What is this medicine?

ENTRECTINIB (en TREK ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat lung cancer and neurotrophic receptor tyrosine kinase gene fusion-positive solid tumors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ROZLYTREK

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • anxiety or panic attacks
  • bone problems
  • dementia
  • depression
  • eye disease, vision problems
  • heart disease or heart failure
  • history of irregular heartbeat
  • kidney disease
  • liver disease
  • trouble sleeping
  • an unusual or allergic reaction to entrectinib, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. Do not take with grapefruit juice. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • cisapride
  • dronedarone
  • pimozide
  • thioridazine

This medicine may also interact with the following medications:

  • aprepitant
  • bosentan
  • certain antibiotics like erythromycin or clarithromycin
  • certain antivirals for HIV or hepatitis
  • certain medicines for depression, anxiety, or psychotic disorders
  • certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
  • certain medicines for irregular heart beat like amiodarone, dofetilide, encainide, flecainide, propafenone, quinidine
  • certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
  • cimetidine
  • ciprofloxacin
  • conivaptan
  • crizotinib
  • cyclosporine
  • digoxin
  • diltiazem
  • enzalutamide
  • grapefruit juice
  • idelalisib
  • imatinib
  • mifepristone
  • mitotane
  • modafinil
  • other medicines that prolong the QT interval (cause an abnormal heart rhythm)
  • rifampin
  • St. John's Wort
  • verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

Tell your doctor or health care professional right away if you have any change in your eyesight.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 5 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Do not breast-feed an infant while taking this medicine or for 7 days after stopping it.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue
  • bone pain
  • changes in vision
  • changes in emotions or moods
  • confusion
  • loss of balance or coordination
  • loss of memory
  • pain, tingling, numbness in the hands or feet
  • sensitivity to light
  • signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
  • signs and symptoms of heart failure like breathing problems, fast, irregular heartbeat, sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired
  • signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
  • vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

  • changes in taste
  • constipation
  • diarrhea
  • dizziness
  • joint pain
  • loss of appetite
  • nausea
  • muscle pain
  • tiredness
  • trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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