Osimertinib
Other Names: Tagrisso®

About This Drug

Osimertinib is used to treat cancer. It is given by mouth (orally).

Possible Side Effects (More Common)

  • Loose bowel movements (diarrhea) that may last for a few days
  • Rash: A rash that looks like acne may happen on your face and upper back when taking this medicine. Your doctor can give you medicine to help treat this.
  • Dry skin.
  • Changes in your nails, including redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails.
  • Bone marrow depression. This is a decrease in the number of white blood cells, red blood cells, and platelets. This may raise your risk of infection, make you tired and weak (fatigue), and raise your risk of bleeding.

Possible Side Effects (Less Common)

  • Eye irritation. You may have dry eyes. Your eyes and eye lids may become red and painful.
  • Nausea.
  • Decreased appetite (decreased hunger).
  • Constipation (not able to move bowels)
  • Inflammation (swelling) of the lungs. You may have a dry cough or trouble breathing.
  • Your heart tissue can be harmed. This may cause your heart to beat in a way that is not normal. Your doctor may order an EKG to check this.
  • Changes in the tissue of the heart. Some changes may happen that can cause your heart to have less ability to pump blood. Your heart function will be checked as needed.
  • Electrolyte changes. Your doctor will check your blood for electrolyte changes as needed.

Treating Side Effects

  • Drink 6-8 cups of fluids each day unless your doctor has told you to limit your fluid intake due to some other health problem. A cup is 8 ounces of fluid. If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • Ask your doctor or nurse about medicine that is available to help stop or lessen the loose bowel movements.
  • Ask your doctor or nurse about medicines that are available to help stop or lessen constipation.
  • If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories
  • If you get a rash do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.
  • Damage to the heart is rare. Your doctor will check your heart function as needed.

Important Information

  • You can take the medicine with or without food. If you have nausea, take it with food.
  • Swallow the medicine whole. Do not chew, break or crush it.
  • Take this medicine at the same time each day
  • If you miss a dose of osimertinib, do not take the missed dose at all and do not double up on the next dose. Instead, continue with your regular dosing schedule and contact your physician.
  • Store this medicine in the original container at room temperature

Food and Drug Interactions

  • Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are a lot of known drug interactions with osimertinib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.

When to Call the Doctor

Call your doctor or nurse immediately if you have any of the following symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Easy bleeding or bruising
  • Wheezing or trouble breathing
  • Feeling dizzy or lightheaded
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Loose bowel movements (diarrhea) more than 4 times a day or diarrhea with weakness or lightheadedness
  • Blurred vision or other changes in eyesight
  • Pain when passing urine; blood in urine
  • Nausea that stops you from eating or drinking
  • Throwing up more than 3 times a day
  • Chest pain or symptoms of a heart attack. Most heart attacks involve pain in the center of the chest that lasts more than a few minutes. The pain may go away and come back. It can feel like pressure, squeezing, fullness, or pain. Sometimes pain is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.

Call your doctor or nurse as soon as possible if any of the following symptoms occur:

  • Blurred vision or other changes in eyesight
  • No bowel movement in 3 days or when you feel uncomfortable
  • Nausea that is not relieved by prescribed medicines
  • Rash that is not relieved by prescribed medicines
  • Heavy menstrual period that lasts longer than normal
  • Fatigue that interferes with your daily activities
  • Headache that does not go away

Reproduction Concerns

  • Infertility warning: Sexual problems and reproduction concerns may happen. In men and women both, this drug may affect your ability to have children. This cannot be determined before your therapy. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.
  • Pregnancy warning: This drug may have harmful effects on the unborn child, so effective methods of birth control should be used during your cancer treatment. Females who are able to become pregnant should use an effective birth control during treatment and for 6 weeks after the final dose. Males who have female partners that are able to become pregnant should use effective birth control during treatment and for 4 months after the final dose. Genetic counseling is available for you to talk about the effects of this drug therapy on future pregnancies. Also, a genetic counselor can look at the possible risk of problems in the unborn baby due to this medicine if an exposure happens during pregnancy.
  • Breast feeding warning: It is not known if this drug passes into breast milk. For this reason, women should not breastfeed during treatment and for 2 weeks after the final dose.

Updated January 2017

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