Question 1

What is Orkambi (Ivacaftor And Lumacaftor) used for?

Accepted Answer

Pulmonary Impairment
Cystic Fibrosis
Cystic Fibrosis with Ileus

Question 2

What is the most important information I should know about Orkambi (Ivacaftor And Lumacaftor)?

Accepted Answer

You should not be treated with ivacaftor and lumacaftor if you are allergic to it, or if you have or have ever had:

high blood pressure;
lung disease;
an organ transplant; or
liver or kidney disease.

It is not known if ivacaftor and lumacaftor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Ask a doctor if it is safe to breastfeed while using this medicine. Ivacaftor and lumacaftor can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Question 3

Can I take Orkambi (Ivacaftor And Lumacaftor) if I’m pregnant or breastfeeding?

Accepted Answer

It is not known if ivacaftor and lumacaftor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Ask a doctor if it is safe to breastfeed while using this medicine. Ivacaftor and lumacaftor can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Question 4

How to take Orkambi (Ivacaftor And Lumacaftor)?

Accepted Answer

Use Orkambi (Ivacaftor And Lumacaftor) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Take this medicine with food that contains fat, such as eggs, milk products such as whole milk, cheese, yogurt, breast milk or infant formula. Follow your doctor's instructions carefully. Swallow the tablet whole and do not crush, chew, or break it. Mix the ivacaftor and lumacaftor granules with 1 teaspoon of soft food or liquid such as pureed fruits or vegetables, yogurt, applesauce, water, breast milk, infant formula, milk, or juice. The food or liquid should be at or below room temperature. Mix only 1 dose at a time and use within 1 hour after mixing. Feed the child a high-fat food after or before giving the granule mixture. Take this medicine at evenly spaced intervals every 12 hours. Doses are based on weight in children. Your child's dose may change if the child gains or loses weight. You will need frequent blood tests to check your liver function, and your blood pressure may need to be checked often. You may also need other medical tests. Your child may need frequent vision exams. Store at room temperature away from moisture and heat. Keep the medicine in the original packaging.

Question 5

What happens if I overdose on Orkambi (Ivacaftor And Lumacaftor)?

Accepted Answer

If you think you or someone else may have overdosed Orkambi (Ivacaftor And Lumacaftor) call your doctor or the Poison Control center '800-222-1222','(800) 222-1222','Poison Control' If someone collapses or isn't breathing after taking Diclofenac (Voltaren), call 911

Question 6

What drugs and food should I avoid while taking Orkambi (Ivacaftor And Lumacaftor)?

Accepted Answer

Grapefruit may interact with ivacaftor and lumacaftor and cause side effects. Avoid consuming grapefruit products during the first week of treatment.

Question 7

What are the side effects of Orkambi (Ivacaftor And Lumacaftor)?

Accepted Answer

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat. Call your doctor at once if you have:

severe headache, blurred vision, pounding in your neck or ears;
eye pain or redness, seeing halos around lights;
chest tightness, trouble breathing; or
liver problems--loss of appetite, nausea, vomiting, confusion, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

breathing problems;
feeling tired;
nausea, gas, diarrhea;
rash;
changes in your menstrual periods, heavy menstrual bleeding;
flu or cold symptoms such as stuffy or runny nose, sneezing, sore throat; or
abnormal blood tests.

Some side effects are more common in children taking ivacaftor and lumacaftor such as increase in mucus, cough with mucus, headache, or stomach pain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.