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AFAtinib

( a-FA-ti-nib )
Funding:
Exceptional Access Program
  • AFAtinib - For first-line monotherapy treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC), according to specific criteria
Other Name(s): Giotrif® (Boehringer Ingelheim)
Appearance: tablet in various strengths and colours

Medication Information Sheet
AFAtinib (a-FA-ti-nib)
This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Giotrif®

Appearance:
tablet

in various strengths and colours

What is this medication for?
  • For treating lung cancer that has spread to other parts of the body.

What should I do before I have this medication?
  • Tell your doctor and pharmacist if you have or had significant medical condition(s), especially if you have or had:
     
    • liver, kidney, lung, heart or skin problems,
    • other medical conditions with diarrhea (such as Crohn's or colitis)
    • or any allergies.
       
  • This drug contains a small amount of lactose. If you cannot tolerate lactose, talk to your doctor or pharmacist.
     
  • People with cancer have a higher risk of getting other cancers or developing blood clots. Some cancer medications may increase these risks, especially if used for a long period of time. Discuss any concerns about this medication with your health care team.
How will this medication affect sex, pregnancy and breastfeeding?
  • The use of this medication in men or women may cause harm to the unborn baby if pregnancy occurs. Let your health care team know if you or your partner is pregnant, becomes pregnant during treatment, or if you are breastfeeding
     
  • If there is ANY chance that you or your partner may become pregnant, you and your partner together must:
     
  • Use 2 effective forms of birth control at the same time while receiving this drug.  Keep using birth control until 2 weeks after the last dose. Discuss with your healthcare team.
     
  • Do not breastfeed while taking this drug and for at least 2 weeks after treatment ends.
     
  • This medication may affect fertility (ability to get pregnant)
How is this medication given?
  • This medication is usually taken once a day by mouth
  • Take it exactly as directed by your doctor
  • Swallow whole with a glass of water; do not crush or chew.
  • Take afatinib on an empty stomach, at least 1 hour before or 3 hours after food or other medications.
  • If you vomit after taking a dose, DO NOT take a replacement dose. Take the next dose at its original scheduled time.
  • If you miss a dose, take it as soon as you remember. If it is within 8 hours from your next dose, skip the missed dose and take your next dose as scheduled.  Do not take 2 doses at the same time. 
What else do I need to know while on this medication?
  • This medication often interacts with other medications and can result in the treatment not working as well or cause severe side effects.

  • Make sure your health care team knows about all your medications (prescription, over-the-counter, herbals and supplements). Check with your health care team before starting or stopping any of them.

  • For mild aches and pain:

    • You may take acetaminophen (Tylenol®) tablets. Ask your health care team about the right dose for you. 
    • Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin (acetylsalicylic acid, ASA), including low dose aspirin for heart conditions, may increase your chance of bleeding.
    • Talk to your health care team before you start or stop these medications.
    • If you feel unwell, take your temperature before taking any of these medications. They may hide a fever. 
    • Talk to your health care team or go to the closest emergency room right away if you have a fever.  See the Fever pamphlet for more information.
  • Drinking alcohol and smoking during your treatment may increase some side effects and make your medication less effective. Speak to your health care team about smoking and drinking alcohol while on treatment.

How should I safely store this medication?
  • Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.

  • Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.

What are the side effects of this medication?

You may not have all of the side effects below. You may have side effects that are not listed.

Side effects and what to do When to contact doctor?
Very Common Side Effects (50 or more out of 100 people)

Diarrhea (may be severe)

May happen days to weeks after you get your treatment.

If you have diarrhea :

  • Take anti-diarrhea medication as your health care team prescribed it.
  • Avoid foods or drinks with artificial sweetener (e.g. chewing gum, “diet” drinks), lactose, coffee and alcohol.
  • Eat many small meals and snacks instead of 2 or 3 large meals.
  • Drink at least 6 to 8 cups of liquids each day. Talk to your health care team if you can’t drink 6-8 cups of liquids each day when you have diarrhea. You may need special liquids with salt and sugar, called Oral Rehydration Therapy.

​See the Diarrhea pamphlet for more information.

Contact your health care team if no improvement or if severe

Mouth sores (may be severe)

You may have round, painful, white or gray sores inside your mouth. They can occur on the tongue, lips, gums, or inside your cheeks. In more severe cases they may make it hard swallow, eat or to brush your teeth. They usually last 1 to 2 weeks.

To help prevent mouth sores: 

  • Take care of your mouth by gently brushing and flossing regularly.
  • Rinse your mouth often. Do not use mouthwashes with alcohol.
  • Instead, try a homemade mouthwash:
  • Mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water.

 

 

If you have mouth sores:

  • Check with your health care team as soon as you notice mouth or lip sores or if it hurts to swallow.
  • Avoid hot, spicy, acidic, hard or crunchy foods.. Your doctor may prescribe a mouthwash to relieve mouth sores and prevent infection.

See the Mouth Care pamphlet for more information.

Contact your health care team as soon as possible

Rash; dry, itchy skin

Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.

To prevent and treat dry skin,

  • Use skin moisturizer.
  • Protect your skin from the sun and the cold.
  • Use sunscreen with UVA and UVB protection and a SPF of at least 30.
Contact your health care team if no improvement or if severe

Nail changes (may be severe)

You may have changes in nail colour, pain or tenderness in the nailbed, swelling of cuticles, or loosening of nails.

  • Will slowly return to normal after treatment ends.
  • Use a moisturizer for nails and cuticles.
  • Avoid nail polish and artificial fingernails until your nails have returned to normal.
  • Wear gloves when doing house chores or gardening.
Contact your health care team if no improvement or if severe

 

 

Side effects and what to do When to contact doctor?
Common Side Effects (25 to 49 out of 100 people)

Low appetite

  • You may not feel like eating or you may lose weight.
  • Try to eat foods that you like and eat small meals throughout the day. 
  • You may need to take meal supplements to help keep your weight up.
  • Talk to your health care team if you have a low appetite.
  • See our Loss of appetite pamphlet for more information.
Contact your health care team if no improvement or if severe

Nausea and vomiting (generally mild)

May occur in hours to days after your treatment. 

If you have nausea or vomiting:

  • Take anti-nausea medication(s) as prescribed to you by your doctor. 
  • Drink clear liquids and have small meals. Get fresh air and rest.
  • Do not eat spicy, fried foods or foods with a strong smell.
  • Limit caffeine (e.g. coffee, tea) and alcohol.
  • Contact your health care team if the prescribed anti-nausea medications are not helping to control your nausea and vomiting.

 Also see Nausea & Vomiting pamphlet for more information.

Contact your healthcare team if no improvement or if severe

 

 

Side effects and what to do When to contact doctor?
Less Common Side Effects (10 to 24 out of 100 people)

Cough; feeling short of breath, nose bleeds

You may have cough and feel short of breath without any signs of infection, such as a sore throat or a stuffed nose.

Rarely this may be severe with chest pain, trouble breathing or coughing up blood.  If this happens get medical help right away.

Contact your health care team if no improvement or if severe

Trouble falling asleep

  • This may be caused by one of your medications and may improve once your body gets used to the medication or when your treatment ends.
  • Talk to your doctor if this bothers you.
Contact your health care team if no improvement or if severe

Headache; mild joint, muscle pain or cramps 

  • Take your pain medication as prescribed by your doctor.
  • You can take acetaminophen (Tylenol®) tablets as needed for mild aches and pains. Ask your doctor or pharmacist about the right dose for you.
  • Talk to your doctor or pharmacist first before taking ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or aspirin. These medication may increase bleeding risk.
  • Rest often and try light exercise as it may help.
Contact your health care team if no improvement or if severe

Fever, chills, infection

You have a fever if your temperature taken in your mouth (oral temperature) is:

  • 38.3°C (100.9°F) or higher at any time OR
  • 38.0°C (or 100.4°F) or higher for at least one hour.

While you are getting treatments:

  • Keep a digital thermometer at home and take your temperature if you feel hot or unwell (for example, chills).
  • Avoid taking medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen) as they may hide a fever.
  • Do not eat or drink anything hot or cold right before taking your temperature.
  • Wash your hands often.
  • Check with your doctor before getting any vaccines, surgeries, medical procedures or visiting your dentist.

If you have a fever, talk to your health care team or go to the closest emergency room. 
 

Get emergency medical help right away

Hair thinning or loss 

  • Use a gentle soft brush and avoid hair sprays, bleaches, dyes and perms.
  • In most cases, your hair will grow back after treatment, but the texture or colour may change. 
 

Constipation

To help prevent constipation :

  • Drink more liquids and eat well. Drink at least 6 to 8 cups of liquids each day unless you have been told otherwise.
  • Be Active. Exercise can help to keep you regular.
  • Try to eat more fiber (e.g. fruits with skin, leafy greens and whole grains). If you take opioid pain medication, ask your health care team if eating more fibre is right for you.

To help treat constipation :

  • If you have not had a bowel movement in 2 to 3 days you may need to take a laxative. Ask your health care team what to do.

See the Constipation Pamphlet for more information.

Contact your health care team if no improvement or if severe

Abnormal liver lab tests (may be severe)

  • You may have yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. Talk to your health care team if this happens.
  • Your doctor may monitor your liver regularly with a blood test.
Contact your health care team if no improvement or if severe

Salt imbalances

It may cause muscle twitching, severe weakness or cramping, confusion and irregular heartbeat.

Get emergency medical help right away

Eye problems (may be severe)

  • You may have dry eyes, redness, irritation, pain, tearing, sensitivity to light or blurred vision.
  • Avoid wearing contact lenses.
  • You may try artificial tears or ointment for dry eyes.
Contact your health care team as soon as possible

Dizziness

  • You may feel light headed.
  • Lay down if this happens.
  • Get up and move slowly once you feel better.
  • Do not drive a motor vehicle or use machinery if you feel dizzy.
Contact your health care team if no improvement or if severe

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

  • Signs of a kidney problem such as lower back pain, swelling, pee less than usual and have unusual weight gain
  • Chest pain, fainting spells or swelling in your legs, ankles and belly
  • Swelling and hardening of the vein in an arm or leg
  • Severe belly pain that extends to your back
  • Pain, thinning, reddening, tingling, numbness and peeling of the skin on your palms or the soles of your feet


For more links on how to manage your symptoms go to www.cancercare.on.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.