Ivacaftor/Tezacaftor Oral Tablet/Ivacaftor Oral Tablet (TEZACAFTOR/IVACAFTOR AND IVACAFTOR - ORAL)

For cystic fibrosis.

Brand Name(s): Symdeko 4-Week Pack

Generic Name: Tezacaftor/Ivacaftor and Ivacaftor

Instructions

Keep the medicine in its original container.

Take with a high fat food.

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.

Avoid grapefruit and grapefruit juice while on this medicine.

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 6 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine 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.

Tell your doctor if symptoms do not get better or if they get worse.

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

Do not take the medicine more than twice during 24 hours.

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.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

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.

If you drink more than a few alcoholic beverages each day, ask your doctor whether you should be on this medicine.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not take St. John's wort while on this medicine.

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

Always refill this medicine before it runs out.

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.

  • dizziness
  • headaches
  • nausea

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

  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • blurring or changes of vision
  • severe or persistent vomiting

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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