INTRODUCTION
XOVOLTIB 20MG contains Afatinib which belongs to a group of medicines called Kinase inhibitors. XOVOLTIB 20MG 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. It is also used in the treatment of patients with metastatic, squamous non-small cell lung cancer (NSCLC) who might have progressing with platinum-based chemotherapy (drug therapy used to treat non-small cell lung cancer). Non-small cell lung cancer is a type of cancer that occurs in the lung when abnormal cells form and multiply into large mass forming tumor or lesions which is characterized by persistent cough, shortness of breath, weight loss or coughing up blood.
Afatinib 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. Your doctor may advice you to do liver function tests if you have liver problems.
XOVOLTIB 20MG is not recommended for use if you are allergic to Afatinib or any other ingredients in this medicine. Consult your doctor before taking XOVOLTIB 20MG if you are a female and have body weight less than 50 kgs. If you have eye, lung, heart, liver, or kidney problems consult your doctor before taking XOVOLTIB 20MG. Pregnant women are advised to consult their doctor before taking XOVOLTIB 20MG. XOVOLTIB 20MG is not recommended for use in breastfeeding women as it may cause unwanted side effects. XOVOLTIB 20MG is not recommended for use in children and adolescents (less than 18 years of age). The most common side effects of taking XOVOLTIB 20MG 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. Contact your doctor if any of the symptoms gets worse.
USES OF XOVOLTIB 20MG
- Treats metastatic non-small cell lung cancer (NSCLC) in adult patients
HOW XOVOLTIB 20MG WORKS
Afatinib is a tyrosine kinase inhibitor. It acts by inhibiting the activity of various proteins (including EGFR, HER2 and HER4) involved in the growth and spread of cancer cells. As a result, it causes down regulation of these protein signaling and inhibits autophosphorylation and proliferation of epidermal growth factor receptor (EGFR) over expressing cancer cells.
DIRECTIONS FOR USE
Take XOVOLTIB 20MG as advised by your physician. Swallow XOVOLTIB 20MG with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration of XOVOLTIB 20MG for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF XOVOLTIB 20MG
COMMON
- diarrhoea
- 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 XOVOLTIB 20MG 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 XOVOLTIB 20MG 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.
Diarrhea:
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 XOVOLTIB 20MG 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
XOVOLTIB 20MG 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 XOVOLTIB 20MG.
BREASTFEEDING
XOVOLTIB 20MG is not recommended for use in breast-feeding women and for at least 2 weeks after taking the last dose of XOVOLTIB 20MG.
DRIVING AND USING MACHINES
XOVOLTIB 20MG 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 XOVOLTIB 20MG.
ALCOHOL
Avoid consumption of alcohol while taking XOVOLTIB 20MG.
KIDNEY
XOVOLTIB 20MG should be used with caution in patients with severe renal impairment or kidney problems. Consult your doctor for advice before taking XOVOLTIB 20MG.
LIVER
XOVOLTIB 20MG should be used with caution in patients with severe liver impairment and dose may be adjusted according to the tolerance of the patients. Consult your doctor for advice before taking XOVOLTIB 20MG.
ALLERGY
XOVOLTIB 20MG is not recommended for use if you are allergic to Afatinib or any of the other ingredients of this medicine.
LUNGS
XOVOLTIB 20MG should be taken with caution in patients with lung or breathing problems seen with cough, or fever. Consult your doctor before taking.
HEART DISEASE
XOVOLTIB 20MG should be used with caution in patients with heart problems. Consult your doctor before taking XOVOLTIB 20MG.
OTHERS
Before taking XOVOLTIB 20MG, 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:
XOVOLTIB 20MG is generally not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking XOVOLTIB 20MG.
Use in Geriatrics:
XOVOLTIB 20MG should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking XOVOLTIB 20MG.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking XOVOLTIB 20MG, 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 XOVOLTIB 20MG, 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 XOVOLTIB 20MG out of reach in children
- Store XOVOLTIB 20MG at room temperature
FAQs ABOUT XOVOLTIB 20MG
What XOVOLTIB 20MG is used for?
XOVOLTIB 20MG 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 XOVOLTIB 20MG works on my body?
XOVOLTIB 20MG 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 XOVOLTIB 20MG?
Patients taking XOVOLTIB 20MG 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 XOVOLTIB 20MG?
The most common side effects of taking XOVOLTIB 20MG 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 XOVOLTIB 20MG safe to use in children?
No. XOVOLTIB 20MG is not recommended for use in children and adolescents (below 18 years of age). If XOVOLTIB 20MG is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.
Can XOVOLTIB 20MG be taken by pregnant or breastfeeding women?
XOVOLTIB 20MG 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 XOVOLTIB 20MG. The medicine is not recommended for use in breast-feeding women and advised not to breast feed while taking XOVOLTIB 20MG and for 2 weeks after taking the last dose of XOVOLTIB 20MG.
REFERENCES
1. KD. Tripathi. Chemotherapy Of Neoplastic Diseases. Essentials of medical pharmacology. Seventh edition. 2013. Page – 870.
2. Boehringer Ingelheim. Afatinib in Patients with Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations.NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in March 2017] [Accessed on 21st April 2022] https://clinicaltrials.gov/ct2/show/NCT02044380
3. 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
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.5147.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.7701.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.7699.pdf
7. 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
8. 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
- Liver function test
PRODUCT DETAILS
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