Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF.
Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine capsules per day over a 14-day period as follows:
The recommended maintenance daily dose of Esbriet is three 267 mg capsules three times a day with food for a total of 2403 mg/day.
Doses above 2403 mg/day are not recommended for any patient (see section 4.9).
Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose.
For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.
In patients who experience intolerance to therapy due to gastrointestinal undesirable effects, patients should be reminded to take the medicinal product with food. If symptoms persist, the dose of pirfenidone may be reduced to 1-2 capsules (267 mg–534 mg) two to three times/day with food with re-escalation to the recommended daily dose as tolerated. If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve.
Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded to use a sunblock daily and to avoid exposure to the sun (see section 4.4). The dose of pirfenidone may be reduced to 3 capsules/day (1 capsule three times a day). If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period.
Patients who experience severe photosensitivity reaction or rash should be instructed to interrupt the dose and to seek medical advice (see section 4.4). Once the rash has resolved, Esbriet may be re-introduced and re-escalated up to the recommended daily dose at the discretion of the physician.
In the event of significant elevation of alanine and/or aspartate aminotransferases (ALT/AST) with or without bilirubin elevation, the dose of pirfenidone should be adjusted or treatment discontinued according to the guidelines listed in section 4.4.
No dose adjustment is necessary in patients 65 years and older (see section 5.2).
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B). However, since plasma levels of pirfenidone may be increased in some individuals with mild to moderate hepatic impairment, caution should be used with Esbriet treatment in this population. Esbriet therapy should not be used in patients with severe hepatic impairment or end stage liver disease (see section 4.3, 4.4 and 5.2).
No dose adjustment is necessary in patients with mild renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment. Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).
There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Esbriet is for oral use. The capsules are to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections 4.8 and 5.2).
There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a total dose of 4,806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period. Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.
Shelf life:
4 years for blisters.
3 years for bottles.
Do not store above 30°C.
2-week treatment initiation pack: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing). Each pack contains a total of 63 capsules.
4-week treatment maintenance pack: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply). There are 14 × 18 capsules in PVC/PE/PCTFE aluminium foil perforated blister strips for a total of 252 capsules per pack.
250 ml white HDPE bottle with child-resistant closure containing 270 capsules.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
