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Entrectinib Oral Capsule (ENTRECTINIB - ORAL)

For treating cancer.

Brand Name(s): Rozlytrek

Generic Name: Entrectinib

Instructions

If you have trouble swallowing this medicine, ask your doctor or pharmacist for specific directions for mixing it with water or milk.

Keep the medicine in its original container.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

You may take with food to prevent stomach upset.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Avoid grapefruit and grapefruit juice while on this medicine.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

Avoid prolonged or excessive sunlight exposure. Use sunscreen lotion with SPF 15 or higher.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the dose. Return to your normal dosing schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 week after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 5 weeks after stopping to prevent pregnancy.

Men should continue using birth control for at least 3 months after finishing this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

If you have had a heart attack or a stroke within the past year, talk to your doctor before using this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • agitated feeling or trouble sleeping
  • decreased appetite
  • constipation
  • dizziness or drowsiness
  • lack of energy and tiredness
  • headaches
  • joint or muscle pain
  • nausea and vomiting
  • changes in taste or unpleasant taste

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bone pain
  • difficulty concentrating
  • depression or feeling sad
  • swelling of the legs, feet, and hands
  • fainting
  • fever or chills
  • numbness or tingling in hands and feet
  • fast or irregular heart beats
  • sensitivity to light
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • nervousness
  • shortness of breath
  • blurring or changes of vision
  • severe or persistent vomiting
  • sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

 
 

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