Ivacaftor and lumacaftor

Generic name: Ivacaftor And Lumacaftor
Brand names: Orkambi
Drug class: CFTR combinations

Usage of Ivacaftor and lumacaftor

Ivacaftor and lumacaftor is a combination medicine used to treat cystic fibrosis in adults and children who are at least 1 year old.

Ivacaftor and lumacaftor tablet can be used in children aged 6 years and older. Ivacaftor and lumacaftor granules can be used in children at least 1 year old.

Your doctor will make sure you have the specific gene mutation related to cystic fibrosis to be treated with ivacaftor and lumacaftor.

Ivacaftor and lumacaftor may also be used for purposes not listed in this medication guide.

Ivacaftor and lumacaftor side effects

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

Ivacaftor and lumacaftor may cause serious side effects. 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 of ivacaftor and lumacaftor 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.

Before taking Ivacaftor and lumacaftor

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 ivacaftor and lumacaftor.

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.

Relate drugs

How to use Ivacaftor and lumacaftor

Usual Adult Dose for Cystic Fibrosis:

Lumacaftor 400 mg/Ivacaftor 250 mg orally every 12 hours with fat-containing food Comments:-A fat containing meal or snack should be consumed just before or just after dosing. Examples include eggs, avocados, nuts, butter, peanut butter, cheese pizza, or whole-milk dairy products. -If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene; safety and efficacy in patients with cystic fibrosis other than homozygous F508del mutation has not been established. Use: For the treatment of cystic fibrosis (CF) in patients who are homozygous for the F508del mutation in the CFTR gene.

Usual Pediatric Dose for Cystic Fibrosis:

Age: 2 through 5 years; weight less than 14 kg: Lumacaftor 100 mg/Ivacaftor 125 mg orally every 12 hours with fat-containing food Age: 2 through 5 years: weight 14 kg or greater: Lumacaftor 150 mg/Ivacaftor 188 mg orally every 12 hours with fat-containing food Age: 6 through 11 years: Lumacaftor 200 mg/Ivacaftor 250 mg orally every 12 hours with fat-containing food Age: 12 years or older: Lumacaftor 400 mg/Ivacaftor 250 mg orally every 12 hours with fat-containing food Comments:-Pediatric patients 2 through 5 years of age should receive oral granules; pediatric patients over 6 years of age, should be dosed with tablets. -A fat containing meal or snack should be consumed just before or just after dosing. Examples include eggs, avocados, nuts, butter, peanut butter, cheese pizza, or whole-milk dairy products.-If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene; safety and efficacy in patients with cystic fibrosis other than homozygous F508del mutation has not been established. Use: For the treatment of cystic fibrosis (CF) in patients 1 year or older who are homozygous for the F508del mutation in the CFTR gene.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What other drugs will affect Ivacaftor and lumacaftor

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect ivacaftor and lumacaftor, especially:

St. John's wort;

seizure medicine such as Carbamazepine, phenobarbital, phenytoin;

medicine to prevent organ transplant rejection--cyclosporine, everolimus (Zortress), sirolimus, tacrolimus;

a sedative--triazolam or midazolam;

an antibiotic--clarithromycin, erythromycin, telithromycin, rifabutin, rifampin; or

antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may affect ivacaftor and lumacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.