Tagrisso

The active ingredient in Tagrisso is osimertinib mesylate. The epidermal growth factor receptor (EGFR) is a protein in our bodies that promotes cell proliferation. People with some non-small cell lung tumors have EGFR mutations, which cause cancer cells to proliferate and spread more quickly. Tagrisso (osimertinib) is an EGFR inhibitor, which means it inhibits the activity of EGFR. More specifically, it targets and inhibits cancer cells with mutant EGFR. As a result, the cancer cells cannot grow and/or spread as efficiently. Tagrisso helps decrease disease progression and improve the overall survival rate.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Tagrisso. However, the following is a synopsis of the general guidelines for the use of Tagrisso:

• Tagrisso is typically taken once a day and can be taken with or without food.
• If you are unable to swallow Tagrisso whole, talk with your healthcare provider about how to make an oral solution with your Tagrisso tablet.
• If you miss a dose of Tagrisso, do not make up for the missed dose. Take your next dose at its next scheduled time.

The most common side effects of Tagrisso seen in clinical trials as compared to placebo include:

• Low red blood cells.
• Low white blood cell count.
• Low platelets.
• Skin rash like acne.
• Muscle pains or aches.
• Dry skin.
• Fatigue.
• Nail changes.
• Cough.
• Nausea or vomiting.
• Constipation.
• Itchy skin.
• Headache.

Some individuals may experience serious side effects while using Tagrisso. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious lung problems: sudden or worsening cough, fever, difficulty breathing, pressure in the chest.
• Serious skin reactions or allergic reactions: painful blisters, wounds, peeling skin, fever, and muscle aches.
• Serious heart problems: heart failure, fluid in the lungs, changes in your heart rhythm, difficulty breathing, swelling, and fatigue.
• Serious blood disorders: abrupt tiredness, bruising, bleeding, and fever.

These are not all of the possible side effects of Tagrisso. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Tagrisso, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• If you are allergic to Tagrisso, osimertinib, or any of the inactive ingredients in the tablets, you should not take them.

-Tell your doctor if you have ever had lung or worsening breathing problems, an electrolyte imbalance (such as high or low blood levels of sodium, calcium, potassium, or magnesium), eye problems, or heart problems, including long QT syndrome (in you or a family member), are pregnant or intend to become pregnant, are breastfeeding, or plan to breastfeed.

• Lung disorders that could lead to death. Symptoms may be similar to those seen with lung cancer. Tagrisso can cause severe and fatal interstitial lung disease.
• Heart issues, including those involving the heart's electrical system, which can be fatal. Your doctor should check your heart function before and during Tagrisso treatment.
• Eye issues and if you have any of the following symptoms while taking Tagrisso; watery eyes, sensitivity to light, eye pain, eye redness, or vision disturbances, notify your healthcare professional immediately. Your healthcare practitioner may refer you to an eye expert (ophthalmologist).
• Blood vessel issues in your skin. Tell your doctor right away if you are taking Tagrisso and develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks, or large hives on the main part of your body (trunk) that do not go away within 24 hours and appear bruised.
• Tagrisso may also cause aplastic anemia, a condition in which your bone marrow fails to produce enough new blood cells, which might result in death. Your doctor will check your blood cell count before and during therapy.
• Postmarketing incidences of erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in Tagrisso patients.
• Permanently discontinue if any Grade (have not received chemoradiation therapy) or Grade ≥2 (have received chemoradiation therapy).

Long QT syndrome can result in a severe or even fatal abnormal cardiac rhythm. If you have a cardiac issue, using Tagrisso with certain antibiotics may raise your risk of developing long QT syndrome. If you have an electrolyte imbalance, you may also be more likely to experience this adverse effect.

Tagrisso begins acting as soon as you take the first dose. Six weeks after you begin taking the medication, your doctor will often do a scan to see how your cancer is reacting to the treatment.

When Tagrisso is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Tagrisso can lead to significant heart issues. If you are also taking certain other medications for infections, asthma, heart issues, high blood pressure, depression, mental illness, cancer, malaria, or HIV, your risk may increase.
• Avoid taking with powerful CYP3A inducers like rifampicin, phenytoin, or St. John's Wort. If avoiding these medicines is not practicable, increase Tagrisso to 160 mg daily in patients receiving a strong CYP3A4 inducer.

The usual dose of Tagrisso is 80mg by mouth, once a day.

If you miss a dose, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Store your Tagrisso medication at room temperature and out of reach of children.

The pharmaceutical company that manufactures Tagrisso is AstraZeneca Inc. AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form.

There are no generic versions of Tagrisso available.

If you experience side effects, your doctor may adjust your dose, and temporarily or permanently discontinue your Tagrisso therapy. Always use Tagrisso exactly as prescribed by your doctor. Do not change your dose or stop taking this medication without talking to them first.

Tagrisso may be harmful to an unborn child if either the mother or father takes it. If you are a woman, you may need to take a pregnancy test to ensure you are not pregnant. Use effective contraception while using this medication and for at least 6 weeks following the final dosage.

It is unknown whether Tagrisso goes into your breast milk. Do not breastfeed while using Tagrisso, and for at least 2 weeks after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.