Generic Ofev ( Nintedanib )

Buy Generic Ofev (Nintedanib) without prescription in Canada

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Ofev (nintedanib, as nintedanib esilate) is an oral protein kinase inhibitor used to treat adults with idiopathic pulmonary fibrosis (IPF), to slow the rate of decline in pulmonary function in patients with systemic sclerosis‑associated interstitial lung disease (SSc‑ILD), and for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. It works by inhibiting multiple receptor tyrosine kinases—including platelet‑derived growth factor receptors (PDGFR) α and β, fibroblast growth factor receptors (FGFR) 1‑3, and vascular endothelial growth factor receptors (VEGFR) 1‑3—that are involved in the fibrotic tissue remodelling underlying these progressive and life‑threatening lung diseases. By blocking these signalling cascades, nintedanib slows the relentless scarring of lung tissue, thereby reducing the rate of decline in forced vital capacity (FVC) and preserving lung function.

Usual adult dose: The recommended dose of Ofev is 150 mg taken orally twice daily, approximately 12 hours apart and taken with food. The 100 mg twice‑daily dose is used for patients who do not tolerate the 150 mg dose, for those with mild hepatic impairment (Child‑Pugh A), or for patients whose liver transaminase (AST or ALT) levels rise to greater than 3 to less than 5 times the upper limit of normal without signs of liver damage. In such cases, therapy may be interrupted or the dose reduced to 100 mg twice daily; once liver enzymes return to baseline, the dose may be re‑escalated to 150 mg twice daily if tolerated. Treatment should be discontinued in patients who cannot tolerate 100 mg twice daily. The maximum daily dose is 300 mg.

Dosage form: Soft gelatin oral capsules: 100 mg and 150 mg (as nintedanib esilate).

Onset of action: Nintedanib does not provide immediate symptomatic relief. Its anti‑fibrotic effect is progressive; in the pivotal INPULSIS trials, a significant difference in the annual rate of decline in FVC between nintedanib and placebo was observed over the 52‑week treatment period. Patients should not expect noticeable improvement in shortness of breath and cough in the short term; the medication works by slowing disease progression over months to years of continuous therapy.

Duration of action: The elimination half‑life of nintedanib is approximately 10 to 15 hours, supporting twice‑daily dosing. Steady‑state plasma concentrations are achieved within one week of regular administration. The therapeutic effect is maintained only with continuous therapy; disease progression resumes upon discontinuation.

Alcohol recommendation: Alcohol consumption does not have a known direct pharmacokinetic interaction with nintedanib, but alcohol should be limited or avoided during treatment. Excessive alcohol intake can independently contribute to liver enzyme elevations and may compound the hepatotoxic potential of nintedanib. Patients should be counselled to minimise alcohol consumption and to report any signs of liver injury promptly.

Most common side effects: Diarrhoea (62.4%), nausea (24.5%), abdominal pain (15.2%), vomiting (11.7%), decreased appetite (10.7%), liver enzyme elevation (13.6%), headache (7.8%), weight decreased (10.1%), and hypertension (5.0%). Diarrhoea is the most frequently reported adverse reaction; it can be persistent and severe, typically occurring within the first 3 months of therapy, and may require dose reduction, treatment interruption, and symptomatic management with loperamide or other anti‑diarrhoeal agents. Less common but serious adverse effects include drug‑induced liver injury, arterial thromboembolic events, bleeding events, gastrointestinal perforation, and nephrotic‑range proteinuria.

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General Information about Ofev (Nintedanib)

• INN (International Nonproprietary Name): Nintedanib (as nintedanib esilate).
• Brand names available in Canada: Ofev® (Boehringer Ingelheim (Canada) Ltd.). The same active ingredient is marketed internationally under the brand name Vargatef® for certain oncology indications. No generic versions are currently marketed in Canada.
• ATC code: L01EX09 (protein kinase inhibitors; antineoplastic agents).
• Dosage forms and strengths: Soft gelatin capsules: 100 mg and 150 mg of nintedanib (as nintedanib esilate). The capsules contain soya lecithin and are contraindicated in patients allergic to peanut or soya.
• Manufacturers in Canada: Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, ON L7L 5H4.
• Registration status in Canada: Approved by Health Canada. Notice of Compliance first issued June 25, 2015. DIN: 02443075 (100 mg), 02443074 (150 mg). Marketed.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. Available only with a valid prescription from a licensed Canadian healthcare professional.

Mechanism of Action and Pharmacology

Nintedanib is a small‑molecule intracellular inhibitor of multiple receptor tyrosine kinases (RTKs) and non‑receptor tyrosine kinases (nRTKs). It binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases, thereby blocking the intracellular signalling cascades that have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodelling in interstitial lung diseases. Specifically, nintedanib potently inhibits platelet‑derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1‑3, vascular endothelial growth factor receptor (VEGFR) 1‑3, colony‑stimulating factor 1 receptor (CSF1R), and Fms‑like tyrosine kinase 3 (FLT3). It also inhibits Lck, Lyn, and Src family kinases. In in vitro studies using human cells, nintedanib inhibited the release of pro‑fibrotic mediators from peripheral blood monocytic cells and macrophage polarisation to alternatively activated macrophages, the proliferation and migration of fibroblasts, transformation to the active myofibroblast phenotype, and secretion of extracellular matrix. In animal models of IPF, SSc/SSc‑ILD, rheumatoid arthritis‑associated ILD, and other organ fibrosis, nintedanib demonstrated anti‑inflammatory and anti‑fibrotic effects in the lung, skin, heart, kidney, and liver. Nintedanib also reduced dermal microvascular endothelial cell apoptosis and attenuated pulmonary vascular remodelling by reducing the proliferation of vascular smooth muscle cells, the thickness of pulmonary vessel walls, and the percentage of occluded pulmonary vessels.

Following oral administration, nintedanib is absorbed with peak plasma concentrations reached approximately 2 to 4 hours after dosing under fed conditions. The absolute oral bioavailability is approximately 4.7%, reflecting extensive first‑pass metabolism. A high‑fat, high‑calorie meal increases the exposure by approximately 20% compared with administration under fasted conditions; consequently, Ofev should always be taken with food to maximise absorption. Nintedanib is a substrate of the efflux transporter P‑glycoprotein (P‑gp) and, to a minor extent, of cytochrome P450 3A4 (CYP3A4). The major metabolic pathway is hydrolytic cleavage by esterases to the free acid moiety BIBF 1202, which is subsequently glucuronidated by UGT enzymes (UGT1A1, UGT1A7, UGT1A8, and UGT1A10) to nintedanib acyl‑glucuronide. The elimination half‑life is approximately 10 to 15 hours. Nintedanib is excreted predominantly via the faecal/biliary route (greater than 90%), with a small contribution (less than 1%) from renal excretion. Plasma protein binding is high (97.8%), mainly to albumin. The pharmacokinetics of nintedanib are not significantly altered by age, body weight, or race, although smokers have approximately 20% lower steady‑state trough concentrations compared with non‑smokers; the clinical significance of this finding is unknown.

Indications

• Idiopathic Pulmonary Fibrosis (IPF): For the treatment of adults with idiopathic pulmonary fibrosis. Nintedanib slows the annual rate of decline in forced vital capacity (FVC), the primary measure of disease progression, by approximately 50% compared with placebo.
• Systemic Sclerosis‑Associated Interstitial Lung Disease (SSc‑ILD): To slow the rate of decline in pulmonary function in adult patients with systemic sclerosis‑associated interstitial lung disease.
• Other Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype (PF‑ILD): For the treatment of adults with other chronic fibrosing interstitial lung diseases with a progressive phenotype, irrespective of the underlying clinical diagnosis.
• Ofev is not indicated for the treatment of acute exacerbations of IPF or ILD.
• Safety and efficacy have not been established in paediatric patients under 18 years of age; Ofev should not be used in this population.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Ofev is contraindicated during pregnancy. Based on findings from animal studies and its mechanism of action, nintedanib can cause fetal harm, including embryofetal lethality and teratogenic effects, when administered to a pregnant woman. A pregnancy test should be performed in females of reproductive potential before initiating treatment and periodically during therapy. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. If pregnancy occurs during therapy, the patient must be informed of the potential hazard to the fetus.
• Breastfeeding: It is not known whether nintedanib is excreted in human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment with Ofev.
• Paediatrics (< 18 years): The safety and efficacy of Ofev in paediatric patients have not been studied in clinical trials; therefore, Ofev should not be used in patients under 18 years of age.
• Elderly (> 65 years): No dose adjustment is necessary in patients 65 years and older. In clinical trials, no overall differences in safety or efficacy were observed between elderly and younger patients.
• Hepatic impairment: In patients with mild hepatic impairment (Child‑Pugh A), the recommended dose of Ofev is 100 mg twice daily. Ofev is not recommended in patients with moderate (Child‑Pugh B) or severe (Child‑Pugh C) hepatic impairment, as safety and efficacy have not been studied in these populations.
• Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance 30 to 90 mL/min). The safety and efficacy of Ofev have not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or end‑stage renal disease on dialysis.
• Drug‑Induced Liver Injury (DILI): Cases of drug‑induced liver injury, including severe liver injury with fatal outcome, have been reported in patients treated with nintedanib. Hepatic transaminase and bilirubin levels should be measured before initiation of treatment, monthly for the first 3 months, and periodically thereafter (e.g., at each patient visit) or as clinically indicated. Patients with a low body weight (< 65 kg), Asian patients, and female patients may have a higher risk of elevations in liver enzymes. Nintedanib should be permanently discontinued in patients with AST or ALT elevations greater than 5 times the upper limit of normal (ULN) or greater than 3 times ULN with signs or symptoms of liver injury.
• Gastrointestinal Disorders: Diarrhoea, nausea, and vomiting are the most common adverse reactions and can be severe. Diarrhoea may lead to dehydration and electrolyte disturbances. Management may include symptomatic treatment (e.g., loperamide), dose reduction, treatment interruption, or permanent discontinuation. Diarrhoea occurred in 62.4% of patients in clinical trials and was severe in approximately 3% of patients.
• Arterial Thromboembolic Events: Myocardial infarction and stroke have been reported in patients taking nintedanib. Ofev should be used with caution in patients with known cardiovascular disease, and treatment should be interrupted in patients who develop signs or symptoms of acute myocardial ischemia.
• Bleeding Risk: Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding, including fatal bleeding events. Patients with a known bleeding diathesis or those on full‑dose anticoagulation should be monitored closely for bleeding, and anticoagulation treatment should be adjusted as necessary.
• Gastrointestinal Perforation: Cases of gastrointestinal perforation have been reported in patients taking nintedanib, some of which were fatal. Ofev should be used with caution in patients with a history of recent abdominal surgery, and treatment should be permanently discontinued in patients who develop gastrointestinal perforation.
• Proteinuria: Nintedanib may increase the risk of proteinuria. Proteinuria should be monitored by urine dipstick at regular intervals during therapy. Treatment should be interrupted or dose‑reduced in patients who develop new or worsening proteinuria.
• Smoking: Smoking has been shown to decrease plasma concentrations of nintedanib by approximately 20%. Patients should be encouraged to stop smoking before and during treatment with Ofev, and to avoid smoking throughout therapy.
• Allergy: Do not take Ofev if you have a known hypersensitivity to nintedanib, peanut, soya, or any other excipient in the capsule formulation (including soya lecithin).

Driving and alcohol

Ofev may cause dizziness, fatigue, and headache in some patients. Patients should be cautious when driving, operating machinery, or engaging in activities that require mental alertness until they know how the medication affects them. Alcohol consumption should be limited or avoided during treatment with Ofev. Although no direct pharmacokinetic interaction between alcohol and nintedanib has been identified, alcohol is a known hepatotoxin and may increase the risk of liver enzyme elevations when combined with nintedanib. Patients should minimise alcohol intake and report any signs of liver injury promptly.

Dosage Instructions

• Standard dosing (adults): The recommended dose of Ofev is 150 mg taken orally twice daily, approximately 12 hours apart, with food. The capsules must be swallowed whole with liquid and must not be chewed because of a bitter taste. The capsules should not be opened or crushed. If contact with the capsule contents occurs, wash hands immediately and thoroughly.
• Patients with mild hepatic impairment (Child‑Pugh A): The recommended dose is 100 mg taken orally twice daily, approximately 12 hours apart, taken with food.
• Dose adjustment for adverse reactions: In addition to symptomatic treatment, the management of adverse reactions may include dose reduction to 100 mg twice daily and temporary treatment interruption until the specific adverse reaction resolves to levels that allow continuation of therapy. Treatment may be resumed at 150 mg twice daily or 100 mg twice daily. If a patient cannot tolerate 100 mg twice daily, treatment should be permanently discontinued.
• Dose adjustment for liver enzyme elevations: For AST or ALT elevations between 3 and 5 times the upper limit of normal (ULN) without signs of liver damage, treatment should be interrupted or the dose reduced to 100 mg twice daily. Once liver enzymes have returned to baseline, treatment may be re‑escalated to 150 mg twice daily if tolerated. Treatment should be permanently discontinued for AST or ALT elevations greater than 5 times ULN or greater than 3 times ULN with signs or symptoms of liver injury.
• Administration: Take Ofev capsules with a full glass of water, with food. Swallow the capsule whole; do not chew, crush, or open. The bitter‑tasting contents of the capsule can cause irritation if they come into contact with the skin or mucous membranes. The medication should be taken at approximately the same times each day, spacing doses 12 hours apart.
• Missed dose: If a dose is missed, the next dose should be taken at the next scheduled time. Patients should not make up for a missed dose by taking an extra dose. Do not exceed the maximum daily dose of 300 mg.
• Duration of therapy: Ofev is a long‑term, continuous maintenance therapy for chronic, progressive lung diseases. Treatment should be continued as long as the patient derives clinical benefit and tolerates the therapy. The need for continued treatment should be re‑evaluated periodically by the prescribing physician.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Diarrhoea (62.4%), nausea (24.5%), abdominal pain (15.2%), vomiting (11.7%), decreased appetite (10.7%), liver enzyme elevation (13.6%), and weight decreased (10.1%). Diarrhoea is the most frequently reported adverse reaction, typically occurring within the first 3 months of therapy; it may require dose reduction, treatment interruption, and symptomatic management with loperamide or other anti‑diarrhoeal agents.
• Common side effects (1‑10%): Headache (7.8%), hypertension (5.0%), dyspepsia, constipation, flatulence, fatigue, and dizziness.
• Serious adverse reactions: Drug‑induced liver injury (including severe liver injury with fatal outcome), arterial thromboembolic events (myocardial infarction and stroke), haemorrhage (including fatal bleeding events), gastrointestinal perforation (some fatal), nephrotic‑range proteinuria, pancreatitis, and thrombocytopenia. Non‑serious and serious bleeding events, some of which were fatal, have been reported in post‑marketing surveillance.
• Post‑marketing experience: Additional adverse reactions identified include pancreatitis, drug‑induced liver injury, thrombocytopenia, pruritus, rash, posterior reversible encephalopathy syndrome (PRES), and proteinuria.
• Contraindications: Hypersensitivity to nintedanib or to any excipient in the formulation, including peanut or soya. Pregnancy. Breastfeeding is not recommended. Moderate or severe hepatic impairment (Child‑Pugh B or C). Concomitant use with strong P‑gp and CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort) should be avoided.

Drug Interactions

• P‑glycoprotein (P‑gp) and CYP3A4 inhibitors — increased nintedanib exposure: Nintedanib is a substrate of the efflux transporter P‑gp and, to a minor extent, of CYP3A4. Co‑administration with ketoconazole, a dual P‑gp and CYP3A4 inhibitor, increased nintedanib exposure by approximately 60%. Concomitant use of P‑gp and CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole, cyclosporine) with Ofev may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of Ofev; management of adverse reactions may require interruption, dose reduction, or discontinuation.
• P‑gp and CYP3A4 inducers — decreased nintedanib exposure (avoid concomitant use): Co‑administration with rifampicin, a dual P‑gp and CYP3A4 inducer, decreased nintedanib exposure by approximately 50% at steady state. Concomitant use of P‑gp and CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort) with Ofev should be avoided, as these drugs may significantly decrease exposure to nintedanib and reduce therapeutic efficacy.
• Anticoagulants and antiplatelet agents — increased bleeding risk: Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding. Patients receiving full‑dose anticoagulation therapy (e.g., warfarin, heparin, direct oral anticoagulants) or antiplatelet agents should be monitored closely for bleeding, and anticoagulation treatment should be adjusted as necessary.
• Pirfenidone — no clinically significant interaction: In a multiple‑dose study, co‑administration of nintedanib with pirfenidone did not alter the exposure of either agent. No dose adjustment is necessary during concomitant administration. However, the combination of nintedanib and pirfenidone is not funded in some Canadian provinces.
• Bosentan — no clinically significant interaction: Co‑administration of nintedanib with bosentan did not alter the pharmacokinetics of nintedanib. No dose adjustment is required.
• Oral hormonal contraceptives — no clinically significant interaction: Nintedanib does not relevantly affect the plasma exposure of oral contraceptives containing ethinylestradiol and levonorgestrel in patients with SSc‑ILD. No dose adjustment of the oral contraceptive is required.
• Alcohol and food: Alcohol should be limited or avoided due to additive hepatotoxic potential. Nintedanib must be taken with food to optimise absorption; a high‑fat, high‑calorie meal increases exposure by approximately 20% compared with fasted conditions. Grapefruit juice may inhibit CYP3A4 and should be consumed in moderation.

Practical Advice

• Administration: Take Ofev capsules exactly as prescribed, twice daily, approximately 12 hours apart, with a full glass of water and always with food. Swallow capsules whole; do not chew, crush, or open them because of the bitter taste. If you or a caregiver accidentally touches the contents of a broken capsule, wash the skin thoroughly with soap and water immediately. Rinse eyes with water if the powder comes into contact with them. Adhere strictly to the twice‑daily schedule; do not take more than 300 mg in one day.
• Monitoring: Liver function tests (ALT, AST, and bilirubin) must be performed before starting Ofev, monthly for the first 3 months, and periodically thereafter (e.g., at each clinic visit). Blood pressure should be monitored regularly. Urine dipstick for protein should be checked at regular intervals during therapy. Pregnancy testing should be conducted before initiation and periodically during treatment in women of childbearing potential. Patients should report new or worsening symptoms promptly, particularly severe or persistent diarrhoea, right upper abdominal pain, jaundice, dark urine, unexplained bruising or bleeding, chest pain, and signs of stroke.
• Storage: Store at room temperature (20 °C to 25 °C); excursions are permitted to 15 °C to 30 °C. Protect from exposure to high humidity and avoid placing in damp areas such as bathrooms. Keep capsules in the original blister packaging until use to protect from moisture. Keep out of the reach and sight of children.
• Lifestyle: Take Ofev with food each time to improve absorption and reduce the likelihood of gastrointestinal upset. If diarrhoea occurs, stay well hydrated and contact your healthcare provider promptly for guidance on symptomatic management, which may include loperamide as recommended. Do not smoke while taking Ofev, as smoking reduces drug exposure and may diminish therapeutic efficacy. Avoid excessive alcohol intake. Inform all healthcare professionals—including dentists and pharmacists—that you are taking nintedanib, particularly if you require any surgical procedure or anticoagulant therapy.
• Missed dose: If you miss a dose, skip it entirely and take the next scheduled dose at your usual time. Do not take two capsules at once to make up for the missed one.
• When to seek medical review: Contact your doctor immediately if you develop persistent severe diarrhoea, nausea, or vomiting leading to dehydration; signs of liver injury such as yellowing of the skin or eyes, dark or brown (tea‑coloured) urine, pain in the upper right side of the abdomen, unusual tiredness, or loss of appetite; signs of bleeding such as easy bruising, black or bloody stools, coughing up blood, or any wound that will not heal; chest pain or pressure, pain spreading to the jaw or arm, shortness of breath, sudden sweating; sudden numbness or weakness (especially on one side of the body), slurred speech, or problems with vision or balance; or severe stomach pain that does not go away or blood in the stools. Seek emergency medical attention immediately for any of the above serious symptoms or for signs of a severe allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.
• Disposal: Return unused or expired capsules to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Pirfenidone (Esbriet®): The only other oral anti‑fibrotic medication approved by Health Canada for the treatment of IPF. Pirfenidone has a different mechanism of action (it is thought to inhibit TGF‑β and other pro‑fibrotic cytokines), and its side‑effect profile includes photosensitivity, nausea, rash, and fatigue. The 2015 INJOURNEY study demonstrated that the combination of nintedanib and add‑on pirfenidone had an acceptable safety profile similar to that of each individual component. However, combination therapy is not routinely funded in many Canadian provinces, and the two drugs are generally used sequentially rather than in combination. Both pirfenidone and nintedanib are considered first‑line anti‑fibrotic options for IPF.
• Nerandomilast: A phosphodiesterase 4B (PDE4B) inhibitor that was approved by the FDA in October 2025 for the treatment of IPF. It represents the first new treatment option for IPF in more than a decade and has demonstrated better gastrointestinal tolerability compared with nintedanib and pirfenidone in the FIBRONEER trials. Nerandomilast is not yet approved or marketed in Canada but may become available in the future.
• Supportive and non‑pharmacological therapies: Supplemental oxygen therapy for patients with resting hypoxaemia; pulmonary rehabilitation to improve exercise tolerance and quality of life; vaccination against influenza, pneumococcal pneumonia, and COVID‑19; smoking cessation; and management of comorbidities (gastro‑oesophageal reflux disease, pulmonary hypertension, obstructive sleep apnoea). For patients with advanced disease who are appropriate candidates, lung transplantation remains the only curative intervention.
• Symptomatic management: Cough suppressants, opioids for dyspnoea in the palliative setting, and treatment of anxiety and depression associated with chronic breathlessness are important supportive measures.

Clinical Efficacy

The clinical efficacy of nintedanib for the treatment of IPF was demonstrated in two Phase III, randomised, double‑blind, placebo‑controlled studies with identical design: INPULSIS‑1 and INPULSIS‑2. A total of 1,066 patients with IPF and a baseline forced vital capacity (FVC) of at least 50% of predicted were randomised 3:2 to receive nintedanib 150 mg twice daily or placebo for 52 weeks. The primary endpoint was the annual rate of decline in FVC. In INPULSIS‑1, the adjusted annual rate of decline in FVC was −114.7 mL/year in the nintedanib group versus −239.9 mL/year in the placebo group (difference: 125.3 mL/year; 95% CI: 77.7 to 172.8; p < 0.001). In INPULSIS‑2, the adjusted annual rate of decline was −113.6 mL/year for nintedanib versus −207.3 mL/year for placebo (difference: 93.7 mL/year; 95% CI: 44.8 to 142.7; p < 0.001). In the pooled analysis, nintedanib reduced the annual rate of FVC decline by approximately 50% compared with placebo (−113.6 mL vs. −223.5 mL/year; difference: 109.9 mL/year; 95% CI: 75.9 to 144.0). The treatment effect was consistent across all pre‑specified subgroups, including age, sex, race, baseline FVC, and concomitant medication use.

The key secondary endpoint of time to first acute IPF exacerbation was significantly prolonged in the nintedanib group in INPULSIS‑2 (hazard ratio 0.38; 95% CI: 0.19 to 0.77; p = 0.005) but not in INPULSIS‑1 (HR 1.15; 95% CI: 0.54 to 2.42; p = 0.67). The pooled analysis showed a non‑significant reduction in the risk of acute exacerbations. For the SSc‑ILD population, the SENSCIS trial randomised 576 patients to nintedanib 150 mg twice daily or placebo for at least 52 weeks. Nintedanib significantly reduced the annual rate of FVC decline by 44% compared with placebo (−52.4 mL vs. −93.3 mL/year; difference: 41.0 mL/year; 95% CI: 2.9 to 79.0; p = 0.04).

For other chronic fibrosing ILDs with a progressive phenotype, the INBUILD trial randomised 663 patients to nintedanib 150 mg twice daily or placebo. The adjusted annual rate of decline in FVC over 52 weeks was −80.8 mL/year in the nintedanib group versus −187.8 mL/year in the placebo group (difference: 107.0 mL/year; 95% CI: 65.4 to 148.5; p < 0.001). Long‑term extension data from study 1199.33 in patients with IPF demonstrated that the effect of nintedanib on slowing FVC decline was durable over a period of up to 84 months of treatment, with no new safety signals.

In Canada, Ofev is reimbursed under most provincial drug benefit programs for the approved indications. The Ontario Exceptional Access Program and similar programs in other provinces require a confirmed diagnosis by a respirologist with a high‑resolution CT scan and evidence of progressive fibrosis. Treatment is generally limited to patients with mild to moderate disease (FVC of at least 45–50% of predicted at initiation), and combination use with pirfenidone is not funded. Ofev remains one of the two first‑line anti‑fibrotic therapies for IPF in Canadian clinical practice guidelines, alongside pirfenidone, and is now also standard of care for progressive fibrosing ILDs regardless of the underlying aetiology.

Important:

Ofev (nintedanib) is a prescription medication that should be used only under the supervision of a qualified healthcare professional experienced in the diagnosis and management of interstitial lung diseases. It can cause serious, life‑threatening adverse effects, including drug‑induced liver injury (some cases fatal), arterial thromboembolic events, severe gastrointestinal perforation, and haemorrhage. Liver function tests must be performed before starting treatment, monthly for the first 3 months, and at regular intervals thereafter. Diarrhoea is very common and can be severe; patients should report persistent or severe diarrhoea to their physician promptly, and management may require dose reduction, treatment interruption, or permanent discontinuation. Ofev is contraindicated during pregnancy and must not be taken by pregnant women; women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Do not smoke while taking Ofev, as smoking reduces drug exposure and may diminish therapeutic efficacy. Take each dose with food and swallow the capsules whole; do not chew, crush, or open them. If you experience signs of a serious allergic reaction, severe stomach pain, chest pain, sudden shortness of breath, signs of stroke, or any unusual bleeding or bruising, stop taking Ofev and seek emergency medical attention immediately. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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