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Trikafta® granules

This product is manufactured by Vertex Pharmaceuticals and is a combination of 3 ingredients, ivacaftor, tezacaftor, and elexacaftor.

This product is taken orally.


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orally


Why is it prescribed?

Ivacaftor is used for the treatment of cystic fibrosis (CF):

  • in children age 2 months and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene

Tezacaftor is used in combination with similar medications for the treatment of cystic fibrosis in patients aged 12 years and older:

  • who are homozygous for the F508del mutation OR
  • who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

Elexacaftor is used in combination with similar medications to treat cystic fibrosis (CF) in patients 2 years of age and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Fat-containing food should be eaten just before or just after taking Trikafta®. This helps the body better absorb the medication.

Instructions for use:

  • Do not remove packet from the wallet until ready to give dose.
  • Shake the packet gently to settle the granules to the bottom of the packet.
  • Tear or cut packet completely open along cut line.
  • Pour all the granules of the packet into 5 mL (1 teaspoon) of soft food or liquid that is between 5°C to 25°C and mix in a small container (like an empty bowl). Some examples of soft foods or liquids include puréed fruits or vegetables, flavoured yogurt or pudding, applesauce, milk, or juice (except grapefruit).
  • After mixing, give within 1 hour. Make sure all medicine is taken. This is very important for it to work properly and be effective.

Alternatives

Other products that have the same ingredients as Trikafta® granules are •Trikafta® tablet ••Trikafta® tablet ••Trikafta® tablet •

See other products used in the treatment of •cystic fibrosis •

The recommended dose of Trikafta granules is:

  • 2 to < 6 years:
    • weighing < 14 kg: One packet of elexacaftor 80 mg/tezacaftor40 mg/ivacaftor 60 mg granules in the morning and one packet of ivacaftor 59.5 mg granules in the evening.
    • weighing ≥ 14 kg: One packet of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg granules in the morning and one packet of ivacaftor 75 mg granules in the evening.
       

Various mutations of the cystic fibrosis gene block the "gates" that allow the flow of salt across the cell membranes. This causes mucus to become thick and clog the lungs. Ivacaftor is a "cystic fibrosis transmembrane conductance regulator (CFTC) potentiator". The CFTR protein is a channel at the surface of the cells that allows the movement of particles such as chloride in and out of the cell, contributing to salt and water balance. Ivacaftor helps this CFTR protein channel or "open the gates" more often allowing more salt to pass through.  The thick mucus is reduced and cystic fibrosis symptoms lessen. 

 

Various mutations of the cystic fibrosis gene block the "gates" that allow the flow of salt across the cell membranes. This causes mucus to become thick and clog the lungs. Tezacaftor is a "cystic fibrosis transmembrane conductance regulator (CFTC) corrector". The CFTR protein is a channel at the surface of the cells that allows the movement of particles such as chloride in and out of the cell, contributing to salt and water balance. Tezacaftor corrects the positioning of the CFTR protein on the cell surface to permit proper channel formation and improved flow of water and salts across the cell membrane.  The thick mucus is reduced and cystic fibrosis symptoms lessen. 

 

Various mutations of the cystic fibrosis gene block the "gates" that allow the flow of salt across the cell membranes. This causes mucus to become thick and clog the lungs. Elexacaftor is a "cystic fibrosis transmembrane conductance regulator (CFTC) corrector". The CFTR protein is a channel at the surface of the cells that allows the movement of particles such as chloride in and out of the cell, contributing to salt and water balance. Elexacaftor corrects the positioning of the CFTR protein on the cell surface to permit proper channel formation and improved flow of water and salts across the cell membrane.  The thick mucus is reduced and cystic fibrosis symptoms lessen. 

 


Contact your doctor if any of these side effects persists or are bothersome:

• Diarrhea
• Nausea
• Stomach (abdominal) pain
• Common cold
• Runny nose
• Upper respiratory tract infection
• Changes in the type of bacteria in your sputum
• Headache
• Dizziness
• Nasal congestion
• Sinus congestion
• Sore throat
• Rash
• Joint pain

 


Use with caution if you:

  • have kidney or liver problems
  • have cataracts

Possible drug interactions: 

  • ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole​
  • some antibiotics such as clarithromycin, erythromycin, rifampin, rifabutin
  • phenobarbital, carbamazepine, phenytoin 
  • midazolam, alprazolam, diazepam, triazolam 
  • digoxin
  • cyclosporine, tacrolimus 
  • warfarin 
  • St. John’s wort 

Use in pregnancy and breastfeeding.  Little is known about the safety of this medication when used in pregnancy and breastfeeding.  Consult your doctor or pharmacist before use.