Summary of the safety profile The safety profile of Alyftrek is based on data from 480 participants aged 12 years and older in two randomized, ivacaftor/tezacaftor/elexacaftor (IVA/TEZ/ELX)- controlled phase 3 studies (studies 121-102 and 121-103) with 52 weeks of treatment duration.
In both studies, all subjects participated in a 4-week run-in period with IVA/TEZ/ELX. 8%. 4%). 1%). Tabulated list of adverse reactions Table 3 shows overall incidence of adverse drug reactions of people with CF treated with Alyftrek.
Adverse drug reactions for Alyftrek are ranked under the MedDRA frequency classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Table 3:
Adverse reactions by preferred term, frequency System Organ Class (SOC) Adverse Drug Reactions (Preferred Term) Frequency for Alyftrek Nervous system disorders Headache very common Gastrointestinal disorders Diarrhoea very common Alanine aminotransferase increased common Hepatobiliary disorders Aspartate aminotransferase increased common Skin and subcutaneous tissue disorders Rash common Investigations Blood creatine phosphokinase increased common Safety data from the following studies were generally consistent with the safety data observed in studies 121-102 and 121-103: • A 24-week, open-label study (study 121-105, Cohort B1) in 78 people with CF aged 6 to less than 12 years.
0% with Alyftrek. 0% with Alyftrek. 5% discontinued treatment for elevated transaminases. 8%, respectively. 0% with Alyftrek. The rash events were generally mild to moderate in severity. 0% in females. A role for hormonal contraceptives in the occurrence of rash cannot be excluded.
For people with CF taking hormonal contraceptives who develop rash, consider interrupting Alyftrek and hormonal contraceptives. Following the resolution of rash, consider resuming Alyftrek without the hormonal contraceptives. If rash does not recur, resumption of hormonal contraceptives can be considered.
9% with Alyftrek. 2% discontinued treatment for increased creatine phosphokinase. Paediatric population The safety data of Alyftrek in study 121-105, Cohort B1 was evaluated in 78 people with CF aged 6 to less than 12 years. The safety profile is generally consistent among adolescents and adult patients.
8%, respectively. 4). Other special populations The safety profile of Alyftrek was generally similar across all subgroups of patients, including analysis by age, sex, baseline percent predicted Forced Expiratory Volume in one second (ppFEV1) and geographic regions.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.