Ivacaftor

Generic name
Ivacaftor
Brand name
ATC Code
R07AX02
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Predicted exposure (AUC) based on simulations is almost twice as high in patients above 12 months (> 7 kg) compared to children aged 1 month to 12 months (< 7 kg) [SmPC Kalydeco]

 

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

When co-administered with moderate or strong CYP3A4 inhibitors, the dose of ivacaftor should be adjusted, see SmPC

Dosages

Cystic fibrosis
  • Oral
    • 6 months up to 18 years and 7 up to 14 kg
      • 100 mg/day in 2 doses.
    • 6 months up to 18 years and 14 up to 25 kg
      • 150 mg/day in 2 doses.
    • 6 months up to 18 years and ≥ 25 kg
      • 300 mg/day in 2 doses.
    • 6 months up to 18 years and 5 up to 7 kg
      • 50 mg/day in 2 doses.
    • 4 months up to 6 months and ≥ 5 kg
      • 50 mg/day in 2 doses.
    • 2 months up to 4 months and ≥ 3 kg
      • 26.8 mg/day in 2 doses.
    • 1 month up to 2 months and ≥ 3 kg
      • 13.4 mg/day in 1 dose in the morning.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Very common: Nasopharyngitis, infection of the upper respiratory tract, rhinitis, headaches, dizziness, blocked nose, oropharyngeal pain, abdominal pain, diarrhoea, rash, bacteria in the sputum. transaminase elevations
Common: Earache, tympanic membrane hyperaemia, tinnitus, pharyngeal erythema, sinus congestion, chest masses.
Seldom: blocked ear, inflammation of the breast, gynaecomastia, nipple disorder, pain in the nipple.

Cloudiness of the eye lens has been reported in children

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

The daily dose should be halved in moderately impaired hepatic function (Child-Pugh class B).

Take with foods that contain fat. Meals and snacks that are recommended in the CF guidelines or meals in the standard nutrition guidelines contain enough fat.

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
R07AX32
R07AX30
R07AX31

Reference

  1. Vertex Pharmaceuticals (U.K.) Limited, SmPC Kalydeco (EU/1/12/782/001-004) Rev 43 16-09-2024, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose