afatinib 40 mg price afanix

Description:

Afatinib is a kinase inhibitor indicated for the First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test & treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy. Afanix is available in tablet form for oral administration. The recommended dose of Afatinib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.
Medicine Information Source: BeaconPharma
 

Afatinib 30 Tablets

Afatinib(Afanix) 40 mg
Price

$315

Afatinib is a targeted therapy. Afatinib is classified as a Tyrosine Kinase inhibitor; Epidermal Growth Factor Receptor (EGFR) inhibitor.

Therapeutic Indications

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer

Afatinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: The safety and efficacy of Afatinib have not been established in patients whose tumors have other EGFR mutations.

Previously Treated,Metastatic Squamous NSLC

Afatinib is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

Superiority of Afanix:

New phase III data have demonstrated superior improvement in progression-free survival (PFS) with afatinib compared with erlotinib in patients with advanced squamous-cell carcinoma (SCC) of the lung.

    • In the Phase III LUX-Lung 8 (advanced squamous cell carcinoma of the lung) trial, afatinib significantly improved overall survival compared to Erlotinib.
    • Afatinib significantly improved outcomes in treatment-naive patients withEGFR-mutated NSCLC compared with gefitinib, with a manageable tolerability profile.
    • Afatinib results in improved progression-free survival compared with gefitinib.

Afatinib is a kinase inhibitor indicated for the First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test & treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy. Afanix is available in tablet form for oral administration. The recommended dose of Afatinib is 40 mg orally, once daily until disease progression or no longer tolerated by the patient.

Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4

(ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation

of ErbB signaling.

Afatinib demonstrated inhibition of autophosphorylation and in vitro proliferation of cell lines

expressing wild-type EGFR or those expressing selected EGFR exon 19 deletion mutations or exon

21 L858R mutations, including some with a secondary T790M mutation, at Afatinib

concentrations achieved, at least transiently, in patients. In addition, Afatinib inhibited in vitro

proliferation of cell lines overexpressing HER2.

Treatment with Afatinib resulted in inhibition of tumor growth in nude mice implanted with tumors

either overexpressing wild type EGFR or HER2 or in an EGFR L858R/T790M double mutant model.

Recommended Dose

The recommended dose of Afatinib is 40 mg orally once daily until disease progression or no

longer tolerated by the patient. Afatinib should be taken at least 1 hour before or 2 hours after a

meal. Patient should not take a missed dose within 12 hours of the next dose.

Dosage Modification

Withhold Afatinib for any drug-related adverse reactions of:

  • NCI CTCAE* Grade 3 or higher
  • Diarrhea of Grade 2 or higher persisting for 2 or more consecutive days while taking

anti-diarrheal medication

  • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable
  • Renal dysfunction of Grade 2 or higher

Resume treatment when the adverse reaction fully resolves, returns to baseline, or improves to

Grade 1. Reinstitute Afatinib at a reduced dose, i.e., 10 mg per day less than the dose at which

the adverse reaction occurred.

Permanently discontinue Afatinib for:

  • Life-threatening bullous, blistering, or exfoliative skin lesions
  • Confirmed interstitial lung disease (ILD)
  • Severe drug-induced hepatic impairment
  • Persistent ulcerative keratitis
  • Symptomatic left ventricular dysfunction
  • Severe or intolerable adverse reaction occurring at a dose of 20 mg per day

P-gp Inhibitors

For patients who require therapy with a P-glycoprotein (P-gp) inhibitor, reduce Afatinib daily dose

by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as

tolerated.

P-gp Inducers

For patients who require chronic therapy with a P-gp inducer, increase Afatinib daily dose by 10

mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer.

Most common adverse reactions (>_20%) are diarrhea, rash/dermatitis acneiform, stomatitis,

paronychia, dry skin, decreased appetite, pruritus.

Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold Afatinib for severe

and prolonged diarrhea not responsive to antidiarrheal agents.

Bullous and Exfoliative Skin Disorders: Severe bullous, blistering, and exfoliating lesions

occurred in 0.15% of patients. Discontinue for life-threatening cutaneous reactions. Withhold

Afatinib for severe and prolonged cutaneous reactions.

Interstitial lung disease (ILD): Occurs in 1.5% of patients. Withhold Afatinib for acute onset

or worsening of pulmonary symptoms. Discontinue Afatinib if ILD is diagnosed.

Hepatic toxicity: Fatal hepatic impairment occurs in 0.18% of patients. Monitor with periodic

liver testing. Withhold or discontinue Afatinib for severe or worsening liver tests.

Keratitis: Occurs in 0.8% of patients. Withhold Afatinib for keratitis evaluation. Withhold or

discontinue Afatinib for confirmed ulcerative keratitis.

Embryofetal toxicity: Can cause fetal harm. Advise females of the potential hazard to the

fetus and to use highly effective contraception.

Pregnancy

Pregnancy Category D

Risk Summary

Based on its mechanism of action, Afatinib can cause fetal harm when administered to a pregnant

woman. Afatinib was embryotoxic and, in animals with maternal toxicity, led to abortions at late

gestational stages in rabbits at doses of 5 mg/kg (approximately 0.2 times the exposure by AUC

at the recommended human dose of 40 mg daily) or greater. If this drug is used during

pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be

apprised of the potential hazard to the fetus.

Nursing Mothers

It is not known whether Afatinib is present in human milk. Afatinib was present in the milk of

lactating rats at concentrations 80-150 times higher than those found in plasma from 1 to 6 hours

after administration. Because many drugs are present in human milk and because of the potential

for serious adverse reactions in nursing infants from Afatinib, a decision should be made whether

to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to

the mother.

Pediatric Use

Safety and effectiveness of Afatinib in pediatric patients have not been established.

Geriatric Use

Of the 3865 patients in the clinical studies of Afatinib, 32% of patients were 65 years and older,

while 7% were 75 years and older. No overall differences in safety were observed between

patients 65 years and over and younger patients. 39% of the 345 patients were 65 years of age

or older and 4% were 75 years or older. No overall differences in effectiveness were observed

between patients 65 years and older and younger patients.

Females and Males of Reproductive Potential

Contraception

Females

Counsel patients on pregnancy planning and prevention. Advise female patients of reproductive

potential to use highly effective contraception during treatment with Afatinib, and for at least 2

weeks after the last dose of Afatinib. Advise patients to contact their healthcare provider if they

become pregnant, or if pregnancy is suspected, while taking Afatinib.

Renal Impairment

Afatinib has not been studied in patients with severely impaired renal function (Creatinine

clearance [CLcr]

necessary in patients with mild (CLcr 60-89 mL/min) renal impairment. Closely monitor patients

with moderate (CLcr 30-59 mL/min) to severe (CLcr

Afatinib dose if not tolerated.

Hepatic Impairment

Afatinib has not been studied in patients with severe (Child Pugh C) hepatic impairment.

Adjustments to the starting dose of Afatinib are not considered necessary in patients with mild

(Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Closely monitor patients with

severe hepatic impairment and adjust Afatinib dose if not tolerated.

Effect of P-glycoprotein (P-gp) Inhibitors and Inducers

Oral administration of a P-gp inhibitor (Ritonavir at 200 mg twice daily) 1 hour before

administration of Afatinib increased systemic exposure to Afatinib by 48%. There was no change

in Afatinib exposure when Ritonavir was administered simultaneously with or 6 hours after

Afatinib. Concomitant taking of P-gp inhibitors (including but not limited to Ritonavir, Cyclosporine

A, Ketoconazole, Itraconazole, Erythromycin, Verapamil, Quinidine, Tacrolimus, Nelfinavir,

Saquinavir, and Amiodarone) with Afatinib can increase exposure to Afatinib.

Co-administration with oral dose of a P-gp inducer (Rifampicin at 600 mg once daily for 7 days)

decreased exposure to Afatinib by 34%. Concomitant taking of P-gp inducers (including but not

limited to Rifampicin, Carbamazepine, Phenytoin, Phenobarbital, and St. John’s wort) with

Afatinib can decrease exposure to Afatinib.

Afanix 20 Tablet: Each commercial box contains 30 tablets in Alu-Alu blister pack.

Afanix 40 Tablet: Each commercial box contains 30 tablets in Alu-Alu blister pack.

 

Buying Afatinib 40 mg Tablets is always costly. But our Afationib 40 mg tablet price is low cost with an excellent quality. Afatinib 40 mg (Afanix)  manufacture by Beacon Pharmaceuticals Limited and It is one of the renowned Pharmaceuticals company of Bangladesh. If you are interested to buy Afanix (Afatinib) 40 mg then contact us.

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