Osimert 80 mg (Osimertinib)

Osimert 80 mg (Osimertinib)

Manufacturer: Everest Pharmaceuticals Ltd

Introduction

Osimert 80 is a protein kinase inhibitor used in the treatment of non-small cell lung cancer. It is used in the treatment of adult patients who have certain EGFR mutations. Osimert 80 can be taken with or without food, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. Diarrhea is a very common side effect of this medicine, so drink plenty of fluids. But, you must inform your doctor if it does not stop. You must have to inform your doctor if you experience difficulty in breathing along with fever and cough, or severe peeling of the skin. This medicine may reduce the number of blood cells (decrease white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.

Uses of Osimert 80

1. Non-small cell lung cancer

Side effects of Osimert 80

• Diarrhea
• Loss of appetite
• Rash
• Stomatitis (Inflammation of the mouth)

How to use Osimert 80

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Osimert 80 may be taken with or without food, but it is better to take it at a fixed time.

How Osimert 80 works

Osimert 80 is an anti-cancer medication. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

What if you forget to take Osimert 80?

If you miss a dose of Osimert 80, skip it and continue with your normal schedule. Do not double the dose.

Indication

Non-small Cell Lung Cancer, Indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)

Administration

May be taken with or without food: Take at the same time each day. Swallow whole, do not crush/split/chew. For patients w/ swallowing difficulties, the tab may be dispersed in 50 mL of non-carbonated water & stir w/o crushing until dispersed. Drink immediately. Rinse the glass w/ another ½ glass of water & drink. The dispersed liquid may also be administered via nasogastric tube by using 15 mL for initial dispersion & 15 mL for residue rinses. The tube should be flushed w/ water after administration. Soln should be administered w/in 30 min of the addition of tab to water.

Adult Dose

Non-small Cell Lung Cancer 80 mg once daily. Hepatic impairment Mild (TB <ULN and AST 1-1.5 ULN, or TB 1-1.5 ULN and any AST): No dose adjustment required Moderate or severe: There is no recommended dose

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment Mild-to-moderate (CrCl 30-89 mL/min): No dose adjustment required Severe or ESRD (CrCl <30 mL/min): There is no recommended dose

Contraindication

None

Mode of Action

Osimertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately 9-fold lower concentrations than wild-type. In cultured cells and animal tumor implantation models, osimertinib exhibited anti-tumor activity against non-small cell lung cancer (NSCLC) lines harboring EGFR-mutations (T790M/L858R, L858R, T790M/exon 19 deletion, and exon 19 deletions) and, to a lesser extent, wild-type EGFR amplifications.

Precaution

Determine EGFR T790M mutation status prior to treatment. Interstitial lung disease (eg, pneumonitis). Avoid use in patients w/ congenital long QT syndrome. Severe & end-stage renal impairment. May affect the ability to drive or operate machinery. Women of childbearing potential not using contraception. Use effective contraception for at least 6 wk for females & 4 mth for males. Not recommended during pregnancy. Lactation. Based on its mechanism of action and animal data, Osimertinib can cause fetal harm when administered to a pregnant woman. There are no available data on Osimertinib use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. There are no data on the presence of Osimertinib in human milk, the effects of Osimertinib on the breastfed infant, or on milk production. Lactating women should be advised not to breastfeed during treatment.

Side Effect

>10% Lymphopenia (63%), Thrombocytopenia (54%), Anemia (44%), Diarrhea (42%), Rash (41%), Neutropenia (33%), Dry skin (31%), Hyponatremia (26%), Nail toxicity (25%), hypermagnesemia (20%), Eye disorders (18%), Nausea (17%), Decreased appetite (16%), Constipation (15%), Pruritus (14%), Fatigue (14%), Cough (14%), Back pain (13%), Stomatitis (12%) 1-10% Headache (10%), Venous thromboembolism (7%), Pneumonia (4%), Interstitial lung disease/pneumonitis (3.3%), QTc increased from baseline >60 msec (2.7%), Cardiomyopathy (1.4%) <1% Keratitis

Interaction

Decreased exposure w/ strong CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine, St. John’s wort). May increase AUC & Cmax of rosuvastatin. This may increase the exposure of BCRP substrates. Decreased AUC & Cmax of simvastatin.