Why is this medication prescribed?

Afatinib is prescribed primarily to treat non-small cell lung cancer that has specific types of abnormal epidermal growth factor receptor (EGFR) genes. It belongs to a class of medications called tyrosine kinase inhibitors (TKIs), which work by blocking the activity of EGFR, a protein that can promote the growth of cancer cells when mutated.

How should this medicine be used?

Here’s a step-by-step guide on how to use Afatinib:

• Dosage: Afatinib is usually taken once daily, at least 1 hour before or 2 hours after a meal. The specific dosage depends on the condition being treated, the patient’s overall health, and how they respond to the medication.
• Administration: Swallow the tablet whole with water; do not crush, chew, or dissolve it. Take it at the same time each day to maintain a consistent level in your bloodstream.
• Precautions: Avoid missing doses. If you do miss a dose, and it’s less than 12 hours until the next dose, skip the missed dose. Do not double the dose to catch up. Regular monitoring by your doctor is essential, including blood tests and assessments of your lung function, liver function, and kidney function.
• Potential Side Effects: Common side effects include diarrhea, rash, mouth sores, and nail infections. Serious side effects can include severe lung problems, liver problems, and heart issues. It’s important to report any unusual symptoms to your doctor immediately.

Always follow your healthcare provider’s instructions when using Afatinib and inform them about any other medications you are taking, as drug interactions can occur.

Other uses for this medicine

• Head and Neck Cancer: Afatinib has been explored as a treatment for squamous cell carcinoma of the head and neck, particularly in cases where the cancer has progressed after platinum-based chemotherapy.
• Other EGFR-Positive Cancers: Research is ongoing to evaluate Afatinib’s effectiveness in treating other cancers that involve mutations in the EGFR gene, such as certain types of breast cancer.

What special precautions should I follow?

When taking Afatinib, it’s important to follow these precautions to minimize risks and ensure effective treatment:

• Medical History: Inform your doctor if you have a history of lung disease, liver disease, kidney disease, or heart disease. Let your doctor know if you have any history of eye disorders, as Afatinib can cause eye irritation or damage.
• Pregnancy and Breastfeeding: Afatinib can harm an unborn baby, so it is important to use effective contraception during treatment and for at least 2 weeks after your last dose. Do not breastfeed while taking Afatinib and for at least 2 weeks after stopping the medication.
• Drug Interactions: Provide your doctor with a list of all medications, supplements, and herbal products you are taking, as Afatinib can interact with other drugs. Avoid using over-the-counter medications, especially those for treating diarrhea or nausea, without consulting your doctor.
• Sun Exposure: Afatinib can make your skin more sensitive to sunlight, leading to a higher risk of sunburn. Use sunscreen and wear protective clothing when outdoors.
• Hydration: Diarrhea is a common side effect of Afatinib and can lead to dehydration. Drink plenty of fluids, and contact your doctor if you experience severe or persistent diarrhea.
• Monitoring: Regular blood tests are needed to monitor your liver and kidney function, and to check your electrolyte levels. Eye exams may be necessary if you experience vision changes or eye irritation.
• Surgery: Inform your doctor or dentist that you are taking Afatinib before any surgery or dental procedures.
• Side Effects: Be vigilant for signs of serious side effects, such as severe skin reactions, breathing difficulties, chest pain, or vision problems, and seek medical attention immediately if they occur.

Following these precautions can help manage potential risks associated with Afatinib and enhance the effectiveness of your treatment.

What special dietary instructions should I follow?

• Meal Timing: Take Afatinib on an empty stomach, at least 1 hour before or 2 hours after a meal.
• Avoid Grapefruit: Do not consume grapefruit or grapefruit juice while taking Afatinib, as it can increase the medication’s levels in your bloodstream, potentially leading to more side effects.
• Stay Hydrated: Ensure adequate fluid intake to prevent dehydration, especially if you experience diarrhea.

What should I do if I forget a dose?

• Timing: If you miss a dose and it’s been less than 12 hours since you were supposed to take it, take the missed dose as soon as you remember.
• Skip the Dose: If it’s been more than 12 hours, skip the missed dose and continue with your regular dosing schedule.
• Do Not Double Up: Never take two doses at the same time to make up for a missed dose.

What side effects can this medication cause?

Afatinib can cause a range of side effects, some of which may be serious. Here’s a rundown of common and serious side effects:

Common Side Effects:

• Diarrhea: Often the most frequent side effect; it can range from mild to severe.
• Rash: Includes acne-like rash, dry skin, or other skin changes.
• Mouth Sores: Painful sores or ulcers in the mouth.
• Nail Infections: Changes in or infections of the nails.
• Fatigue: Feeling unusually tired or weak.
• Appetite Loss: Decreased interest in food or difficulty eating.

Serious Side Effects:

• Lung Problems: Symptoms may include persistent cough, shortness of breath, or chest pain. Afatinib can cause lung inflammation or interstitial lung disease (ILD).
• Liver Problems: Symptoms include yellowing of the skin or eyes (jaundice), dark urine, or upper abdominal pain.
• Severe Skin Reactions: Includes severe rash, blistering, or peeling skin.
• Eye Problems: Symptoms such as vision changes, eye irritation, or pain.
• Heart Issues: Uncommon, but symptoms may include chest pain or swelling of the legs and ankles.
• Severe Diarrhea: May lead to dehydration and electrolyte imbalances; can be severe and require medical attention.
• Infections: Increased risk of infections due to weakened immune response.

Inform your doctor about any side effects you experience, especially if they are severe or persistent. Contact your healthcare provider if diarrhea is severe or does not improve with over-the-counter remedies. Keep track of any new or worsening symptoms and seek medical advice promptly.

Your healthcare provider can help manage these side effects and adjust your treatment plan as needed to ensure the best possible outcome.

What should I know about storage and disposal of this medication?

Storage and Disposal of Afatinib:

Storage:

• Temperature: Store Afatinib at room temperature, between 68°F to 77°F (20°C to 25°C).
• Protection: Keep the medication in its original container, tightly closed, and protected from moisture and light.
• Keep Out of Reach: Store the medication out of reach of children and pets.

Disposal:

• Medication Take-Back Programs: Dispose of Afatinib through a drug take-back program if available in your area. These programs are often offered by pharmacies or local community organizations.
• FDA Disposal Recommendations: If a take-back program is not available, follow any specific disposal instructions provided with the medication. Some medications can be flushed down the toilet if instructed, but check if this applies to Afatinib.
• Do Not Flush: Generally, avoid flushing medications down the toilet or pouring them down the drain unless instructed to do so.

In case of emergency/overdose

• Emergency Contact: Contact your local emergency services or go to the nearest emergency room if you suspect an overdose.
• Symptoms of Overdose: Symptoms may include severe diarrhea, nausea, vomiting, or other severe reactions.
• Poison Control: Call a poison control center for advice on how to handle an overdose. You can reach the Poison Control Center in the U.S. by calling 1-800-222-1222.

What other information should I know?

• Follow-Up Appointments: Regularly attend follow-up appointments with your healthcare provider to monitor your condition and the effects of the medication.
• Lab Tests: Expect regular lab tests to check your liver, kidney function, and other relevant parameters.
• Allergic Reactions: Inform your doctor if you have a history of allergies to medications, as Afatinib can cause allergic reactions.
• Communication: Keep open communication with your healthcare team about any new or worsening symptoms, or if you have concerns about your treatment.
• Adherence: Adhere to the prescribed dosage and schedule; do not adjust your dose or stop taking Afatinib without consulting your healthcare provider.

By following these guidelines and maintaining good communication with your healthcare provider, you can help manage your treatment with Afatinib safely and effectively.