Tezacaftor Ivacaftor

What is Tezacaftor Ivacaftor

Tezacaftor ivacaftor is an orally available ion channel modulator approved for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who are homozygous for the F508del mutation or who have at least 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor; ivacaftor based on in vitro data and/or clinical evidence.

The F508del mutation is the most frequent genotype in patients with CF; approximately 46% of CF patients in the United States are homozygous for this allele.

CFTR modulators, such as tezacaftor; ivacaftor, target specific defects caused by mutations in CFTR, thereby treating the underlying cause of CF. Clinical trials have demonstrated that combination corrector and potentiator treatment enhance CFTR function and improve lung function.

During Phase 3 trials in patients 12 years and older, mean improvement in FEV1 ranged from 1.2% to 6.8% in patients treated with tezacaftor; ivacaftor (p-value less than 0.0001).

In a 24-week trial, effects on pulmonary function were evident by day 15, and significant effects were maintained throughout the 24-week trial period.

Adverse reactions related to elevated liver transaminases have been reported in patients receiving tezacaftor ivacaftor and, in pediatric patients, ivacaftor has been associated with the development of cataracts. Hence, liver function monitoring and eye exams are required at baseline and periodically throughout therapy.

Brand Name

Symdeko

Indications

  • cystic fibrosis

Side Effects

  1. dizziness
  2. elevated hepatic enzymes
  3. headache
  4. nasal congestion
  5. nausea

Monitoring Parameters

  • LFTs
  • ophthalmologic exam

Contraindications

  • breast-feeding
  • cataracts
  • children
  • hepatic disease
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment

Interactions

  • Acetaminophen; Caffeine; Dihydrocodeine
  • Acetaminophen; Diphenhydramine
  • Acetaminophen; Hydrocodone
  • Acetaminophen; Oxycodone
  • Acetaminophen; Tramadol
  • Afatinib
  • Alfentanil
  • Alprazolam
  • Amiodarone
  • Amlodipine; Celecoxib
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Apalutamide
  • Aprepitant, Fosaprepitant
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Oxycodone
  • Atazanavir
  • Atazanavir; Cobicistat
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Benzhydrocodone; Acetaminophen
  • Betrixaban
  • Bexarotene
  • Boceprevir
  • Brigatinib
  • Brompheniramine; Guaifenesin; Hydrocodone
  • Brompheniramine; Hydrocodone; Pseudoephedrine
  • Budesonide
  • Budesonide; Formoterol
  • Buprenorphine
  • Buprenorphine; Naloxone
  • Caffeine; Ergotamine
  • Candesartan
  • Candesartan; Hydrochlorothiazide, HCTZ
  • Carbamazepine
  • Carbetapentane; Diphenhydramine; Phenylephrine
  • Carbinoxamine; Hydrocodone; Phenylephrine
  • Carbinoxamine; Hydrocodone; Pseudoephedrine
  • Carvedilol
  • Celecoxib
  • Ceritinib
  • Chloramphenicol
  • Chlorpheniramine; Dihydrocodeine; Phenylephrine
  • Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
  • Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
  • Chlorpheniramine; Hydrocodone
  • Chlorpheniramine; Hydrocodone; Phenylephrine
  • Chlorpheniramine; Hydrocodone; Pseudoephedrine
  • Ciprofloxacin
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Colchicine
  • Colchicine; Probenecid
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabigatran
  • Danazol
  • Dapsone
  • Darunavir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Delavirdine
  • Dextromethorphan; Diphenhydramine; Phenylephrine
  • Diazepam
  • Diclofenac
  • Diclofenac; Misoprostol
  • Digoxin
  • Dihydrocodeine; Guaifenesin; Pseudoephedrine
  • Dihydroergotamine
  • Diltiazem
  • Diphenhydramine
  • Diphenhydramine; Hydrocodone; Phenylephrine
  • Diphenhydramine; Ibuprofen
  • Diphenhydramine; Naproxen
  • Diphenhydramine; Phenylephrine
  • Disopyramide
  • Doravirine; Lamivudine; Tenofovir disoproxil fumarate
  • Doxepin
  • Doxorubicin
  • Dronabinol
  • Dronedarone
  • Duvelisib
  • Efavirenz; Emtricitabine; Tenofovir
  • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
  • Eletriptan
  • Eliglustat
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
  • Emtricitabine; Tenofovir disoproxil fumarate
  • Enalapril; Felodipine
  • Encorafenib
  • Enzalutamide
  • Ergotamine
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Esomeprazole; Naproxen
  • Estazolam
  • Everolimus
  • Ezetimibe; Simvastatin
  • Famotidine; Ibuprofen
  • Fedratinib
  • Felodipine
  • Fentanyl
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Fluoxetine; Olanzapine
  • Flurbiprofen
  • Fluvastatin
  • Fluvoxamine
  • Fosamprenavir
  • Fosphenytoin
  • Glecaprevir; Pibrentasvir
  • Glimepiride
  • Glimepiride; Pioglitazone
  • Glimepiride; Rosiglitazone
  • Glipizide
  • Glipizide; Metformin
  • Glyburide
  • Glyburide; Metformin
  • grapefruit juice
  • Guaifenesin; Hydrocodone
  • Guaifenesin; Hydrocodone; Pseudoephedrine
  • Homatropine; Hydrocodone
  • Hydrochlorothiazide, HCTZ; Losartan
  • Hydrocodone
  • Hydrocodone; Ibuprofen
  • Hydrocodone; Phenylephrine
  • Hydrocodone; Potassium Guaiacolsulfonate
  • Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
  • Hydrocodone; Pseudoephedrine
  • Ibuprofen
  • Ibuprofen; Oxycodone
  • Ibuprofen; Pseudoephedrine
  • Idelalisib
  • Imatinib
  • Indinavir
  • Indomethacin
  • Isavuconazonium
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Itraconazole
  • Ivosidenib
  • Ixabepilone
  • Ketoconazole
  • Lamivudine; Tenofovir Disoproxil Fumarate
  • Lanreotide
  • Lansoprazole; Naproxen
  • Lapatinib
  • Lefamulin
  • Lemborexant
  • Letermovir
  • Loperamide
  • Loperamide; Simethicone
  • Lopinavir; Ritonavir
  • Losartan
  • Lovastatin
  • Lovastatin; Niacin
  • Maraviroc
  • Meloxicam
  • Methadone
  • Midazolam
  • Mifepristone
  • Mitotane
  • Morphine
  • Morphine; Naltrexone
  • Naproxen
  • Naproxen; Pseudoephedrine
  • Naproxen; Sumatriptan
  • Nateglinide
  • Nefazodone
  • Nelfinavir
  • Netupitant, Fosnetupitant; Palonosetron
  • Niacin; Simvastatin
  • Nifedipine
  • Nilotinib
  • Nintedanib
  • Nisoldipine
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole; Amoxicillin; Rifabutin
  • Oxycodone
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piroxicam
  • Posaconazole
  • Prasugrel
  • Prednisolone
  • Primidone
  • Quetiapine
  • Quinine
  • Ramelteon
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifampin
  • Rifaximin
  • Rimegepant
  • Ritonavir
  • Rivaroxaban
  • Saquinavir
  • Sertraline
  • Sildenafil
  • Simvastatin
  • Simvastatin; Sitagliptin
  • Sirolimus
  • Sofosbuvir; Velpatasvir
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • St. John’s Wort, Hypericum perforatum
  • Sufentanil
  • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
  • Tacrolimus
  • Talazoparib
  • Telithromycin
  • Temsirolimus
  • Tenofovir Alafenamide
  • Tenofovir, PMPA
  • Terbinafine
  • Ticagrelor
  • Tipranavir
  • Tolbutamide
  • Tolvaptan
  • Topotecan
  • Torsemide
  • Tramadol
  • Trandolapril; Verapamil
  • Triazolam
  • Tucatinib
  • Ubrogepant
  • Venetoclax
  • Verapamil
  • Voriconazole
  • Warfarin
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