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Pirfenidone

Immunosuppressant Prescription
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Indications

Pulbo is used in adults to treat mild to moderate idiopathic pulmonary fibrosis (IPF), a condition in which scar tissue builds up in the lungs for no known cause.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Pirfenidone is a newer medicine that works by calming inflammation, fighting cell damage from oxidative stress, and slowing the scarring process in the lungs. In people with idiopathic pulmonary fibrosis (IPF), it may help preserve lung function and cut down on flare-ups of the disease. Exactly how it does this at the molecular level is still not fully understood, but researchers have identified some likely pathways. One important one is that it holds back TGF-β1 (transforming growth factor-β1), a signalling protein that drives scar tissue formation and the buildup of fibrous material in the lungs. It also appears to tone down other strong inflammation-promoting substances, such as TNF-α, interleukin-1, and interferon-gamma. In animal studies, pirfenidone reduced both the movement of inflammatory cells into lung tissue and the increase in blood vessel leakiness that bleomycin exposure normally causes.

Pregnancy & Breastfeeding

Pregnancy: No data exist on the use of Pirfenidone in pregnant women. In animal studies, pirfenidone and/or its metabolites cross the placenta and can accumulate in the amniotic fluid. At a high dose of 1000 mg/kg/day, rats showed a longer gestation period and reduced fetal viability. As a precaution, it is best to avoid Pirfenidone during pregnancy.

Lactation: It is not known whether pirfenidone or its metabolites pass into human breast milk. Animal pharmacokinetic studies have shown that pirfenidone and/or its metabolites are excreted in milk and may accumulate there, so a risk to the breastfeeding infant cannot be ruled out. A decision should be made to either stop breastfeeding or stop Pirfenidone treatment, weighing the benefit of breastfeeding for the child against the benefit of the therapy for the mother.

Fertility: Pirfenidone did not affect fertility or reproductive performance in rats at doses up to 1000 mg/kg/day, roughly 3 times the maximum recommended daily dose (MRDD) in adults on an mg/m2 basis.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Pirfenidone is taken by mouth with food. Adults: When treatment begins, the dose is increased gradually over 14 days until it reaches the recommended daily dose of nine 267 mg tablets or three 801 mg tablets per day, as follows. On days 1 to 7, one 267 mg tablet is taken three times a day (801 mg per day). On days 8 to 14, two 267 mg tablets are taken three times a day (1602 mg per day). From day 15 onward, three 267 mg tablets or one 801 mg tablet are taken three times a day (2403 mg per day). The recommended daily dose of Pirfenidone for patients with IPF is three 267 mg tablets or one 801 mg tablet three times a day with food, giving a total of 2403 mg per day. Doses above 2403 mg per day are not recommended for any patient. Patients who miss 14 or more consecutive days of Pirfenidone treatment should restart therapy by repeating the initial 2-week step-up schedule up to the recommended daily dose. If treatment is interrupted for fewer than 14 consecutive days, the previous recommended daily dose can be resumed without stepping up again. Dose adjustments and other points for safe use: Gastrointestinal events: Patients who cannot tolerate therapy because of gastrointestinal side effects should be reminded to take the medicine with food. If symptoms persist, Pirfenidone may be reduced to 1 to 2 tablets (267 mg to 534 mg) 2 to 3 times a day with food, and then increased again to the recommended daily dose as tolerated. If symptoms continue, patients may be told to stop treatment for 1 to 2 weeks so that the symptoms can settle. Photosensitivity reaction or rash: Patients who develop a mild to moderate photosensitivity reaction or rash should be reminded to apply a sunblock every day and to avoid sun exposure. The dose of Pirfenidone may be reduced to three 267 mg tablets per day (one 267 mg tablet three times a day). If the rash is still present after 7 days, Pirfenidone should be stopped for 15 days and then increased again to the recommended daily dose in the same way as during the initial step-up period. Patients who develop a severe photosensitivity reaction or rash should be told to stop taking the medicine and to seek medical advice. Once the rash has cleared, Pirfenidone may be restarted and increased again up to the recommended daily dose at the physician's discretion. Hepatic function: If there is a significant rise in alanine and/or aspartate aminotransferases (ALT/AST), with or without a rise in bilirubin, the dose of Pirfenidone should be adjusted or treatment stopped according to the guidelines.

Side Effects & Interactions

Side Effects

No side-effect data recorded yet.