OSIMERTINIB

Background and Date of Approval

Osimertinib is an anticancer medication that the Food and Drug Administration approved on the 18th of April 2018 as a first-line treatment for patients having non-small cell lung cancer (NSLC), that has spread to other parts and whose tumors have epidermal growth factor receptor (EGFR) mutations. Later on the 18th of December 2020, Osimertinib got approval for being used as an additional therapy after tumor removed by surgery in patients having metastatic non-small cell lung cancer (NSLC) whose tumors have epidermal growth factor receptor (EGFR) mutations.

Uses

Osimertinib is indicated to treat non-small cell lung cancer (NSCLS) in adults. It is also used as a first-line treatment for patients having metastatic non-small cell lung cancer (NSLC) whose tumors have epidermal growth factor receptor (EGFR) mutations. In addition, it is also used after the removal of tumors by surgery.

How is it administered?

Osimertinib is an prescription medicine available as a tablet in two doses Osimertinib 40mg and Osimertinib 80mg. This medication is to be taken by mouth and swallowed as a whole with or without food at the same time every day as prescribed by your doctor. It should not be crushed, split, or chewed. If you cannot swallow the tablets, you can dissolve them as per your doctor's advice.

Side Effects

The common side effects of Osimertinib are headache, low WBC and platelets, diarrhea, decreased appetite, anemia, rash, muscle and joint pain, nail changes, dry skin, tiredness , cough, inflamed and sore mouth. Other serious side effects of Osimertinib tablets are decreased heart function, irregular heartbeats, breathing difficulty together with a cough or fever, eye problems, anemia, skin lesions.

Warnings

Inform your doctor immediately if you experience difficulty breathing with fever or cough, as it might indicate lung inflammation. Notify your doctor immediately if you have any symptoms like dizziness, lightheadedness, and syncope. This medicine can cause cardiomyopathy, inform your physician of any signs or symptoms of heart failure.

Precautions

Osimertinib is unsafe for pregnancy, and effective contraceptive methods must be discussed with the doctor while taking this medication. This medication is not to be taken by people below the age of 18 years. Breastfeeding must be done only after two weeks from the last dose. If you have a history of heart disorders, and eye problems inform your doctor as this condition requires monitoring. Before starting treatment with this medication, report to your doctor about any medication you are taking.

Word of Advice

Osimertinib may interact with oral contraceptives, hence discuss with your doctor the most appropriate method of contraception. If you are a male patient with a female partner of reproductive potential, use contraceptives during the treatment and for 4 months after the last dose. Your doctor will regularly do lab tests to check whether the medicine is working. Do not breastfeed during the treatment with this medicine and for 2 weeks after your last dose. This medicine may impair fertility in females and males of reproductive potential; consult your doctor if you are planning for pregnancy.

References

TAGRISSO 80 mg film-coated tablets - Patient Information Leaflet (PIL) - (emc) [Internet]. www.medicines.org.uk. [Revised on July 2022] [cited 2023 Mar 28]. Available from: https://www.medicines.org.uk/emc/product/7615/pil Highlights Of Prescribing Information - Osimertinib. [revised on 2020] [cited 2023 Mar 28]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf Edward Chu, Cancer Chemotherapy, Lange’s Basic and Clinical Pharmacology, 14th Edition, 2018, 948-976.

Frequently Asked Questions

What are Osimertinib indications?

Osimertinib uses are, to treat non-small cell lung cancer (NSCLS) in adults, as a first-line treatment for patients having metastatic non-small cell lung cancer (NSLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, and after the removal of tumors by surgery.

What are the side effects of Osimertinib?

Headache, decreased concentration, fatigue, weakness, back pain, cough, throat infection, runny nose, congested nose, eyesight changes, hair loss, lack of appetite, sores in the mouth, decrease in the number of platelets and white blood cells, and diarrhea are some common Osimertinib side effects.

Can I take macrolide antibiotics with Osimertinib?

Osimertinib may interact with certain antibiotics and decrease the effectiveness of the medicine. Inform your physician about all the medicines, including over-the-counter medicines that you are taking or have taken before.

Does Osimertinib cause hair loss?

Although uncommon, Osimertinib can cause hair loss. Consult your doctor if you have more hair fall.

Does Osimertinib shrink tumors?

Osimertinib has been shown to be effective at shrinking tumors in patients and slowing down the worsening of cancer.

Is Osimertinib safe to use in patients with liver conditions?

Osimertinib is safe to use in patients with liver diseases as this medication does not require any dosage adjustment. However, it is better to consult your doctor and periodically monitor liver enzymes and parameters.

Available Brands 2

Written By: P. Thirumal Reddy

Reviewed By: Dr. Tejashwin Adiga