Consumer medicine information

1. Why am I taking PIRFENIDET?

PIRFENIDET contains the active ingredient Pirfenidone. PIRFENIDET is used to treat Idiopathic Pulmonary Fibrosis (IPF).
For more information, see Section 1. Why am I taking PIRFENIDET? in the full CMI.

2. What should I know before I take PIRFENIDET?

Do not use if you have ever had an allergic reaction to PIRFENIDET or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take PIRFENIDET? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PIRFENIDET and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take PIRFENIDET?

• Upon initiating treatment, your doctor will explain the appropriate dose for the first 7 days, then the appropriate dose for days 8 to 14, and finally the appropriate dose for day 15 and onwards

5. What should I know while taking PIRFENIDET?

6. Are there any side effects?

Call your doctor immediately or go to the nearest emergency department if you develop (Jaundice) yellowing of the skin or the white part of the yes, dark or brown urine, pain in the upper right side of the stomach area, bleeding or bruising more easily than normal. Or if you have an allergic reaction with swelling of the face, lips, and/or tongue, difficulty in breathing or wheezing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Pirfenidone.

2 Qualitative and Quantitative Composition

Pirfenidet 267 mg film coated tablets contain 267 mg pirfenidone.
Pirfenidet 801 mg film coated tablets contain 801 mg pirfenidone.
List of excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pirfenidet 267 mg tablets are yellow, oval, biconvex, bevel-edged film-coated tablets debossed with "D1" on one side and plain on other side.
Pirfenidet 801 mg tablets are brown, oval, biconvex, bevel-edged film-coated tablets debossed with "D2" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

There is limited clinical experience with overdose. Multiple dosages of Pirfenidet up to a total dose of 4806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period. Adverse reactions were mild, transient and consistent with most frequently reported adverse reactions for pirfenidone.
In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Pirfenidone showed no indication of genotoxic activity in assays for bacterial mutagenicity, for chromosomal aberrations in vitro in mammalian cells, for clastogenicity in vivo in mice, and for DNA damage in rats. No significant mutagenic activity was observed with pirfenidone in bacteria when tested under UV exposure.
Carcinogenicity. An increased incidence of liver tumours (hepatocellular adenomas and carcinomas, and hepatoblastomas) was observed in 2-year carcinogenicity studies conducted by the oral route in rats and mice. This occurred at doses ≥ 750 mg/kg/day and ≥ 800 mg/kg/day in the respective species, associated with systemic exposure (plasma AUC) less than that of patients at the maximum recommended human dose. These hepatic findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving Pirfenidet. These findings are considered unlikely to be relevant to humans but this cannot be excluded.
A statistically significant increase in uterine tumours (adenocarcinoma) was observed in female rats administered 1500 mg/kg/day, yielding systemic exposure (plasma AUC) similar to that in patients at the maximum recommended human dose of 2403 mg/day. The relevance of this finding to humans is unclear.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPIRFEN.gif CAS number. 53179-13-8.
The chemical name of pirfenidone is 5-methyl-1-phenyl-2-1(H)-pyridone. It has a molecular formula of C₁₂H₁₁NO and a molecular weight of 185.23.
Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in methanol, ethyl alcohol, acetone and chloroform. Sparingly soluble in 1.0 N HCl, water and 0.1 N sodium hydroxide. The melting point is approximately 109°C.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PIRFENST.gif