Ivacaftor + Tezacaftor + Elexacaftor

Generic name
Ivacaftor + Tezacaftor + Elexacaftor
Brand name
ATC Code
R07AX32
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Ivacaftor + Tezacaftor + Elexacaftor

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Pharmacokinetic parameters for children ≥12 years [SmPC Kaftrio]:

  Dose Cmax (µg/ml)
Elexacaftor 200 mg/day 9,15 ± 2,09
Tezacaftor 100 mg/day 7,67 ± 1,68
Ivacaftor 150 mg/2 dd 1,24 ± 0,34

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

General Dose Info

The dose should be adjusted when combined with Cyp3A4 inhibiting drugs or in hepatic impairment (see SmPC)

Dosages

Cystic fibrosis
  • Oral
    • 6 years up to 18 years and ≥ 30 kg

      • In the morning: ivacaftor / tezacaftor / elexacaftor: 150 / 100 / 200 mg/dosis 
        In the evening: ivacaftor: 150 mg/dosis

    • 6 years up to 18 years and < 30 kg

      • In the morning: ivacaftor / tezacaftor / elexacaftor: 75 / 50 / 100 mg/dosis 
        In the evening: ivacaftor: 75 mg/dosis

    • 2 years up to 6 years and 10 up to 14 kg

      • In the morning: ivacaftor / tezacaftor / elexacaftor: 60 / 40 / 80 mg/dosis 
        In the evening: ivacaftor: 59,5 mg/dosis

    • 2 years up to 6 years and ≥ 14 kg

      • In the morning: ivacaftor / tezacaftor / elexacaftor: 75 / 50 / 100 mg/dosis 
        In the evening: ivacaftor: 75 mg/dosis

Renal impaiment in children > 3 months

No dose adjustment is recommended for patients with mild and moderate renal impairment.

[SmPC Kaftrio]

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Side effects in children are comparable to those observed in adults. 

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Cataract: Ophthalmic examinations are recommended in children prior to and dureing treatment, as cases of cloudiness of the eye lens have been reportet [SmPC Kaftrio].

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER RESPIRATORY SYSTEM PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Lung surfactants
R07AA02
R07AA05
Respiratory stimulants
R07AB01
Other respiratory system products
R07AX02
R07AX30
R07AX31

Reference

  1. Vertex Pharmaceuticals (Ireland) Limited, SmPC Kaftrio (EU/1/20/1468/001) Rev 24. 24-10-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose