Esbriet (pirfenidone) is an oral medicine for idiopathic pulmonary fibrosis, taken three times a day with food after a 14-day titration to 801 mg, and it ships at ambient temperature with no cold chain.

They are the two strengths of Esbriet (pirfenidone) used for idiopathic pulmonary fibrosis. The US label lists 267 mg capsules and 267 mg and 801 mg tablets, and DailyMed carries a Genentech, Inc. label and a separate Legacy Pharma USA Inc. tablet label. The UK SmPC on emc lists 267 mg and 801 mg film-coated tablets only, and the South African professional information lists the same two film-coated tablet strengths. The 267 mg unit covers titration and the 801 mg tablet is the maintenance strength. Confirm the presentation your destination registers before ordering.

The US label and the UK SmPC give the same titration. Days 1 to 7 are 267 mg three times daily, days 8 to 14 are 534 mg three times daily, and from day 15 the maintenance dose is 801 mg three times daily, a total of 2403 mg a day; the UK SmPC does not recommend doses above that. The US label says to take it with food at the same time each day, and the UK SmPC says to take the tablets with food to reduce nausea and dizziness. After a break of 14 or more consecutive days, the UK SmPC says to repeat the titration. This is label information for procurement, not a prescribing instruction.

In the US, the openFDA Drugs@FDA data lists many pirfenidone products approved under abbreviated applications, as tablets and as capsules, from sponsors including Sandoz, Teva, Amneal and Aurobindo, alongside the Esbriet entries. For the EU and UK we state no generic position, because we could not confirm one from sources we fetched for this page. M Care Exports supplies originator and regulator-registered brands as well as Indian-made lines such as Pirfenex 200 mg tablets. We do not claim any Indian-made line is registered in a destination, and we confirm what your regulator accepts per enquiry.

This compares label facts only and recommends neither. Esbriet is pirfenidone, taken as film-coated tablets or, on the US label, capsules, at 801 mg three times daily with food after a 14-day titration, and the UK SmPC says its mechanism has not been fully established. The US Ofev (nintedanib) label describes a kinase inhibitor in capsules, with the recommended dosage 150 mg twice daily about 12 hours apart, taken with food, and 100 mg twice daily in mild hepatic impairment. The US Ofev label lists IPF, chronic fibrosing ILDs with a progressive phenotype and systemic sclerosis-associated ILD, while the US Esbriet label lists IPF. Both labels call for liver tests. See our nintedanib page.

Read the full label for the complete list. Points a pharmacist checks first: the US label reports photosensitivity reactions in 9% of Esbriet patients against 1% on placebo, with advice to avoid or minimise sunlight, including sunlamps, to use a sunblock and to wear protective clothing. Liver enzyme elevations can occur, so the UK SmPC calls for ALT, AST and bilirubin before starting, monthly for the first 6 months, then every 3 months. The UK SmPC says Esbriet should be withdrawn immediately if Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS is suspected. Food is advised to reduce nausea and dizziness. Fluvoxamine is contraindicated in the UK SmPC.

We do not publish prices. The landed cost depends on whether you want originator Esbriet or an Indian-made pirfenidone line, the strength and pack size, the quantity, the registration route in your destination and Incoterms. The US, UK and South African texts we read require no refrigeration, so freight is simpler than for refrigerated products. The SFDA hosts an Esbriet safety checklist that it states it reviewed and approved, and the South African regulator's repository holds Esbriet professional information; neither document settles registration in your market, so M Care Exports confirms the route. We quote per destination once we have the strength, pack and quantity.