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INTRODUCTION
AFANAT 30 TABLET contains Afatinib which belongs to a group of medicines called Kinase inhibitors. AFANAT 30 TABLET is used as a first line of treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations (genetic mutation) in cancer cells which can be detected by FDA-approved test.
AFANAT 30 TABLET is also used to treat metastatic squamous non-small cell lung cancer (NSCLC) in patients who might had some progress with platinum-based chemotherapy (drug therapy used to treat non-small cell lung cancer).
AFANAT 30 TABLET is not recommended for use if you are allergic to Afatinib. Before taking AFANAT 30 TABLET, inform your doctor if you have eye, lung, heart, liver, and/or kidney problems.
AFANAT 30 TABLET is not recommended for use during pregnancy since it may cause harm to the unborn baby. It is also not recommended for use in breastfeeding women since it may pass though breast milk and cause unwanted side effects in breastfed baby.
AFANAT 30 TABLET is also not recommended for use in children and adolescents (aged below 18 years).
The most common side effects of taking AFANAT 30 TABLET are decreased appetite/weight, diarrhea, nausea, vomiting, dry skin, pain/peeling of skin (hands and feet), and/or stomach pain. Contact your doctor if any of the symptoms gets worse.
USES OF AFANAT 30 TABLET
- Treats metastatic non-small cell lung cancer (NSCLC) in affected individuals
- Treats metastatic squamous non-small cell lung cancer which had a limited/insufficient response to platinum-based chemotherapy
HOW AFANAT 30 TABLET WORKS
AFANAT 30 TABLET works by blocking the activity of a group of proteins called ErbB1, ErbB2 (HER2), ErbB3 and ErbB4 in the cancer cells which are required for the growth and spread of cancer cells that gets inhibited resulting in the inhibited growth and spread of the cancer cells.
DIRECTIONS FOR USE
Take AFANAT 30 TABLET as advised by your physician. Swallow AFANAT 30 TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration of AFANAT 30 TABLET for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF AFANAT 30 TABLET
COMMON
- diarrhea
- skin reactions such as dry skin, skin rash, itching, lip inflammation
- runny nose
- dry eye
- mouth sores and inflammation
- nail infection
- reduced desire to eat (decreased appetite)
- bleeding from nose
- nausea and vomiting
- pain, redness, swelling or peeling of skin of your hands and feet
- frequent burning sensation during urination, urgent need to urinate (cystitis)
- abnormal taste sensation (dysgeusia)
- stomach pain, indigestion, heartburn
- weight loss
- muscle spasms
- fever
UNCOMMON
- bloating, loss of appetite or sweating due to inflammation of the pancreas (a gland that controls blood sugar level in our body)
- severe stomach pain and tenderness due to tear in stomach or intestine
RARE
- severe blistering or peeling of the skin
Stop taking AFANAT 30 TABLET and contact your doctor immediately if you experience any of the following side effects:
- diarrhea for more than 2 days or severe diarrhea leading to fluid loss in the body
- skin reactions such as redness, rash, and acne
- signs of lung or breathing problems due to inflammation of the lungs (trouble breathing or shortness of breath, cough, or fever)
- signs of liver problems (yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling very tired)
- Signs of eye problems (eye pain, swelling, redness, or tearing, blurred vision, sensitivity to light, other changes in your vision)
- Signs of heart problems (new or worsening shortness of breath while at rest or with activity, cough, tiredness, swelling of your ankles, feet, or legs (edema), feeling your heart to be pounding or racing (palpitations), sudden weight gain)
HOW TO MANAGE SIDE EFFECTS
Stomach pain:
If AFANAT 30 TABLET causes stomach pain, then try to take rest and relax and have frequent smaller meals. Drink slowly and try to place a covered hot water bottle on your stomach to ease the pain. If you pain persists then, consult your doctor.
Decreased appetite:
Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts.
Diarrhoea:
Drink lots of fluids, such as water to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom gets worse.
Nausea and vomiting:
Try to take AFANAT 30 TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult the doctor if symptoms gets worse.
Indigestion:
Try to have smaller and more frequent meals and eat and drink slowly. Consult your doctor, if symptoms get worse.
WARNING & PRECAUTIONS
PREGNANCY
AFANAT 30 TABLET is not recommended for use in pregnant women since it may cause fetal harm. Women of childbearing potential should use effective birth control during treatment and for at least 2 weeks after the last dose of taking AFANAT 30 TABLET.
BREASTFEEDING
AFANAT 30 TABLET is not recommended for use in breast-feeding women and for at least 2 weeks after taking the last dose of AFANAT 30 TABLET.
DRIVING AND USING MACHINES
AFANAT 30 TABLET is not recommended for use if you experience symptoms affecting your ability to concentrate and react such as redness and irritation of the eye, dry eye, tearing, and/or light-sensitivity. Consult and inform your doctor before taking AFANAT 30 TABLET.
ALCOHOL
Avoid consumption of alcohol while taking AFANAT 30 TABLET.
KIDNEY
AFANAT 30 TABLET should be used with caution in patients with kidney problems such as severe renal impairment. Consult your doctor for advice before taking AFANAT 30 TABLET.
LIVER
AFANAT 30 TABLET should be used with caution in patients with liver problems such as severe liver impairment. Consult your doctor for advice before taking AFANAT 30 TABLET.
ALLERGY
AFANAT 30 TABLET is not recommended for use if you are allergic to Afatinib or any of the other ingredients of this medicine.
LUNGS
AFANAT 30 TABLET should be taken with caution in patients with lung problems. Consult your doctor before taking.
HEART DISEASE
AFANAT 30 TABLET should be used with caution in patients with heart problems. Consult your doctor before taking AFANAT 30 TABLET.
OTHERS
Before taking AFANAT 30 TABLET, inform your doctor if you:
- are female and have low body weight less than 50 kg
- have eye problems such as severe dry eyes, or ulcers involving the outer part of the eye (sclera) or use contact lenses
- are informed of intolerant to some sugars such as lactose
Use in Pediatrics:
AFANAT 30 TABLET is generally not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking AFANAT 30 TABLET.
Use in Geriatrics:
AFANAT 30 TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking AFANAT 30 TABLET.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking AFANAT 30 TABLET, inform your doctor, if you are taking any of the following medicine:
- ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir (medicines used to treat different kinds of infections)
- verapamil, quinidine, amiodarone (medicines used to treat heart conditions)
- cyclosporine A, tacrolimus (medicines used in organ transplant therapy)
- carbamazepine, phenytoin, phenobarbital (medicines used to treat seizures)
- st. John’s wort ( a herbal medicine to treat depression)
- rifampicin (an antibiotic used to treat tuberculosis)
- sulfasalazine (medicine used to treat inflammation or infection)
- rosuvastatin (medicine used for lowering cholesterol)
Overdosage:
If you or anyone else accidentally take more AFANAT 30 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose can be nausea, vomiting, asthenia (physical weakness), dizziness, headache, and abdominal pain.
SYNOPSIS
| Drug | : | Afatinib |
| Pharmacological Category | : | Tyrosine Kinase inhibitor |
| Therapeutic Indication | : | Non-Small Cell Lung Cancer |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep [GBNKEYWORD] out of reach in children
- Store AFANAT 30 TABLET at room temperature
FAQs ABOUT AFANAT 30 TABLET
What AFANAT 30 TABLET is used for?
AFANAT 30 TABLET is an anticancer drug used to treat metastatic and squamous non-small cell lung cancer as a first line of treatment or if prior chemotherapy treatment is insufficient to provide cure in adult patients. Non-small cell lung cancer (NSCLC) is a type of cancer that occurs in the lung when abnormal cells form and multiply into large mass forming tumor or lesions characterized by persistent cough, shortness of breath, weight loss or coughing up blood.
How AFANAT 30 TABLET works on my body?
AFANAT 30 TABLET works by blocking the activity of a group of proteins called ErbB1, ErbB2 (HER2), ErbB3 and ErbB4 in the cancer cells which are required for the growth and spread of cancer cells in the lungs.
What precautions do I need to follow while taking AFANAT 30 TABLET?
Patients taking AFANAT 30 TABLET must inform their doctor about their pre-existing disease conditions related to eye, lung, heart, kidney, liver problems since it may cause some unwanted side effects.
What are the side effects of AFANAT 30 TABLET?
The most common side effects of taking AFANAT 30 TABLET are decreased appetite, decreased weight, diarrhea, nausea, vomiting, dry skin, pain or peeling of skin (hands and feet), allergic reactions (such as runny nose, rash, itching, inflammation of the lip, mouth sores), stomach pain, indigestion, heartburn, eye irritation, and fever. Consult your doctor for advice if your symptoms get worsen over the time.
Is AFANAT 30 TABLET safe to use in children?
No. AFANAT 30 TABLET is not recommended for use in children and adolescents (below 18 years of age). If AFANAT 30 TABLET is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.
Can AFANAT 30 TABLET be taken by pregnant or breastfeeding women?
AFANAT 30 TABLET is not recommended for use in pregnant women since it may cause fetal harm. Women of childbearing potential should use effective birth control during treatment and should continue it for at least next 2 weeks after receiving the last dose of AFANAT 30 TABLET. The medicine is not recommended for use in breast-feeding women and advised not to breast feed while taking AFANAT 30 TABLET and for 2 weeks after taking the last dose of AFANAT 30 TABLET.
REFERENCES
1. KD. Tripathi. Chemotherapy Of Neoplastic Diseases. Essentials of medical pharmacology. Seventh edition. 2013. Page – 870.
2. Scott M. Wirth. Afatinib in Non–Small Cell Lung Cancer.NCBI; PMC US National Library of Medicine, National Institute of Health. September 2015 [Accessed on 21st April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4803462/#:~:text=Afatinib%20is%20a%20second%2Dgeneration,and%20HER4%20(ErbB4)%20receptors
3. Boehringer Ingelheim Pharma GmbH & Co. K. Electronic Medicines Compendium (EMC) [Revised in July 2021] [Accessed on 21st April 2022] https://www.medicines.org.uk/emc/files/pil.5147.pdf
4. Boehringer Ingelheim Pharma GmbH & Co. K. Electronic Medicines Compendium (EMC) [Revised in July 2021] [Accessed on 21st April 2022] https://www.medicines.org.uk/emc/files/pil.7701.pdf
5. Boehringer Ingelheim Pharma GmbH & Co. K. Electronic Medicines Compendium (EMC) [Revised in July 2021] [Accessed on 21st April 2022] https://www.medicines.org.uk/emc/files/pil.7699.pdf
6. Boehringer Ingelheim Pharma GmbH & Co. K. Electronic Medicines Compendium (EMC) [Revised in July 2021] [Accessed on 21st April 2022] https://www.medicines.org.uk/emc/files/pil.7698.pdf
7. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in January 2018] [Accessed on 21st April 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Liquid biopsy
- Low dose CT scan
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 29 Nov 2022 | 06:57 PM(IST)
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