What is Pirfenex?

Pirfenex® is an international brand name for Pirfenidone which is manufactured by one of the leading global pharmaceutical company in India, known as Cipla and it is also approved by UFFDA. Pirfenex (Pirfenidone) is an anti-fibrotic medicine indicated for the treatment of the lung disease known as IPF (Idiopathic Pulmonary Fibrosis). It is believed to fight with the fibrosis and inflammation that lead to the progression of IPF (Idiopathic Pulmonary Fibrosis). Pirfenex 200 mg tablets helps to reduce fibrosis (scarring) and swelling in the lungs. Pirfenex® is a generic version of Esbriet, hence the cost of Pirfenex® is comparatively less than Esbriet.

 

What is IPF (Idiopathic Pulmonary Fibrosis)?

IPF (Idiopathic Pulmonary Fibrosis) is a progressive disease in which the formation of scar tissue occurs in the lungs. This scar tissue gets thicker as the disease increases, which results in stiff lungs. As a result of this, lung function is reduced and it is more difficult for oxygen to get from the lungs to the blood and vital organs. Breathing difficulties could also occur. This medicine may affect TGF (transforming growth factor) and TNF (tumour necrosis factor) production, which can result in reduced inflammation and disruption of fibrosis. Though treatment will not cure the condition, but it is used to slow down the advancement of the disease.

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Dosage Details 

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Dosage and Management

The initial dose for adults is 200mg, three times in a day (66mg/day), after having a meal. Steadily increase the dose to 600mg, three times in a day (1,800mg/day). Moreover, approximately Increase or decrease the dosage from time to time relying upon the symptoms.

Tips for dosage adjustment

Start with 200mg pills given three times in a day (600mg/day). And after 2 weeks, steadily increase the dosage by 200mg at a time. it is desirable to apply or acquire a very last dose of 600mg at a time (1,800mg/day).

Patients who miss 14 successive days or more of pirfenidone treatment have to re-provoke therapy via undergoing the preliminary dose titration routine as much as the recommended day by day dose. For treatment interruption of less than 14 successive days, the dose may be resumed at the preceding endorsed daily dose without titration.

Recommendations in case of alt/ast elevations

If a patient reveals an aminotransferase elevation to >3 to ≤5 x ULN after starting pirfenidone therapy, confounding medicinal merchandise ought to be discontinued, different causes excluded, and the affected person monitored intently. If clinically appropriate the dose of pirfenidone must be decreased or interrupted. Once liver function tests are within normal limits pirfenidone may be re-escalated to the endorsed each day dose if tolerated.

If a patient reveals an aminotransferase elevation to ≤5 x ULN observed with the aid of signs\symptoms orhyperbilirubinaemia, pirfenidone must be discontinued and the affected person must not be re-challenged.

If a affected person reveals an aminotransferase elevation to >5 x ULN, pirfenidone have to be discontinued and the affected person have to no longer be re-challenged.

Hepatic impairment:

No dose adjustment is essential in patients with slight to moderate hepatic impairment (i.e. Child-Pugh Class A and B). However, seeing that plasma stages of pirfenidone can be multiplied in a few people with mild to moderate hepatic impairment, Caution must be used with pirfenidone treatment in this population. Patients have to be monitored carefully for signs and symptoms of toxicity especially if they are concomitantly taking a acknowledged CYP1A2 inhibitor. Pirfenidone has no longer been studied in patients with intense hepatic impairment or end level liver disease, and it have to no longer be utilized in patients with these situations. it is recommended to reveal liver function all through treatment, and dose modifications may be essential in the event of elevations.

Renal Impairment:

No dose adjustment is essential in patients with slight to moderate renal impairment. Pirfenidone therapy should not be utilized in patients with intense renal impairment (CRCL<30 ml/min) or final stage renal disease requiring dialysis.

Paediatric Population:

There may be no relevant utilisation of pirfenidone in the paediatric population inside the treatment of IPF.

Elderly:

No dose adjustment is vital in patients 65 years and older.

Dose modifications and different issues for safe use

Gastrointestinal occasions:

Patients who revealed intolerance to therapy due to gastrointestinal side effect, it is recommended to administer pirfenidone after a meals to prevent/lessen side effects. If signs persist pirfenidone can be reduced to 1-2 tablets given 2-3 times/day after food with re-escalation to the recommended daily dosage as tolerated. if signs continues, patients can be informed to break the treatment for 1 to 2 weeks to allow symptoms to resolve.

Photosensitivity reaction or rash:

Patients who experience a slight to moderate photosensitivity reaction or rash have to be reminded of the guidance to use a sunblock day by day and to avoid direct sunlight. The dosage of pirfenidone may be reduced to 3 tablets/day (1 tablet 3 times in a day). If the rash persists after 7 days, pirfenidone ought to be stopped for 15 days, with re-escalation to the endorsed to daily dose within the same way as the dose escalation period. Patients who experience intense photosensitivity reaction or rash ought to be advised to break the dose and to find medical advice. Once the rash has resolved, pirfenidone can be re-introduced and re-escalated up to the recommended daily dosage on the discretion of the doctor.

Hepatic function:

In the event of substantial elevation of alanine and /or aspartate aminotransferases (ALT/AST) without or with bilirubin elevation, the dose of pirfenidone ought to be adjusted or treatment discontinued in keeping with the pointers indexed underneath.

Warnings and Precautions

Warning:

Using pirfenidone has been proven to reason an odd chromosomal structure on exposure to light in genotoxicity tests; therefore, the drug has the capability to cause carcinogenesis of the skin on exposure to Light.

Drug Interactions:

Pirfenidone is mainly metabolised by means of CYP1A2. In vitro metabolism studies with hepatic microsomes indicate that approximately 48% of pirfenidone is metabolised via CYP1A2 with different CYP isoenzymes which include CYP2C9, 2C19, 2D6, and 2E1 each contributing less than 13%. Consumption of grapefruit juice is related with inhibition of CYP1A2 and must be averted during the treatment with pirfenidone. Strong CYP1A2 inhibitors have to, consequently, be used with caution in patients receiving pirfenidone because of the capability for decreased clearance.

Fluvoxamine and Inhibitors of CYP1A2: Pirfenidone is contraindicated in patients with concomitant use of fluvoxamine. Fluvoxamine have to be discontinued prior to the initiation of pirfenidone therapy and avoided during pirfenidone therapy because of the decreased clearance of pirfenidone. Different treatments which are inhibitors of each CYP1A2 and one or extra other CYP isoenzymes involved within the metabolism of pirfenidone (e.g. CYP2C9, 2C19, and 2D6) must be averted during the pirfenidone treatment.

Special care have to also be exercised if CYP1A2 inhibitors are being used concomitantly with mighty inhibitors of one or more other CYP isoenzymes concerned within the metabolism of pirfenidone which includes CYP2C9 (e.g. amiodarone, fluconazole), 2C19 (e.g. chloramphenicol) and 2D6 (e.g. fluoxetine, paroxetine).

Pirfenidone need to be used with caution in patients handled with other moderate or strong inhibitors of CYP1A2 (e.g. ciprofloxacin, amiodarone, propafenone).

Cigarette smoking and inducers of cyp1a2: Pirfenidone clearance is notably higher in cigarette people who smoke than non-people , possibly due to the higher CYP1A2 enzyme activity in smokers.

Smoking has the capability to result in hepatic enzyme production and hence increased medicinal product clearance and reduce exposure. Concomitant use of strong inducers of CYP1A2 together with smoking should be prevented at some stage in pirfenidone therapy primarily based on the observed relationship between cigarette smoking and its ability to set off CYP1A2. Patients have to be advocated to stop use of strong inducers of CYP1A2 and to prevent smoking earlier than and all through treatment with pirfenidone.

Within the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may also theoretically result in a decreasing of pirfenidone plasma levels.

Co-administration of medicinal products that act as powerful inducers of each CYP1A2 and the alternative CYP isoenzymes include inside the metabolism of pirfenidone (e.g. rifampicin) might also result in significant decreasing of pirfenidone plasma levels. This medicinal merchandise have to be prevented whenever feasible.

Photosensitivity reaction and rash:

Contact with direct sunlight (which include sunlamps) should be averted or minimised at some stage in treatment with Pirfenidone. It is far endorsed to wear lengthy-sleeved clothing while outdoor, put on a hat or use an umbrella, and apply powerful sunscreens (SPF50+, PA+++) in an effort to keep away from the UV rays and to keep away from different medicinal products recognized to cause photosensitivity.

Patients ought to be informed to file symptoms of photosensitivity reaction or rash or itching to their doctor. Intense photosensitivity reactions are uncommon. Dose modifications or temporary treatment discontinuation can be important in slight to intense cases of photosensitivity reaction or rash.

Using pirfenidone has been proven to cause an abnormal chromosomal structure on contact to light in genotoxicity tests; consequently, it’s far vital to give an explanation to the patient about the capability of the drug to cause carcinogenesis of the pores and skin on contact to light.

Angioedema:

Reviews of angioedema (some severe) together with swelling of the face, lips and/or tongue which may be related to trouble in breathing or wheezing were received in association with use of pirfenidone within the post-advertising placing. Therefore, patients who develop signs and symptoms of angioedema following administration of pirfenidone must immediately discontinue treatment. Patients with angioedema should be managed in accordance to conventional of care. Pirfenidone must not be used in patients with a records of angioedema because of pirfenidone.

Dizziness:

Dizziness has been observed in patients taking pirfenidone. Therefore, patients have to recognise how they react to this medicinal product earlier than they engage in activities requiring mental alertness or coordination. In scientific studies, most patients who skilled dizziness had a single event and most events resolved, with an average duration of 22 days. If dizziness does now not improve or if it worsens in severity, dose adjustment or maybe discontinuation of pirfenidone may be warranted.

Fatigue:

Fatigue has been observed in patients taking pirfenidone. Consequently, patients have to realize how they react to this medicinal product before they interact in activities requiring mental alertness or coordination.

Weight loss:

Weight loss has been observed in patients treated with pirfenidone. Physicians ought to monitor patients weight, and when suitable inspire improved caloric intake if weight loss is taken into consideration to be of scientific importance.

Effects on potential to drive and use machines:

Drowsiness, dizziness and fatigue may additionally arise because of pirfenidone, which may also reason the patients to stagger. No studies on the outcomes of the capacity to drive and use machines had been accomplished. Patients on pirfenidone should, therefore, be recommended not to operate or drive any machinery or motor vehicles.

Renal impairment:

There is confined experience with pirfenidone in patients with renal impairment.

Hepatic Impairment:

In subjects with slight hepatic impairment (i.e. Child-Pugh Class B), pirfenidone exposure was increased with 60%. Pirfenidone must be used with caution in patients with pre-current mild to moderate hepatic impairment (i.e. Child-Pugh Class A & B) given the potential for multiplied pirfenidone exposure. Patients should be monitored intently for signs of toxicity specifically if they’re concomitantly taking a known CYP1A2 inhibitor. Pirfenidone has now not been studied in people with excessive hepatic impairment and pirfenidone should not be used in patient with excessive hepatic impairment.

Hepatic Function: Pirfenidone can also cause liver disfunction followed by a rise in the aspartate transaminase (AST) and alanine transaminase (ALT) stages, suggestive of jaundice. it’s therefore, advocated that the liver enzymes be periodically monitored. Liver function tests (ALT, AST and bilirubin) should be conducted prior to the initiation of treatment with pirfenidone, and eventually at month-to-month durations for the first 6 months after which each 3 months thereafter. Patients must be told to report symptoms of liver disease (e.g. dark urine and/or jaundice) to their physician. For patients with showed elevations in ALT, AST or bilirubin all through therapy, dose changes or therapy discontinuation can be important.

Pregnancy:

It is recommended not to prescribe pirfenidone to pregnant women or to women who are likely to be pregnant. There aren’t any data from the usage of pirfenidone in pregnant women. No unfavourable effects on fertility had been observed in preclinical studies.

Lactation:

Nursing mothers receiving therapy with pirfenidone ought to be recommended to avoid breastfeeding. It is unknown whether pirfenidone or its metabolites are excreted in human milk. A decision should be made whether to stop breast-feeding or to discontinue from pirfenidone therapy, contemplating the gain of breast-feeding for the child and the gain of pirfenidone therapy for the mother.

Paediatric use:

Protection of pirfenidone in infants with low birth weight, new-born babies, nursing infants, infants or kids has not been established.

Fertility:

No unfavourable effects on fertility have been observed in preclinical studies.

Geriatric use:

Aged patients typically have declined physiological function; consequently, pirfenidone have to be administered with

Contraindications

  • Allergy to the lively substance or to any of the excipients,
  • History of angioedema with pirfenidone
  • Concomitant use of fluvoxamine
  • Intense hepatic impairment or final stage liver disease
  • Intense renal impairment (CRCL <30 ml/min) or final stage renal disease requiring dialysis

Over dosage

Insufficient information available. Multiple doses of pirfenidone as much as a dose of 4806 mg/day were administered as six 267 mg pills 3 times day by day to healthy person over a 12-day dose escalation period. Adverse reactions were mild, temporary, and steady with the maximum frequently reported adverse reactions for pirfenidone. In the event of a suspected overdose, supportive medical care must be provided such as monitoring of important signs and symptoms and close observation of the medical status of the patient

Undesirable Effects

The most commonly intense effects of pirfenidone are photosensitivity, loss of appetite (anorexia), stomach discomfort and nausea, and multiplied gamma glutamyl transpeptidase levels and AST (SGOT) and ALT (SGPT) levels.

The maximum mentioned (≥10%) adverse reactions stated in clinical studies with pirfenidone at a dose of 2403 mg/day as compared to placebo, respectively, were nausea (32.8% as opposed to 13.3%), rash (28.7% as oppose to 8.6%), fatigue (22.3% as opposed to 13.3%), diarrhoea (21.7% as opposed to 13.5%), dyspepsia (16.8% as oppose to 5.5%), and photosensitivity reaction (12.2% as opposed to 1.7%).

Extreme intense reactions have been recorded at same frequencies among patient operated with 2403 mg/day of pirfenidone and placebo in medical research.

The table below shows the intense reactions pronounced at a frequency of ≥2% in 345 patients receiving pirfenidone at the endorsed dose of 2403 mg/day in two pivotal Phase 3 studies. Intense reactions are listed through System Organ Class and within every frequency grouping the adverse reactions are presented in order of decreasing seriousness.

FAQ's

What is Pirfenidone?

Pirfenidone is an anti-fibrotic drug which is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It works by decreasing the lung fibrosis through down regulation of the production of increase elements and procollagens I and II.

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Brand Name
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Pirfenex 200 Mg
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