INTRODUCTION

PIRFENEX 400MG contains Pirfenidone which belongs to the group of medicines called Anti-fibrotics or Anti-inflammatory agents. It is used in the management of mild to moderate Idiopathic pulmonary fibrosis in adults. Idiopathic pulmonary fibrosis is a condition in which the tissues in the lungs (alveoli) become swollen and scarred over time and making it difficult to breathe. This makes it hard for the lungs to work properly.

PIRFENEX 400MG is not recommended for use in patients with severe or end-stage liver or kidney disease. Before taking PIRFENEX 400MG inform your doctor if you have mild to moderate liver disease, kidney problems or photosensitivity reactions. PIRFENEX 400MG is not recommended for use in pregnant women unless advised by your doctor. It is not known whether PIRFENEX 400MG passes into breast milk, hence consult your doctor before taking this medicine.

PIRFENEX 400MG is not recommended for use in children and adolescents below 18 years of age. PIRFENEX 400MG should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking this medicine. Avoid smoking while using PIRFENEX 400MG as it reduces the effect of this medicine. Also, avoid drinking grapefruit juice as it may lead to unwanted effects.

The most common side effects of taking PIRFENEX 400MG are nausea, stomach problems such as acid reflux, vomiting, constipation, diarrhoea, indigestion or stomach upset, weight loss, decreased appetite, tiredness, dizziness, headache. Consult your doctor if any of the above side effects worsen.

USES OF PIRFENEX 400MG

• Manages idiopathic pulmonary fibrosis

HOW PIRFENEX 400MG WORKS

PIRFENEX 400MG works by exhibiting anti-inflammatory, antioxidant and antifibrotic properties that suppress the factors (transforming growth factor -β (TGF-β)) causing scarring and swelling of the tissues. As a result, it manages and controls the fibrosis of the tissues resulting in improving lung function.

DIRECTIONS FOR USE

Take PIRFENEX 400MG as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF PIRFENEX 400MG

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Apply a pain-relieving balm on the forehead if necessary. Contact your doctor if the symptom does not improve.

Nausea and Vomiting:

Take the PIRFENEX 400MG, with or just after a meal. Stick to simple meals. Avoid eating oily, fried or spicy foods. Contact your doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own to manage diarrhoea. Contact your doctor if the symptom does not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Contact your doctor if the symptom does not improve.

Decreased appetite:

Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Contact your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before taking PIRFENEX 400MG, inform your doctor if you are taking any of the following medicines:

• fluvoxamine (used to manage depression and obsessive-compulsive disorder)
• chloramphenicol, enoxacin, ciprofloxacin, doxycycline (used to manage bacterial infections)
• amiodarone, propafenone, mexiletine, quinidine (used to manage heart rhythm disorders)
• omeprazole, esomeprazole (used to manage indigestion or acid reflux)
• rifampicin, rifampin (used to manage tuberculosis).
• methoxsalen (used to manage skin diseases like psoriasis and vitiligo)
• oral contraceptives such as ethinyl estradiol or norethindrone (used to prevent pregnancy)
• miconazole, fluconazole, voriconazole, terbinafine (used to manage fungal infections)
• moclobemide, fluoxetine, duloxetine, paroxetine (used to manage depression)
• bupropion (helps to stop smoking)
• cinacalcet (used to manage hyperparathyroidism)
• phenytoin, carbamazepine (used to manage fits)

B. Drug - Food interaction:

Avoid drinking grapefruit juice while taking PIRFENEX 400MG as it may lead to unwanted effects. Consult your doctor before taking PIRFENEX 400MG.

Overdosage:

If you or anyone else accidentally take too much of PIRFENEX 400MG, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep PIRFENEX 400MG out of reach of children
• Store at room temperature

FAQs ABOUT PIRFENEX 400MG

Can PIRFENEX 400MG be used for manageing lung disease?

Yes, PIRFENEX 400MG is used to manage mild to moderate idiopathic pulmonary fibrosis (condition in which the lungs become scarred and breathing becomes increasingly difficult) in adults above 18 years of age. Consult your doctor before taking PIRFENEX 400MG.

Does PIRFENEX 400MG cause liver damage?

Yes, PIRFENEX 400MG may cause liver damage. Stop taking PIRFENEX 400MG and contact your doctor if you experience any unusual symptoms like yellowish discolouration of skin and white of the eyes, dark urine, itching of the skin, pain on the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily and tiredness. Consult your doctor before taking PIRFENEX 400MG.

Does PIRFENEX 400MG cause dizziness?

Yes, PIRFENEX 400MG may cause dizziness. To manage this effect, try to rest and relax and get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom does not improve.

Is PIRFENEX 400MG a steroid medicine?

No, PIRFENEX 400MG is not a steroid medication. It is used to manage mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. It causes scarring and swelling of the lung tissue resulting in breathing difficulties. This medicine helps to reduce the symptoms of the disease and make you breathe better.

Is PIRFENEX 400MG safe to use during pregnancy?

PIRFENEX 400MG is not recommended for use if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown. Consult your doctor before taking PIRFENEX 400MG.

REFERENCES

1. Laurance Brunton. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. Chemotherapy of neoplastic diseases 12th Edition, 2011. Page - 1718.

2. Genentech, Inc. Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) (ASCEND). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2017] [Accessed on 18th June 2022] https://clinicaltrials.gov/ct2/show/NCT01366209

3. Paul W. Noble, Carlo Albera, Williamson Z. Bradford, Ulrich Costabel, Roland M. du Bois, Elizabeth A. Fagan, Robert S. Fishman, Ian Glaspole, Marilyn K. Glassberg, Lisa Lancaster, David J. Lederer, Jonathan A. Leff, Steven D. Nathan, Carlos A. Pereira, Jeffrey J. Swigris, Dominique Valeyre, and Talmadge E. King, Jr. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. NIH. National Library of Medicine, National center for biotechnology information. January 2016. [Accessed on 18th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697914/

4. Roche Products Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 18th June 2022] https://www.medicines.org.uk/emc/files/pil.2731.pdf

5. InterMune, Inc. U.S. Food & Drug Administration. [Revised in October 2014] [Accessed on 18th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf

6. Roche Pharma AG. European Medical Agency (EMA). [Revised in September 2015] [Accessed on 18th June 2022] https://www.ema.europa.eu/en/documents/product-information/esbriet-epar-product-information_en.pdf

7. Hoffmann-La Roche Limited. Pirfenidone. [Revised in August 2021] [Accessed on 18th June 2022] https://www.rochecanada.com/PMs/Esbriet/Esbriet_PM_E.pdf

USEFUL DIAGNOSTIC TESTS

• Liver function tests