Afatinib (Oral)

Afatinib is used in the treatment of metastatic cancer and non-small cell lung cancer.

Overview

Afatinib is known in the US under the brand name, Gilotrif.

The medication is used to treat metastatic cancer and non-small cell lung cancer (NSCLC) that shows some forms of abnormal growth factor receptor genes in patients who have not already been treated for cancer that has spread to other areas of the body.

Afatinib is a form of chemotherapy drug called a tyrosine kinase inhibitor (TKI), or cancer growth inhibitor. The medication works by blocking proteins in the body from sending signals to stimulate the growth of cancer cells. Interrupting these signals causes the cancer cells to die, slowing the growth of the cancer or stopping it altogether.

Afatinib is only available on prescription from your doctor or oncology specialist.

Conditions treated

  • metastatic cancer
  • non-small cell lung cancer (NSCLC)

Type of medicine

  • tyrosine kinase inhibitor
  • tablet

Side-effects

Together with the benefits of taking Afatinib, you may experience some unwanted or unpleasant side-effects. Many of these side-effects may not occur, but you should consult your medical professional if they do, as you may require medical attention.

You should consult your doctor immediately if you notice that you have cloudy or bloody urine, painful or difficult urination, or a frequent urge to urinate. Some patients have diarrhea. You could develop itchy, dry or burning eyes, or find that you have swelling around your eye, eyelid or inner lining of the eyelid. Some people taking this medication report that the skin on their feet and hands becomes flaky, scaly or ulcerated. You may experience a tingling feeling in your feet and hands.

Other commonly experienced side-effects include a fever, breathing difficulties, or a persistent cough.

The following side-effects can occur less commonly and usually resolve themselves without medical intervention as your body becomes accustomed to the new medication. If any of these effects prove to be particularly bothersome, have a chat with your doctor for advice on how best to manage and prevent them.

  • Skin blemishes
  • canker sores
  • red, chapped, or swollen lips
  • loss of appetite
  • unexplained weight loss
  • fingernails becoming loose
  • nosebleeds
  • outbreaks of pimples
  • soreness or reddening around the fingernails
  • runny nose
  • inflammation or ulceration of the lips
  • white spots on the tongue or inside the mouth

In the event that you inadvertently overdose with this medication, you should call 911 or seek urgent medical attention from your doctor. The following are symptoms of an overdose of Afatinib.

  • stomach pain
  • headache
  • dizziness
  • nausea
  • vomiting
  • weakness or unusual loss of strength

This list of side-effects is not exhaustive. If you notice any other effects, report them to your doctor straight away.

Dosage

Chemotherapy medicines that are used to treat cancer are very strong and can have many side-effects as listed above. Before you start to take this medicine, it is important that you fully understand the risks as well as the benefits. Be sure to work closely with your medical team during your treatment with Afatinib.

You must only take this medication exactly as instructed by your doctor. Do not exceed the prescribed dose, do not increase the frequency of the dose, and do not continue taking the medication for longer than instructed by your doctor. To do so could increase the effect of you suffering side-effects.

Afatinib is supplied with a patient Medication Guide. Make sure that you read and understand this information and ask your doctor if it contains anything that you do not understand.

The dose of this medicine will vary between patients. Always follow your doctor's instructions or the directions on the product label. The dosage levels given below are based on the average. If your prescribed dose is different, do not alter it, unless instructed to do so by your doctor. The amount of medication that you are prescribed depends on the strength of the preparation, as do the number of doses you must take each day, and the length of time for which you will take the medication, depending on the condition you are being treated for.

Never share your medication with anyone else.

Note that certain laboratory tests will be carried out before you begin treatment with this medication to check for EGFR protein in your tumor. Liver function tests should also be carried out periodically during the course of your treatment with Afatinib to monitor your progress and to check for any side-effects that the drug may be causing. Your doctor will provide you with further information on any tests that you will have.

This medication should be taken on an empty stomach at least one hour preceding or two hours following a meal. The medication comes in tablet form. You should swallow the tablet whole with water. Do not crush, bite, or chew the tablet.

For the treatment of metastatic non-small cell lung cancer:

  • adults: 40 mg once daily
  • children: dose and use as determined by your doctor

If you omit a dose of this medication and less than 12 hours has elapsed since your usual dosage time, you should take it as soon as possible. Do not double-dose in an effort to catch up. If it has been more than 12 hours since your usual dose time, you should omit the missed dose and revert to your usual dosing regimen.

Major drug interactions

Some forms of medication must not be used together. However, in other cases, some drugs may be used concurrently, even though an interaction may occur. In this case, your doctor may elect to change the dose of one of your medications or alternatively may suggest precautions that you can take.

Some other medications may affect the way your body removes Afatinib from your system, which can in turn affect how the drug works. If you are taking any of the following medication, inform your doctor, before you begin your course of Afatinib.

  • rifamycins
  • St John's wort
  • Phenytoin
  • Phenobarbital

Warnings

While you are taking this medication, you must attend your doctor or oncologist for regular check-ups. This is important as it allows your doctor to make sure that the medicine is working correctly and gives you the chance to mention any side-effects that you may be experiencing. Your doctor will carry out blood tests to check for any unwanted effects that the medication is causing.

Do not take this medication if you are pregnant, as it can harm the unborn baby. If you think you are pregnant, tell your doctor immediately before you begin taking Afatinib. You should use an effective form of contraception to avoid becoming pregnant during your therapy and for at least two weeks following the final dose of your medication.

It should be noted that this drug can be readily absorbed through the skin and lungs. For this reason, women who are pregnant or who are at risk of becoming pregnant should not handle this medication without wearing protecting gloves and a face mask so that dust from the tablets is not inhaled.

If you begin to suffer from diarrhea while taking this medication, tell your doctor immediately. Your doctor will prescribe you something to prevent or manage the diarrhea. Diarrhea can cause serious dehydration. Always drink plenty of water while you are taking this medication, especially if you do develop diarrhea.

Some people experience severe skin reactions while taking this medication. If you develop acne, a skin rash, or reddening or peeling of the skin, tell your doctor immediately. This medication can make your skin especially sensitive to sunlight. Avoid sunbathing or spending long periods in the sun without adequate protection. Always use a good-quality sunscreen product or sun blocking lotion. Keep your skin covered and wear a hat to keep the sun off your face.

If you begin to experience serious breathing difficulties, shortness of breath, chest pain, coughing, chills or a fever, these could be symptoms of a serious lung problem. Consult your doctor straight away.

If you notice tenderness or pain in your upper stomach, dark urine, pale stools, feelings of nausea, a loss of appetite, jaundice, or unusual weakness or tiredness, you should contact your doctor immediately. All these signs could indicate a severe liver problem.

During the course of your treatment with this medication, notify your doctor if your vision changes, becomes blurred or you have difficulty reading. Painful, irritated or swollen eyes during or after treatment with this medicine can indicate a serious eye problem. You should also tell your doctor if you wear contact lenses, before you begin treatment with this medicine. Your doctor may refer you to an ophthalmologist during the course of your treatment to make sure that your eyes have not been adversely affected by the drug. If your vision begins to deteriorate or you are suffering from blurred vision, refrain from driving or operating machinery until the problem has resolved.

You should consult your doctor immediately if you have a cough, fast or uneven heartbeat, rapid unexplained weight gain, swelling of your ankles or legs, or if you feel unusually weak or tired.

If you are planning on having children, you should be aware that this medication can cause infertility in both men and women.

Although it is unknown if the drug can be passed into breast milk, you should avoid breastfeeding while you are using this medication and for at least two weeks after you have stopped using it. Always consult your doctor before breastfeeding.

You should tell your doctor if you are currently taking any other form of medication, including over-the-counter products, herbal remedies, or vitamin supplements. You should also mention if you have any allergies to food colourings, certain food stuffs, preservatives, or animal derivatives.

Storage

Always keep your supply of Afatinib in a sealed, airtight container and store it at room temperature. This medication is not suitable for freezing. You should not expose the medication to direct sunlight or to sources of extreme heat. Keep the medication away from children and pets. In the event that a pet consumes Afatinib, you must seek veterinary advice immediately.

You should not store this medication in your bathroom.

Do not keep any leftover medication and do not use any drugs that have become out-of-date. Do not throw any unwanted or unused medication out with your trash or flush it down the toilet, as this could present a danger to small children. Always ask your pharmacist or doctor for guidance on the safe disposal of unused or unwanted medication.

Summary

Afatinib is known in the US under the brand name, Gilotrif. It is used to treat metastatic cancer and non-small cell lung cancer (NSCLC) in patients who have not already been treated for cancer that has spread to other areas of the body.

Afatinib is a form of chemotherapy drug called a tyrosine kinase inhibitor (TKI), or cancer growth inhibitor. The drug works effectively by preventing the body's proteins from sending signals that would stimulate the growth of cancer cells. Interrupting these signals causes the cancer cells to die, slowing the growth of the cancer or stopping it altogether.

This medication is very strong and can cause serious side-effects, including diarrhea, visual disturbance, lung disease, and in rare cases liver disease. There are also a number of commonly prescribed and over-the-counter that can interact adversely with this medication, including St John's Wort, which is commonly used to combat feelings of depression. Therefore, you must mention any medical conditions that you have and the drugs that you are taking for them, including any non-prescription herbal products.

Afatinib is very effective in slowing the spread of metastatic cancer and non-small cell lung cancer. To achieve the best results and to enjoy the full benefits of this medication, you must work closely with your doctor to find the appropriate dose and frequency of use for this medication. This will include attending for regular check-ups and blood tests to make sure that the drug is working effectively and that there are no unwanted side-effects.