1 What is Esbriet?

Brand: Esbriet

Generic: Pirfenidone

Esbriet is an anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis. It works by reducing lung fibrosis through down regulation of the production of growth factors and procollagens I and II. This drug requires a prescription.

2 What to Know Before Using

Before using Esbriet, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of pirfenidone have not been performed while safety and efficacy have not been established. Studies in the elderly have not reported any geriatric-specific problems that would limit the utility of pirfenidone.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Abiraterone, Ciprofloxacin, Enoxacin, Ethinyl, Estradiol, Fluvoxamine, Methoxsalen, Mexiletine, Peginterferon Alfa-2b, Phenylpropanolamine, Thiabendazole, or Zileuton.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as bowel problems, kidney or liver diseases.

3 Proper Usage

Esbriet must be used exactly as directed by your healthcare professional. To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional. It is recommended to take this drug with food and at the same time each day. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with idiopathic pulmonary fibrosis are given 1 capsule three times a day for the 1st week. 2 capsules three times a day are given on the 2nd week. 3 capsules three times a day are given after on the 3rd week and onwards. Each capsule contains 267 milligrams of pirfenidone.

The dose must not exceed 2,403 mg or 9 capsules per day. Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

In using Esbriet, you must be careful and take some precautions as advised by your doctor.

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests. Check with your healthcare professional immediately if you have symptoms of liver problems such as pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

It is recommended to use sunscreen or sunblock lotions with a sun protection factor (SPF) 50 or higher on a regular basis when you are outdoors as this drug may make your skin more sensitive to sunlight. Wear protective clothing and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.

Consult with your healthcare professional immediately if you experience diarrhea, nausea, vomiting, heartburn, stomach pain or upset while using this drug. It is recommended to avoid smoking while taking this drug. Consult with your healthcare professional before taking any other prescription or non-prescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Esbriet.

Side effects may vary for each individual and prompt medical attention should be given if they occur. Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as diarrhea, itching or skin rash, nausea, redness or other discoloration of the skin, severe sunburn, stomach discomfort, upset, or pain, vomiting, cough or hoarseness, fever with or without chills, general feeling of tiredness or weakness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, lower back or side pain, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, unusual bleeding or bruising.

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials