Since its FDA approval in the United States in 2015, Osimertinib has been widely used and recognized globally. In China, Osimertinib is marketed and included in the national medical insurance system.
Osimertinib Indications
Non-Small Cell Lung Cancer
(1) Adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have been confirmed by FDA-approved testing to have EGFR exon 19 deletion or exon 21 L858R mutation.
(2) First-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have been confirmed by FDA-approved testing to have EGFR exon 19 deletion or exon 21 L858R mutation.
(3) Treatment of adult patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed after or during EGFR tyrosine kinase inhibitor (TKI) treatment, as confirmed by FDA-approved testing.
Osimertinib Dosage and Administration
1. Administration
(1) Osimertinib is usually taken once daily, with or without food.
(2) To facilitate swallowing, place the osimertinib tablet in about 2 ounces (about 59 ml) of water. Stir until the tablet is mostly dissolved and drink immediately. Alternatively, add 4 to 8 ounces (about 118 to 237 ml) of water to a cup, stir gently, and drink immediately.
2. Usual Dosage
(1) Usual adult dose for non-small cell lung cancer
80 mg orally once daily.
(2) Duration of Treatment
Adjuvant therapy: Until disease progression, unacceptable toxicity, or up to 3 years. Metastatic lung cancer: Until disease progression or unacceptable toxicity occurs.
Osimertinib Side Effects
1. Serious Side Effects
Call your doctor immediately if any of the following occur:
(1) Redness or purple spots on the skin that do not fade upon pressure and remain red or bruised after 24 hours (may appear on the arms, legs, buttocks, or abdomen);
(2) Redness, rash, or blisters on the palms or soles;
(3) New or worsening cough or difficulty breathing; rapid heartbeat or palpitations; swelling of the lower legs, weight gain, feeling short of breath; dizziness, feeling like you might faint;
(4) Low blood cell count, fever, chills, fatigue, mouth ulcers, skin ulcers, easy bruising, abnormal bleeding, pale skin, cold hands and feet;
(5) Eye problems, changes in vision, tearing, increased sensitivity to light, eye pain, or redness.
2. Common Side Effects
Low blood cell count; muscle, bone, or joint pain; diarrhea; fatigue; cough, mouth ulcers; dry skin, rash; redness, tenderness, pain, or other problems with fingernails or toenails.
Osimertinib Precautions
1. Osimertinib should not be used by patients with known hypersensitivity to osimertinib or any of its components.
2. Taking osimertinib during pregnancy may harm the unborn child.
3. Female patients may need to undergo a pregnancy test to confirm they are not pregnant. Use contraception during treatment and for at least 6 weeks after the last dose. Male patients should use contraception if their sexual partner may become pregnant. Continue contraception for at least 4 months after the last dose.
4. Inform your doctor immediately if you become pregnant.
5. Do not breastfeed during treatment and for at least 2 weeks after the last dose.
Osimertinib Missed Dosage Management
If you miss a dose of osimertinib, skip the missed dose and take the next dose at the usual time. Do not take two doses at once.
