Strength267 mg
Formoral.solid
Titrated over 14 days: days 1 to 7, 267 mg three times a day (801 mg/day); days 8 to 14, 534 mg three times a day (1602 mg/day); from day 15, 801 mg three times a day (2403 mg/day). Maintenance is 801 mg three times a day WITH FOOD, total 2403 mg a day; doses above 2403 mg/day are not recommended. After a break of 14 consecutive days or more, restart at the beginning of the titration. - Long-term, while it is tolerated and the disease is being modified
Paediatric doseNot a paediatric drug. SmPC verbatim: "There is no relevant use of Esbriet in the paediatric population for the indication of IPF."
Dose sourceEsbriet 267 mg Film-coated Tablets (pirfenidone) SmPC sections 4.2 and 4.4 (eMC product 2731, emc-esbriet-267mg-pirfenidone.txt)
WhyThe card named this drug in prose and gave no dose, so a physician could see what the referral was for but not what the patient had been put on. The article states the indication - "Antifibrotic medications, including pirfenidone and nintedanib (tyrosine kinase inhibitors), are approved for use in IPF." - and the SmPC states the same indication and the dose. The SmPC's titration is used rather than the article's one-line figure, because the article's "267 mg (1 capsule) taken 3 times daily" is 801 mg a day, which the label defines as the FIRST WEEK; its own stated maximum, 2403 mg a day, is the label's maintenance dose. Both numbers are the article's, so nothing is contradicted - the label supplies the fortnight between them. Four Egyptian products are registered and the cost is the real barrier: PERDOFENEX 267 mg is 767 EGP for 30 capsules and 19,543 EGP for the 270-capsule pack (a month at maintenance is 270 capsules).
Cautions- LIVER MONITORING IS PART OF THE PRESCRIPTION. SmPC verbatim: "Liver function tests (ALT, AST and bilirubin) should be performed prior to the initiation of treatment with Esbriet, and subsequently at monthly intervals for the first 6 months and then every 3 months thereafter". And: "If a patient exhibits an aminotransferase elevation to ≥5 x ULN, Esbriet should be permanently discontinued and the patient should not be rechallenged."
- CONTRAINDICATED, SmPC verbatim: hypersensitivity; "History of angioedema with pirfenidone"; "Concomitant use of fluvoxamine"; "Esbriet therapy should not be used in patients with severe hepatic impairment or end stage liver disease"; and "Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis". The article says the same about the kidney.
- Photosensitivity is the commonest reason patients stop. Daily sunblock and sun avoidance from the first tablet, which matters in Cairo; a mild-to-moderate reaction is managed by dropping to 267 mg three times a day, a severe one by interrupting and seeking advice.
- Take it with food - it reduces the nausea and dizziness, and the maintenance dose is specified with food.
- Started and supervised by an ILD centre. SmPC verbatim: "Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF." This row exists so that the regimen is visible and a patient already on it is not left without it.
- What it does and does not do: on the article's reading of the studies, both drugs slow the disease down and may reduce all-cause mortality and acute exacerbations, which is why it recommends starting treatment early. It slows the disease; it does not reverse it.
- The article's own dosing sentence, printed so the difference is visible: it puts pirfenidone at 267 mg - 1 capsule - given 3 times a day, up to a ceiling of 2403 mg daily split into 3 doses. That first figure is the label's week-one dose, not the maintenance dose.