What is JAMP PIRFENIDONE?

JAMP PIRFENIDONE 267 MG contains PIRFENIDONE : 267 MG. It is listed in the Health Canada Drug Product Database under DIN 02509938, held by JAMP PHARMA CORPORATION, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 04-Jun-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is JAMP PIRFENIDONE used for?

JAMP Pirfenidone (pirfenidone capsules) is indicated for treatment of idiopathic pulmonary fibrosis (IPF) in adults.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended daily dose of JAMP 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 Doses above 2403 mg/day are not recommended for any patient. Patients who miss 14 consecutive days or more of JAMP 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. JAMP Pirfenidone is to be swallowed whole with water and taken with food to reduce the possibility of nausea or dizziness. If gastrointestinal events do not improve, or worsen in severity, dose reduction or discontinuation of JAMP Pirfenidone may be warranted. The dose 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. For mild to moderate photosensitivity reaction or rash, use sunblock daily and avoid sun exposure. The dose may be reduced to 801 mg each day. If rash persists after 7 days, discontinue for 15 days, with re-escalation as tolerated. For severe photosensitivity reaction or rash, discontinue promptly and seek medical advice. Once rash resolved, re-introduce and re-escalate at physician's discretion. If ciprofloxacin (750 mg twice daily) cannot be avoided, reduce JAMP Pirfenidone to 1602 mg daily (534 mg, three times a day). Use caution when ciprofloxacin is used at 250 to 1000 mg total daily dose. No dose adjustment is necessary for patients 65 years and older. Pirfenidone has not been studied in pediatric patients and is not recommended for use in this population. No dose adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B). However, monitor closely for toxicity if concomitantly taking a known CYP1A2 inhibitor. JAMP Pirfenidone should not be used in patients with severe hepatic impairment or end-stage liver disease. Liver chemistry tests (ALT, AST, bilirubin) should be monitored before and during treatment. Dose adjustments, including discontinuation, may be necessary for elevations in ALT, AST, and/or bilirubin. If Grade 2 ALT/AST elevation (>3 to <5 × ULN) without hyperbilirubinaemia, exclude other causes, monitor closely. Consider discontinuing other liver toxic medicines. Reduce or interrupt JAMP Pirfenidone dose. Re-escalate once ALT/AST levels resolve. If ALT/AST elevation (>3 to <5 × ULN) with clinical signs of liver injury or hyperbilirubinaemia, discontinue promptly, monitor closely until resolution. Do NOT re-challenge. If ALT/AST elevation (≥5 × ULN), discontinue promptly, monitor closely until resolution. Do NOT re-challenge. No dose adjustment is necessary in patients with mild to moderate renal impairment. JAMP Pirfenidone should not be used in patients with severe renal impairment or end-stage renal disease requiring dialysis (CrCl <30mL/min). If severe cutaneous adverse reactions (SCARs) occur, immediately withdraw JAMP Pirfenidone. If SCAR is confirmed, do not restart.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at 15-25°C, excursions permitted up to 30°C.

How is it supplied?

JAMP Pirfenidone capsules are supplied in white high-density polyethylene (HDPE) bottle with child-resistant closure containing 270 capsules, or in carton packs as follows: 7 x PVC/PE/Aclar aluminium foil blister, each blister containing 9 capsules, packed together in a carton for a total of 63 capsules per pack.

Contraindications

Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. History of angioedema with pirfenidone. Concomitant use of fluvoxamine. Severe hepatic impairment or end-stage liver disease. Severe renal impairment (CrCl <30 mL/min) or end stage renal disease requiring dialysis.

Warnings and precautions

Serious Warnings and Precautions Box: Drug Interactions with Inhibitors of CYP1A2 and Other CYP Isoenzymes: Fluvoxamine: JAMP Pirfenidone is contraindicated with concomitant use of fluvoxamine (a strong inhibitor of CYP1A2). Fluvoxamine should be discontinued prior to and avoided during JAMP Pirfenidone treatment due to potential for reduced clearance of pirfenidone. Ciprofloxacin: Co-administration of pirfenidone and 750 mg of ciprofloxacin (moderate and selective inhibitor of CYP1A2) increased pirfenidone exposure by 81%. If ciprofloxacin 750 mg twice daily (total 1500 mg) cannot be avoided, JAMP Pirfenidone dose should be reduced to 1602 mg daily (534 mg, three times a day). Use caution when ciprofloxacin is used at 250 to 1000 mg total daily dose. Strong and Selective Inhibitors of CYP1A2: These inhibitors have the potential to increase pirfenidone exposure by approximately 2 to 4-fold. If concomitant use cannot be avoided, JAMP Pirfenidone dose should be reduced to 801 mg daily (267 mg, three times a day). Patients should be closely monitored for adverse reactions. Discontinue JAMP Pirfenidone if necessary. Other CYP1A2 Inhibitors: Agents or combinations that are moderate to strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes (CYP2C9, 2C19, 2D6, and 2E1) should be avoided. Use caution with moderate inhibitors of CYP1A2 that do not inhibit other CYP isoenzymes. General: Treatment should be initiated and supervised by specialist physicians experienced in IPF. Take with food to reduce dizziness or nausea. Monitor patients for toxicities and any additional medication used. Consider treatment of symptoms, dose reduction, or discontinuation for significant side effects. Driving and Operating Machinery: May cause dizziness and fatigue, which could influence ability to drive or use machines. Patients should know how they react before engaging in such activities. Exercise caution. Fatigue: Reported in patients. Patients should know how they react before activities requiring mental alertness. Dose reduction or discontinuation may be warranted if fatigue does not improve or worsens. Gastrointestinal: Events like nausea, diarrhoea, dyspepsia, vomiting reported. Take with food. Dose reduction or discontinuation may be warranted if events do not improve or worsen. Hepatic/Biliary/Pancreatic: Drug-Induced Liver Injury (DILI) and transient elevations in transaminases commonly reported. Uncommonly, these elevations were associated with bilirubin increases and serious clinical consequences, including isolated cases with fatal outcome. Liver chemistry tests (ALT, AST, bilirubin) should be performed prior to initiation, monthly for 6 months, then every 3 months. Promptly measure liver function tests if symptoms of liver injury occur. Dose reduction or treatment discontinuation may be needed for elevations in ALT and/or AST, or clinical signs/symptoms of liver injury. JAMP Pirfenidone should be used with caution in patients with pre-existing mild to moderate hepatic impairment (Child-Pugh Class A and B) due to potential for increased exposure. Monitor closely for toxicity, especially if taking a CYP1A2 inhibitor. Contraindicated in severe hepatic impairment or end-stage liver disease. Immune (Angioedema): Reports of angioedema (some serious) such as swelling of the face, lips, and/or tongue with difficulty breathing or wheezing in post-marketing setting. Discontinue immediately if signs/symptoms occur. Manage according to standard of care. Contraindicated in patients with a history of angioedema due to pirfenidone. Monitoring and Laboratory Tests: Liver chemistry tests (ALT, AST, bilirubin) should be performed prior to initiation, monthly for 6 months, then every 3 months. Promptly measure liver function tests if symptoms of liver injury occur. Dose reduction or discontinuation may be needed for elevations in ALT and/or AST, or clinical signs/symptoms of liver injury. Renal: Contraindicated in severe renal impairment

What can be used instead?

Other Canadian products sharing ATC code L04AX05 PIRFENIDONE. 12 of 19 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies PIRFENIDONE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. PIRFENIDONE appears in 148 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.