Lumacaftor And Ivacaftor (Oral Route)

Name: Lumacaftor And Ivacaftor (Oral Route)

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lumacaftor and ivacaftor combination in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of lumacaftor and ivacaftor combination have not been performed in the geriatric population.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Doravirine
  • Isavuconazonium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abemaciclib
  • Abiraterone Acetate
  • Acalabrutinib
  • Alfentanil
  • Aprepitant
  • Aripiprazole
  • Atazanavir
  • Axitinib
  • Benzhydrocodone
  • Bictegravir
  • Boceprevir
  • Bosutinib
  • Brigatinib
  • Budesonide
  • Buprenorphine
  • Buspirone
  • Carbamazepine
  • Ciprofloxacin
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Copanlisib
  • Crizotinib
  • Cyclosporine
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Deflazacort
  • Desogestrel
  • Dienogest
  • Dihydrocodeine
  • Dihydroergotamine
  • Diltiazem
  • Dronedarone
  • Drospirenone
  • Duvelisib
  • Eletriptan
  • Eliglustat
  • Encorafenib
  • Enzalutamide
  • Eplerenone
  • Eravacycline
  • Ergotamine
  • Erlotinib
  • Erythromycin
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Everolimus
  • Felodipine
  • Fentanyl
  • Fluconazole
  • Fluticasone
  • Fluvoxamine
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fostamatinib
  • Gestodene
  • Hemin
  • Hydrocodone
  • Ibrutinib
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Ketoconazole
  • Letermovir
  • Levonorgestrel
  • Lopinavir
  • Lovastatin
  • Lurasidone
  • Macimorelin
  • Maraviroc
  • Meperidine
  • Mestranol
  • Methadone
  • Midazolam
  • Midostaurin
  • Mitotane
  • Morphine
  • Morphine Sulfate Liposome
  • Nefazodone
  • Nelfinavir
  • Neratinib
  • Netupitant
  • Nilotinib
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olaparib
  • Osimertinib
  • Oxycodone
  • Paliperidone
  • Pentazocine
  • Perampanel
  • Phenytoin
  • Pimozide
  • Posaconazole
  • Quetiapine
  • Quinidine
  • Regorafenib
  • Ribociclib
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Sildenafil
  • Simvastatin
  • Sirolimus
  • Stiripentol
  • St John's Wort
  • Sufentanil
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telithromycin
  • Temsirolimus
  • Thiotepa
  • Tipranavir
  • Tofacitinib
  • Tolvaptan
  • Tramadol
  • Triazolam
  • Ulipristal
  • Valbenazine
  • Vardenafil
  • Velpatasvir
  • Vemurafenib
  • Verapamil
  • Voriconazole
  • Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aripiprazole Lauroxil
  • Risperidone

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (granules, tablets):
    • For cystic fibrosis:
      • Adults and children 12 years of age and older—2 tablets every 12 hours, taken with fat-containing food. Each tablet contains 200 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children 6 to 11 years of age—2 tablets every 12 hours, taken with fat-containing food. Each tablet contains 100 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children 2 to 5 years of age and weighing 14 kilograms (kg) or more—1 packet of granules every 12 hours, taken with fat-containing food. Each packet contains 150 milligrams (mg) lumacaftor and 188 mg ivacaftor.
      • Children 2 to 5 years of age and weighing less than 14 kg—1 packet of granules every 12 hours, taken with fat-containing food. Each packet contains 100 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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