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KALYDECO is a brand name for Ivacaftor. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Kalydeco tablets are indicated: • As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance…
Verbatim from this product's MHRA label. Tap a section to expand.
Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis. 1). The phase of the poly-T variant identified with the R117H mutation should be determined in accordance with local clinical recommendations.
Posology Adults, adolescents, and children aged 6 years and older should be dosed according to Table 1. 5 mg/tezacaftor 25 mg/elexacaftor 50 mg tablets One ivacaftor 75 mg tablet 6 years to < 12 years, ≥ 30 kg Two ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg tablets One ivacaftor 150 mg tablet 12 years and older Two ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg tablets One ivacaftor 150 mg tablet The morning and evening dose should be taken approximately 12 hours apart with fat- containing food (see Method of administration).
Missed dose If 6 hours or less have passed since the missed morning or evening dose, the patient should be advised to take it as soon as possible and then take the next dose at the regularly scheduled time. If more than 6 hours have passed since the time the dose is usually taken, the patient should be advised to wait until the next scheduled dose.
Patients receiving Kalydeco in a combination regimen should be advised not to take more than one dose of either medicinal product at the same time. Concomitant use of CYP3A inhibitors When co-administered with moderate or strong inhibitors of CYP3A, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor, the dose should be reduced based on dosing recommended for the age and weight (see Table 2 for the recommended dose).
5).
Table 2:
Dosing recommendations for concomitant use with moderate or strong CYP3A inhibitors Moderate CYP3A inhibitors Strong CYP3A inhibitors Ivacaftor as monotherapy 6 years and older, ≥ 25 kg One morning tablet of ivacaftor 150 mg once daily.
No evening dose. One morning tablet of ivacaftor 150 mg twice a week, approximately 3 to 4 days apart. No evening dose. Ivacaftor in a combination regimen with tezacaftor/ivacaftor 6 years to < 12 years, < 30 kg Alternate each morning: - one tablet of tezacaftor 50 mg/ivacaftor 75 mg on the first day - one tablet of ivacaftor 75 mg on the next day Continue alternating tablets each day.
8 Paediatric population The safety and efficacy of ivacaftor have not been established in children less than 1 month of age as monotherapy, neither in combination with tezacaftor/ivacaftor in children less than 6 years of age or in combination with ivacaftor/tezacaftor/elexacaftor in children less than 2 years of age.
No data are available. Limited data are available in patients less than 6 years of age with an R117H mutation in the CFTR gene. 2. Method of administration For oral use. Patients should be instructed to swallow the tablets whole. The tablets should not be chewed, crushed, or broken before swallowing because there are no clinical data currently available to support other methods of administration.
Ivacaftor tablets should be taken with fat-containing food. 5). 1. 1). In study 5, four patients with the G970R mutation were included. In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
1). 1). Therefore, use of ivacaftor as monotherapy in these patients is not recommended. 1). 1. Elevated transaminases and hepatic injury In a patient with cirrhosis and portal hypertension, liver failure leading to transplantation has been reported while receiving ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor.
, cirrhosis, portal hypertension) and only if the benefits are expected to outweigh the risks. 2). Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor as monotherapy and in combination regimens with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor.
In patients taking ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor, these elevations have sometimes been associated with concomitant elevations in total bilirubin. Therefore, assessments of transaminases (ALT and AST) and total bilirubin are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
1). In study 5, four patients with the G970R mutation were included. In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
1). 1). Therefore, use of ivacaftor as monotherapy in these patients is not recommended. 1). 1. Elevated transaminases and hepatic injury In a patient with cirrhosis and portal hypertension, liver failure leading to transplantation has been reported while receiving ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor.
, cirrhosis, portal hypertension) and only if the benefits are expected to outweigh the risks. 2). Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor as monotherapy and in combination regimens with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor.
In patients taking ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor, these elevations have sometimes been associated with concomitant elevations in total bilirubin. Therefore, assessments of transaminases (ALT and AST) and total bilirubin are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
For all patients with a history of liver disease or transaminase elevations, more frequent monitoring of liver function tests should be considered. , patients with ALT or AST > 5 × the upper limit of normal (ULN), or ALT or AST > 3 × ULN with bilirubin > 2 × ULN), dosing should be interrupted, and laboratory tests closely followed until the abnormalities resolve.
2). Hepatic impairment Use of ivacaftor, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No evening dose. One morning tablet of tezacaftor 50 mg/ivacaftor 75 mg twice a week, approximately 3 to 4 days apart. No evening dose. 6 years to < 12 years, ≥ 30 kg Alternate each morning: - one tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily on the first day - one tablet of ivacaftor 150 mg on the next day Continue alternating each day.
No evening dose. One morning tablet of tezacaftor 100 mg/ivacaftor 150 mg twice a week, approximately 3 to 4 days apart. No evening dose. 12 years and older Alternate each morning: - one tablet of tezacaftor 100 mg/ivacaftor 150 mg on the first day - one tablet of ivacaftor 150 mg on the next day Continue alternating tablets each day.
No evening dose. One morning tablet of tezacaftor 100 mg/ivacaftor 150 mg twice a week, approximately 3 to 4 days apart. No evening dose. 5 mg/tezacaftor 25 mg/ elexacaftor 50 mg on the first day - one tablet of ivacaftor 75 mg on the next day Continue alternating tablets each day.
No evening dose. 5 mg/tezacaftor 25 mg/elexacaftor 50 mg twice a week, approximately 3 to 4 days apart. No evening dose. 6 years to < 12 years, ≥ 30 kg Alternate each morning: - two tablets of ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg on the first day - one tablet of ivacaftor 150 mg on the next day Continue alternating tablets each day.
No evening dose. Two morning tablets of ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg twice a week, approximately 3 to 4 days apart. No evening dose. 12 years and older Alternate each morning: - two tablets of ivacaftor 75 mg/tezacaftor 50 mg/ elexacaftor 100 mg on the first day - one tablet of ivacaftor 150 mg on the next day Continue alternating tablets each day.
No evening dose. Two morning tablets of ivacaftor 75 mg/tezacaftor 50 mg/elexacaftor 100 mg twice a week, approximately 3 to 4 days apart. No evening dose. Special populations Elderly Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen).
2). Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment. 2). Hepatic impairment No dose adjustment is necessary for ivacaftor as monotherapy or in a combination regimen in patients with mild hepatic impairment (Child-Pugh Class A).
For patients […]
For all patients with a history of liver disease or transaminase elevations, more frequent monitoring of liver function tests should be considered. , patients with ALT or AST > 5 × the upper limit of normal (ULN), or ALT or AST > 3 × ULN with bilirubin > 2 × ULN), dosing should be interrupted, and laboratory tests closely followed until the abnormalities resolve.
2). Hepatic impairment Use of ivacaftor, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks.
Patients with severe hepatic impairment should not be treated with ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor. 2). For patients with moderate hepatic impairment, use of ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor is not recommended.
Treatment should only be considered when there is a clear medical need and the benefits are expected to outweigh the risks. 2). 2). Patients after organ transplantation Ivacaftor, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor, has not been studied in patients with CF who have undergone organ transplantation.
Therefore, use in transplanted patients is not recommended. 5 for interactions with ciclosporin or tacrolimus. Rash events The incidence of rash events with ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor was higher in females than in males, particularly in females taking hormonal contraceptives.
A role for hormonal contraceptives in the occurrence of rash cannot be excluded. […]
Patients with severe hepatic impairment should not be treated with ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor. 2). For patients with moderate hepatic impairment, use of ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor is not recommended.
Treatment should only be considered when there is a clear medical need and the benefits are expected to outweigh the risks. 2). 2). Patients after organ transplantation Ivacaftor, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor or ivacaftor/tezacaftor/elexacaftor, has not been studied in patients with CF who have undergone organ transplantation.
Therefore, use in transplanted patients is not recommended. 5 for interactions with ciclosporin or tacrolimus. Rash events The incidence of rash events with ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor was higher in females than in males, particularly in females taking hormonal contraceptives.
A role for hormonal contraceptives in the occurrence of rash cannot be excluded. For patients taking hormonal contraceptives who develop rash, interrupting treatment with ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor and hormonal contraceptives should be considered.
Following the resolution of rash, it should be considered if resuming ivacaftor in a combination regimen with ivacaftor/tezacaftor/elexacaftor without hormonal contraceptives is appropriate. 8). 5). CYP3A inhibitors Exposure to ivacaftor, tezacaftor and elexacaftor are increased when co-administered with strong or moderate CYP3A […]