Pirfenidone
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Pyridone
Controlled Drug Substance
No
Summary
Indications and Purpose
How does Pirfenidone work?
Pirfenidone works by inhibiting the production of certain substances in the body that contribute to fibrosis, or scarring, of the lungs. This action helps slow the progression of idiopathic pulmonary fibrosis (IPF) and maintain lung function over time.
Is Pirfenidone effective?
Pirfenidone has been shown to be effective in treating idiopathic pulmonary fibrosis (IPF) through several clinical trials. These studies demonstrated that Pirfenidone can slow the decline in lung function, as measured by forced vital capacity (FVC), and reduce the risk of disease progression compared to placebo.
What is Pirfenidone?
Pirfenidone is used to treat idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lungs. It works by blocking the action of certain substances in the body that lead to fibrosis. This helps slow the progression of lung damage and maintain lung function.
Directions for Use
For how long do I take Pirfenidone?
Pirfenidone is typically used as a long-term treatment for idiopathic pulmonary fibrosis (IPF). The duration of use depends on the patient's response and tolerance to the medication, as well as the progression of the disease. Regular monitoring by a healthcare provider is essential to determine the appropriate length of treatment.
How do I dispose of Pirfenidone?
If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.
How do I take Pirfenidone?
Pirfenidone should be taken with food three times a day to help reduce side effects like nausea and dizziness. Patients should avoid unnecessary sun exposure and use sunscreen, as the medication can increase sensitivity to sunlight. There are no specific food restrictions, but patients should follow their doctor's dietary advice.
How long does it take for Pirfenidone to start working?
Pirfenidone starts working within a few weeks, but it may take several months to see its full effect in slowing lung scarring. The time to peak plasma concentration is about 30 minutes to 4 hours after taking it. Individual factors like age, liver function, and other medications can affect how quickly it works. Always follow your healthcare provider's instructions for the best results.
How should I store Pirfenidone?
Store Pirfenidone at room temperature, between 20º to 25ºC (68º to 77ºF). Keep it in a tightly closed container, away from excess heat and moisture. Do not store it in the bathroom. Ensure it is out of reach of children and safely dispose of any expired or unneeded medication.
What is the usual dose of Pirfenidone?
The usual daily dose for adults is 801 mg taken three times a day, totaling 2,403 mg per day. Pirfenidone is not recommended for use in children, as its safety and effectiveness have not been established for this age group.
Warnings and Precautions
Can I take Pirfenidone with other prescription drugs?
Pirfenidone interacts with strong CYP1A2 inhibitors like fluvoxamine, which can increase Pirfenidone levels in the body. Moderate CYP1A2 inhibitors like ciprofloxacin also affect its metabolism. Patients should inform their doctor about all medications they are taking to avoid potential interactions and adjust dosages accordingly.
Can Pirfenidone be taken safely while breastfeeding?
There is no information on the presence of Pirfenidone in human milk or its effects on the breastfed infant. Due to the lack of data, breastfeeding mothers should weigh the benefits of breastfeeding against the potential risks of Pirfenidone exposure to the infant and consult their healthcare provider.
Can Pirfenidone be taken safely while pregnant?
There is insufficient data on the use of Pirfenidone during pregnancy to determine its safety. Animal studies have not shown teratogenic effects, but the potential risk to humans is unknown. Pregnant women should only use Pirfenidone if the potential benefits justify the potential risks to the fetus.
Does Pirfenidone have adverse effects?
Adverse effects are unwanted or harmful effects caused by a medicine. Pirfenidone can cause nausea, rash, fatigue, diarrhea, and headache. These are common but usually mild. Rarely, it can cause serious liver problems, which need immediate medical attention. If you notice yellowing of the skin or eyes, dark urine, or severe fatigue, contact your doctor right away. Always report new symptoms to your healthcare provider and never stop taking a medicine without consulting them.
Does Pirfenidone have any safety warnings?
Pirfenidone has safety warnings related to liver function. It can cause liver damage, so regular blood tests are needed to monitor liver health. Symptoms like yellowing of the skin or eyes, dark urine, or severe fatigue should be reported immediately. Another warning is for skin reactions; avoid sun exposure and use sunscreen to prevent rashes. Always follow your doctor's advice and report any unusual symptoms.
Is it safe to drink alcohol while taking Pirfenidone?
Most people tolerate Pirfenidone well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Pirfenidone and alcohol that would interfere with the medicine's action or cause harm. However, it's always wise to consume alcohol in moderation and consult your healthcare provider if you have any concerns.
Is it safe to exercise while taking Pirfenidone?
Pirfenidone itself does not directly limit the ability to exercise. However, idiopathic pulmonary fibrosis, the condition it treats, can affect lung function and exercise capacity. If you experience any new or worsening symptoms while exercising, consult your doctor for advice.
Is it safe to stop Pirfenidone?
Pirfenidone is used for managing chronic conditions like idiopathic pulmonary fibrosis, which requires long-term treatment. Stopping it suddenly can lead to worsening of the condition. There are no known withdrawal symptoms, but the disease may progress if the medication is stopped. It's crucial to consult with a doctor before making any changes to your medication regimen to avoid complications.
Is Pirfenidone addictive?
Pirfenidone is not known to be addictive. It does not have habit-forming potential, and there are no known physical or psychological dependence issues associated with its use. Therefore, there are no specific behaviors or warning signs to watch for regarding addiction. It's important to use the medication as prescribed by your healthcare provider.
Is Pirfenidone safe for the elderly?
No specific dosage adjustment is required for elderly patients taking Pirfenidone. However, as with any medication, elderly patients should be monitored closely for side effects and overall response to the treatment. Regular follow-ups with a healthcare provider are recommended to ensure safe use.
What are the most common side effects of Pirfenidone?
A side effect is an unwanted effect of a medicine. Common side effects of Pirfenidone include nausea, rash, fatigue, diarrhea, and headache. These occur in more than 10% of users. It's normal to experience new symptoms when starting a medicine, and they may not be related to the drug. Always talk to your healthcare provider before stopping any medication.
Who should avoid taking Pirfenidone?
Important warnings for Pirfenidone include the risk of liver enzyme elevations, photosensitivity reactions, and severe skin reactions. Patients should avoid sun exposure and use sunscreen. Contraindications include severe liver impairment and a history of angioedema with Pirfenidone. Regular monitoring and consultation with a healthcare provider are essential.
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