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Osimertinib is the generic name for the trade drug Tagrisso™. In some cases, health care professionals may use the trade name Tagrisso™ when referring to the generic drug name osimertinib.
Drug Type: Osimertinib is a targeted therapy. It is an oral EGFR Kinase inhibitor - (For more detail, see "How this drug works," below.)
What Osimertinib Is Used For:
- For the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by FDA-approved test, who have progressed on or after EGFR TKII therapy.
Note: if a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Osimertinib Is Given:
- Osimertinib is a pill, taken by mouth, one daily. It can be taken with or without food.
- Take osimertinib exactly as prescribed.
- Try to swallow osimertinib tablets whole.
- If you cannot swallow osimertinib tablets whole:
- Place your dose of osimertinib in a container that contains 2 ounces of water. Do not use carbonated water or any other liquids
- Stir the osimertinib tablet and water until the tablet is in small pieces (the tablet will not completely dissolve). Do not crush or heat.
- Drink the osimertinib and water mixture right away.
- Add 4 to 8 ounces of water to the container and drink to make sure you take your full dose.
- Do not change your dose or stop osimertinib unless your health care provider tells you to.
- If you miss a dose, skip the missed dose and take your next dose at your regular time.
- Do not take more than 1 dose of osimertinib at one time. Call your health care provider right away if you take too much.
The amount of osimertinib that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Higher doses do not give a better response and may cause increased toxicity. Your doctor will determine your dose and schedule.
Important things to remember about the side effects of osimertinib:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and duration.
- Side effects are almost always reversible and will go away after treatment is complete.
- There are many options to help minimize or prevent side effects.
- There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
The following side effects are common (occurring in greater than 30%) for patients taking osimertinib:
These side effects are less common side effects (occurring in about 10-29%) of patients receiving osimertinib:
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4° F (38° or higher, chills)
Always inform your health care provider if you experience any unusual symptoms.
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Diarrhea (4-6 episodes in a 24-hour period)
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24 hour period)
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness
- Any sudden change in eyesight (blurred or distorted vision, eye irritation, increased tears)
- Sudden onset of shortness of breath, accompanied by cough and/or fever
- Persistent coughing or wheezing
- Shortness of breath
- Dizziness, lightheadedness or fainting
- Skin or whites of your eyes turn yellow
- Urine turns dark or brown (tea color)
- Decreased appetite
- Stomach pain
- Unusual bleeding or bruise more easily than normal
- Red or black stools that look like tar
- Blood in urine
- Irregular heartbeat
- Swelling of your ankles or feet
- Any skin change, irritation, itching or rash
Always inform your health care provider if you experience any unusual symptoms.
- Before starting osimertinib treatment, make sure you tell your doctor about any other medications you are taking (including prescriptions, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking osimertinib.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Osimertinib may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.
- For both men and women: Do not conceive a child (get pregnant) while taking osimertinib. Women of child bearing age should use effective contraception during therapy and for 6 weeks after the last dose of osimertinib. Males should also use effective contraception during therapy and for 4 months after the last dose of osimertinib. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking this medication.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
- Avoid sun exposure. When you go outside wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and wear SPF 30 (or higher) sun block.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Osimertinib can cause visual changes, dizziness and tiredness. If you have any of these symptoms, use caution when driving a car, using machinery, or anything that requires you to be alert and make sure your provider is aware.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing
You will be checked regularly by your health care professional while you are taking osimertinib to monitor side effects and check your response to therapy. Blood work will be done periodically to check your blood counts to monitor your liver, muscle and bone health as well as your electrolytes.
How Osimertinib Works:
Targeted therapy is the result of years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy involves identifying other features of cancer cells. Scientists look for specific differences between cancer cells and normal cells. This information is used to create a targeted therapy to attack cancer cells without damaging normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
Osimertinib is a targeted therapy that targets the mutated epidermal growth factor receptor (EGFR) T790M within the cancer cell.
The EGFR gene plays an important role in both normal and cancer cells. This gene leads to the production of EGFR protein. This protein is normally part of a chain of molecules that relay a signal that tells cells how to grow and divide. A change in the EGFR gene (called a mutation) can alter the way that the EGFR protein works. Instead of waiting for its turn to signal a cell to divide or grow, the EGFR protein is out of control and signals all of the time, this out of control EGFR signaling may drive the uncontrolled growth of cancer cells. Osimertinib targets select mutant forms of EGFR, including t790M, L858R and exon 19-deletion. Osimertinib is selective for sensitizing mutations and the T790M resistance mutation, which is the most common mechanism of resistance to EGFR tyrosine kinase inhibitors.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.