Uses
What is Tagrisso used for?
Tagrisso (osimertinib) is commonly used for treating different kinds of epidermal growth factor receptor (EGFR) mutated lung cancer. EGFR is a protein on the surface of cells and helps cells to grow and multiply. When there is a mutation in EGFR, cancer cells can grow and multiply nonstop. Tagrisso may be used by itself or in combination with other medicines to treat certain EGFR mutated non-small cell lung cancer (NSCLC). 

Tagrisso may also be used for other conditions as determined by your healthcare provider.

How does Tagrisso work (mechanism of action)?
Tagrisso is a type of medicine called a kinase inhibitor. It attaches itself to the mutant EGFR protein and turns the protein off. When EGFR is turned off, it quits sending the signal to cells to grow and multiply. This causes the cells to die and can cause tumors to shrink in size. 

How is Tagrisso supplied (dosage forms)?
Tagrisso is available in the following dosage forms that are taken by mouth.

• 40 mg oral tablets
• 80 mg oral tablets

How should I store Tagrisso?

Tagrisso should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects
What are the most common side effects of Tagrisso?

The most common side effects of Tagrisso are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

• Blood disorders (see below)
• Diarrhea
• Rash
• Muscle or bone pain
• Nail changes
• Dry skin
• Mouth sores
• Tiredness

There may be other side effects of Tagrisso that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tagrisso?
While less common, the most serious side effects of Tagrisso are described below, along with what to do if they happen.

Severe Allergic Reactions. Tagrisso may cause allergic reactions, which can be serious. Stop taking Tagrisso and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Lung Inflammation. Tagrisso can cause inflammation in your lungs, also called interstitial lung disease. This can be serious or even life-threatening. Tell your healthcare provider right away if you have trouble breathing, shortness of breath, wheezing, or chest tightness. You may also have a cough and/or fever.

Heart Rhythm Changes. Tagrisso may cause heart rhythm problems that can lead to an irregular heartbeat and fainting. In rare cases, this may cause the heart to suddenly stop beating (cardiac arrest). Some people have a higher risk of this, including people with existing heart disease or who take other medicines that affect the heart. Get emergency help if you experience any of the following signs of heart rhythm changes.

• Chest pain
• Shortness of breath
• Feeling dizzy, lightheaded, or fainting
• Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat

Heart Failure. Tagrisso may increase your risk of heart failure. Tell your healthcare provider right away if you have any of the following symptoms of heart failure.

• Shortness of breath or trouble breathing, especially while lying down
• Swelling in your feet, ankles, or legs
• Unusually fast weight gain
• Unusual tiredness

Eye Issues. Tagrisso can cause swelling or an ulcer in the eye. Get help right away if you have any of the following symptoms of eye issues.

• Swelling or redness in the eye
• Watery eyes
• Sensitivity to light
• Blurry vision
• Eye pain

Severe Skin Reactions. Tagrisso can cause severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop Tagrisso and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS or TEN.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes

Immune System Reactions. Tagrisso can cause inflammation of your liver, blood vessels, or lymph vessels, and cause symptoms that look like a condition called lupus. This is known as cutaneous vasculitis. People also experienced other specific types of vasculitis, called leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis. Stop taking Tagrisso and call your healthcare provider right away if you develop any of the following symptoms.

• Purple spots, redness, or discoloration of your skin that does not fade when you press on it
• Large hives on the main part of your body (torso)
• Rash
• Joint pain
• Fever
• Weakness or unusual tiredness

Blood Disorders. Tagrisso can cause blood disorders, such as aplastic anemia, low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia). Stop taking Tagrisso and get help right away if you have any of the following symptoms of blood disorders.

• Fever
• Shortness of breath
• Pale or yellowish skin
• Easy bruising or bleeding
• Frequent infection
• Unusual weakness or tiredness
• Dizziness, lightheadedness, or feeling like you are about to pass out
• Headache
• Fast or abnormal heartbeat

Warnings & Precautions
Who should not use Tagrisso?
Allergies to Ingredients. People who are allergic to any of the following should not take Tagrisso.

• Osimertinib
• Tagrisso
• Any of the ingredients in the specific product dispensed
• Your pharmacist can tell you all of the ingredients in Tagrisso.

What should I know about Tagrisso before using it?
Do not take Tagrisso unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Tagrisso with other people, even if they have the same condition as you. It may harm them.

If you are unable to swallow Tagrisso, ask your pharmacist or other healthcare provider about options to take the medicine. They can give you instructions about how to mix the tablets in water to make it easier to swallow. It is important to not crush or chew Tagrisso tablets. 

Keep Tagrisso out of the reach of children.

What should I tell my healthcare provider before using Tagrisso?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Tagrisso is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

• Heart problems
• Breathing or lung problems
• Electrolyte problems
• Eye problems

Other Medicines and Supplements. Tagrisso may interact with other medicines and supplements. Before taking Tagrisso, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Tagrisso may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Tagrisso. If you can become pregnant, use effective birth control during treatment with Tagrisso and for 6 weeks after your last dose. If you are a male who has a female partner that can become pregnant, use effective birth control during treatment with Tagrisso and for 4 months after your last dose.

Breastfeeding. Do not undergo treatment with Tagrisso while you are breastfeeding and for 2 weeks after your last dose. It is not known if Tagrisso passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Tagrisso?
For more information about Tagrisso, you can visit the manufacturer’s website at www.tagrisso.com or call them at 844-275-2360.

Interactions
Does Tagrisso interact with foods or drinks?
There are no known interactions between Tagrisso and foods or drinks.

It is unknown if drinking alcohol will affect Tagrisso.

Does Tagrisso interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Tagrisso.

• Medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Some other medicines may alter the blood levels of Tagrisso, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Tagrisso. Always check with your healthcare provider.

Overdose/Missed Dose
What should I do if I accidentally use too much Tagrisso?
If you or someone else has used too much Tagrisso, get medical help right away, contact a Poison Control center.

What should I do if I miss a dose of Tagrisso?

If you miss a dose, do not take the missed dose. Take your next dose at your regular time.

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