TAGRISSO 80 mg/1 (Osimertinib TABLET, FILM COATED) 80 mg/1

TAGRISSO 80 mg/1 is used in the treatment of non-small cell lung cancer (NSCLC) with specific genetic mutations. It targets cancer cells with EGFR mutations, helping to slow tumor growth. Here are the key indications:

• EGFR T790M mutation-positive metastatic non-small cell lung cancer: Treatment of patients with this specific mutation who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
• First-line treatment of EGFR mutation-positive non-small cell lung cancer: Used as the initial treatment for patients with NSCLC whose tumors have certain EGFR mutations.

• Osimertinib works by irreversibly inhibiting the epidermal growth factor receptor (EGFR) tyrosine kinase, including both sensitizing and T790M resistance mutations. This inhibition leads to the suppression of downstream signaling pathways, ultimately reducing tumor cell proliferation and promoting apoptosis.

TAGRISSO 80 mg/1 can cause various side effects, ranging from common to serious or rare. It is important to be aware of these potential effects when using this medication.

Common Side Effects

• Diarrhea: May come and go during treatment; inform your doctor if it worsens.
• Skin and nail problems: Includes pain, itching, dry skin, and rash, often in sun-exposed areas.
• Loss of appetite: May occur during treatment.
• Reduction in white blood cells: Can increase the risk of infections.
• Nosebleeds: A common side effect that may occur during treatment.
• Hair thinning: May be experienced by some patients.
• Hand-foot syndrome: Includes redness, swelling, and cracking of the skin on palms and soles.
• Increase in blood creatinine: May be monitored during treatment.

Serious or Rare Side Effects

• Interstitial lung disease: Sudden difficulty in breathing, cough, or fever; requires immediate medical attention.
• Eye problems: Watery eyes, sensitivity to light, eye pain, or vision changes; consult your doctor immediately.
• QT prolongation: Changes in heart electrical activity; symptoms include rapid or irregular heartbeats, dizziness, and fainting.
• Stevens-Johnson syndrome or toxic epidermal necrolysis: Severe skin reactions; requires immediate medical attention.
• Aplastic anemia: A blood disorder where bone marrow stops producing new blood cells; symptoms include persistent fever, bruising, and increased tiredness.

Before using TAGRISSO 80 mg/1, it is important to be aware of certain precautions and warnings. Always follow your doctor's advice and the instructions provided with the medication.

• Inform your doctor if you have a history of lung inflammation or heart problems: May require medical supervision.
• Avoid using St. John’s Wort: Concomitant use should be avoided.
• Inform your doctor if you are pregnant or breastfeeding: Safety in pregnancy and breastfeeding is not established.
• Inform your doctor if you have a history of eye problems: May require monitoring.
• Store below 25°C: Keep in the original pack, protect from moisture.

TAGRISSO 80 mg/1 can interact with other medications, which may affect its efficacy or increase the risk of side effects. It is important to be aware of these potential interactions.

Major Interactions (Avoid)

• St. John’s Wort: Concomitant use should be avoided as it can decrease the effectiveness of TAGRISSO.
• Strong CYP3A inducers: Can decrease the plasma concentrations of osimertinib.
• Strong CYP3A inhibitors: Can increase the plasma concentrations of osimertinib, leading to an increased risk of side effects.

Moderate Interactions (Monitor Closely)

• Moderate CYP3A inducers: May decrease the plasma concentrations of osimertinib; monitor for reduced efficacy.
• Moderate CYP3A inhibitors: May increase the plasma concentrations of osimertinib; monitor for increased side effects.
• Drugs that prolong the QT interval: May increase the risk of QT prolongation when used concomitantly with TAGRISSO.