Pricing
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All price changes →Indications & Uses
Atanib is indicated for:
Pharmacology
Afatinib binds covalently to the kinase domains of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4). It blocks tyrosine kinase autophosphorylation irreversibly, and this lowers ErbB signalling. Some mutations in EGFR, including non-resistant mutations in its kinase domain, increase autophosphorylation of the receptor. The receptor then becomes active, sometimes even without a ligand attached, and this can support cell proliferation in NSCLC.
Non-resistant mutations are those in the exons that make up the kinase domain of EGFR, where they lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib that can be sustained at the recommended dosage, according to validated methods. The most common of these mutations are exon 21 L858R substitutions and exon 19 deletions.
Afatinib inhibited autophosphorylation and/or in vitro proliferation of cell lines expressing wild type EGFR. It did the same in cell lines expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at the afatinib concentrations reached in patients. Afatinib also inhibited in vitro proliferation of cell lines overexpressing HER2.
In nude mice, treatment with afatinib inhibited the growth of implanted tumors that overexpressed either wild type EGFR or HER2, and of tumors in an EGFR L858R/T790M double mutant model.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Patient selection for EGFR mutation-positive metastatic NSCLC works like this: for first-line treatment of metastatic NSCLC with GILOTRIF, patients should be chosen based on EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor specimens. The recommended dose of Afatinib is 40 mg orally, once daily, until the disease progresses or the patient can no longer tolerate it. In severe renal impairment (estimated glomerular filtration rate 15 to 29 mL/min /1.73 m²), the recommended dose is 30 mg orally, once daily. Afatinib should be taken at least 1 hour before or 2 hours after a meal. A missed dose should not be taken within 12 hours of the next dose. Or, as directed by the registered physicians. For pediatric use, the safety and effectiveness of Afatinib in pediatric patients have not been established.
Side Effects
Afatinib Dimaleate can cause diarrhea, bullous and exfoliative skin disorders, interstitial lung disease, hepatic toxicity and keratitis.
Cautions & Contraindications
Warnings & Precautions
Diarrhea: Diarrhea has led to dehydration, with or without renal impairment, in clinical experience, and some cases were fatal. Grade 3-4 diarrhea occurred in 697 (16%) of the 4257 patients who received Afatinib Dimaleate across 44 clinical trials. In Study 1, 96% of patients treated with Afatinib Dimaleate (n=229) had diarrhea. Of these, 15% had Grade 3 diarrhea, and it occurred within the first 6 weeks. Renal impairment as a consequence of diarrhea occurred in 6% of patients, and 1.3% of these were Grade 3. If a patient develops prolonged Grade 2 diarrhea lasting more than 48 hours, or diarrhea of Grade 3 or higher, Afatinib Dimaleate should be withheld until the diarrhea settles to Grade 1 or less. It is then resumed with an appropriate dose reduction. Bullous and Exfoliative Skin Disorders: Grade 3 skin reactions with bullous, blistering and exfoliating lesions occurred in 0.2% of the 4257 patients who received Afatinib Dimaleate across clinical trials. In Study 1, skin reactions consisting of rash, erythema and acneiform rash occurred in 90% of patients, and Grade 3 skin reactions occurred in 16%. Grade 1-3 palmar-plantar erythrodysesthesia syndrome was seen in 7%. Afatinib Dimaleate should be discontinued in patients who develop life-threatening bullous, blistering or exfoliating lesions. Interstitial Lung Disease (ILD): Interstitial lung disease or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in 1.6% of the 4257 patients who received Afatinib Dimaleate across clinical trials, and 0.4% of these were fatal. Afatinib Dimaleate should be withheld while a patient with suspected ILD is being evaluated, and discontinued if ILD is confirmed. Hepatic Toxicity: Among the 4257 patients who received Afatinib Dimaleate across clinical trials, 9.7% had liver test abnormalities, and 0.2% were fatal. In Study 1, liver test abnormalities of any grade occurred in 17.5% of patients, and 3.5% had Grade 3-4 abnormalities. Liver tests should be done periodically during treatment with Afatinib Dimaleate. The medicine should be withheld in patients whose liver function gets worse. If severe hepatic impairment develops, treatment should be discontinued. Keratitis: Keratitis means acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye. It occurred in 0.7% of the 4257 patients treated with Afatinib Dimaleate across clinical trials, and 0.05% had Grade 3 keratitis. In Study 1, keratitis was reported in 2.2% of patients, with Grade 3 in 0.4%. Afatinib Dimaleate should be withheld while a patient with suspected keratitis is being evaluated. If ulcerative keratitis is confirmed, treatment should be interrupted or discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. Afatinib Dimaleate should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
Contraindications
Afatinib Dimaleate must not be given to anyone who is known to be hypersensitive to Afatinib or to any other component of the product.
Pregnancy & Breastfeeding
Afatinib can cause harm to the unborn baby when a pregnant woman takes it. There are no data on the use of Afatinib in pregnant women. There are also no data on whether Afatinib passes into human milk, what it does to a breastfed infant, or whether it affects milk production. Because nursing infants could have serious adverse reactions to Afatinib, a woman who is breastfeeding should be advised not to breastfeed during treatment and for 2 weeks after her final dose.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Overdose with Afatinib Dimaleate was reported in 2 healthy adolescents. Each of them took 360 mg (as part of a mixed-drug ingestion), and both had nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase. Both recovered.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Afatinib Dimaleate in a cool, dry place below 30°C, away from sunlight. Always keep it out of reach of children.
Drug Interactions
Common questions about Atanib 40 mg
What is Atanib 40 mg Tablet?
Atanib 40 mg Tablet is a medicine that contains Afatinib Dimaleate. It is made by Aristopharma Limited. It belongs to the Tyrosine Kinase Inhibitor group of medicines.
What is Atanib used for?
Atanib is used for: Cancer.
What are the side effects of Atanib?
Afatinib Dimaleate can cause diarrhea, bullous and exfoliative skin disorders, interstitial lung disease, hepatic toxicity and keratitis.
Can I take Atanib during pregnancy or while breastfeeding?
Afatinib can cause harm to the unborn baby when a pregnant woman takes it. There are no data on the use of Afatinib in pregnant women. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Atanib?
Overdose with Afatinib Dimaleate was reported in 2 healthy adolescents. Each of them took 360 mg (as part of a mixed-drug ingestion), and both had nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Atanib?
Keep Afatinib Dimaleate in a cool, dry place below 30°C, away from sunlight. Always keep it out of reach of children.
Can I take other medicines with Atanib?
Some medicines can interact with Afatinib Dimaleate, for example: Cyclosporine, Erythromycin, Carbamazepine, Rifampicin, Itraconazole, Tacrolimus. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Atanib is already among the lowest-priced brands of Afatinib Dimaleate at this strength.
Do I need a prescription for Atanib?
Atanib is a prescription (Rx) medicine. Take it as your doctor advises.