Anib-40 (Afatinib INN 40 mg)

 

 

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

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 Afatinib 40 mg (Anib)

Buy Afatinib generic 40 mg

Anib 40 Tablet: Each film coated tablet contains Afatinib Dimaleate INN equivalent to Afatinib 20 mg.

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Indications

• 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: Safety and efficacy of Afatinib have not been established in patients whose
• tumors have other EGFR mutations.

Dosage & Administration

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.

Side Effects

Most common adverse reactions (>_20%) are diarrhea, rash/dermatitis acneiform, stomatitis, paronychia, dry skin, decreased appetite, pruritus.

 

Precautions

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.

 

Contraindications

None

Use in Pregnancy & Lactation

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.

Drug Interaction

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.

Commercial Packaging

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

 

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