FDA approved osimertinib tablets to use as a first-line treatment for patients with Non-Small cell lung cancer (NSCLC) that has spread to other body parts and where the tumor has specific gene mutations confirmed by an FDA-approved test.
Osimertinib tablets are prescribed for non-small cell lung cancer that has spread to other parts of the body.
Before using the drug ensure that the patients have specific gene mutations and this is confirmed by an FDA-approved test.
Osimertinib is also recommended in patients whose cancer condition has progressed during or after other forms of treatments like EGFR tyrosine kinase inhibitor therapy.
Osimertinib should not be used in patients:
• If there is an allergy to the previous dose of osimertinib
• Children under 18 years of age due to the unavailability of safety and effectiveness
• Pregnant and breastfeeding mothers
• Patients undergoing treatment to correct fertility
The dose of Osimertinib to be prescribed is 80 mg per day.
The treatment with osimertinib can be continued until there is a disease progression. It should be continued indefinitely if the drug does not result in intolerable toxicity.
The dose of osimertinib can be reduced if any side effects occur and can be continued with the usual dose if the side effects are under control.
Permanently discontinue osimertinib therapy if the side effects are life-threatening particularly to the lungs or heart.
If a dose is missed or skipped, it is advised not to take the missed dose immediately.
Take the next scheduled dose of osimertinib as prescribed usually the next day.
Osimertinib is available in the tablet form to be taken by mouth (orally) once a day with or without food.
In case of difficulty in swallowing, disperse the tablet in a glass of 60 mL or 2 ounces of non-carbonated water and stir until the tablet is dispersed into small pieces and swallow immediately.
Rinse the glass again with sufficient quantity of water and drink immediately as there will be some leftover tablet pieces in the container.
If the patient is on a nasogastric tube, give the tablet by dispersing it in 15 mL of non-carbonated water. Additionally, 15 mL of water may be used to transfer any residues to the syringe. The final 30 mL liquid should be administered as per the nasogastric tube instructions with water flushes not more than 30 ml.
•Withhold osimertinib treatment in patients showing symptoms of a cough, chest pain or difficulty breathing.
•Discontinue the treatment permanently if pneumonitis or interstitial lung disease (ILD) is confirmed.
•Periodic monitoring of heart function including ECG and electrolyte levels should be done as osimertinib may cause abnormal heart rhythm.
•Refer patients to an ophthalmologist if any symptoms and signs of corneal swelling or keratitis such as tear secretion, sensitivity to light, blurred vision, redness or pain in the eye occur while taking osimertinib tablets.
•Advise pregnant women not to take osimertinib tablets as it may affect the unborn baby resulting in birth defects or miscarriage.
•Females of reproductive potential are advised to use effective contraception during treatment with osimertinib and should continue the contraception for at least 6 weeks after the last dose of osimertinib.
•Male patients with active female partners are advised to use an effective contraception during the osimertinib treatment and for at least 4 months after the final dose of osimertinib.•Patients who wish to have a baby in the future can be advised to use sperm or egg bank services as osimertinib can cause infertility in men and women.
•Extreme caution is required while giving osimertinib tablets to patients with severe liver or kidney disease.
•Women should not breastfeed their children during the treatment with osimertinib and for at least 2 weeks after stop taking the final dose.
The most common side effects of Osimertinib tablets are diarrhea, nausea, and vomiting.
• Skin: Dry skin, mouth sores, rashes, itching, redness, tenderness, pain, swelling of the skin, brittleness of nails, shedding of nails
• Lab abnormalities: High levels of magnesium, Abnormal levels of red blood cells, platelets, lymphocytes, and neutrophils, low levels of sodium and potassium
• Others: Tiredness, decreased appetite, cough, back pain.
Caution is needed in patients who had a history of lung, heart and eye diseases who are prescribed osimertinib tablets.
Consult your doctor right away if you have any worsening symptoms like chest pain, eye pain, shortness of breath, cough, or fever while taking osimertinib.
Co-administering osimertinib with rifampicin may decrease the effectiveness of osimertinib leading to treatment failure.
Avoid taking rosuvastatin with osimertinib as this combination may result in rosuvastatin toxicity.
Do not give osimertinib with medications that cause abnormal heart rhythm. If such combination is unavoidable monitor the patient regularly by evaluating their ECG pattern.
Store osimertinib tablets at room temperature (20°C to 25°C).
Protect osimertinib tablets from direct sunlight and excess moisture.
Keep the osimertinib tablets away from the reach of the children.
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