INTRODUCTION

AFANAT 40 contains Afatinib which belongs to the group of medicines called antineoplastic agents. It is indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in adult patients with non-resistant epidermal growth factor receptor (EGFR) mutations either as a first line therapy or if prior chemotherapy treatment has been insufficient. It can also be used to treat metastatic squamous NSCLC if prior chemotherapy treatment has been insufficient.

Afatinib works by inhibiting the activity of various proteins (including EGFR, HER2 and HER4) involved in the growth and spread of cancer cells. AFANAT 40 must be taken without meals. It should be taken preferably 1 hour before or 3 hours after meals. Your doctor will decide the correct dose and duration of therapy for you depending upon the severity of the disease. The most common side effects of taking this medicine are nausea, vomiting, indigestion, mouth sores, dry skin, itching and weight loss. Contact your doctor if any of the symptoms bothers you.

Before taking this medicine, inform your doctor if you have or had any lung, liver, kidney or heart problems. Proper dose titrations and careful monitoring are required in such patients. Avoid getting pregnant while taking this medicine, because it may harm your unborn fetus. Also, consult your doctor for advice after taking the last dose of this medicine, if you are planning to become pregnant, because your body may not have fully eliminated this medicine. This medicine is strictly not recommended for use in lactating mothers and in children (under 18 years). Consult your doctor before taking.

USES OF AFANAT 40

• Treats metastatic non-small cell lung cancer (NSCLC) in adult patients

HOW AFANAT 40 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 downregulation of these protein signaling and inhibits autophosphorylation and proliferation of epidermal growth factor receptor (EGFR) overexpressing cancer cells.

DIRECTIONS FOR USE

Take AFANAT 40 as directed by your physician. It must be taken without meals either 1 hour before or 3 hours after a meal. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon the severity of your disease. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF AFANAT 40

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

This side effect is more common while taking chemotherapy and it is nothing to worry about. Stick to simple meals. Do not eat rich or spicy food. Contact your doctor if it really bothers you.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

Skin drying or itching:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If the symptom still persists, contact your doctor.

Decreased appetite:

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines used to treat various infections (e.g. ritonavir, nelfinavir, saquinavir, itraconazole, ketoconazole or erythromycin)
• medicines used to treat heart problems (e.g. verapamil, quinidine, amiodarone)
• medicines used to suppress your immune system (e.g. cyclosporine A and tacrolimus)
• medicines used to treat epilepsy (e.g. phenytoin, carbamazepine and phenobarbital)
• St. John’s wort (a herbal medicine used for depression and other mental illness)
• rifampicin (used to treat tuberculosis)
• sulfasalazine (used to treat inflammation or infection)
• rosuvastatin (used to treat high blood cholesterol levels)
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen, aspirin)
• corticosteroids (used to treat allergies and inflammation) e.g. dexamethasone, prednisolone

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT AFANAT 40

Is AFANAT 40 a chemotherapy?

However, this medicine does not belong to conventional chemotherapy, it is also an anticancer agent used to treat NSCLC in adults.

What happens if I forget to take AFANAT 40?

Take the missed dose as soon as you remember until it is time for your next dose. At any cause, do not take a double dose to make up a forgotten dose.

How long should I take AFANAT 40?

You should continue to take this medicine as long as your doctor tells you to do so. Do not stop taking this medicine abruptly as it may reduce its effectiveness. Your doctor will decide the duration of the therapy depending upon the severity of the disease.

REFERENCES

1. KD. Tripathi. Anticancer agents. 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 on March 2017] [Accessed 27th January 2021] 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 27th January 2021] 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. KG. Electronic Medicines Compendium (EMC); [Revised on September 2020] [Accessed 27th January 2021] https://www.medicines.org.uk/emc/files/pil.7699.pdf

5. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC); [Revised on September 2020] [Accessed 27th January 2021] https://www.medicines.org.uk/emc/files/pil.7701.pdf

6. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC); [Revised on September 2020] [Accessed 27th January 2021] https://www.medicines.org.uk/emc/files/pil.7698.pdf

7. Boehringer Ingelheim Pharma GmbH & Co. KG. Electronic Medicines Compendium (EMC); [Revised on September 2020] [Accessed 27th January 2021] https://www.medicines.org.uk/emc/files/pil.5147.pdf

8. Boehringer Ingelheim Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised on January 2018] [Accessed 27th January 2021] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf