prolonged diarrhea not responsive to antidiarrheal agents
Postmarketing cases consistent with toxic epidermal necrolysis (TEN), including bullous and exfoliative skin disorders, and Stevens Johnson syndrome (SJS) reported; discontinue if life-threatening bullous, blistering, or exfoliating lesions occur; withhold therapy for severe and prolonged cutaneous reactions
May increase risk for sunburn/phototoxicity; may worsen rash or acne; caution patients to limit sun exposure and where sunscreen and protective clothing
Interstitial lung disease (ILD) or ILD-like adverse reactions reported (eg, lung infiltration, pneumonitis, acute respiratory distress syndrome, alveolitis allergy) occurred in 1%, of these, 0.4% were fatal; discontinue therapy if ILD diagnosed
Hepatotoxicity reported; monitor with periodic liver testing; withhold or discontinue therapy for severe or worsening liver tests
Keratitis, characterized as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye occurred in 0.8%; withhold or discontinue therapy for confirmed ulcerative keratitis
Gastrointestinal perforation, including fatal cases, reported; patients receiving concomitant corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) or anti-angiogenic agents, or patients with increasing age or who have an underlying history of gastrointestinal ulceration, underlying diverticular disease or bowel metastases may be at increased risk of perforation; permanently discontinue therapy in patients who develop gastrointestinal perforation
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women; administration to pregnant rabbits during organogenesis at exposures approximately 0.2 times exposure in humans at recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages; advise pregnant women of potential risk to a fetus
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for at least 2 weeks after the last dose of afatinib
Based on results from an animal fertility study, afatinib may reduce fertility in females and males of reproductive potential
Unknown if the effects on fertility are reversible
Lactation
There are no data on presence of afatinib in human milk or effects on breastfed infant or on milk production; presence shown in milk of lactating rats; because of potential for serious adverse reactions in nursing infants, advise a lactating woman not to breastfeed during treatment and for 2 weeks after final dose
Interactions
Increased plasma concentration w/ strong P-gp inhibitors (e.g. ritonavir, nelfinavir, saquinavir, ciclosporine A, tacrolimus, ketoconazole, itraconazole, erythromycin, verapamil, amiodarone, quinidine). Decreased plasma concentration w/ strong P-gp inducers (e.g. rifampin, phenytoin, phernobarbital, carbamazepine). May increase bioavailability of breast cancer resistance protein (BCRP) substrates (e.g. rosuvastatin, sulfasalazine).
Side Effects
Side effects of Afatinib :
>10%
Diarrhea (75-96%)
Rash/dermatitis acneiform (70-90%)
Stomatitis (30-71%)
Paronychia (11-58%)
Increased ALT (10-54%)
Decreased creatinine clearance (49%)
Increase alkaline phosphate (34-51%)
Increased AST (7-46%)
Decreased lymphocytes (38%)
Dry skin (31%)
Decreased potassium (11-30%)
Decreased appetite (25%)
Pruritus (21%)
Nausea (21%)
Epistaxis (17%)
Decreased weight (17%)
Rash/dermatitis acneiform, Grade 3 or 4 (7-16%)
Increased bilirubin (3-16%)
Diarrhea, Grade 3 or 4 (11-15%)
Vomiting (13%)
Cystitis (13%)
Decreased WBC (12%)
Cheilitis (12%)
Rhinorrhea (11%)
Paronychia, Grade 3 or 4 (1-11%)
1-10%
Stomatitis, Grade 3 or 4 (9%)
Decreased lymphocytes, Grade 3 or 4 (9%)
Decreased potassium, Grade 3 or 4 (1-8%)
Stomatitis, Grade 3 or 4 (4%)
Decreased appetite, Grade 3 or 4 (3%)
Increased AST, Grade 3 or 4 (1-3%)
Increase alkaline phosphate, Grade 3 or 4 (2-3%)
Decreased creatinine clearance (2%)
Nausea, Grade 3 or 4 (2%)
Increased ALT, Grade 3 or 4 (1-2%)
Decreased WBC, Grade 3 or 4 (1%)
Vomiting, Grade 3 or 4 (1%)
Cystitis, Grade 3 or 4 (1%)
Decreased weight, Grade 3 or 4 (1%)
Increased bilirubin, Grade 3 or 4 (1%)
<1%
Keratitis (0.8%)
Mode of Action
Afatinib is a selective 2nd generation tyrosine kinase inhibitor of the ErbB family, epidermal growth factor receptor (EGFR/ErbB1), and human epidermal growth factor receptor types 2 (HER2/ErbB2) and 4 (HER4/ErbB4), resulting in tumour growth inhibition and tumour regression.
Note
AFB 30 mg Tablet generic name is Afatinib. AFB 30 mg Tablet is manufactured by Jenphar Bangladesh Ltd.AFB is availble in all over Bangladesh.
Mes BD drug index information on AFB Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.