Classification: tyrosine kinase inhibitor
About Osimertinib (Tagrisso™)
Osimertinib works by inhibiting tyrosine kinase, an enzyme associated with the human Epidermal Growth Factor Receptor (EGFR). By inhibiting this enzyme, osimertinib prevents EGFRs from stimulating the uncontrolled growth of cells, which contributes to tumor growth.
How to take Osimertinib
This medication comes in tablet form that you take by mouth. The recommended dose is 80mg once a day, but your dose may be modified due to side effects experienced and the severity of these side effects. It can be taken with or without food. If you miss a dose, do not make up the missed dose. Take your next dose as scheduled.
If you have trouble swallowing pills, the tablet can be placed in container with 4 tablespoons of non-carbonated water. Do not crush the tablet or heat the liquid. Stir until the tablet is in small pieces (it will not dissolve completely). You can drink the water or administer the medication through a naso-gastric tube. Add an additional 4 to 8 ounces of water to the container and either drink or administer the fluid into the naso-gastric tube to ensure the entire dose is administered.
The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include: grapefruit, grapefruit juice, verapamil, ketoconazole, itraconazole, rifampin, phenytoin, St. John’s wort, modafanil, telithromycin, ritonavir and nefasodone. Be sure to tell your healthcare provider about all medications and supplements you take.
Because this medication only works in non-small cell lung cancer that has a mutation called T790M, this abnormality must be tested for prior to starting the medication to identify patients appropriate for therapy. In order to test for T790M mutation, a sample of the tumor is sent to a special laboratory that performs this test.
Storage and Handling
Store this medication at room temperature in the original container. If you prefer to use a pillbox, discuss this with your oncology pharmacist. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash. Keep containers out of reach of children and pets.
Where do I get this medication?
Osimertinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.
This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.
Possible Side Effects
There are a number of things you can do to manage the side effects of osimertinib. Talk to your doctor or nurse about these recommendations. They can help you decide what will work best for you. These are some of the most common side effects:
Diarrhea is common with this medication and can become severe. Notify your healthcare team if you have diarrhea, as they can recommend medications to help manage the diarrhea. In addition, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses on non-alcoholic, un-caffeinated fluid a day to prevent dehydration.
Nail and Skin Changes
This class of medications has some unique nail and skin side effects that you may develop. Patients may develop a rash. While this rash may look like acne, it is not, and should not be treated with acne medications. The rash may appear red, swollen, crusty, dry and feel sore. You may also develop very dry skin, which may crack, be itchy or become flaky or scaly. The rash typically starts in the first week of treatment, but can occur at any time during treatment. Tips for managing your skin include:
- Use a thick, alcohol-free emollient lotion or cream on your skin at least twice a day, including right after bathing.
- Avoid sun exposure, as it can worsen the rash or cause a severe burn. Use a sunscreen with an SPF of 30 or higher and wear a hat and sunglasses to protect your head and face from the sun.
- Bathe/shower in cool or lukewarm (not hot) water and pat your skin dry.
- Use soaps, lotions and laundry detergents without alcohol, perfumes or dyes.
- Wear gloves to wash dishes or do housework or gardening.
- Drink plenty of water and try not to scratch or rub your skin.
- Notify your healthcare team if you develop a rash, as they can provide suggestions to manage the rash and/or prescribe a topical medication to apply to the rash or an oral medication.
- If you develop peeling or blistering of the skin, notify your healthcare team right away.
While receiving this medication, you may develop an inflammation of the skin around the nail bed/cuticle areas of toes or fingers, which is called paronychia. It can appear red, swollen or pus filled. Nails may develop "ridges" in them or fall off. You may also develop cuts or cracks that look like small paper cuts in the skin on your toes, fingers or knuckles. These side effects may appear several months after starting treatment, but can last for many months after treatment stops.
- Follow the same recommendations for your skin (above).
- Don't bite your nails or cuticles or cut the cuticles.
- Keep your fingernails and toenails clean and dry.
- You may use nail polish, but do not wear fake nails.
- Notify your doctor or nurse if any nails fall off or you develop any of these side effects or other skin abnormalities.
While receiving this medication, some patients may develop irritation or damage to the cornea (clear part covers the eyeball), changes in your eyesight, watery or dry eyes. Notify your healthcare team if you develop any eye pain, swelling or redness of the eye, any vision changes, including blurriness, seeing floaters, and sensitivity to light.
Nausea and/or Vomiting
Talk to your doctor or nurse so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try antacids, (e.g. milk of magnesia, calcium tablets such as Tums), saltines, or ginger ale to lessen symptoms.
Call your doctor or nurse if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.
Decrease in Appetite
Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your nurse about nutritional counseling services at your treatment center to help with food choices.
- Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
- If you are not eating enough, nutritional supplements may help.
- You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
- Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
- Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.
There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.
Osimertinib can cause changes to your lungs including interstitial lung disease and pneumonitis. Contact your provider if you are experiencing any new or worsening lung symptoms, including shortness of breath, difficulty breathing, new cough or fever.
This medication can cause the development or worsening of, congestive heart failure, decreased left ventricular ejection fraction, and an abnormal heart rhythm called QT prolongation. Your heart function will be tested prior to you starting the medication with an electrocardiogram. Notify your healthcare provider if you develop swelling of the feet or ankles, shortness of breath, feel abnormal heartbeats, or if you feel dizzy or faint.
Sexual & Reproductive Concerns
This drug may affect a man’s reproductive system, resulting in sperm production becoming irregular or stopping permanently. It has not been studied what the affects of this medication are on a woman’s reproductive system.
Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 6 weeks after treatment for women, and 4 months after treatment for men, even if your menstrual cycle stops or you believe you are not producing sperm. You may want to consider sperm banking or egg harvesting if you may wish to have a child in the future. Discuss these options with your oncology team. Do not breastfeed while taking this medication or for 2 weeks after treatment has stopped.