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Treatment Name: Osimertinib (Tagrisso®)

Osimertinib (Tagrisso®) is a Chemotherapy Regimen for Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)

How does osimertinib work?
Osimertinib is a kinase inhibitor designed to bind to the epidermal growth factor receptor (EGFR) on the surface of lung cancer cells. When this happens, osimertinib blocks the signal that tells the cancer cells to grow and divide. The EGFR receptor is normally found on the surface of healthy cells, but can be found in much higher amounts on the surface of lung cancer cells.

Osimertinib can be effective against certain mutations of EGFR, such as T790M, that may be resistant to other medications that target EGFR. FDA-approved testing may be done prior to starting osimertinib to determine if you have a T790M mutation.

Goals of therapy:
Osimertinib is a first-line metastatic lung cancer treatment taken to slow the growth of non-small cell lung cancer and prevent it from spreading further. It is not commonly given with the goal of cure.

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  • Usual starting dose: one 80 mg oral tablet by mouth once daily

Osimertinib must be dispensed by a specialty pharmacy and is taken at home.

Osimertinib is taken continuously until it no longer works or unacceptable side effects occur.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Side Effects

In clinical studies, the most commonly reported side effects of osimertinib (Tagrisso®) are shown here. Drug side effects sometimes have percentage ranges [example: 34 – 58%] because they differed between clinical studies:

Rash (34-58%),
Diarrhea (33-58%),
Dry skin (23-36%),
Fingernail or toenail infection (22-35%),
Mouth inflammation and sores (11-29%),
Decreased appetite (18-20%),
Itching (13-17%),
Cough (16%),
Nausea (14-16%),
Fatigue (14-16%),
Constipation (14-15%),
Shortness of breath (9-13%),
Headache (10-12%),
Low red blood cells [anemia] (5-12%),
Vomiting (11%),
Back pain (10%),
Sinus infection (10%),
Low platelets [thrombocytopenia] (8-10%),
Fever (6-10%),
Prolonged QT interval (5-10%),
Liver injury (5-9%),
Low white blood cells [neutropenia] (5-8%),
Weakness (7%),
Hair loss (7%). 

On average, 5-13% of patients discontinue treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingFatigue Fatigue ConstipationConstipationPainPainHair LossHair LossAnemiaAnemiaNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment then as directed by your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. Heart function is commonly checked at baseline and during treatment if necessary.

How often is imaging needed?
Imaging may be checked before treatment then approximately every 6 to 12 weeks. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans. An electrocardiogram, commonly referred to as an ECG or EKG, may be used to evaluate the QTc interval prior to therapy and periodically throughout treatment.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue osimertinib as planned, reduce the dose, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Diarrhea can be common during therapy and is may be able to be managed using over-the-counter medications such as loperamide (Imodium®)
  • Medications that lengthen the time to make the heart beat, such as QT-prolonging medications should be minimized (used less) while receiving osimertinib
  • Contact your doctor immediately if you experience severe shortness of breath, cough, and fevers as this may be a sign of severe lung injury
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for non-small cell lung cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Osimertinib (Tagrisso®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Osimertinib (Tagrisso®). Depending upon your income, they may be able to help cover the cost of:

  • Osimertinib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Osimertinib (Tagrisso®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Osimertinib (Tagrisso®)

Individual Drug Label Information

Osimertinib (Tagrisso®)

  • ​Is available in 80 mg and 40 mg oral tablets
  • Can be taken with or without food. If you have trouble swallowing pills, you may place the tablet into 4 tablespoons of non-carbonated water. Stir until tablet is completely dispersed then swallow immediately. Finally, rinse the container with 4 to 8 ounces of water and immediately drink
  • If you miss a dose, skip that dose and take your next dose at the regularly scheduled time. Do not double your dose to make up for the missed dose
  • Should be stored at 77°F 
  • Dosage adjustments may be required for significant side effects
  • Keratitis is rare (inflammation of the cornea of the eye) but should be watched for closely and reported immediately to a doctor.  Symptoms are: swelling of the eye, watering eyes, light sensitivity, blurry vision, red eye, or eye pain
  • May interact with certain antifungal and seizure medications. This drug may also have reactions with drugs that are strong CYP3A4 inducers. Ask your doctor or pharmacist to review your medications for any possible interactions with these type of medications
  • May interact with grapefruit and grapefruit juice causing increased blood levels of osimertinib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
  • May cause fetal harm if taken while pregnant. Females should use effective contraception during therapy and for 6 weeks after stopping therapy. Males should use effective contraception during therapy and for 4 months after stopping therapy. Do not to breastfeed during treatment and for 2 weeks after stopping therapy
General side effects from osimertinib
  • Rash
  • Diarrhea
  • Dry skin
  • Fingernail or toenail infection
  • Decreased appetite
  • Cough
  • Nausea and vomiting
  • Fatigue and weakness
  • Constipation
  • Itching
  • Mouth inflammation and sores
  • Headache
  • Hair loss
  • Fever
  • Click on the osimertinib (Tagrisso®) package insert link below for reported side effects, possible drug interactions, and other osimertinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

Mok TS, Wu Y-L, Ahn M-J, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med 2017;376(7):629-640.

Goss G, Tsai CM, Shepherd FA, et al. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol 2016;17(12):1643-1652.

Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med 2018;378(2):113-125.

Created: January 27, 2019 Updated: January 27, 2019

What is Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)?

What is Non-Small Cell Lung Cancer?
A disease of the tissue found in the lung.  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Known causes include smoking and exposure to environmental toxins.  The stage of NSCLC can vary at diagnosis and throughout treatment.  Stages include stage I, II, III, and IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does metastatic mean?

Metastatic disease is when cancer cells have spread from their primary (original) location to other parts of the body and started more tumor(s).

What is Specialty Pharmacy?

A pharmacy that manages the handling and services for drugs used by patients with rare or chronic diseases. This has expanded in the last several years to include very expensive drugs used to treat cancer, mainly oral cancer medications or injections that can be taken at home.

What is QTc interval? Arsenic

The time it takes your heart to make one beat can be measured using an electrocardiogram (ECG, or EKG) and is reported as the QTc interval. Arsenic is generally safe to give when the QTc interval for men is less than 450 milliseconds per beat, and for women, less than 460 milliseconds per beat.

The QTc interval is prolonged if the heart takes too long to make the next beat, and could lead to a dangerous heartbeat known as an arrhythmia.

Certain medications, in addition to arsenic, may prolong the QTc interval. The list includes: ondansetron (Zofran®), Levofloxacin or ciprofloxacin antibiotics. Make sure your pharmacist checks all new medications to make sure they do not prolong the QTc interval.

Common Starting Doses

  • Usual starting dose: one 80 mg oral tablet by mouth once daily

Olaparib must be dispensed by a specialty pharmacy and is taken at home.

Osimertinib is usually taken at home and is continues until it no longer works or until unacceptable side effects occur.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Clinical Studies

Mok TS, Wu Y-L, Ahn M-J, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med 2017;376(7):629-640.

Goss G, Tsai CM, Shepherd FA, et al. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol 2016;17(12):1643-1652.

Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med 2018;378(2):113-125.