Pirfenidone: Uses,Dosage,Side Effects

Generic Name

Pirfenidone
Therapeutic Class:  Anti-fibrinolytic (Immunosuppressant)

Indications:
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Presentation:
Pirfenidone 267 capsule: Each capsule contains Pirfenidone BP 267 mg.
Pirfenidone801 tablet: Each tablet contains Pirfenidone BP 801 mg.

Description:
Pirfenidone is an anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF). It is assumed that it works by reducing lung fibrosis through downregulation of the production of growth factors and procollagens. IPF is a condition in which the tissues in the lungs become swollen and scarred over time and as a result, makes it difficult to breathe deeply. This makes it hard for the lungs to work properly. Pirfenidone helps to reduce scarring and swelling in the lungs and helps breathe better

Dosage & Administration:
1.Recommended dosage: The recommended daily maintenance dosage of pirfenidone is 801 mg (1 Tablet/3 capsule) three times daily taken with food. Doses should be taken at the same time each day.

2.Upon initiation of treatment, the daily dosage should be titrated to the full dosage of 3 Tablets/9 capsules per day over a 14-day period as follows:
Days 1 through 7 is 267 mg (1 capsule) three times a day with meals
Days 8 through 14 is 534 mg (2 capsules) three times a day with meals
Days 15 onward is 801 mg (1 tablet/3 capsule) three times a day with meals

3.Dosages above 2403 mg/day (3 tablets/9 capsules per day) are not recommended for any patient. Patients who miss 14 or more days of pirfenidone should be re-initiated treatment by undergoing the initial 2-week titration regimen up to full maintenance dosage. For the treatment interruption of fewer than 14 days, the dosage prior to the interruption can be
resumed.

Side Effects:
The most common adverse reactions are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhoea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastro-oesophagal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia etc

Precautions:

• Elevated liver enzymes: ALT, AST, and bilirubin elevations have occurred with Pirfenidone. Monitor ALT, AST and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required.
• Photosensitivity and rash: Photosensitivity and rash have been noted with Pirfenidone. Avoid exposure to sunlight and sunlamps. Wear sunscreen and protective clothing daily. Temporary dosage reductions or discontinuations may be required.
• Gastrointestinal disorder: Gastrointestinal events of nausea, diarrhoea, dyspepsia, vomiting, gastro-oesophagal reflux disease and abdominal pain are more frequently reported by patients in the treatment with Pirfenidone

Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It is not known whether it is excreted in human milk.
Use in a specific population
No dosage adjustment is required for the geriatric patient. Pirfenidone should be used with caution in patients with mild to moderate hepatic and renal impairment. There is no relevant use of Pirfenidone in the paediatric population for the indication of IPF

Interaction:
The concomitant administration of Fluvoxamine, Ciprofloxacin or other strong and moderate CYP1A2 inhibitors with Pirfenidone is not recommended because they significantly increase exposure to pirfenidone.

Overdose Effects:
There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a dose of 4806 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.

Storage:
Do not store above 30 0 C. Keep away from light and out of the reach of children