AFANIX (AFATINIB) 40MG TABLETS 30`S

AFANIX contains afatinib, a targeted cancer medicine that works by blocking the action of certain proteins (ErbB receptors, including EGFR and HER2) found on the surface of cancer cells. By blocking these signals, afatinib slows or stops the growth of cancer cells.

Afatinib 40 mg is indicated for: First-line treatment of adults with non-small cell lung cancer (NSCLC) with specific EGFR mutations (deletion of exon 19 or substitution in exon 21 L858R); Treatment of adults with locally advanced or metastatic squamous cell carcinoma of the lung after prior platinum-based chemotherapy.

Afatinib is an irreversible ErbB family blocker, distinguishing it from first-generation EGFR inhibitors such as erlotinib and gefitinib. Selecting patients with confirmed EGFR mutations is essential before initiating therapy.

The recommended dose is 40 mg taken ONCE daily. Take on an empty stomach — at least 1 hour before or 3 hours after eating. Swallow whole with water.

•       Take at the same time every day.

•       If you miss a dose, take it as soon as you remember — unless the next dose is within 8 hours. If so, skip and continue with the next scheduled dose.

•       Your doctor may reduce your dose to 30 mg or 20 mg if you experience significant side effects.

Dose Reductions

•       Dose reductions are in 10 mg steps (40 mg → 30 mg → 20 mg).

•       A minimum dose of 20 mg is supported in clinical trials.

Very Common Side Effects (>1 in 10 patients)

•       Diarrhoea — often severe; start an antidiarrhoeal (loperamide) at first sign and maintain hydration. Report if it persists >48 hours.

•       Skin rash / acneiform rash — appears on face, chest, back; topical treatments can help.

•       Paronychia — inflammation/infection around the fingernails and toenails.

•       Dry skin, stomatitis (mouth sores).

•       Nausea, decreased appetite, vomiting.

Serious Side Effects — Seek Urgent Medical Attention

•       Interstitial lung disease (ILD) / pneumonitis — new or worsening breathlessness, cough, fever. Stop afatinib and seek emergency help.

•       Severe diarrhoea causing dehydration.

•       Severe skin reactions: blistering, peeling, mucous membrane involvement.

•       Eye inflammation (keratitis): eye pain, redness, blurred vision.

•       Heart problems: reduced left ventricular ejection fraction.

Diarrhoea Management

Diarrhoea is the most common dose-limiting side effect. At the first sign of loose stools, start loperamide as directed and maintain good fluid intake. Report to your oncologist if diarrhoea continues for more than 48 hours or is severe.

Skin and Nail Care

Skin rash is expected with EGFR inhibitors and can be a sign that the drug is active. Use gentle, non-perfumed moisturisers. Keep nails short and clean to prevent paronychia. Wear gloves when gardening or doing wet work.

Pregnancy and Breastfeeding

Afatinib can harm an unborn baby. Women must use effective contraception during treatment and for at least 2 weeks after the last dose. Breastfeeding is not recommended.

Sun Protection

The skin rash worsens with sun exposure. Use SPF 30+ sunscreen and protective clothing daily.

•       P-glycoprotein (P-gp) inhibitors (e.g., ritonavir, cyclosporine, ketoconazole, erythromycin) — increase afatinib exposure; reduce afatinib dose by 10 mg if not tolerated.

•       P-gp inducers (e.g., rifampicin, carbamazepine, phenytoin, St John's Wort) — decrease afatinib exposure; increase afatinib dose by 10 mg if tolerated.

•       Store below 25°C in a dry place, away from direct light.

•       Keep in the original bottle with the desiccant (silica gel sachet) — do not remove it.

•       Keep out of reach of children.

AFANIX is a prescription-only medicine (POM) in Kenya. It must only be initiated by a qualified oncologist following molecular testing confirming EGFR mutation status.

•       Patient selection: Confirm EGFR mutation (exon 19 deletion or L858R substitution) before initiating first-line afatinib.

•       Hepatic impairment: No dose adjustment for mild-moderate. Not recommended in severe hepatic impairment (Child-Pugh C).

•       Renal impairment: No adjustment for CrCl ≥15 mL/min. Avoid if CrCl <15 mL/min (insufficient data).

•       Monitor: LFTs, renal function, LVEF (cardiac function), respiratory symptoms.

•       Afatinib should be taken at the same time each day relative to P-gp inhibitors (12 hours apart where possible).

What is AFANIX (afatinib) used for?

AFANIX is a targeted therapy for non-small cell lung cancer (NSCLC). It is used as a first-line treatment in patients whose cancer has specific EGFR gene mutations, or as a second-line treatment for advanced squamous lung cancer.

Do I need a genetic test before starting AFANIX?

Yes. Your tumour must be tested for EGFR mutations (specifically exon 19 deletions or L858R mutation in exon 21) before starting afatinib. Without confirmed mutation, afatinib is not indicated for first-line NSCLC.

Why must I take AFANIX on an empty stomach?

A high-fat meal can reduce afatinib absorption by up to 50%. Taking it at least 1 hour before food or 3 hours after ensures reliable blood levels.

What should I do if I get diarrhoea?

Start loperamide (e.g., Imodium) immediately at the first sign of loose stools and maintain fluid intake. If diarrhoea persists beyond 48 hours or is severe, contact your oncologist — you may need a dose reduction or temporary interruption.

What does the skin rash mean? Should I be worried?

An acneiform (pimple-like) rash on the face, chest, and back is common and is often a sign that the drug is working. Use gentle moisturisers and SPF 30+ sunscreen. Report severe rashes (blistering, peeling) to your oncologist.