Entrectinib (en-TREK-ti-nib)

Treats non-small cell lung cancer (NSCLC) and solid tumors.

Brand Name(s):

Rozlytrek

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Pellet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Swallow the capsule whole. Do not crush or chew it.
• If you are taking the capsules prepared as a suspension:
  • Open the prescribed number of capsules and pour them into room temperature drinking water or milk. Let the suspension sit for 15 minutes before taking it.
  • Measure the correct dose of medicine with the provided oral dosing syringe or measuring cup.
  • Drink water after taking the suspension to make sure you swallow all the medicine. Store no longer than 2 hours at room temperature.
  • If you are using a nasogastric tube or gastric feeding tube, the suspension can be given through the tube. Flush the tube with water or milk after each dose.
• Oral pellets:
  • Tap the packets to make sure that the pellets are on one side of the packet. Make sure you do not cut the pellets with scissors.
  • Sprinkle the required number of packets on one or more spoonfuls of soft food (including applesauce, yogurt, or pudding). Take the mixture within 20 minutes. Drink water after taking the mixture to make sure you swallow all the medicine.
  • Do not crush or chew the pellets to avoid bitter taste. Use the whole packet. Do not use part of the packet.
  • Do not use the pellets to make an oral liquid. Do not give it using a nasogastric tube or gastric feeding tube, the pellets may clog the feeding tube.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Take a dose as soon as you remember. If your next dose is within 12 hours, skip the missed dose and return to your regular dosing schedule. If you vomit after taking a dose, take a dose as soon as possible.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how entrectinib works. Tell your doctor if you are using digoxin, itraconazole, lansoprazole, midazolam, rifampin, or medicines that may prolong the QT interval.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 5 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment and for 7 days after your last dose of this medicine.
• Tell your doctor if you have kidney disease, liver disease, eye or vision problems, heart disease, or nervous system problems.
• This medicine may cause the following problems:
  • Congestive heart failure
  • Nervous system problems
  • Increased risk of bone fractures
  • Liver problems
  • High uric acid in the blood
  • Heart rhythm problems, including QT prolongation
  • Eye or vision problems
• This medicine may cause dizziness, tiredness, or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, changes in vision
• Bone pain, changes in movement
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dizziness, fainting, tiredness, memory loss, mood changes
• Swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Constipation, diarrhea
• Headache
• Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088