Tagrisso 80mg Tablets

Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that irreversibly binds to and inhibits the activity of specific mutated forms of EGFR, including T790M, Exon 19 deletions, and Exon 21 L858R substitutions. These mutations are common in non-small cell lung cancer (NSCLC) and lead to constitutive activation of the EGFR signaling pathway, promoting cell proliferation and survival. Osimertinib spares wild-type EGFR, which may contribute to its improved tolerability compared to earlier generation TKIs.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Urinary Tract Infection (UTI): Blood in the urine, painful or burning urination, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Dizziness
Vision Changes: Blurred vision, eye pain, or severe eye irritation.
Sensitivity to Light: If bright lights bother your eyes.
Watery Eyes
Skin Problems: Purple spots, red skin on the lower arms, legs, or buttocks that does not fade when pressed, or persistent hives that look bruised.
Lung Problems: Shortness of breath, trouble breathing, cough, or fever. These symptoms can be similar to those of lung cancer.
Heart Failure: Shortness of breath, sudden weight gain, swelling in the arms or legs, or bulging neck veins.
Abnormal Heartbeat (Prolonged QT Interval): Fast or irregular heartbeat, or fainting.
Low Blood Cell Counts: Fever, chills, sore throat, signs of infection, unexplained bruising or bleeding, pale skin, or feeling extremely tired or weak.
Severe Skin Reactions: Red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes. These reactions can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin conditions.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dry skin
Nail changes, including pain, redness, swelling, or loss of nails
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Mouth irritation or mouth sores
Headache
Fatigue or weakness
Common cold symptoms
Back, bone, joint, muscle, or neck pain

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are taking any medications that can cause an abnormal heartbeat, known as a prolonged QT interval. There are numerous medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
If you are taking any prescription or over-the-counter medications, natural products, or vitamins that should not be taken with this medication. This includes certain medications used to treat HIV, infections, seizures, and other conditions. There are many medications that interact with this drug, so it is crucial to discuss your medication regimen with your doctor.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication and for 2 weeks after your last dose, unless your doctor advises otherwise. Make sure you understand how long to avoid breastfeeding.

This is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter medications, natural products, and vitamins, as well as any health problems you have. Before starting, stopping, or changing the dose of any medication, consult with your doctor to ensure it is safe to take this medication with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will instruct you to undergo regular blood tests and other laboratory examinations to monitor your condition. Additionally, some individuals may require electrocardiogram (ECG) tests to check their heart rhythm.

If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Elderly patients (65 years or older) should exercise caution when using this medication, as they may be more susceptible to side effects.

This medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. In females, fertility may return to normal, but in males, it is unclear if fertility will be restored. If you have concerns, discuss them with your doctor.

This medication can cause harm to an unborn baby. To confirm you are not pregnant, a pregnancy test will be conducted before initiating treatment. If you may become pregnant, use birth control during treatment and for 6 weeks after the last dose, unless otherwise instructed by your doctor. It is vital to understand the duration of birth control use. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control during treatment and for 4 months after the last dose. If your partner becomes pregnant, contact the doctor right away.

• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort): May significantly decrease osimertinib exposure, leading to reduced efficacy. Avoid co-administration.
• QT-prolonging drugs (e.g., amiodarone, sotalol, quinidine, disopyramide, chloroquine, haloperidol, methadone, moxifloxacin, ondansetron, pimozide, ziprasidone): Increased risk of QTc prolongation. Avoid or use with extreme caution and monitor ECG.

• Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin): May decrease osimertinib exposure. Consider alternative agents or monitor for reduced efficacy.
• Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir, ketoconazole, telithromycin, nefazodone): May increase osimertinib exposure, increasing risk of adverse reactions. Monitor for adverse reactions.

• P-glycoprotein (P-gp) substrates (e.g., dabigatran, digoxin): Osimertinib is a weak inhibitor of P-gp. Monitor for increased exposure of P-gp substrates if co-administered.

• New or worsening respiratory symptoms (e.g., dyspnea, cough, fever) for Interstitial Lung Disease (ILD)
• Diarrhea (frequency, severity)
• Skin rash, dry skin, acneiform dermatitis
• Nail changes (paronychia, nail bed inflammation)
• Stomatitis (mouth sores)
• Fatigue
• Decreased appetite
• Visual changes, eye irritation, redness, pain, blurred vision (for keratitis)
• Symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet, rapid weight gain)

Osimertinib can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, it is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus.

It is not known whether osimertinib or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with Tagrisso and for 6 weeks after the final dose.

The safety and effectiveness of Tagrisso in pediatric patients have not been established.

No dose adjustment is recommended for patients ≥65 years of age. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients.

• Osimertinib is a third-generation EGFR TKI effective against the T790M resistance mutation, which often develops after treatment with first- or second-generation EGFR TKIs.
• It is also approved for first-line treatment of EGFR-mutated metastatic NSCLC and as adjuvant therapy after tumor resection in EGFR-mutated NSCLC.
• Patients should be monitored closely for interstitial lung disease (ILD) symptoms; prompt interruption and investigation are crucial.
• Cardiac monitoring (ECG for QTc, LVEF) is important due to the risk of QTc prolongation and cardiomyopathy.
• Manage dermatologic and nail toxicities proactively with emollients, topical steroids, and nail care.
• Strong CYP3A4 inducers should be avoided due to significant reduction in osimertinib exposure and potential loss of efficacy.

• Other EGFR TKIs for NSCLC (e.g., gefitinib, erlotinib, afatinib, dacomitinib, lazertinib)
• Chemotherapy (e.g., platinum-based regimens)
• Immunotherapy (e.g., pembrolizumab, nivolumab, atezolizumab)
• Other targeted therapies depending on specific mutations (e.g., ALK inhibitors, ROS1 inhibitors)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.