Afanat 30mg Tablet contains Afatinib (as afatinib dimaleate), a targeted anticancer medicine that belongs to a group of medicines called tyrosine kinase inhibitors. It is made by Natco Pharma and is supplied as a bottle of 28 tablets. It is used in adults with certain types of non-small cell lung cancer (NSCLC).

Afanat 30mg is a lower-dose strength. The usual recommended dose of afatinib is 40 mg once daily. The 30 mg strength may be prescribed when the dose needs to be reduced because of side effects, or in people with severe kidney impairment. Your oncologist decides the dose that is right for you.

Afanat 30mg Tablet is used to treat:

• First-line treatment of metastatic NSCLC: In adults whose tumours have certain non-resistant EGFR gene mutations, confirmed by a test.

• Metastatic squamous NSCLC: In adults whose cancer has progressed after platinum-based chemotherapy.

• Dose-adjusted treatment: The 30 mg strength allows treatment to continue at a lower dose when needed to manage side effects or severe kidney impairment.

The safety and effectiveness of afatinib have not been established in tumours with resistant EGFR mutations.

Afanat 30mg Tablet contains afatinib, which irreversibly binds to EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4). These are proteins on the surface of cells that send growth signals. Certain EGFR mutations keep these signals switched on and drive cancer growth.

By blocking these signals, afatinib helps slow or stop the growth and spread of the cancer cells.

Tell your oncologist about all prescription medicines, over-the-counter medicines, vitamins and herbal products you take before starting Afanat.

• P-gp inhibitors: Medicines such as ritonavir, ciclosporin, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir and amiodarone can increase afatinib levels. Your doctor may reduce the dose if side effects are not tolerated.

• P-gp inducers: Medicines such as rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s wort can lower afatinib levels. Your doctor may increase the dose.

• NSAIDs, corticosteroids and anti-angiogenic medicines: These may increase the risk of a tear in the stomach or intestine. Tell your oncologist before taking painkillers such as ibuprofen.

• Food: A high-fat meal reduces how much afatinib your body absorbs, so Afanat must be taken on an empty stomach.

• Other cancer treatments and supplements: Tell your oncologist about any other cancer treatment and any supplements you use.

• Store Afanat 30mg Tablet at 20°C to 25°C. Short periods between 15°C and 30°C are acceptable.

• Keep the tablets in the original bottle to protect them from high humidity and light.

• Keep the bottle tightly closed.

• Keep out of the reach of children and pets.

• Dispose of unused or expired tablets safely, as advised by your pharmacist.

Take Afanat 30mg Tablet exactly as prescribed by your oncologist. Take it once a day at the same time each day, on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the tablet whole with water.

• Treatment continues until the cancer progresses or you can no longer tolerate it. Do not stop without your doctor’s advice.

• If you miss a dose, take it when you remember, unless your next dose is due within 12 hours. In that case, skip the missed dose. Never take two doses together.

• Your doctor may lower the dose in steps of 10 mg or pause treatment if you have severe side effects such as diarrhoea or skin reactions.

• An anti-diarrhoeal medicine such as loperamide is usually prescribed. Start it at the first loose stool as advised and keep drinking fluids.

• Regular blood tests, including liver function tests, are needed during treatment.

Common side effects of Afanat 30mg Tablet may include:

• Diarrhoea

• Rash or acne-like skin reactions

• Mouth sores

• Nail infections around the nail bed

• Dry skin

• Itching

• Decreased appetite

• Nausea

• Vomiting

Diarrhoea occurs in most people taking afatinib. Tell your doctor early so it can be managed.

Serious side effects

Seek medical attention if you develop:

• Severe or persistent diarrhoea with signs of dehydration, such as dry mouth, dizziness or passing less urine.

• Severe skin reactions, such as blistering, peeling or blisters in the mouth.

• New or worsening cough, shortness of breath or fever, which can be signs of lung inflammation.

• Yellowing of the skin or eyes, dark urine, pain in the upper right abdomen or easy bruising, which can be signs of liver problems.

• Severe stomach pain, which can be a sign of a tear in the stomach or intestine.

• Eye pain, redness, sensitivity to light or blurred vision.

• Shortness of breath, swollen ankles or legs, palpitations or sudden weight gain, which can be signs of heart problems.

• Take Afanat on an empty stomach, at least 1 hour before or 2 hours after a meal.

• Start your anti-diarrhoeal medicine at the first loose stool as advised, and drink plenty of fluids.

• Look after your skin. Use a moisturiser, wear protective clothing and sunscreen, and treat rashes early.

• Tell your doctor if you have dry eye or wear contact lenses, and report any eye symptoms straight away.

• Tell your doctor if you have a history of stomach ulcers or diverticular disease, and do not take NSAIDs or steroids unless prescribed.

• Keep your appointments for blood tests and liver checks.

• Report new breathing problems immediately.

• Use effective contraception during treatment and for at least 2 weeks after the last dose.

• Do not change your dose or stop treatment without your oncologist’s advice.