Lumacaftor + ivacaftor - oral

Patient Medicine Information
Why do I need this medicine?
Lumacaftor + Ivacaftor is used to treat cystic fibrosis (an inherited disease that causes excessively thick and sticky mucus build up in the lungs or intestines).

This medicine is specifically indicated for those with F508del mutation to cystic fibrosis transmembrane conductance regulator (CFTR) gene.
How do I take this medicine?
Take Lumacaftor + Ivacaftor exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

Take this medicine with fat-containing food (e.g. eggs, avocados, nuts, peanut butter, cheese, soy-based or whole-milk dairy products). Try to take it at the same time each day.

Lumacaftor + Ivacaftor is available as a film-coated tablet or oral granules in sachet.

If you are taking a film-coated tablet, swallow it whole. Do not divide, chew or crush the tablet.

If you are taking the granules, mix the entire contents of a sachet with 5 mL or teaspoonful of soft foods such as pureed fruits, yogurt, or pudding, or other liquid such as water, milk or juice. Once it is mixed, take it immediately. Do not store the mixture for future use.

Lumacaftor + Ivacaftor must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.
What should I do if I have forgotten to take this medicine?
If you miss a dose and less than 6 hours have passed since you missed your dose, take the missed dose with fat-containing meal and return to your normal dosing schedule.

If more than 6 hours have passed, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose to make up for a missed dose.

If you often forget to take your medicine, let your doctor and pharmacist know.
What should I take note of while taking this medicine?
Inform your doctor if you have the following conditions:
  • lung problems
  • kidney disease
  • liver disease
Let your doctor know if you are pregnant or breastfeeding.

Be sure to check with your doctor or pharmacist before giving this medicine to a child.

Lumacaftor + Ivacaftor is not recommended for those who have undergone an organ transplant.

If you are going for certain laboratory test (e.g. urine screening test for the active component of cannabis), inform your doctor that you are taking this medicine.

This medicine is indicated only for those with F508del gene mutation. Your doctor may need to perform genetic testing before giving you this medicine to know if it is suitable for you.

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.
  • You may need to have routine blood tests to make sure that your liver function is normal before you take this medicine and thereafter depending on your doctor’s advise.
  • You may also need to have your eyes checked regularly. Your doctor will advise you about how often you will need to have this test.
  • Regular monitoring of your blood pressure and lung function may also be needed.
What side effects could I experience?
Lumacaftor + Ivacaftor may cause dizziness. If affected, do not drive or take part in any activity in which you need to be alert.

Other side effects may include any of the following: headache, common cold, stuffy or runny nose, ear pain or discomfort, ringing in the ears, cough with sputum, sore throat, nausea, stomach pain, vomiting, diarrhoea, and throat pain.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:
  • rashes, breathlessness, swollen eyes, face or mouth
  • yellowing of the skin or eyes, severe stomach pain, unusual tiredness, dark coloured urine
  • breathing problems such as shortness of breath or chest tightness
  • clouding of the lens of the eyes
Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.
Can I take this with other medicines?
Inform your doctor and pharmacist if you are taking any of these medicines:
  • medicines to treat fungal infection e.g. ketoconazole, itraconazole, posaconazole, voriconazole
  • medicines to treat TB (infection known as tuberculosis) e.g. rifampicin, rifabutin, rifapentine
  • medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenytoin, phenobarbital
  • medicines to treat depression e.g. sertraline, escitalopram, citalopram, bupropion
  • medicines used in organ transplant or certain immune disorders e.g. ciclosporin, tacrolimus
  • gastric medicines e.g. omeprazole, lansoprazole, esomeprazole
  • anti-inflammatory medicines e.g. prednisone, methylprednisolone
  • blood-thinning medicines e.g. dabigatran, warfarin
  • ranitidine (medicine that reduces stomach acid production)
  • repaglinide (medicine for diabetes)
  • digoxin (medicine for heart disease)
  • St. John’s wort (herbal medicine)
This list does not include all medicines that may interact with Lumacaftor + Ivacaftor.

Inform your doctor if you are currently taking birth control pills as this medicine can reduce the effectiveness of hormonal birth control. You should not stop or start any birth control pills without first informing your doctor. Ask your doctor about using non-hormonal birth control as an alternative while being treated with Lumacaftor + Ivacaftor.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements and medicines that you buy without a prescription.
What special dietary instructions should I follow?
Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice.

Avoid Seville oranges.
How should I store this medicine?
Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.
This information is independently developed by MIMS based on lumacaftor + ivacaftor - oral and is provided for your reference only. It is not a replacement for and should only be used in conjunction with full consultation with a licensed healthcare professional, the information provided by your pharmacist and/or the manufacturer of the medication. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, we shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by
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