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MAR-PIRFENIDONE is a brand name for Pirfenidone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MAR-PIRFENIDONE (pirfenidone) is indicated for treatment of idiopathic pulmonary fibrosis (IPF) in adults. 1.1 Pediatrics Pediatrics (<18 years of age): The safety and effectiveness of pirfenidone in pediatric patients have not been established. 1.2 Geriatrics Geriatrics: No dose adjustment is necessary in patients 65…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Treatment with MAR-PIRFENIDONE should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. • MAR-PIRFENIDONE should be taken with food (see 9 DRUG INTERACTIONS).
• MAR-PIRFENIDONE should not be taken concomitantly with fluvoxamine (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). • Reduction of the MAR-PIRFENIDONE dose may be required for ciprofloxacin and strong but selective inhibitors of CYP1A2 (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
2 Recommended Dose and Dosage Adjustment Adults The recommended daily dose of MAR-PIRFENIDONE for patients with IPF is 801 mg three times a day with food, for a total dose of 2403 mg/day. Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/ day over a 14-day period to improve tolerability as follows: Days 1 to 7: a dose of 267 mg administered, three times a day (801 mg/day) with food.
Days 8 to 14: a dose of 534 mg administered, three times a day (1602 mg/day) with food. Day 15 onward: a dose of 801 mg administered, three times a day (2403 mg/day) with food. with caution when ciprofloxacin is used at a total daily dose of 250 to 1000 mg (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS).
Strong and Selective Inhibitors of CYP1A2 In vitro-in vivo extrapolations indicate that strong and selective inhibitors of CYP1A2 have the potential to increase the exposure to pirfenidone by approximately 2 to 4-fold. If concomitant use of MAR-PIRFENIDONE with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of MAR-PIRFENIDONE should be reduced to 801 mg daily (267 mg, three times a day).
Patients should be closely monitored for emergence of adverse reactions associated with MAR-PIRFENIDONE therapy. Discontinue MAR-PIRFENIDONE if necessary (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS). , CYP2C9, 2C19, 2D6, and 2E1) should be avoided during MAR-PIRFENIDONE treatment.
MAR-PIRFENIDONE should be used with caution in patients treated with moderate inhibitors of CYP1A2 that do not inhibit other CYP isoenzymes (see 9 DRUG INTERACTIONS). MAR-PIRFENIDONE (Pirfenidone Tablets) Page 6 of 42 Doses above 2403 mg/day are not recommended for any patient (see
, Post-Market Adverse Reactions). Liver chemistry tests (ALT, AST, and bilirubin) should be performed prior to the initiation of treatment with MAR-PIRFENIDONE, and subsequently at monthly intervals for the first 6 months and then every 3 months thereafter.
In addition, liver function tests should be promptly measured in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. In the event of elevations of ALT and/or AST, or clinical signs and symptoms of liver injury, the dose of MAR-PIRFENIDONE may need to be reduced or treatment discontinued (see 7 WARNINGSAND PRECAUTIONS, Monitoring and Laboratory Tests and 4 DOSAGE AND ADMINISTRATION, Recommendations in Case of ALT, AST, Bilirubin Elevations).
, Child-Pugh Class B), pirfenidone exposure was increased by 60%. , Child-Pugh Class A and B) given the potential for increased MAR-PIRFENIDONE exposure. Patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor (see
). • Concomitant use of fluvoxamine (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). • Severe hepatic impairment or end-stage liver disease (see 7 WARNINGS AND PRECAUTIONS). • Severe renal impairment (CrCl <30 mL/min) or end stage renal disease requiring dialysis (see 7 WARNINGS AND PRECAUTIONS).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Drug Interactions with Inhibitors of CYP1A2 and Other CYP Isoenzymes Fluvoxamine MAR-PIRFENIDONE is contraindicated in patients with concomitant use of fluvoxamine (a strong inhibitor of CYP1A2 with inhibitory effects on CYP2C9, 2C19, and 2D6).
Fluvoxamine should be discontinued prior to the initiation of treatment with MAR-PIRFENIDONE and avoided during MAR- PIRFENIDONE therapy due to the potential for reduced clearance of pirfenidone (see 2 CONTRAINDICATIONS and 9 DRUG INTERACTIONS).
Ciprofloxacin Co-administration of pirfenidone and 750 mg of ciprofloxacin (a moderate and selective inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%. If ciprofloxacin at the dose of 750 mg twice daily (a total daily dose of 1500 mg) cannot be avoided, the dose of MAR-PIRFENIDONE should be reduced to 1602 mg daily (a dose of 534 mg, three times a day).
1 Dosing Considerations • Treatment with MAR-PIRFENIDONE should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. • MAR-PIRFENIDONE should be taken with food (see 9 DRUG INTERACTIONS).
• MAR-PIRFENIDONE should not be taken concomitantly with fluvoxamine (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). • Reduction of the MAR-PIRFENIDONE dose may be required for ciprofloxacin and strong but selective inhibitors of CYP1A2 (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
2 Recommended Dose and Dosage Adjustment Adults The recommended daily dose of MAR-PIRFENIDONE for patients with IPF is 801 mg three times a day with food, for a total dose of 2403 mg/day. Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/ day over a 14-day period to improve tolerability as follows: Days 1 to 7: a dose of 267 mg administered, three times a day (801 mg/day) with food.
• Hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
• History of angioedema with pirfenidone (see 7 WARNINGS AND PRECAUTIONS). • Concomitant use of fluvoxamine (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). • Severe hepatic impairment or end-stage liver disease (see 7 WARNINGS AND PRECAUTIONS).
• Severe renal impairment (CrCl <30 mL/min) or end stage renal disease requiring dialysis (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pirfenidone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Days 8 to 14: a dose of 534 mg administered, three times a day (1602 mg/day) with food. Day 15 onward: a dose of 801 mg administered, three times a day (2403 mg/day) with food. with caution when ciprofloxacin is used at a total daily dose of 250 to 1000 mg (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS).
Strong and Selective Inhibitors of CYP1A2 In vitro-in vivo extrapolations indicate that strong and selective inhibitors of CYP1A2 have the potential to increase the exposure to pirfenidone by approximately 2 to 4-fold. If concomitant use of MAR-PIRFENIDONE with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of MAR-PIRFENIDONE should be reduced to 801 mg daily (267 mg, three times a day).
Patients should be closely monitored for emergence of adverse reactions associated with MAR-PIRFENIDONE therapy. Discontinue MAR-PIRFENIDONE if necessary (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS). , CYP2C9, 2C19, 2D6, and 2E1) should be avoided during MAR-PIRFENIDONE treatment.
MAR-PIRFENIDONE should be used with caution in patients treated with moderate inhibitors of CYP1A2 that do not inhibit other CYP isoenzymes (see 9 DRUG INTERACTIONS). MAR-PIRFENIDONE (Pirfenidone Tablets) Page 6 of 42 Doses above 2403 mg/day are not recommended for any patient (see 5 OVERDOSAGE).
Patients who miss 14 consecutive days or more of MAR-PIRFENIDONE treatment should re- initiate therapy by undergoing the initial 2 week titration regimen up to the recommended daily dose. If treatment is interrupted for less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.
Dose Adjustments Gastrointestinal Events:
In patients who experience intolerance to therapy due to gastrointestinal side effects, patients should be reminded to take MAR-PIRFENIDONE with food. If gastrointestinal events do not improve, or worsen in severity, dose reduction or discontinuation of MAR-PIRFENIDONE may be warranted.
The dose of MAR-PIRFENIDONE may be reduced to 267 mg – 534 mg, two to three times a day with food with re-escalation to the recommended daily dose as tolerated.
Photosensitivity Reaction or Rash:
Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded to use a sunblock daily and to avoid exposure to the sun. The dose of MAR-PIRFENIDONE may be reduced to 801 mg each day. If the rash persists after 7 days, MAR-PIRFENIDONE should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period.
Patients who experience severe photosensitivity reaction or rash should be instructed to discontinue MAR-PIRFENIDONE promptly and to seek medical advice without delay (see 7 WARNINGS AND PRECAUTIONS). Once the rash has resolved, MAR-PIRFENIDONE may be re- introduced and re-escalated up to the recommended daily dose at the discretion of the physician.
Ciprofloxacin:
Co-administration of pirfenidone and 750 mg of ciprofloxacin (a moderate and selective inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%. If ciprofloxacin at the dose of 750 mg twice daily (a total daily dose of 1500 mg) cannot be avoided, the dose of MAR-PIRFENIDONE should be reduced to 1602 mg daily (a dose of 534 mg, three times a day).
MAR-PIRFENIDONE should be used with caution when ciprofloxacin is used at a total daily dose of 250 to 1000 mg (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). […]