Generic Esbriet ( Pirfenidone )

Buy Generic Esbriet (Pirfenidone) without prescription in Canada

In our Canadian pharmacy, you can buy Esbriet (Pirfenidone) without a prescription, with delivery across Canada within 5‑14 days. Discreet and anonymous packaging.

Esbriet (pirfenidone) is an oral anti‑fibrotic agent indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and fatal lung disease characterized by scarring of lung tissue. It works by reducing fibroblast proliferation, inhibiting the synthesis of collagen and other extracellular matrix proteins, and decreasing the production of inflammatory and pro‑fibrotic mediators such as transforming growth factor‑beta (TGF‑β) and tumour necrosis factor‑alpha (TNF‑α). By targeting multiple pathways involved in fibrosis, pirfenidone slows the decline in lung function, preserves exercise capacity, and extends progression‑free survival.

Usual adult dose: The recommended dose is 400 mg taken orally three times daily with food (total daily dose 1200 mg), following an initial 3‑week titration period: 200 mg three times daily (600 mg/day) for week 1, 400 mg twice daily (800 mg/day) for week 2, and 400 mg three times daily (1200 mg/day) from week 3 onward. For patients weighing 40 to 50 kg, the target maintenance dose is 200 mg three times daily (600 mg/day). In Canada, the branded product Esbriet is supplied as 267 mg capsules, with a different titration schedule to reach 801 mg three times daily; internationally sourced tablets of 200 mg and 400 mg may be used under similar dose‑titration principles as directed by a physician. Doses above 400 mg three times daily are not recommended. Treatment must be taken with food to reduce gastrointestinal intolerance.

Dosage form: Oral tablets: 200 mg and 400 mg (internationally sourced; the Canadian‑approved Esbriet is a 267 mg hard gelatin capsule).

Onset of action: Pirfenidone does not provide immediate symptom relief. Its anti‑fibrotic effect is cumulative; clinical trials demonstrated a significant reduction in the rate of forced vital capacity (FVC) decline over 52 weeks. Patients should not expect an improvement in cough or shortness of breath in the short term; the medication slows disease progression over months to years of continuous therapy.

Duration of action: The elimination half‑life of pirfenidone is approximately 2.4 hours. With three‑times‑daily dosing, therapeutic plasma levels are maintained. The clinical benefit persists as long as the drug is taken; lung function decline resumes upon discontinuation.

Alcohol recommendation: Alcohol consumption should be avoided during treatment with Esbriet. Alcohol can increase the risk of liver toxicity, and pirfenidone is known to be associated with elevations in hepatic transaminases. The combination may place additional strain on the liver. Patients with a history of heavy alcohol use should inform their prescriber before starting therapy.

Most common side effects: Nausea (36%), rash (30%), fatigue (25%), diarrhoea (24%), dyspepsia (18%), vomiting (13%), decreased appetite (10%), and photosensitivity reaction (10%). Elevations in liver enzymes (ALT/AST) occur in approximately 10‑15% of patients and are usually mild to moderate. Severe hepatic injury is rare. Gastrointestinal side effects are most pronounced during the first few months and can be managed with dose reduction, taking the medication with food, and symptomatic treatment. Because of the risk of photosensitivity, patients must avoid direct sunlight and use broad‑spectrum sunscreen daily.

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General Information about Esbriet (Pirfenidone)

• INN (International Nonproprietary Name): Pirfenidone
• Brand names available in Canada: Esbriet® (Hoffmann‑La Roche Limited) is the original brand‑name product, supplied as 267 mg hard gelatin capsules. Generic versions are available, including APO‑Pirfenidone (Apotex Inc.), Sandoz Pirfenidone (Sandoz Canada Inc.), and others. Internationally, pirfenidone is marketed in 200 mg and 400 mg tablet strengths under various brand names (e.g., Pirfenex®). Our pharmacy supplies internationally sourced tablets upon request.
• ATC code: L04AX05 (immunosuppressants, other immunosuppressants).
• Dosage forms and strengths: In Canada: 267 mg hard gelatin capsules. Internationally: film‑coated tablets of 200 mg and 400 mg.
• Manufacturers in Canada: Hoffmann‑La Roche Limited (Esbriet), Apotex Inc., Sandoz Canada Inc., and other generic manufacturers. International tablet formulations are manufactured by various companies and imported for personal use.
• Registration status in Canada: Approved by Health Canada. Esbriet 267 mg capsule received its Notice of Compliance on October 3, 2012. DIN: 02388606. Multiple generic formulations are currently marketed and available by prescription.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

The exact mechanism of action of pirfenidone in IPF has not been fully established, but it is known to exhibit both anti‑fibrotic and anti‑inflammatory properties in a variety of in vitro systems and animal models of fibrosis. Pirfenidone inhibits the proliferation of fibroblasts and the differentiation of fibroblasts into myofibroblasts, the key effector cells in the fibrotic process. It reduces the synthesis and deposition of collagen and other extracellular matrix proteins. At the molecular level, pirfenidone down‑regulates the production of transforming growth factor‑beta (TGF‑β), a master pro‑fibrotic cytokine, as well as tumour necrosis factor‑alpha (TNF‑α) and other inflammatory mediators. It also possesses antioxidant properties by scavenging reactive oxygen species. The net effect is a slowing of the progressive scarring and architectural distortion of the lung parenchyma that characterises IPF. Pirfenidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 0.5 to 1 hour. Food significantly reduces the rate and extent of absorption; therefore, the medication must be taken with food to minimise gastrointestinal side effects and to avoid high peak plasma concentrations. Pirfenidone is metabolised primarily by cytochrome P450 1A2 (CYP1A2), with minor contributions from other CYP isoenzymes, to the inactive metabolite 5‑carboxy‑pirfenidone. The elimination half‑life is approximately 2.4 hours. Steady‑state concentrations are achieved within 1 to 2 days of three‑times‑daily dosing.

Indications

• Treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. Esbriet slows the annual rate of decline in forced vital capacity (FVC), the primary measure of disease progression, and reduces the risk of all‑cause mortality and IPF‑related mortality over 52 weeks of treatment.
• Pirfenidone has also been studied in other fibrosing interstitial lung diseases, but its use outside of IPF is off‑label in Canada.
• Not recommended for use in patients with severe hepatic impairment or end‑stage renal disease requiring dialysis.
• Safety and efficacy have not been established in paediatric patients under 18 years of age.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: There are no adequate and well‑controlled studies of pirfenidone in pregnant women. Based on animal data, pirfenidone can cause fetal harm. Esbriet should be used during pregnancy only if the potential benefit clearly justifies the potential risk. Women of childbearing potential should use effective contraception during treatment and for at least 2 weeks after the last dose.
• Breastfeeding: It is not known whether pirfenidone is excreted in human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment.
• Paediatrics (< 18 years): Safety and efficacy have not been established. Esbriet is not indicated for paediatric use.
• Elderly: No dose adjustment is required based on age alone. However, elderly patients may have age‑related decline in hepatic or renal function and may be at greater risk for adverse effects, including hepatotoxicity and gastrointestinal intolerance.
• Hepatic impairment: Pirfenidone is contraindicated in patients with severe hepatic impairment or end‑stage liver disease. In patients with mild or moderate hepatic impairment (Child‑Pugh A or B), no dose adjustment is required, but close monitoring of liver function is necessary. Liver enzymes (ALT, AST, and bilirubin) should be measured before initiating therapy, monthly for the first 6 months, and every 3 months thereafter. In patients who develop significant elevations of aminotransferases (ALT/AST > 3 to 5 times the upper limit of normal) with or without hyperbilirubinaemia, the dose should be reduced or interrupted; treatment should be permanently discontinued if the elevation persists or is accompanied by signs or symptoms of liver injury.
• Renal impairment: No dose adjustment is required for mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance < 30 mL/min) or end‑stage renal disease requiring dialysis, pirfenidone has not been studied and is not recommended.
• Photosensitivity and Rash: Pirfenidone causes photosensitivity reactions, including severe sunburn, rash, and, rarely, Stevens‑Johnson syndrome. Patients must avoid direct sunlight and sunlamps, wear protective clothing, and use a broad‑spectrum sunscreen (SPF 50 or higher) daily throughout treatment. Rash is common (∼30%) and is usually mild to moderate; management includes dose reduction, topical corticosteroids, and temporary interruption. If the rash is severe or does not improve, permanent discontinuation should be considered.
• Gastrointestinal Adverse Reactions: Nausea, vomiting, diarrhoea, dyspepsia, and anorexia are very common. Taking the medication with food, dose reduction, and symptomatic treatment (e.g., anti‑emetics, loperamide) can help manage these effects. In cases of severe or persistent gastrointestinal symptoms, the dose may be reduced to 200 mg two or three times daily (or the equivalent), and re‑escalated as tolerated.
• Weight Loss: Unintended weight loss has been reported. Body weight should be monitored regularly, and the dose should be reduced or interrupted if significant weight loss occurs.
• Dizziness and Fatigue: Pirfenidone may cause dizziness and fatigue. Patients should be cautious when driving, operating machinery, or performing activities that require mental alertness until they know how the medication affects them.
• Allergy: Do not take Esbriet if you have a known hypersensitivity to pirfenidone or any excipient in the formulation.

Driving and alcohol

Pirfenidone may cause dizziness, fatigue, and somnolence. Patients should be cautioned about driving or operating hazardous machinery until they are reasonably certain that the medication does not adversely affect their mental alertness and motor coordination. Alcohol should be avoided during treatment. Both alcohol and pirfenidone are metabolised by the liver, and chronic or heavy alcohol consumption may increase the risk of hepatotoxicity. Alcohol may also worsen gastrointestinal side effects.

Dosage Instructions

• Standard adult dose (200 mg / 400 mg tablets): The recommended dose is 400 mg taken orally three times daily (1200 mg/day) with food. Treatment is initiated with a 3‑week titration schedule: 200 mg three times daily (600 mg/day) for week 1, 400 mg twice daily (800 mg/day) for week 2, and 400 mg three times daily (1200 mg/day) from week 3 onward. For patients weighing 40 to 50 kg, the target maintenance dose is 200 mg three times daily (600 mg/day).
• In Canada (Esbriet 267 mg capsules): The approved regimen uses the 267 mg capsule: 267 mg once daily on days 1‑7, 267 mg twice daily on days 8‑14, and 267 mg three times daily from day 15 onward. The maximum daily dose is 801 mg (three 267 mg capsules). The 200 mg and 400 mg tablet strengths may be used under the same principles of dose titration as directed by a physician.
• Dose adjustment for adverse reactions: For gastrointestinal intolerance, photosensitivity, or liver enzyme elevations, the dose may be reduced to 200 mg two or three times daily, temporarily interrupted, or permanently discontinued based on severity. If a dose is missed, it should be taken with food as soon as remembered; if it is close to the time of the next dose, the missed dose should be skipped. Do not double the dose.
• Administration: Swallow the tablet whole with a glass of water, and always take with food to reduce gastrointestinal upset. The tablet should not be crushed, chewed, or split unless scored and specifically instructed. Take doses at evenly spaced intervals throughout the day, e.g., with breakfast, lunch, and dinner.
• Missed dose: If a dose is missed, take it with food as soon as remembered on the same day. If it is close to the time of the next scheduled dose, skip the missed dose and resume the regular schedule. Do not take a double dose to make up for a missed one.
• Duration of therapy: Pirfenidone is intended for long‑term maintenance therapy. The need for continued treatment should be reassessed periodically by the prescribing physician. Discontinuation leads to a loss of treatment benefit and continued disease progression.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Nausea (36%), rash (30%), fatigue (25%), diarrhoea (24%), dyspepsia (18%), vomiting (13%), decreased appetite (10%), photosensitivity reaction (10%), and elevated liver transaminases (10‑15%).
• Common side effects (1‑10%): Headache, dizziness, insomnia, weight loss, abdominal distension, gastro‑oesophageal reflux disease, arthralgia, and taste disturbance.
• Serious adverse reactions: Hepatotoxicity (including severe liver injury, though rare), severe photosensitivity reactions, Stevens‑Johnson syndrome (very rare), and drug‑induced liver injury. Cases of angioedema have been reported in post‑marketing experience.
• Contraindications: Known hypersensitivity to pirfenidone or any excipient. History of angioedema with pirfenidone. Concomitant use of fluvoxamine (a strong CYP1A2 inhibitor). Severe hepatic impairment or end‑stage liver disease. Severe renal impairment (CrCl < 30 mL/min) or end‑stage renal disease requiring dialysis. Pregnancy and breastfeeding.

Drug Interactions

• Fluvoxamine — contraindicated: Fluvoxamine is a strong CYP1A2 inhibitor and can increase pirfenidone exposure by approximately 4‑fold. Concomitant use is contraindicated.
• Other strong CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin): These agents may increase pirfenidone levels. Use with caution; a lower dose of pirfenidone may be required.
• Moderate CYP1A2 inhibitors (e.g., mexiletine, oral contraceptives, amiodarone): May increase pirfenidone exposure. Monitor for adverse effects.
• CYP1A2 inducers (e.g., omeprazole, rifampicin, smoking): These agents may decrease pirfenidone plasma concentrations, potentially reducing therapeutic efficacy. Smoking should be avoided; an increased dose of pirfenidone may be considered in patients who smoke, although data are limited.
• Other drugs: No clinically significant interactions have been observed with pirfenidone and warfarin, digoxin, or other commonly prescribed medications. However, additive liver effects may occur with other hepatotoxic drugs; caution is advised.
• Alcohol: Avoid alcohol due to additive hepatotoxic risk.

Practical Advice

• Administration: Take each dose with food (e.g., with a meal or a substantial snack) to reduce nausea. Swallow the tablet whole with a glass of water. Adherence to the three‑times‑daily schedule is important for maintaining steady therapeutic levels. Do not stop taking the medication abruptly without consulting your doctor.
• Monitoring: Liver function tests (ALT, AST, and bilirubin) must be measured before starting treatment, monthly for the first 6 months, and every 3 months thereafter. Body weight should be monitored regularly. Skin should be examined periodically for rash or other photosensitivity reactions. Because of the risk of photosensitivity, patients should use a broad‑spectrum sunscreen with SPF 50 or higher daily, wear protective clothing, and avoid direct sun exposure and tanning beds. Any new or worsening skin reactions should be reported to the physician promptly.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep out of the reach and sight of children.
• Lifestyle: Pirfenidone works best when combined with a comprehensive management plan for IPF that includes pulmonary rehabilitation, supplemental oxygen as needed, smoking cessation, and vaccination against influenza, pneumococcal pneumonia, and COVID‑19. Avoid smoking, as it reduces drug exposure and independently accelerates lung function decline. Limit or avoid alcohol. Rise slowly from sitting or lying down to minimise dizziness.
• Missed dose: If you miss a dose, take it with food as soon as you remember on the same day. If it is close to the time of your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
• When to seek medical review: Contact your doctor immediately if you develop signs of liver injury (jaundice, dark urine, right upper abdominal pain, unexplained fatigue, loss of appetite), severe or persistent gastrointestinal symptoms leading to dehydration or significant weight loss, a widespread or severe skin rash, or signs of a serious allergic reaction (swelling of the face, lips, or throat, difficulty breathing). Seek emergency care for any of these severe symptoms.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Nintedanib (Ofev®): The only other oral anti‑fibrotic agent approved by Health Canada for IPF. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in fibrosis. It has a different side‑effect profile, most notably diarrhoea (62%), nausea, and liver enzyme elevations. Both nintedanib and pirfenidone are considered first‑line anti‑fibrotic options for IPF. The combination of the two is not routinely funded in Canada, though studies have shown acceptable safety.
• Nerandomilast: A phosphodiesterase 4B (PDE4B) inhibitor that was approved by the FDA in 2025 for IPF and has shown better gastrointestinal tolerability. It is not yet available in Canada but represents a potential future alternative.
• Supportive therapies: Supplemental oxygen therapy for patients with resting or exertional hypoxaemia, pulmonary rehabilitation, and symptomatic management of cough and dyspnoea are essential components of IPF care.
• Lung transplantation: The only curative intervention for IPF. It should be considered early in appropriate surgical candidates, as disease progression can be rapid.

Clinical Efficacy

The efficacy of pirfenidone for the treatment of IPF was demonstrated in four randomised, double‑blind, placebo‑controlled Phase III trials (PIPF‑004, PIPF‑006, CAPACITY, and ASCEND). In the pooled analysis of these studies, pirfenidone significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo. In the ASCEND trial, the primary endpoint of change in FVC at week 52 was met, with a mean absolute difference in FVC decline of 132.5 mL between the pirfenidone and placebo groups (p < 0.001). Pirfenidone also reduced the risk of all‑cause mortality by 48% (hazard ratio 0.52, p = 0.01) and IPF‑related mortality by 68% (hazard ratio 0.32, p = 0.006) in the pooled analysis at 52 weeks. The treatment effect was consistent across all pre‑specified subgroups, including age, sex, race, baseline FVC, and concomitant medication use. The long‑term extension study (RECAP) demonstrated that the benefit on FVC decline persisted over a period of up to 9 years of continuous treatment. Pirfenidone is recommended by the Canadian Thoracic Society and international guidelines as a first‑line anti‑fibrotic therapy for patients with IPF, particularly those with mild to moderate disease (FVC > 50% predicted and DLCO > 35% predicted). The medication is generally well tolerated when dose titration and supportive measures are employed, with the most common adverse events being gastrointestinal and skin‑related.

Important:

Esbriet (pirfenidone) is a prescription medication that should be used only under the supervision of a qualified healthcare professional experienced in the diagnosis and management of idiopathic pulmonary fibrosis. It can cause serious liver injury; liver function tests must be measured before starting treatment, monthly for the first 6 months, and every 3 months thereafter. Pirfenidone causes photosensitivity reactions; patients must avoid direct sunlight and sunlamps, wear protective clothing, and use a broad‑spectrum sunscreen (SPF 50 or higher) daily throughout treatment. Severe skin reactions, including Stevens‑Johnson syndrome, have been reported rarely. This medication should not be taken with fluvoxamine. Do not stop taking Esbriet abruptly, as the benefit on lung function will be lost. If you experience signs of liver injury (jaundice, dark urine, severe abdominal pain, unexplained fatigue), a severe skin rash, or severe gastrointestinal symptoms, contact your doctor immediately. Women of childbearing potential must use effective contraception during treatment and for at least 2 weeks after the last dose, as pirfenidone can cause fetal harm. Avoid alcohol and smoking. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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