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SANDOZ 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: Sandoz 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 No dose adjustment is necessary in patients 65 years…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 05/2024 7 WARNINGS AND PRECAUTIONS, Severe Cutaneous Adverse Reactions 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
8 5 OVERDOSAGE............................................................................................................... 8
1 Adverse Reaction Overview The safety of pirfenidone has been evaluated in more than 1400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials. The most common adverse reactions (≥10%) are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased appetite, gastro- esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
2% on placebo had a dose interruption or reduction because of an adverse event. The most common (>1%) adverse reactions leading to discontinuation were rash and nausea. The most common (>3%) adverse reactions leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Pirfenidone capsules was studied in 3 randomized, double-blind, placebo-controlled trials (Studies PIPF-016, PIPF-004 and PIPF-006) in which a total of 623 patients received 2403 mg/day of pirfenidone capsules and 624 patients received placebo.
Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%). The mean duration of exposure to pirfenidone capsules was 62 weeks (range: 2 to 118 weeks) in these 3 trials. Patients in these studies could elect to participate in an open-label extension study to examine the long-term safety of pirfenidone capsules (Study PIPF 012).
, Severe Cutaneous Adverse Reactions 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
8 5 OVERDOSAGE............................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................
• 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.
Table 2 below describes the related treatment-emergent adverse events occurring in ≥3% patients on pirfenidone capsules with a greater frequency than placebo in Studies PIPF-004, PIPF-006, and PIPF-016. 7) a Includes abdominal pain, upper abdominal pain, abdominal distension, abdominal discomfort, and stomach discomfort.
Demographic Factors No effect was seen between adverse events and sex (male versus female), age (<65 versus ≥65 years), or Baseline IPF severity (FVC <70% predicted versus FVC 70% to 80% predicted versus FVC ≥80% predicted) within the pirfenidone group.
No effect also was seen for race (white versus non-white); however, there were only 65 non-white patients in the three predominantly North American Phase III studies combined Dose-Response Relationship (PIPF-004 and PIPF-006) Study PIPF-004 included a group receiving a lower dose of pirfenidone (1197 mg/day) than the marketed dose of 2403 mg/day.
Adverse drug reaction rates in the lower dose pirfenidone group were intermediate to the pirfenidone 2403 mg/day and placebo groups for a number of the more frequently occurring adverse drug reactions including nausea, dyspepsia, abdominal pain, decreased appetite, dizziness, headache, photosensitivity reaction and rash.
Adverse Drug Reactions in SP3 The safety analysis in the randomized, double-blind Phase III study (SP3) conducted in Japan included 109 patients who were treated with 1800 mg/day pirfenidone. This dose is comparable to the 2403 mg/day dose administered in […]
1 Special Populations................................................................................................ 1 Pregnant Women ............................................................................................... 2 Breast-feeding ...................................................................................................
3 Pediatrics ........................................................................................................... 4 Geriatrics ...........................................................................................................
13 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings ..........................................................................
5 Post-Market Adverse Reactions ............................................................................ 17 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
22 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ............................................................................................
3 Pharmacokinetics ............................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 25 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
26 PART II: SCIENTIFIC INFORMATION ........................................................................................ 27 13 PHARMACEUTICAL INFORMATION .............................................................................
27 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication .................................................................................
27 Idiopathic Pulmonary Fibrosis ......................................................................................... 2 Comparative Bioavailability Studies ................................................................... 31 15 MICROBIOLOGY .........................................................................................................
34 16 NON-CLINICAL TOXICOLOGY […]