Hepatic function abnormalities, hepatic impairment, photosensitivity reaction or rash, angioedema, dizziness, fatigue & wt loss. May affect ability to drive or operate machinery. Avoid use in pregnancy & lactation.
Indication
Idiopathic pulmonary fibrosis (IPF)
Contra Indication
Hypersensitivity. History of angioedema. Severe hepatic & renal impairment or end stage liver & renal disease. Concomitant use w/ fluvoxamine.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Precise mechanism by which pirfenidone may work in pulmonary fibrosis has not been established
Inhibits transforming growth factor (TGF)-beta, a chemical mediator that controls many cell functions including proliferation and differentiation
Also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation
Interaction
Inhibition of CYP1A2 w/ concomitant grapefruit juice. Increased exposure w/ fluvoxamine & other strong & selective CYP1A2 inhibitors, ciprofloxacin, amiodarone, propafenone. Potential to induce hepatic enzyme production by smoking. Lowered plasma levels w/ omeprazole, rifampicin.
Pregnancy Category Note
Pregnancy: Data in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage
Lactation: No information is available on presence of pirfenidone in human milk, effects of drug on breastfed infant, or effects of drug on milk production; lack of clinical data during lactation precludes clear determination of risk of pirfenidone to infant during lactation; developmental and health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and potential adverse effects on breastfed child from pirfenidone or from underlying maternal condition
Adult Dose
Idiopathic Pulmonary Fibrosis
Initial dose titration
Days 1-7: 267 mg (1 capsule) PO TID
Days 8-14: 534 mg (2 capsules) PO TID
Day 15 and thereafter: 801 mg (3 capsules) PO TID
Maintenance dose
801 mg (3 capsules) PO TID with food
Not to exceed 2403 mg/day (9 capsules/day)
Hepatic impairment
Mild-to-moderate (Child Pugh A or B): Use caution; monitor and consider dosage modification or discontinuation as needed
Severe (Child Pugh C): Not recommended (not studied)
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild, moderate, or severe: Use caution; monitor and consider dosage modification or discontinuation as needed
ESRD requiring dialysis: No recommended (not studied)
Administration
Should be taken with food: Take w/ food to reduce the possibility of nausea & dizziness. Swallow whole w/ water. Take doses at same time each day.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.