Pirfenidone

Pirfenidone (brand name Esbriet) may be used to treat adults with idiopathic pulmonary fibrosis (IPF), a lung condition that causes inflammation and scarring in the lungs.

Pirfenidone’s mechanism of action involves slowing down the build-up of scar tissue in the lungs. The exact way it works for IPF is not known, but it does have anti-inflammatory, antioxidant, and anti-fibrotic properties. Pirfenidone is not a cure for IPF, but it does slow how quickly the condition progresses. Clinical studies have reported that pirfenidone may prolong overall survival in patients with IPF by 2.5 to 5 years (see Does Esbriet improve survival?).

Pirfenidone gained FDA approval on October 15, 2014, under the brand Esbriet. An Esbriet generic is available as pirfenidone.

Pirfenidone is available as a generic or as the brand Esbriet. With the Esbriet Copay Program, eligible patients with commercial insurance could pay as little as $5 per 30-day supply of Esbriet. See here for eligibility criteria.

For people with financial difficulty or who do not have insurance coverage, the Genentech Patient Foundation gives free Esbriet to eligible people (see here for criteria).

See Pirfenidone Prices, Coupons, Copay Cards & Patient Assistance for the cost of pirfenidone generic capsules and tablets.

Take pirfenidone exactly as your doctor tells you to take it. Your doctor may change your dose of pirfenidone as needed.

• Pirfenidone is usually taken three times a day.
• Take pirfenidone with food at the same times each day. This may help to decrease side effects such as nausea and dizziness.
• Pirfenidone is usually taken long-term (see How long can you take Esbriet for?).

Your doctor should do certain blood tests before you start taking pirfenidone.

Before you take pirfenidone, tell your doctor about all of your medical conditions, including if you:

• have liver problems
• have kidney problems
• are a smoker
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if pirfenidone will harm your unborn baby.

Breastfeeding

It is not known if pirfenidone passes into your breast milk. You and your doctor should decide if you will take pirfenidone or breastfeed.

The most common side effects of pirfenidone are:

• feeling tired
• difficulty sleeping
• upper respiratory tract infections, such as a cold
• sinus infections
• headache
• dizziness
• weight loss
• and lower or loss of appetite.

Serious side effects and warnings

Pirfenidone may cause the following serious side effects.

Liver problems. High liver enzymes and liver damage have occurred in people taking pirfenidone. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired.

Your doctor will do blood tests to check how your liver is working during your treatment with pirfenidone.

Pirfenidone may make your skin more sensitive to sunlight and cause a rash. See “What should I avoid while taking pirfenidone?”

Pirfenidone has caused severe skin reactions. Call your doctor right away if you have a severe skin reaction, such as skin blisters, rash, sores in the mouth, hives, or any other severe skin symptoms. Your doctor may stop your treatment with pirfenidone.

Stomach problems, such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain have also been reported with pirfenidone. Tell your doctor right away if your stomach problems get worse or do not go away.

Your doctor may need to change your dose of pirfenidone if you develop any of these reactions.

It is not known if pirfenidone is safe or effective in children.

These are not all the possible side effects of pirfenidone. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The recommended dosage of pirfenidone for adults for IPF is below. The maximum total daily dose of pirfenidone is 2403 mg/day.

Avoid sunlight. Pirfenidone can make your skin sensitive to the sun and the light from sunlamps and tanning beds.

• You could get a severe sunburn. Use sunscreen (SPF 50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn or a rash.
• Avoid taking pirfenidone with other medicines that can make your skin sensitive to the sun, the light from sunlamps, and tanning beds.

Avoid smoking. Smoking may affect how well pirfenidone works.

Take the missed dose as soon as you remember but if it is almost time for your next dose, miss that dose, and go back to your regular dosing schedule. Do not take 2 doses at the same time to make up for your missed dose.

If you miss 14 days or more of pirfenidone call your doctor right away for further instructions about how to take your medicine.

Do not take more than 3 doses of pirfenidone each day. If you take too much pirfenidone, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Moderate (such as ciprofloxacin) and strong inhibitors of CYP1A2 (such as fluvoxamine) increase blood levels of pirfenidone and may increase the risk of side effects.

• Discontinue fluvoxamine before administering pirfenidone or reduce the dosage to 267 mg three times a day.
• Your healthcare provider may consider a dosage reduction with the use of ciprofloxacin.

Store pirfenidone capsules and tablets at room temperature, 77°F (25°C). Keep in a tightly closed container.

Safely throw away any pirfenidone that is out of date or no longer needed. Keep pirfenidone and all medicines out of reach of children

Pirfenidone is available as Esbriet and as a pirfenidone generic.

Active ingredient: pirfenidone

Inactive ingredients (Esbriet capsules): microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate. Capsule Shell: gelatin and titanium dioxide. Capsule Brown Printing Ink: shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.

Inactive ingredients (Esbriet film-coated tablets): microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.

Inactive ingredients (Amneal Pharmaceuticals pirfenidone generic): croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate. Capsule Shell: gelatin and titanium dioxide. Capsule Black Printing Ink: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.

Available as pirfenidone 267 mg capsules, pirfenidone 267 mg tablets, and pirfenidone 801 mg tablets.

Genentech USA, Inc makes pirfenidone under the brand name Esbriet.

Amneal Pharmaceuticals NY LLC., Avkare, Cipla USA Inc., and several other manufacturers make generic pirfenidone.