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Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Osinib 80. Please consult your doctor.
CONSULT YOUR DOCTOR
Osinib 80 may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Osinib 80 is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
SAFE
Osinib 80 does not usually affect your ability to drive.
SAFE IF PRESCRIBED
Osinib 80 is safe to use in patients with kidney disease. No dose adjustment of Osinib 80 is recommended.
SAFE IF PRESCRIBED
Osinib 80 is safe to use in patients with liver disease. No dose adjustment of Osinib 80 is recommended.
Medicine Overview of Osinib 80mg Tablet
Introduction
Osinib 80 is a protein kinase inhibitors used in the treatment of non-small cell lung cancer. It is used in the treatment of adult patients who have certain EGFR mutations. Osinib 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...
... Show moreUses of Osinib 80
- Non-small cell lung cancer
Side effects of Osinib 80
Common
- Diarrhea
- Loss of appetite
- Rash
- Stomatitis (Inflammation of the mouth)
How to use Osinib 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. Osinib 80 may be taken with or without food, but it is better to take it at a fixed time.
How Osinib 80 works
Osinib 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 Osinib 80?
If you miss a dose of Osinib 80, skip it and continue with your normal schedule. Do not double the dose.
Quick Tips
- Osinib 80 is used for the treatment of thyroid cancer.
- Take it with or without food, preferably at the same time each day.
- Diarrhea may occur as a side effect. Drink plenty of fluids and inform your doctor if it doesn't stop or if you find blood in your stools.
- Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for a month after you stop taking it.
- Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure such as severe headache, confusion, problems with your eyesight, nausea or vomiting.
- It may cause serious bleeding problem. Inform your doctor if you get headaches, stomach pain or if you notice blood in your urine or stools.
- Do not take this medicine if you are pregnant, planning to conceive or breastfeeding.
Brief Description
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, tab may be dispersed in 50 mL non-carbonated water & stir w/o crushing until dispersed. Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd 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 kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) 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 deletion) 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 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...
... Show moreSide Effect
>10%
Lymphopenia (63%),Thrombocytopenia (54%),Anemia (44%),Diarrhea (42%),Rash (41%),Neutropenia (33%),Dry skin (31%),Hyponatremia (26%),Nail toxicity (25%),ypermagnesemia (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. May increase the exposure of BCRP substrates. Decreased AUC & Cmax of simvastatin.
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