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Brand Name : Osimertinib 80mg
Composition : Osimertinib
Strength : 80 mg
Form :  Tablets
Packing : Pack of 30 Tablets

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Buy Osimertinib Generic Tagrisso

Generic Name: osimertinib (OH sim ER ti nib)
Brand Name:Tagrisso

WHAT IS OSIMERTINIB?

Osimertinib is used to treat a certain type of non small cell long cancer. Osimertinib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Osimertinib is usually given after other treatments have failed.

Osimertinib may also be used for purposes not listed in this medication guide.

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IMPORTANT INFORMATION

Osimertinib can cause serious side effects on your heart, lungs, or vision.

Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, a cough, fever, shortness of breath, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed.

BEFORE TAKING THIS MEDICINE

You should not use osimertinib if you are allergic to it.

Tell your doctor if you have ever had:

  • a breathing disorder;
  • an electrolyte imbalance (such as high or low levels of calcium, potassium, or magnesium in your blood);
  • eye problems; or
  • long QT syndrome (in you or a family member).

Osimertinib can harm an unborn baby if the mother or the father is using osimertinib.

  • If you are a woman, do not use osimertinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 weeks after your last dose.
  • If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using osimertinib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because osimertinib can harm an unborn baby.

You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

HOW SHOULD I TAKE OSIMERTINIB?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Osimertinib is usually given once per day.

You may take osimertinib with or without food.

open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

To make swallowing easier, you may place the tablet in a glass with about 4 tablespoons of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Add 4 to 8 ounces more water to the glass, swirl gently and drink right away.

You may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Osimertinib is usually given until your body no longer responds to the medication.

Store at room temperature away from moisture and heat.

WHAT HAPPENS IF I MISS A DOSE?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

WHAT HAPPENS IF I OVERDOSE?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WHAT SHOULD I AVOID WHILE TAKING OSIMERTINIB?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

OSIMERTINIB SIDE EFFECTS

Get emergency medical help if you have signs of an allergic reaction:hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • shortness of breath even with mild exertion;
  • fast or pounding heartbeats;
  • a light-headed feeling, like you might pass out;
  • swelling, rapid weight gain;
  • new or worsening lung symptoms–sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath; or
  • eye problems–vision changes,watery eyes, increased sensitivity to light, eye pain or redness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • mouth sores, loss of appetite
  • feeling tired;
  • Dry Skin , rash; or
  • tenderness, discoloration, infection, or other problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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OSIMERTINIB DOSING INFORMATION

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

 

Use: Treatment for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

WHAT OTHER DRUGS WILL AFFECT OSIMERTINIB?

Many drugs can affect osimertinib. This includes prescription and over-the-counter medicines, Vitamins, and herbal products Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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Follow the following prescription medicine precautions :

Osimertinib may be harmful for your baby during pregnancy. Take proper medical help in case you are pregnant, may be pregnant or planning to become pregnant in the near future.
  This medicine is not indicated for use in women. It is not known if Osimertinib is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Osimertinib a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.
  Your health care professional can check blood tests to regularly monitor your liver and kidney function, while you are taking Osimertinib. It is also important to check your levels of blood cells and other substances in the blood.
  Before taking this medicine, tell your doctor and pharmacist if you are allergic to Osimertinib, any other medications, or any of the ingredients in Osimertinib medicine. This medication is not recommended for use in patients with a known allergy to Osimertinib.
  If you take Osimertinib, you must stop drinking alcohol. This is one of the ways to prevent this disease from getting worse. If you are dependent on alcohol and want to stop drinking, your doctor can recommend a therapy that’s tailored for your needs.
If you use other prescription drugs or over the counter products at the same time, the effects of this cancer medicine may change. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that your pharmacist can help you prevent or manage drug interactions.
  Missing a dose of Osimertinib can upset your treatment plan. If you do miss one of your doses, take it as soon as you remember, unless it’s almost time to take your next dose. In this case, you should just skip the missed dose. Don’t take a double dose to “make up” for the one you missed. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Do not take Osimertinib the use by (expiry) date printed on the pack. Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
  During your treatment with Osimertinib, it is very important for your doctor to know about your medical history if you have Kidney problems, hepatitis, liver problems, HIV (human immunodeficiency virus), triglycerides, diabetes or other health problems.

 

What are the storage instructions for Osimertinib?

Patients must properly store the drug to retain its quality and efficacy. Following storage instructions will be helpful in storing the drug in the best of manner.

  • Store Osimertinib at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
  • Make sure to always keep your medicine in an area of your home that is out of the reach of children and pets.
  • Do not freeze Osimertinib.

Note:

The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Remember, keep this and all other medicines out of the reach of children and away from pets, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

How to use Osimertinib Tablet

Read the Patient Information Leaflet if available from your pharmacist before you start taking osimertinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

If you have trouble swallowing the tablet whole, place the tablet into a container with a small amount of non-carbonated water (2 ounces/60 milliliters). Stir well until the tablet breaks into small pieces. The tablet will not completely dissolve. Do not crush the tablet or heat the mixture. Drink all of the mixture right away. Add at least another half a glass of water (4 ounces/120 milliliters) to the container and drink all of the mixture to make sure you are getting all of the drug. Use only non-carbonated water for mixing, and do not prepare a supply in advance. The mixture may also be given through a tube into the stomach (nasogastric tube). If you are giving this medication through a nasogastric tube, ask your health care professional for detailed instructions on how to give it.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Side Effects

Diarrheanauseamouth sores, dry/itchy skin, tiredness, back painheadache, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, such as: easy bruising/bleeding, changes in your nails (such as nail tenderness/irritation/redness, change in nail color), signs of eye disease (such as vision changes, eye redness/pain, light sensitivityeye discharge), signs of low level of sodium in the blood (such as nausea, extreme drowsiness, mental/mood changes, seizures).

Get medical help right away if you have any very serious side effects, such as: slow/fast/irregular heartbeat, severe dizzinessfainting, slow/shallow breathing, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), new or worsening symptoms of lung disease (such as trouble breathingchest paincough, fever), signs of blood clots (such as pain/swelling/warmth in the groin/calf).

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn’t go away, fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rashitching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking osimertinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Osimertinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizzinessfainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using osimertinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills“) or if you have conditions such as severe sweatingdiarrhea, or vomiting. Talk to your doctor about using osimertinib safely.

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Osimertinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpoxmeaslesflu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and after treatment. Females should use reliable forms of birth control (such as condomsbirth control pills) during treatment and for 6 weeks after the end of treatment. Males with female partners should use reliable forms of birth control (such as condoms) during treatment and for 4 months after the end of treatment. If you become pregnant or think you may be pregnant or may have caused pregnancy, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after the end of treatment. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Does Osimertinib Tablet interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Certain lab tests should be done before you start treatment to check for the EGFR protein in your tumor.

Lab and/or medical tests (such as heart imaging) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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