Pirfenidone axunio 267 mg

What Is Pirfenidone axunio and What Is It Used For?

Pirfenidone axunio (pirfenidone 267 mg) is a generic antifibrotic medicine prescribed to treat idiopathic pulmonary fibrosis (IPF) in adults. It helps slow the scarring of lung tissue, preserves forced vital capacity (FVC), and slows disease progression compared with no treatment.

Pirfenidone axunio is manufactured and marketed by axunio Pharma GmbH, a German pharmaceutical company that specialises in high-quality generic medicines. It contains the active substance pirfenidone, which belongs to a class of medicines called antifibrotic agents. The European Medicines Agency (EMA) first approved pirfenidone under the brand name Esbriet in 2011, and the U.S. Food and Drug Administration (FDA) followed in 2014. Following patent expiry, generic versions – including Pirfenidone axunio – have become available across European markets, substantially improving access to this life-prolonging therapy.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and ultimately fatal lung disease in which the delicate tissue of the lungs becomes progressively thickened, stiff, and scarred. The word "idiopathic" signals that, despite extensive investigation, no specific cause can be identified in most patients. As fibrosis advances, the lungs lose elasticity, gas exchange deteriorates, and patients experience worsening breathlessness, a dry persistent cough, reduced exercise tolerance, and fatigue. IPF predominantly affects adults over the age of 50 and is more common in men and in current or former smokers. Median survival without antifibrotic therapy has historically been estimated at 3–5 years from diagnosis.

While pirfenidone does not cure IPF or reverse existing lung damage, pivotal randomised controlled trials have demonstrated that it significantly slows the rate of decline in lung function. The landmark ASCEND trial (King TE Jr et al., N Engl J Med 2014) and the earlier CAPACITY trials (Noble PW et al., Lancet 2011) showed that pirfenidone reduces the decline in forced vital capacity (FVC) by roughly half compared with placebo, and pooled analyses suggest improvements in progression-free survival and, in some analyses, overall mortality. A 2017 Cochrane systematic review concluded that pirfenidone probably reduces disease progression over 12 months.

The exact mechanism by which pirfenidone works is not fully understood, but preclinical and clinical research suggests three complementary properties. It is anti-fibrotic, reducing the proliferation of fibroblasts and downregulating transforming growth factor-beta (TGF-β), a key driver of fibrosis. It is anti-inflammatory, inhibiting the release of pro-inflammatory cytokines such as tumour necrosis factor-alpha (TNF-α). And it has antioxidant activity, reducing oxidative damage caused by reactive oxygen species. Together, these actions interfere with the pathological scarring cascade that characterises IPF.

What Should You Know Before Taking Pirfenidone axunio?

Before starting Pirfenidone axunio, your doctor must evaluate your liver and kidney function, review all current medicines and supplements, and counsel you on strict sun protection. Several medical conditions and drug interactions can make this medicine unsafe or require dose adjustments.

It is essential that your prescribing physician has a complete picture of your medical history, all current medicines (including over-the-counter products and herbal supplements), and your lifestyle before initiating treatment with Pirfenidone axunio. Certain conditions absolutely prevent the use of this medicine, while others require careful monitoring and possible dose reductions. Tell your doctor about any prior allergic reactions, liver or kidney disease, and whether you smoke, as smoking significantly alters pirfenidone metabolism.

Contraindications

You must not take Pirfenidone axunio in any of the following situations:

• Hypersensitivity to pirfenidone or to any of the excipients in the tablet (microcrystalline cellulose, croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate, and film-coating components)
• History of angioedema with pirfenidone – symptoms include swelling of the face, lips, eyelids, tongue, and/or throat, which may be associated with difficulty breathing or wheezing and can be life-threatening
• Concurrent use of fluvoxamine – this antidepressant (used in depression and obsessive-compulsive disorder) is a potent CYP1A2 inhibitor that dramatically increases pirfenidone blood levels, creating a risk of serious toxicity; it is absolutely contraindicated during pirfenidone treatment
• Severe hepatic impairment or end-stage liver disease – pirfenidone is extensively metabolised in the liver, and impaired function can lead to dangerous drug accumulation
• Severe renal impairment (creatinine clearance <30 mL/min) or end-stage kidney disease requiring dialysis – impaired renal clearance affects drug elimination and safety

Warnings and Precautions

Discuss the following issues with your doctor before starting and throughout treatment with Pirfenidone axunio. Several of these warnings relate to rare but potentially serious adverse events that require prompt recognition.

Photosensitivity reactions: Pirfenidone significantly increases your skin's sensitivity to ultraviolet (UV) radiation from both sunlight and artificial sources. You may develop severe sunburn, blistering, painful redness, or lasting hyperpigmentation even after brief exposure. From the first dose, you should use a broad-spectrum sunscreen of SPF 50 or higher on all exposed skin every day (reapplied every 2 hours outdoors), wear protective clothing that covers the arms, legs, and head, and avoid direct sunlight during the middle of the day. Do not use sunlamps or tanning beds. Avoid concurrent use of other photosensitising medicines such as tetracycline antibiotics (doxycycline, minocycline), fluoroquinolones, and certain diuretics unless the benefit clearly outweighs the risk.

Hepatotoxicity: Pirfenidone can cause elevations in hepatic transaminases (ALT and AST) and, rarely, serious liver injury, including fatal cases. Liver function tests (ALT, AST, bilirubin) are required before starting treatment, monthly during the first six months of therapy, and every three months thereafter for the duration of treatment. If transaminase levels rise above three times the upper limit of normal (3×ULN), your prescriber will consider dose reduction or interruption, with more frequent monitoring until normalisation. Elevations greater than 5×ULN generally require permanent discontinuation.

Severe cutaneous adverse reactions: Rare but potentially fatal skin reactions have been reported with pirfenidone, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Seek emergency care and stop taking Pirfenidone axunio if you develop widespread skin rash, painful blistering, skin peeling, mucosal ulcers (mouth, eyes, genitals), or a rash accompanied by fever and swollen lymph nodes.

Renal impairment: Pirfenidone should be used with caution in patients with mild or moderate renal impairment (creatinine clearance 30–89 mL/min). More frequent monitoring for side effects may be required, and dose adjustment should be considered on an individual basis. Pirfenidone is not recommended in severe renal impairment or in patients requiring dialysis, as relevant clinical data are lacking.

Smoking and pirfenidone: Cigarette smoking is a potent inducer of the CYP1A2 enzyme that metabolises pirfenidone. Smoking can substantially reduce pirfenidone blood levels, potentially lowering its efficacy. Patients are strongly advised to stop smoking before and during treatment. Smoking cessation also has independent benefits on IPF progression and overall pulmonary health.

Dizziness, somnolence, and fatigue: Pirfenidone can cause dizziness, drowsiness, and significant tiredness, particularly during the early weeks of treatment. Exercise caution when driving, operating machinery, or performing any activities that require alertness and coordination. Alcohol may intensify these effects and should be limited.

Weight loss and malnutrition risk: Pirfenidone commonly causes decreased appetite, nausea, and measurable weight loss. Regular monitoring of weight and nutritional status is advisable, especially in older, frail, or already underweight patients. A dietitian referral may be helpful when weight loss exceeds 5% of baseline.

Pregnancy and Breastfeeding

As a precautionary measure, it is advisable to avoid Pirfenidone axunio if you are pregnant, planning to become pregnant, or think you may be pregnant, as the risks to the unborn child have not been adequately characterised. There are no adequate and well-controlled clinical studies of pirfenidone in pregnant women. Animal studies have shown effects at high doses but have not provided sufficient data to fully characterise reproductive risks in humans. Women of childbearing potential should use effective contraception during treatment.

It is not known whether pirfenidone or its metabolites pass into human breast milk. Limited animal data suggest excretion is possible. If you are breastfeeding or planning to breastfeed, discuss the risks and benefits thoroughly with your specialist before continuing Pirfenidone axunio. In most cases, a decision will be made either to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of the medicine to the mother.

Children and Adolescents

Pirfenidone axunio should not be given to children and adolescents under 18 years of age. The safety and efficacy of pirfenidone have not been established in paediatric patients, and IPF is almost exclusively a disease of older adults. Paediatric interstitial lung disease has a different aetiology and pathogenesis and requires specialist evaluation.

Elderly Patients and Comorbidities

Pirfenidone can be used in elderly patients without routine dose adjustment based on age alone. However, older patients often have reduced hepatic or renal reserve, polypharmacy, and greater sensitivity to gastrointestinal and neurological side effects. Close monitoring, proactive management of nausea, and regular review of concomitant medicines are advisable. Comorbid conditions such as gastro-oesophageal reflux disease (very common in IPF) should be actively treated, as reflux can worsen nausea and may contribute to disease progression.

Sodium Content

Pirfenidone axunio contains less than 1 mmol (23 mg) sodium per tablet, which means it is essentially "sodium-free" and is unlikely to affect patients who require a low-sodium diet, such as those with hypertension, heart failure, or chronic kidney disease.

How Does Pirfenidone axunio Interact with Other Drugs?

Pirfenidone is primarily metabolised by the CYP1A2 enzyme in the liver. Drugs that inhibit CYP1A2 raise pirfenidone blood levels and the risk of side effects, while CYP1A2 inducers reduce its efficacy. Several common medicines, grapefruit juice, and cigarette smoking have clinically significant interactions.

Pirfenidone is metabolised mainly by the cytochrome P450 enzyme CYP1A2 (approximately 70–80%), with minor contributions from CYP2C9, CYP2C19, CYP2D6, and CYP2E1. Any medicine that significantly affects CYP1A2 activity can therefore alter pirfenidone blood levels, potentially leading to increased toxicity or reduced efficacy. Always inform your doctor and pharmacist about every medicine, supplement, or herbal product you are taking, including those bought without a prescription. Below are the most clinically relevant interactions.

Major Interactions (Avoid or Use with Extreme Caution)

Interactions That May Reduce Effectiveness

Food, Drink, and Lifestyle Interactions

Grapefruit and grapefruit juice: Avoid grapefruit, grapefruit juice, and related citrus (Seville oranges, pomelo) while taking Pirfenidone axunio. These contain furanocoumarins that inhibit hepatic and intestinal CYP enzymes, potentially raising pirfenidone concentrations and the risk of side effects. Choose other fruit juices or water.

Alcohol: While there is no absolute contraindication to moderate alcohol intake, alcohol shares a hepatic metabolism pathway and may compound hepatotoxicity risk. Alcohol also worsens dizziness and somnolence. Keep intake low or avoid completely during treatment, especially if liver enzymes are elevated.

Photosensitising drugs: Tetracycline antibiotics (doxycycline, minocycline), fluoroquinolones (ciprofloxacin, levofloxacin), thiazide diuretics, and certain NSAIDs can increase photosensitivity. Their combination with pirfenidone can cause severe phototoxic reactions. Inform every prescriber that you are taking pirfenidone.

What Is the Correct Dosage of Pirfenidone axunio?

Pirfenidone axunio 267 mg is gradually titrated over 14 days to minimise side effects. The target maintenance dose is three 267 mg tablets (801 mg) taken three times daily with food, totalling 2,403 mg per day. Treatment should be started and supervised by a specialist in interstitial lung disease.

Treatment with Pirfenidone axunio must be initiated and supervised by a specialist physician experienced in the diagnosis and management of idiopathic pulmonary fibrosis, typically a respiratory physician (pulmonologist) working within a multidisciplinary interstitial lung disease team. The dose is gradually increased over two weeks to allow your body to adjust to the medicine and to reduce the likelihood of gastrointestinal and other side effects. Because Pirfenidone axunio is only available in the 267 mg strength, each "dose step" is achieved by adding tablets rather than changing tablet size.

Adults – Standard Dose Titration

Swallow the tablets whole with a glass of water, during or immediately after a meal. Taking Pirfenidone axunio with food is important because it reduces peak plasma concentrations by approximately 50%, which correspondingly reduces the incidence of nausea and dizziness. Spacing doses evenly across the day (for example, at breakfast, lunch, and the evening meal) maintains therapeutic drug levels and improves tolerability.

Dose Reduction for Side Effects

If you experience bothersome side effects, your doctor may reduce the dose temporarily rather than discontinuing therapy altogether. Common reasons for dose adjustment include persistent nausea or vomiting, diarrhoea, photosensitivity reactions, and liver enzyme elevations. After the side effect has resolved, the dose can be gradually increased back to the maintenance level of 2,403 mg/day. If ALT/AST rise above 3×ULN, the dose is typically reduced or interrupted; above 5×ULN, permanent discontinuation is usually required.

Children and Adolescents

Pirfenidone axunio is not approved for use in children or adolescents under 18 years of age. IPF does not typically occur in the paediatric population, and safety and efficacy data in children are not available. Paediatric interstitial lung diseases require different specialist evaluation and management.

Elderly Patients

No routine dose adjustment is required in elderly patients based on age alone. However, elderly patients may be more susceptible to side effects, particularly gastrointestinal symptoms, dizziness, and weight loss. Comprehensive medication review at each visit is advisable, with particular attention to polypharmacy and kidney function. Close clinical monitoring and dose adjustments should be made based on tolerability and laboratory results.

Hepatic Impairment

Pirfenidone axunio should be used with caution in mild and moderate hepatic impairment (Child-Pugh A and B). Close monitoring of liver function is required, and dose reduction may be necessary. Pirfenidone is contraindicated in severe hepatic impairment (Child-Pugh C), as pirfenidone exposure is significantly increased and the risk of hepatotoxicity is unacceptable.

Renal Impairment

In mild renal impairment (creatinine clearance 60–89 mL/min), no dose adjustment is routinely required, but more frequent monitoring is advised. In moderate renal impairment (30–59 mL/min), pirfenidone should be used only after careful risk–benefit assessment. Pirfenidone is not recommended in severe renal impairment or dialysis.

Missed Dose

If you forget a dose, take it as soon as you remember with food. Do not take a double dose to make up for a missed one. There should be at least 3 hours between doses. Do not take more tablets each day than the total prescribed daily dose, even if doses have been missed. If multiple doses are missed, contact your prescriber for guidance, as treatment interruption of more than 14 days requires re-titration.

Overdose

If you (or someone in your care) have taken too many tablets, contact your doctor, pharmacist, or the nearest emergency department immediately, and bring the medicine packaging with you. Symptoms of overdose are generally an intensification of the known side effects, particularly gastrointestinal distress, dizziness, somnolence, fatigue, headache, and elevation of liver enzymes. Treatment is supportive and symptomatic; there is no specific antidote for pirfenidone. Gastric decontamination may be considered shortly after ingestion.

What Are the Side Effects of Pirfenidone axunio?

Like all medicines, Pirfenidone axunio can cause side effects, although not everyone gets them. The most common effects are gastrointestinal (nausea, diarrhoea, dyspepsia), fatigue, dizziness, and photosensitivity reactions. Serious but rare side effects include severe liver injury, anaphylaxis/angioedema, and Stevens-Johnson syndrome.

Side effects with pirfenidone tend to be most prominent during the initial dose titration period and often improve as your body adjusts to the medicine. Taking each dose with food significantly reduces the incidence and severity of gastrointestinal side effects. Proactive anti-emetic therapy, splitting doses more evenly across the day, and temporary dose reduction can usually keep treatment on track. If side effects are bothersome, persistent, or severe, contact your prescriber rather than stopping the medicine on your own.

If you experience any side effect, including those not listed here, talk to your doctor or pharmacist. Reporting side effects helps regulatory authorities continuously monitor the benefit–risk profile of medicines. In the European Economic Area, contact your national medicines agency (for example, BfArM in Germany, MPA in Sweden, or ANSM in France). In the United Kingdom, use the MHRA Yellow Card scheme. In the United States, side effects can be reported to the FDA MedWatch programme.

How Should You Store Pirfenidone axunio?

Store Pirfenidone axunio tablets at room temperature (below 30°C), in the original packaging, out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister.

Keep Pirfenidone axunio out of the sight and reach of children. Store the tablets at room temperature, below 30°C. The medicine does not require any special storage conditions such as refrigeration or protection from light, but keeping the blister in its outer carton helps prevent mechanical damage and accidental exposure.

Do not use Pirfenidone axunio after the expiry date (EXP) printed on the carton and blister. The expiry date refers to the last day of the stated month. Once a blister strip has been opened, use the tablets within any period stated in the patient information leaflet supplied with your pack.

Do not dispose of medicines via wastewater or household waste. Return unused or expired medicines to your pharmacy for safe disposal. These measures help protect the environment and prevent accidental exposure by other people or animals.

What Does Pirfenidone axunio Contain?

Each Pirfenidone axunio film-coated tablet contains 267 mg of the active substance pirfenidone, together with standard pharmaceutical excipients in the tablet core and a pale yellow film coating.

Each film-coated tablet contains 267 mg of pirfenidone as the active substance.

Tablet core (typical excipients): microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, and magnesium stearate. These excipients are used in many oral tablets and are generally well tolerated, although patients with specific excipient allergies should always check the current patient information leaflet supplied with their medicine.

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172). The coating gives the tablet its pale yellow colour and makes it easier to swallow. It also masks the slightly bitter taste of pirfenidone.

Appearance and pack sizes: Pirfenidone axunio 267 mg tablets are pale yellow, oval, biconvex film-coated tablets. They are typically supplied in blister packs. Pack sizes vary by market; common European pack sizes include 63, 84, 252, and 270 tablets, aligned with the 2-week titration and the 4-week maintenance dosing schedule. Not all pack sizes may be marketed in every country.

Marketing authorisation holder: axunio Pharma GmbH, Germany. The manufacturer and authorised distributor information is printed on the outer carton of each pack.