For the Patient: LUAVOSIF

Other Names: First-Line Treatment of Epidermal Growth

Factor Receptor (EGFR) Mutation-Positive Advanced
Non-Small Cell Lung Cancer (NSCLC) with Osimertinib

LU = LUng
AV = AdVanced
OSI = OSImertinib
F = First-line

ABOUT THIS MEDICATION

What is this drug used for?

Osimertinib is a drug given to treat non-small cell lung cancer that is EGFR mutation-
positive. It is a tablet which is taken by mouth.

How does this drug work?

Osimertinib works by interfering with certain enzymes called tyrosine kinases that are
important in transmitting the chemical signals needed for essential processes like cell
division and replication in cancer cells.

INTENDED BENEFITS

This treatment is being given to slow down the growth of cancer cells in your body. This
treatment can help with controlling some of the symptoms the cancer may be causing
and may delay or prevent new symptoms from starting.

LUAVOSIF TREATMENT SUMMARY

How is this drug given?

• Osimertinib is taken once a day, continuously, as long as you are benefiting from
treatment and not having too many side effects.
• Osimertinib may be taken with food or on an empty stomach.

What will happen when I get the drug?

• A blood test is done within one month of starting treatment.
• A blood test is also done each time you see your oncologist.
• The dose of your treatment may be changed based on your blood test results and/or
other side effects.

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 1 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023
INSTRUCTIONS:

What other drugs can interact with LUAVOSIF?

• Other drugs such as rifampin (RIFADIN®) and rosuvastatin (CRESTOR®) may
interact with osimertinib. Tell your doctor if you are taking these or any other drugs
as you may need extra blood tests or your dose may need to be changed.
• Check with your doctor or pharmacist before you start or stop taking any new
prescription or non-prescription drugs, including natural health products.

Other important things to know:

• Avoid grapefruit and grapefruit juice for the duration of your treatment, as these may
interact with osimertinib.
• If you miss a dose of osimertinib, take it as soon as you can if it is within 12 hours of
the missed dose. If it is more than 12 hours since your missed dose, skip the
missed dose and go back to your usual dosing times.
• The drinking of alcohol (in small amounts) does not appear to affect the safety or
usefulness of this treatment.
• Osimertinib may damage sperm and may harm the baby if used during pregnancy.
It is best to use birth control while you are being treated with osimertinib. Tell your
doctor right away if you or your partner becomes pregnant. Do not breast feed
during treatment.
• Store osimertinib tablets out of the reach of children, at room temperature, away
from heat, light and moisture.
• Tell all doctors or dentists you see that you are being treated with osimertinib before
you receive any treatment from them.

SIDE EFFECTS AND MANAGEMENT:

• Your healthcare team will review the risks of treatment and possible side effects with
you before starting treatment.
• A member of your healthcare team will review how to take the medication and
possible side effects with you on the day you first pick up your medication.
• Unexpected and unlikely side effects can occur with any drug treatment. The ones
listed below are particularly important for you to be aware of.

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 2 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023
 SERIOUS MANAGEMENT
SIDE EFFECTS
Slow or abnormal heart Minimize your risk of abnormal heart rhythm by:
rhythm (QT prolongation) rarely • Always checking with your doctor and pharmacist
occurs about drug interactions when starting a new
medication, herbal product or supplement.
• Avoiding grapefruit and grapefruit juice and other
similar fruits when taking osimertinib.
Tell your doctor immediately or get emergency help
if your heart is beating irregularly or fast, or if you feel
faint, lightheaded or dizzy.
Heart failure rarely occurs • Regular heart tests will be done throughout your
treatment to monitor your heart function.
• Immediately report any signs of heart failure such
as shortness of breath, fatigue or leg swelling.
Lung problems rarely occur Tell your doctor immediately or get emergency help if
you have difficulty breathing, shortness of breath,
cough or tightness in the chest.
Eye problems rarely occur Tell your doctor right away if you get any symptoms
of eye problems: eye pain, swelling, redness with a
gritty feeling, watery eyes, blurred vision, sensitivity to
light, sudden changes in your eyesight, or any other
changes. You may be at increased risk if you wear
contact lenses. Use caution when driving or
operating machinery.

OTHER MANAGEMENT
SIDE EFFECTS
Nausea and vomiting may You may be given a prescription for antinausea
occur after your treatment. If you drug(s) to take at home. It is easier to prevent
are vomiting and it is not nausea than treat it once it has occurred, so follow
controlled, you can quickly directions closely.
become dehydrated. • Drink plenty of fluids.
• Eat and drink often in small amounts.
• Try the ideas in Practical Tips to Manage
Nausea.*
• Tell your healthcare team if nausea or vomiting
continues or is not controlled with your antinausea
drug(s).

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 3 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023
 OTHER MANAGEMENT
SIDE EFFECTS
Diarrhea may sometimes occur. If diarrhea is a problem:
If you have diarrhea and it is not • Drink plenty of fluids.
controlled, you can quickly
• Eat and drink often in small amounts.
become dehydrated.
• Avoid high fibre foods as outlined in Food Choices
to Help Manage Diarrhea.*
• Tell your healthcare team if you have diarrhea for
more than 24 hours.
Constipation may sometimes • Drink plenty of fluids.
occur • Exercise if you can.
• Try ideas in Food Choices to Manage
Constipation.*
Skin rash and dry or itchy skin • Moisturizing creams can help reduce skin dryness
commonly occur • Avoid hot showers
• Exposure to the sun might make these symptoms
worse. Refer to Your Medication Sun Sensitivity
and Sunscreens* or the BC Health Guide for more
information.
• If your symptoms get worse, or are very irritating,
call your doctor. Otherwise, be sure to mention it
at your next visit.
Nail changes, including • Avoid trauma to nails or fingertips
loosening or loss of the nail, and • Avoid harsh soaps, detergents, and nail products.
swelling sometimes occurs
• Keep hands clean and dry.
• If nail changes interfere with your activity, or are
painful, call your doctor. Otherwise, be sure to
mention it at your next visit.
Sore mouth sometimes occurs. • Brush your teeth gently after eating and at
Mouth sores can occur on the bedtime with a very soft toothbrush. If your gums
tongue, the sides of the mouth, bleed, use gauze instead of a brush. Use baking
or in the throat. Mouth sores or soda instead of toothpaste.
bleeding gums can lead to an • Make a mouthwash with ¼ teaspoon baking soda
infection. AND ¼ teaspoon salt in 1 cup warm water and
rinse several times a day.
• Try the ideas in Food Ideas to Try with a Sore
Mouth.*
Headache may sometimes • Take acetaminophen (e.g., TYLENOL®) every 4-6
occur. hours if needed, to a maximum of 4 g (4000 mg)
per day.

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 4 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023
 OTHER MANAGEMENT
SIDE EFFECTS
Muscle or joint pain may You may take acetaminophen (e.g., TYLENOL®)
sometimes occur. every 4-6 hours to a maximum of 4 g (4000 mg) per
day or ibuprofen (e.g., ADVIL®) for mild to moderate
pain. Tell your healthcare team if the pain interferes
with your activity.
Loss of appetite sometimes Try the ideas in Food Ideas to Help with Decreased
occurs. Appetite.*
Tiredness and lack of energy • Do not drive a car or operate machinery if you are
may sometimes occur. feeling tired.
Try the ideas in Fatigue/Tiredness – Patient
Handout.*
Hair loss is rare with If hair loss is a problem, refer to Resources for Hair
osimertinib. Loss and Appearance Changes – Patient Handout.*
*Please ask your chemotherapy nurse or pharmacist for a copy.

STOP TAKING OSIMERTINIB AND CHECK WITH YOUR HEALTHCARE TEAM OR

GET EMERGENCY HELP IMMEDIATELY IF YOU HAVE

• Signs of an infection such as fever (over 100°F or 38°C by an oral thermometer),

shaking chills; severe sore throat, productive cough (coughing up thick or green
sputum); cloudy or foul smelling urine; painful, tender, or swollen red skin wounds or
sores.
• Signs of bleeding problems such as black, tarry stools; blood in urine; pinpoint red
spots on skin; extensive bruising.
• Signs of a stroke such as sudden onset of severe headache, eyesight changes,
slurred speech, loss of coordination, weakness or numbness in arm or leg.
• Signs of a blood clot such as tenderness or hardness over a vein, calf swelling and
tenderness, sudden onset of cough, chest pain, or shortness of breath.
• Signs of heart or lung problems such as fast or uneven heartbeat, chest pain,
chest pressure, shortness of breath or difficulty in breathing, swelling of feet or lower
legs, or fainting.

CHECK WITH YOUR HEALTHCARE TEAM AS SOON AS POSSIBLE (DURING

OFFICE HOURS) IF YOU HAVE:
• Signs of anemia such as unusual tiredness or weakness.
• Signs of liver problems such as yellow eyes or skin, white or clay-coloured stools.
• Eye pain, sensitivity to light, red or itchy eyes, or blurry vision.
• Signs of bladder problems such as changes in urination, painful burning sensation,
presence of blood, or abdominal pain.

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 5 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023
CHECK WITH YOUR HEALTHCARE TEAM IF ANY OF THE FOLLOWING
CONTINUE OR BOTHER YOU:
• Headache not controlled with acetaminophen (e.g., TYLENOL®).
• Easy bruising or minor bleeding.
• Redness, swelling, pain, or sores on your lips, tongue, mouth, or throat.
• Dizziness or ringing in your ears.
• Heartburn, hiccups, upset stomach, or changes in taste.
• Muscle spasms or tremors.
• Unusual mood changes or trouble sleeping.
• For diabetic patients: uncontrolled blood sugars.

If you experience symptoms or changes in your body that have not been
described above but worry you, or if any symptoms are severe, contact:
_____________________________at telephone number:________________

BC Cancer Protocol Summary (Patient Version) LUAVOSIF Page 6 of 6

Developed: 1 Jan 2020
Revised: 1 Feb 2023