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Ivacaftor/Lumacaftor Oral Granules (LUMACAFTOR/IVACAFTOR - ORAL)

For cystic fibrosis.

Brand Name(s): ORKAMBI

Generic Name: Ivacaftor/Lumacaftor

Instructions

Mix the medicine in a small amount of liquid or soft food and then swallow it.

Use only liquids or soft foods at or below room temperature to mix the medicine. Do not use hot liquid or food.

After mixing the medicine, use it within 1 hour. Throw away any leftover medicine. Do not save for later use.

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.

Shake the bottle well before using the medicine.

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.

The foods you eat can change how well this medicine works. Tell your doctor about the types of food you normally eat. Ask your doctor for a list of foods that can affect this medicine. Do not significantly change the foods you normally eat while on this medicine.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

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 has been associated with a rare but serious skin rash. If you notice any red, peeling or blistered skin, contact your doctor immediately.

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.

If possible, avoid using with 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.

If you drink alcohol regularly, please speak with your doctor.

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.

Call your doctor right away if you notice slow or shallow breathing.

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.

  • bloating
  • diarrhea
  • dizziness
  • headaches
  • nausea

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

  • chest pain
  • severe, watery or bloody diarrhea
  • high blood pressure
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • red, burning, or itchy skin
  • shortness of breath
  • blurring or changes of vision
  • severe or persistent vomiting
  • worsening breathing symptoms

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.